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Building on A(H1N1) Vaccine Safety-monitoring Lessons

July 27

CDRAP News reported that over the next few months, United States healthcare providers will transition from the current pandemic A(H1N1) vaccine monitoring effort to a more routine system for seasonal influenza, which includes distributing a seasonal influenza vaccine that contains a new combination of influenza viruses. The CDC's routine seasonal influenza surveillance does not include counting individual flu cases, except in the case of pediatric influenza deaths, but instead monitors activity levels and virus characteristics through a nationwide surveillance system.

The Department of Health and Human Service's National Vaccine Advisory Committee (NVAC) discussed the transition on July 27 during a public teleconference. Gus Birkhead, chairman of NVAC Vaccine Working Group and deputy commissioner of the New York Department of Health, said that a main lesson learned during pandemic vaccine safety monitoring was the usefulness of coordination among federal agencies on vaccine safety monitoring issues.

Marie McCormick, a member of NVAC's A(H1N1) influenza and seasonal influenza vaccine safety working groups, said that A(H1N1) vaccine safety monitors have collected important information from A(H1N1) influenza patient medical records that was used to detect possible safety signals (i.e., new, unexpected, or rare adverse events). McCormick said that monitors may offer insight on more efficient data collection that will prove useful for upcoming flu seasons. McCormick noted that it is important to ensure that future influenza vaccine safety monitoring systems observe diverse subgroups, such as ethnic minorities and patients with certain medical conditions.

The full report can be accessed at: http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/jul2710monitor.html

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Assessing Health Care Workers' Willingness to Work During Pandemic

July 27

A U.S. research team studied hospital workers' willingness to report to duty during an influenza pandemic through a threat- and efficacy-based assessment and published its findings in the July 27 issue of BMC Public Health. The research team used Witte's Extended Parallel Process Model (EPPM) - a behavior model based on decades of fear appeal research - to study health care employees' perceptions of threat and efficacy in responding to an influenza pandemic, and how this affected their willingness to work in such a situation.

The team administered the online EPPM-based survey to The Johns Hopkins Hospital's 18,612 employees in Baltimore, Maryland during January - March 2009. 3,426 employees (18.4%) completed the anonymous survey, of who approximately one-third were health professionals. Survey results showed that more than 28% of hospital workers were unwilling to respond to an influenza pandemic scenario if asked but not required to do so. 32% reported they would be unwilling to respond in the event of a more severe pandemic influenza scenario.

Based on survey results there are several attitudinal indicators that help identify hospital employees unwillingness to respond, such as: hospital-based communication and training strategies that boost employees' response willingness; promotion of pre-event plans for home-based dependents; ensuring adequate supplies of personal protective equipment, vaccines and antiviral drugs for all hospital employees; and establishing norms of awareness and preparedness.

The full report can be accessed at: http://www.biomedcentral.com/content/pdf/1471-2458-10-436.pdf

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CDC Endorses New Recommendations for Universal Influenza Immunization

July 29

The CDC's endorsement of the Advisory Committee on Immunization Practices (ACIP) recommendations for 2010 is published in the July 29 issue of Morbidity and Mortality Weekly Report (MMWR). The updated ACIP recommendations include vaccination of all healthy, non-pregnant adults aged 18 to 49 (the only group that was not previously recommended for routine vaccination). Recommendations also include advice on pandemic A(H1N1) influenza vaccination coverage for younger children. Children between the ages of six months and eight years who have not received at least one dose of pandemic A(H1N1) vaccine should receive two doses of the trivalent seasonal vaccine for the upcoming influenza season, which includes the pandemic strain.

The MMWR can be accessed at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr59e0729a1.htm

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FDA Approves Season's influenza Vaccines

July 30

The FDA announced on July 30 that it has given its approval to six U.S. companies to manufacture the upcoming season's influenza vaccine. This season's vaccine includes three strains: A/California/7/09 (H1N1)-like virus (pandemic H1N1); A/Perth /16/2009 (H3N2)-like virus; and B/Brisbane/60/2008-like virus. Flu vaccine makers told health officials that they expect to manufacture a record 170 million vaccine doses for the upcoming flu season.

The companies supplying inactivated vaccines this year, and their vaccines, are: CSL Limited, Afluria; GlaxoSmithKline (GSK) Biologicals, Fluarix; ID Biomedical Corp. (a Canadian subsidiary of GSK), FluLaval; Novartis Vaccines, Agriflu and Fluvirin; and Sanofi Pasteur, Fluzone and Fluzone High-Dose. MedImmune Vaccines produces the live nasal vaccine, FluMist. Vaccine manufacturers must obtain an FDA release for each lot of the vaccine they produce before they can ship the product to distributors. So far, the FDA has issued lot releases to four companies, which therefore are permitted to start shipping their first vaccine lots.

The FDA press release can be accessed at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220718.htm

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Oseltamivir for Treatment and Prevention of A(H1N1) Virus Infection

July 20

An international research team, funded by the NIH, studied the effects of an antiviral drug, oseltamivir, on treating and preventing pandemic influenza A(H1N1) virus in 362 households in Milwaukee, WI, and published its results in the journal BMC Infectious Diseases on July 20.

The team reported three main conclusions: 1) using oseltamivir at symptom onset reduced the odds of one or more secondary infection in households by 42 percent; 2) household size greater than 3 showed an increased risk of at least one secondary case in the household; and 3) younger household members had the highest risk for contracting infection. The team concluded that there is a need for larger randomized trials to confirm its findings.
The full article can be accessed at: http://www.biomedcentral.com/content/pdf/1471-2334-10-211.pdf

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FDA Clears Molecular Diagnostic Test for Influenza A Virus

July 26

On July 26, the U.S. Food and Drug Administration (FDA) cleared for general use Gen-Probe Incorporated's molecular diagnostic test, which simultaneously detects and differentiates three common influenza A virus subtypes – seasonal influenza virus, A(H3N2) virus, and A(H1N1/2009) virus. Carl Hull, Gen-Probe's president and CEO observed that "FDA clearance of our ProFAST+ assay [diagnostic test] is important for public health, as the test enables physicians to accurately differentiate among influenza A subtypes that have different antiviral susceptibilities." For example, while the antiviral drug oseltamivir is ineffective against seasonal influenza, it does reduce the ill effects of A(H1N1/2009) influenza and A(H3N2) influenza.

The ProFAST+ assay is an in vitro diagnostic test that detects influenza A virus in nasal swabs within approximately four hours. Gen-Probe asserts that ProFAST+ uses the same internal control and format as other FDA-cleared tests for respiratory infectious diseases, and is therefore easily integrated into current laboratory practices and regulations.
The full press release can be accessed at: http://www.prnewswire.com/news-releases/fda-clears-prodesses-profast-assay-to-identify-three-strains-of-influenza-a-including-2009-h1n1-99258209.html

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Infectious Disease Society of America (IDSA) Urges Mandatory Flu Shot for Health Workers

15 July

IDSA President Richard Whitely sent a letter formally requesting that the CDC make influenza vaccinations mandatory for health care workers (HCWs) and not just stress the importance of flu shots. Whitely wrote that "IDSA supports universal immunization of HCWs against seasonal influenza by health care institutions (impatient and outpatient) through mandatory vaccination programs, as these programs are likely to be the most effective means to protect patients against the transmission of seasonal influenza by HCWs." IDSA recommended that if employees decline vaccination due to religious or medical reasons, companies re-assign or require them to wear masks. If there was to be a vaccine supply shortage, employees should be obliged to wear masks.

Whitely cited evidence that organizations requiring A(H1N1) vaccination have higher HCW immunization rates than organizations with voluntary programs. He noted that many healthcare systems and hospitals, as well as professional societies, including the American College of Physicians, the Association for Professionals in Infection Control and Epidemiology, and the Society for Healthcare Epidemiology of America support mandatory vaccine policies.

The IDSA letter can be accessed at: http://www.idsociety.org/

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National Institutes of Health (NIH) Scientists Advance Universal Flu Vaccine

15 July

Scientists at the NIH's National Institute of Allergy and Infectious Diseases (NIAID) have developed a universal influenza vaccine that "potentially provides protection from all influenza strains for decades" which could control the spread of influenza, said Dr. Gary J. Nabel research team's lead scientist. Tests of the vaccine on mice, ferrets and monkeys have revealed that animals that received the 'prime-boost', which includes 'priming' test animals with a vaccine made from DNA encoding the influenza virus hemagglutinin (HA) surface protein, and then giving them a 2006-2007 seasonal influenza vaccine, had higher immune levels than subjects that received only the DNA vaccine. For example, out of 20 mice that received the boost, 80% survived. Nabel said, "We are excited by these results... The prime-boost approach opens a new door to vaccinations for influenza that would be similar to vaccination against such diseases as hepatitis, where we vaccinate early in life and then boost immunity through occasional, additional inoculations in adulthood." He estimates that in three to five years it may be possible to begin large-scale efficacy trials of the universal influenza vaccine.

The NIH report can be accessed at: http://www.nih.gov/news/health/jul2010/niaid-15.htm

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Song Birds Carry Low-Risk A(H5N1) Influenza

23 June

In the 23 June issue of BMC Infectious Diseases, a U.S. research team, funded by the National Science Foundation and National Institutes of Health, reported the results of a study mapping the risk of avian influenza occurring in wild birds in the United States. According to researchers, by analyzing the geographic distribution of avian influenza virus (AIV) they are able to identify areas where reassortment events might occur and how high pathogenicity influenza virus might travel if it enters wild bird populations in the United States. The team's findings showed that songbirds, such as sparrows and thrushes, carry various forms of the A(H5N1) virus that could potentially spread to pigs and poultry. In particular, these birds carry a low-pathogenic influenza virus (a less dangerous type), but these viruses are able to swap genes and mutate into the more dangerous high-pathogenic forms. Researchers concluded that land birds constitute an important natural reservoir of influenza virus in the contiguous United States.

Researchers fear that the passerine species of songbirds may be more effective at transmitting influenza virus to humans because these birds are common in urban areas. Passerines may therefore, be more effective at transmitting influenza to people than aquatic birds, which are typically referred to as the most important avian vector of influenza virus. In addition, in the event that a bird is co-infected with distinct influenza viruses and a highly pathogenic subtype evolve through mutation, or reassortment, the threat increases. Scientists also worry that birds would infect pigs, which are known "mixing vessels" in which genes from different influenza virus strains may combine to create new viral strains that could readily be transmitted to people and cause illness.

The Great Plains and the Pacific Northwest are the highest risk geographical regions for influenza virus being carried in wild birds. Consequently, reassortment events that produce pandemic influenza subtypes are most likely to take place in these regions.

The full article can be accessed at: http://www.biomedcentral.com/1471-2334/10/187/abstract

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Predicting the Next Pandemic

June 2010

John M. Barry's article, "The Next Pandemic," published in the summer 2010 issue of the World Policy Journal describes how A(H1N1/2009) influenza affected the world and identifies important lessons learned from this pandemic. In comparing the A(H1N1/2009) influenza outbreak to past pandemics in 1918, 1957 and 1968 (which sickened 25 percent of the population or more in every country), the 2009 pandemic had the lowest case mortality rate of any of the known influenza outbreaks. Nevertheless, Barry found that it "threw the world off balance... and revealed flaws in both health systems and international relations."

Barry writes that based on analysis of epidemiologic, virologic, and public health data, health organizations will likely adopt some management changes, local hospitals will upgrade their practices, and vaccine delivery systems will improve. He states that, "These are good starting points, but on larger policy and scientific questions any efforts to draw conclusions could mislead."

Barry notes that WHO has come under harsh scrutiny for "exaggerating" the severity of the pandemic. However, the real overreaction came from nations that implemented extreme measures when faced with the outbreak, such as the 25 countries that limited trade with or travel to Mexico (the country of origin of A(H1N1/2009) influenza) and countries that horded influenza vaccine for the sole use of domestic populations.

In preparing for the next influenza pandemic, which Barry said, "will come again," improved response mechanisms are crucial, and a failure to improve pandemic preparedness, "will threaten chaos and magnify the terror, the economic impact and the death toll."

The full article can be accessed at: http://www.mitpressjournals.org/doi/pdf/10.1162/wopj.2010.27.2.10

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Dynavax Announces First Human Trial in Universal Influenza Vaccine Program

7 July

On 7 July, Dynavax Technologies Corporation announced the first human clinical trial of its Universal Flu vaccine program. Dynavax started a phase 1 trial in late June whose objective is to assess the safety of N8295, the novel component of its Universal Flu vaccine candidate. To conduct the trial, approximately 40 people are divided into three dose groups and each test subject in two groups was injected with two N8295 preparations, one month apart. The third control group was injected with placebos. The company expects to report phase 1 trial results by the end of 2010.

According to Dynavax, its Universal Flu vaccine is designed to protect against different influenza strains, as well as be more efficient than standard influenza vaccines. Preclinical data have already confirmed the ability of the vaccine to provoke an immune response.

The press release can be accessed at: http://www2.marketwire.com/mw/emailprcntct?id=2F064B15F5A76B00

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Analysts Say WHO Miscommunication Spurred 'False Pandemic' Accusations

29 June

Peter Sandman and Jody Lanard, two private risk-communication consultants, published an article on 29 June, claiming that the World Health Organization's (WHO) errors in communication caused undeserved criticism of the organization's response to the A(H1N1) influenza pandemic threat. The article references accusations made by two reports released on 3 June 2010, which charged the WHO with exaggerating the pandemic in order to benefit pharmaceutical companies. Sandman and Lanard concluded that charges made against the WHO were "absurd", but identified three main communication errors in the WHO's reporting on the pandemic:

The absurd charge that the World Heath Organization (WHO) hyped a fake pandemic in order to enrich Big Pharma has gained undeserved mainstream credibility mostly because WHO has badly mishandled its risk communication about three issues: (a) the mildness of the pandemic (so far); (b) the debatable meaning of the term "influenza pandemic"; and (c) the inevitable-but not clubbable-structural conflicts of interest of WHO advisors.

The full article can be accessed at: http://www.psandman.com/col/swine-old.htm#Jun29

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The Food and Drug Administration (FDA) Inspection Uncovers Issues of Noncompliance

28 June

The FDA identified a number of manufacturing problems when investigating the Commonwealth Serum Laboratories (CSL) Biotherapies facility in Australia, which produces the seasonal influenza vaccine Afluria, and Influenza A(H1N1) Monovalent Vaccine for the U.S. market. FDA sent a letter to Australia's CSL, stating that it found, "deviations from current good manufacturing practice (CGMP) requirements in the manufacture of licensed biological vaccine products and Monovalent influenza bulks," at its Parkville, Victoria facility.

The letter described problems in CSL's compliance with CGMP. First, CSL conducted an "inadequate" investigation into "the formation of dark particles" in vials of Afluria. The company's investigation failed to document the traceability of corrective and preventive actions, and also failed to examine the possibility that the particles were caused by an interaction between the vaccine and the vial or stopper.

Second, CSL continued to use a certain type of rubber stopper on multi-dose vials containing the preservative thimerosal, which the manufacturer had advised against because the two may react. Additionally, the company did not study possible interactions between the vaccine and the stoppers and vials used in 29 lots of Afluria and H1N1 vaccine that were marketed in the United States. Third, CSL failed to ensure that deterioration testing was performed at least once a year on representative samples from vaccine lots.

CSL responded to the FDA on 14 May, requesting more information on the FDA investigation findings. CSL gave assurance that it intends to address all issues of noncompliance and requested a formal meeting with the FDA to discuss the matter.

The FDA Untitled Letter can be accessed at: http://www.fda.gov/BIOLOGICSBLOODVACCINES/GUIDANCECOMPLIANCEREGULATORYINFORMATION/ COMPLIANCEACTIVITIES/ENFORCEMENT/UNTITLEDLETTERS/ucm217293.HTM

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Computer-Aided Influenza Virus Vaccine Created

16 June

Nature Biotechnology reports that a team of molecular biologists and computer scientists at State University of New York at Stony Brook have designed a new and effective influenza vaccine by using a process called synthetic attenuated virus engineering (SAVE), which utilizes computer-aided rational design. The team developed a method to weaken (attenuate) influenza virus by designing hundreds of mutations to its genetic code. SAVE is similar to the method used previously to create artificial polio virus. Researchers tested the new influenza vaccine on mice and found that very small amounts of it safely and effectively immunized them against an otherwise lethal virus strain. SAVE may prove to be a major new step in developing more effective and safe influenza vaccines against seasonal influenza epidemics and pandemic threats such as A(H5N1) influenza or A(H1N1/2009) influenza. In describing their work, Steffen Mueller, senior author and research assistant professor of molecular genetics and microbiology, stated:

Essentially, we have rewritten the virus' genetic instructions manual in a strange dialect of genetic code that is difficult for the host cell machinery to understand...This poor line of communication leads to inefficient translation of viral protein and, ultimately, to a very weak virus that proves to be ideal for immunization.

Theoretically, SAVE can be applied to design vaccines against any influenza virus that may emerge in the future.

The full article can be accessed at: http://www.nature.com/nbt/journal/vaop/ncurrent/full/nbt.1636.html

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The U.S. Centers for Disease Control and Prevention (CDC) Proposes New Influenza Guidance for Healthcare Settings

22 June

The CDC proposed an updated guidance on 22 June for preventing pandemic A(H1N1) influenza and seasonal influenza in healthcare settings, including hospitals, nursing homes, physicians' offices, urgent-care centers, and home health care. The guidance stresses the importance of providing seasonal influenza vaccination for healthcare personnel, providing face masks for healthcare workers, minimizing the potential of patient, visitor and personnel exposure, proper handling of ill healthcare workers, and managing droplet and aerosol-generating procedure precautions, surveillance, and environmental and engineering controls.

The proposed guidance includes a request for comments from the public by 22 July. The CDC will consider all comments and intends to publish a final guidance document prior to the 2010-2011 influenza season. The CDC requests the public submit written comments to the following address:

Influenza Coordination Unit, Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
Attn: Prevention Strategies for Seasonal Influenza in Healthcare Settings
1600 Clifton Road, NE., MS A-20,
Atlanta, GA 30333

Written comments may also be submitted via e-mail to: ICUpubliccomments@cdc.gov.

The CDC guidance statement can be accessed at: http://edocket.access.gpo.gov/2010/2010-15015.htm

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Employers Took Many Measures to Protect Employees from Contracting A(H1N1/2009) Influenza

22 June

A Harvard School of Public Health (HSPH) research team published the results of a national poll of employees that revealing that most U.S. businesses took measures to protect employees from A(H1N1/2009) influenza. The researchers polled 1,491 employees from private sector businesses outside of education and health that employ 20 or more persons during 21 April – 13 May 2010. Of the polled employees, 81% reported that their employers followed recommendations by public health officials in providing hand sanitizers at the workplace; 80% said employers encouraged them to stay home if they were sick with flu-like symptoms; 42% percent reported that employers created a back-up system to help manage employee illnesses; 77% said employers provided information about prevention at the workplace; and 60% said employers encouraged them to get the A(H1N1/2009) influenza vaccine. Vaccination rates were significantly higher among employees whose companies encouraged vaccination (29%) than among employees whose companies did not (9%).

A majority of employees (81%) said they were pleased with their company's preparedness; however, only 44% said their company was "very prepared" and 3% "somewhat prepared". 50% of employees believed that the A(H1N1/2009) influenza outbreak had stimulated their company to become more prepared for a possible future outbreak of a serious, contagious illness. Overall, large companies (500 or more employees) were more likely than medium-sized companies (100 to 499 employees) or smaller companies (20 to 99 employees) to take measures to protect employees from illness.

Robert Blendon, Professor of Health Policy and Political Analysis at HSPH and director of the Harvard Opinion Research Program (HORP) said, "These results suggest that in a future contagious disease outbreak, many businesses will try to adapt their policies to mitigate the impact on employees, with most adopting protective precautions, such as encouraging sick workers to stay home, and a minority taking other important measures, such as expanding sick leave policies".

The press release can be accessed at: http://www.hsph.harvard.edu/news/press-releases/2010-releases/businesses-took-measures-to-protect-employees-from-h1n1-flu.html

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Public Health Emergency Declaration Expires

23 June

The Department of Health and Human Services (HHS) announced on 23 June that the public health emergency declaration of April 2009, prompted by the A(H1N1/2009) influenza outbreak, has expired. HHS decided to let the declaration expire after months of low pandemic influenza activity, low levels of hospitalizations for flu-like illness, and the vaccination of 80 million Americans. HHS reported, "There is no longer a significant demand for the medical countermeasures that required a public health emergency declaration and emergency use authorizations... It is likely that other countries will be taking similar actions in the coming weeks and months based on their own assessments."

With the end of the emergency, authorizations for certain special uses of antiviral drugs and other items also end, including Emergency Use Authorizations (EUAs) for certain antiviral drugs, medical tests, and respiratory protection devices issued by the Food and Drug Administration (FDA). EUAs expiration will affect the availability of antiviral oseltamivir (Tamiflu) for under 1 year old babies and intravenous peramivir for critically ill patients. HHS reports that, "Physicians and public health officials will still be able to get access to these tests, drugs, and tools, but there will be a different process for doing so. For example, clinicians will be able to obtain intravenous antiviral drugs through participation in clinical trials." HSS adds that it is possible that another health emergency will be declared in the event of a new wave of A(H1N1) influenza infections.

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A(H1N1) Vaccine Appears to Protect Against 1918 Spanish Influenza

15 June

Several research projects performed in 2009 and early 2010 have found that the 2009 H1N1 pandemic virus shows antigenic similarities to 1918-like H1N1 virus. This is an important finding since the 1918 influenza A virus caused one of the most devastating pandemic the world has ever experienced, killing approximately 50 million people worldwide. In view of these findings, a team of researchers from Mount Sinai School of Medicine in New York and Saint Louis University, St. Louis, led by Adolfo Garcia-Sastre, decided to conduct research whose objective was to discover whether vaccination with the 2009 pandemic H1N1 vaccine would protect against the highly virulent 1918 H1N1 virus strain.

The team first worked with mice. A cohort of mice were vaccinated with the A(H1N1) monovalent vaccine and after 21 days were challenged with 300 times the lethal dose of the 1918 H1N1 virus. The vaccinated mice showed limited morbidity (reduced weight loss), but experienced no deaths.

The team then vaccinated a group of human volunteers, 18-82 years of age, with the A(H1N1) monovalent vaccine. The results were that the vaccinated individuals demonstrated a substantial rise in antibody response, which also proved protective against the 1918 H1N1 virus. This response was specific in that other human volunteers who had received the seasonal trivalent influenza vaccine did not evidence a protective response against the 1918 H1N1 virus.

From the results of their research, the authors concluded that "the spread of the 2009 H1N1 influenza virus in the population worldwide, in addition to the large number of individuals already vaccinated, suggests that a large proportion of the population now have cross-protective antibodies against the 1918 virus, greatly alleviating concerns and fears regarding the accidental exposure/release of the 1918 virus from the laboratory and the use of the virus as a bioterrorist agent."

The article can be accessed at: http://www.nature.com/ncomms/journal/v1/n3/full/ncomms1026.html

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Vitamin D May Reduce the Severity of Influenza

14 June

A study published in PLoSOne on 14 June reported that taking 25-hydroxyvitamin D may reduce the incidence of acute viral respiratory tract infections in healthy adults. The study measured serum concentrations of 25-hydroxyvitamin D in 198 healthy adults over the fall and winter of 2009-2010 to determine if there is any correlation between the incidence of acute viral respiratory tract infections and serum vitamin D concentrations. The study's major finding was that subjects who ingested sufficient 25-hydroxyvitamin D to maintain a serum concentration of 38 ng/ml or higher had reduced occurrence of acute viral respiratory tract infections.

The full article can be accessed at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0011088;jsessionid=3A6799A214337B8D33B77010B828CE15.ambra02

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Pregnant Women are Encouraged to Enroll as Research Subjects

17 June

The New England Journal of Medicine published an article on 17 June titled "Enrolling Pregnant Women in Research – Lessons from the H1N1 Influenza Pandemic," by the U.S. Food and Drug Administration (FDA). The article noted that pregnant women have always been a marginalized study population and the lack of data regarding the proper medical treatment of pregnant women could result in incorrect dosing and ineffective or subtherapeutic treatment. It stated that "The fact that the H1N1 influenza pandemic caused higher morbidity and mortality among pregnant women than in the general population underscores the medical community's urgent need for data regarding the safe and effective use of medications during pregnancy."

The article provided information on the circumstances under which inclusion of pregnant women in clinical studies is ethically acceptable. The FDA requests physicians to encourage pregnant patients to enroll in research studies. In addition, advocacy groups and professional organizations are asked to act to raise the level of public awareness on this topic. The author concluded that "change often occurs in response to a crisis; the public health impact of the H1N1 pandemic should be the driving force in changing our culture and our thinking about conducting studies of pregnant women." The full article can be accessed at: http://content.nejm.org/cgi/content/short/362/24/2241?rss=1&query=current

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U.S. Food and Drug Administration Warns the Public about Fraudulent Tamiflu

17 June

A U.S. Food and Drug Administration (FDA) news release on 17 June warned consumers about a fraudulent antiviral oseltamivir product being sold over the Internet through a website claiming to be an online drug store. While the website is no longer operational, the fraudulent product might still be available on other sites.

Analysis of the product, represented as "Generic Tamiflu," revealed that it contains cloxacillin, which is similar to the antibiotic penicillin. The FDA warns that consumers who are allergic to penicillin products would be at risk of experiencing similar, potentially life-threatening reactions were they to consume cloxacillin. Consumers are advised to check on products offered over the Internet by accessing the National Association of Boards of Pharmacy Verified Internet Pharmacy Sites Seal (VIPPS) before making a purchase. Anyone who encounters fraudulent Tamiflu drugs is requested to contact the FDA's Office of Criminal Investigations (OCI) by calling 800-551-3989, or by visiting the OCI website (http://www.fda.gov/OCI). Adverse events resulting from use of fraudulent medical products of any type should be reported to the FDA's MedWatch Program by calling 800-FDA-1088, by fax at 800-FDA-0178, or by mail at: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787.

The full report can be accessed at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm216148.htm

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Canine Influenza Vaccine Approved

9 June

PR Newswire reported on the approval of a vaccine that protects dogs from canine A(H3N8) influenza. The vaccine "Nobivac" was developed by Intervet in response to a request made by the American Veterinary Medical Association (AVMA) in 2006. AVMA had identified a growing threat of canine influenza, stating that "there is urgent need for an effective canine influenza vaccine to improve the health and welfare of animals and reduce the financial impacts of canine influenza." The company Intervet/Schering Plough Animal Health first released the vaccine under a conditional U.S. Department of Agriculture (USDA) license in May 2009. Since its release, nearly one million doses of the vaccine have been sold to veterinary clinics and shelters in the U.S. After having confirmed the safety and effectiveness of Nobivac, this first-ever canine influenza vaccine was licensed by the USDA on 9 June.

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Strengthening Interagency Collaboration within National Strategy for Pandemic Influenza

09 June

The U.S. Government Accountability Office (GAO) issued a report on 9 June that identifies key challenges to and solutions for national interagency cooperation in federal pandemic influenza preparedness efforts. The GAO report states that federal leadership roles currently defined in the pandemic influenza strategy are 'unclear', claiming the strategy does not clearly identify leadership roles for implementing the pandemic influenza strategy and supporting plans. The National Strategy for Pandemic Influenza designates authority to the Secretary of the Department of Homeland Security (DHS) and Secretary of the Department of Health and Human Services (HHS). Under the plan, DHS is responsible for overall domestic incident management and federal coordination, while HHS is responsible for leading the medical response in a pandemic. "However," the GAO report states, "since a pandemic extends well beyond health and medical boundaries – to include sustaining critical infrastructure, private-sector activities, the movement of goods and services across the nation and the globe, and economic and security considerations – it is not clear when, in a pandemic, the Secretary of Health and Human Services would be in the lead and when the Secretary of Homeland Security would lead."

The report warns that such vaguely defined roles and responsibilities could cause confusion among agencies and prevent effective interagency cooperation, ultimately leading to a delayed federal response in case of a significant outbreak. GAO identifies opportunities to strengthen interagency collaboration by focusing on four key areas: 1) developing overarching strategies, 2) creating collaborative organizations, 3) developing a well-trained workforce, and 4) improving information sharing.

The full report can be accessed at: http://www.gao.gov/new.items/d10822t.pdf

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AVI BioPharma Deals with DTRA on Study of A(H1N1) Influenza

07 June

The drug company AVI BioPharma Inc. has secured a new contract with the U.S. Defense Threat Reduction Agency (DTRA) to develop A(H1N1) influenza therapeutic. The contract calls for AVI BioPharma to conduct advanced development its drug AVI-7100 for the treatment of A(H1N1) influenza. The new contract, which could be worth up to $18 million, follows an earlier, similar $4 million deal with the DTRA Transformational Medical Technologies Initiative (TMTI). Under the TMTI contract, AVI BioPharma was funded to develop swine A(H1N1) influenza drugs and research avian A(H5N1) influenza and drug-resistant strains of influenza.

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Simultaneous Detection of A (H1N1) Influenza and A (H5N1) Influenza

02 June

An article in Virology Journal describes a study that generated findings for the simultaneous detection of A (H1N1/2009) influenza virus and A (H5N1) influenza virus. A Beijing Institute of Microbiology and Epidemiology research team improved on an already existing duplex real-time reverse transcriptase polymerase chain (RT-PCR) assay, a powerful and widely used method to detect and identify viruses in clinical samples, to accomplish the simultaneous detection of A (H5N1) avian influenza virus and A (H1N1/2009) influenza virus. According to the article, this improved method of simultaneous detection is suitable for early diagnosis of influenza in patients and for epidemiological surveillance. Considering the similar clinical symptoms of pandemic A (H1N1/2009) influenza and A (H5N1) influenza at the early stage of infection, article authors call "early detection of these two pathogens an essential prerequisite for effective control and prevention of the pandemic."

The full article can be accessed at: http://www.virologyj.com/content/pdf/1743-422x-7-113.pdf.

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CDC Monitors Guillain-Barré Syndrome Risks Associated with Influenza A (H1N1) 2009 Monovalent Vaccine

02 June

The Centers for Disease Control and Prevention (CDC) issued the preliminary results of a study that estimated the prevalence of Guillain-Barré Syndrome (GBS) in recipients of the influenza A (H1N1/2009) monovalent vaccine. In October 2009, CDC's Emerging Infections Program (EIP) began an active surveillance program to assess the risk of GBS after receipt of the A (H1N1) vaccine. The study surveyed GBS patients hospitalized through 31 March 2010, and then calculated and compared the incidence of GBS in vaccinated and unvaccinated populations. Preliminary results showed an "estimated age-adjusted rate ratio of 1.77 (GBS incidence of 1.92 per 100,000 person-years among vaccinated persons and 1.21 per 100 000 person-years among unvaccinated persons)." The CDC reports that these findings, if confirmed at the end of the study, "would correspond to 0.8 excess cases of GBS per 1 million vaccinations, similar to that found in seasonal influenza vaccines."

The CDC's preliminary analysis identifies an elevated and statistically significant association between GBS and the A (H1N1) vaccine, but also recognizes the possibility that some GBS cases occurring after vaccination might be attributed to other antecedent illnesses. While the CDC recommends that persons with a history of GBS should discuss the risks and benefits of any influenza vaccine with their health care providers, the report also notes that "vaccination remains the most effective method to prevent serious illness and death from 2009 H1N1 influenza infection". According to CDC, data collection and analyses are ongoing and the final report is expected be published by early fall 2010.

The full article can be accessed at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0602a1.htm?s_cid=mm59e0602a1_e

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A (H1N1) Flu Pandemic Continues

03 June

After reviewing the status of the influenza pandemic on 2 June, the WHO Emergency Committee issued a report stating that the A (H1N1) influenza pandemic is not over yet. In particular, it remains a threat to vulnerable populations such as pregnant women, young children, and people with respiratory issues.

WHO reports that as of 30 May, more than 214 countries and overseas territories or communities worldwide have reported laboratory confirmed cases of pandemic influenza A (H1N1/2009), including over 18,138 deaths. Virus activity in Africa is currently low, but it remains most active in parts of the Caribbean and Southeast Asia. Although the A (H1N1) virus has to date tended to produce mild symptoms, WHO experts fear that the virus might mutate to a more dangerous or lethal form. WHO Director-General Margaret Chan is quoted in Reuters Health as saying "it remains critical for countries to maintain vigilance concerning the pandemic, including necessary public health measures for disease control and surveillance."

Reuters Health reports that WHO has yet to make a full pronouncement on the state of the pandemic as the Emergency Committee continues to track virus development in the southern hemisphere. Chan told Reuters Health that the committee plans to meet again by mid-July to review the status of the outbreak.

The 4 June WHO weekly update can be accessed at: http://www.who.int/csr/don/2010_06_04/en/index.html

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Emerging Infectious Diseases and the Theory of "Original Antigenic Sin"

June 2010

The June 2010 issue of Emerging Infectious Diseases published a letter by Amesh A. Adalja and D.A. Henderson of the University of Pittsburgh Medical Center and an accompanying expert commentary, which explores the idea of 'original antigenic sin'(OAS). OAS is based on the theory that "a person who is exposed to influenza A virus in childhood will, in later encounters with related flu viruses, mount an immune response primarily directed at the original virus, even when the newly encountered virus is antigenically different." One reported implication of this theory is that a person may show ineffective or less effective immune response to a virus related to the original virus.

According to the theory, the A (H1N1) virus that circulated between 1918 and 1957 may explain the partial protection older people exhibit against the A (H1N1/2009) influenza. To support this theory, Adalja and Henderson point to the recent A (H1N1/2009) influenza pandemic, in which cases of A (H1N1) influenza infection in people in their 50s and 60s were scarce. Although public health planning generally assumes a high rate of influenza illness in elderly people, the letter suggests that heath care facilities be prepared to treat a larger number of young people, if the current age pattern continues.

An accompanying commentary written by three other experts generally agreed with the OAS theory but offered additional commentary not related to the OAS phenomenon. The commentary cited several studies showing ample data to explain age patterns that do not necessarily invoke 'original sin' to explain the observations. The commentary suggests that studies be done to compare antibody levels and the OAS phenomenon within various age-groups exposed to different strains of A (H1N1) influenza, to include the 25 million American patients who received the A (H1N1) influenza vaccine during the 1976 outbreak. "Is original sin really a sin from which our immune systems need to be saved? Or is it an epidemiologic blessing in disguise? We have much more to learn," the commentary concluded.

The letter and commentary can be accessed at: http://www.cdc.gov/eid/content/16/6/1023.htm.

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Alabama A(H1N1/2009) Outbreak Contained

25 May

According to a report by WAFF48News, the outbreak of A(H1N1) influenza in Alabama has officially been declared over. "It's run it's course it appears", Alabama State Health Department Spokesman Dr. Jim McVay told WAFF. Alabama State Health Department reports that the A(H1N1) virus has caused 53 deaths in the state since the 2009 outbreak began. Now, according to health officials, it has been over three weeks since a specimen has been brought to the lab that contained H1N1 virus. In preparing for the upcoming flu season, Dr. McVay told WAFF48News that this year's flu vaccine will afford protection against both A(H1N1) influenza and seasonal influenza.

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Diagnostic Test for A(H1N1) Virus Cleared by FDA

24 May

A U.S. Food and Drug Administration (FDA) news release announced that Simplexa Influenza A(H1N1), a test kit for detecting the 2009 A(H1N1) virus, has been cleared for continued use. Prior to the FDA clearance, the test was available only through an Emergency Use Authorization (EUA) for testing patients with signs and symptoms of respiratory infection. Expiration of the public health emergency declaration would have rendered the EUA ineffective but this approval will allow clinicians to continue using the test even after the public health emergency expires.

Simplexa Influenza A(H1N1) 2009 is a test designed to detect viruses that may populate specimens collected by nasal swab or nasal aspirates. It does so by amplifying two regions of the influenza virus genome, which can then be compared to reference strains. A positive test result evidences the presence of H1N1 influenza virus in the specimen, but does not indicate the stage of infection. The test is manufactured by Focus Diagnostics Inc., of Cypress, Calif.

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Pregnant Women Infected with A(H1N1) Virus are at Risk of Complications

24 May

The results of a new study published in the Archives of Internal Medicine attests that pregnant women infected with A(H1N1) virus are at high risk of suffering serious complications. Risks include early-term delivery, emergency cesarean delivery, fetal distress, or fetal fatality. Results also show that early antiviral treatment may decrease these risks.

Researchers conducted observational analysis of 18 hospitalized pregnant patients infected with A(H1N1) virus, all of whom received the antiviral drug oseltamivir (Tamiflu) on the day of admittance. During hospitalization (median length of 4 days) half of the patients presented with gastrointestinal complaints, 13 met sepsis criteria, and 3 were admitted to the intensive care unit. Five patients experienced fetal distress, with one resulting in miscarriage. Of the six patients who delivered prematurely during hospitalization, two resulted in fetal deaths. All maternal patients were released from the hospital with favorable outcomes.

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China Accepting U.S. Pork After A(H1N1)-related Ban

14 May

Feedstuffs reported that negotiations that began in March between Chinese and U.S. officials has led to an agreement by which China pledged to reopen its markets to U.S. pork. U.S. pork produced on or after May 1 can now be exported to China. China had closed its markets to U.S. pork in April 2009 following the outbreak of A(H1N1) influenza in North America because the A(H1N1) virus mutated from a strain of the virus that is endemic to pigs.

This is "tremendous news" for U.S. pork producers, said National Pork Producers Council (NPPC) president Sam Carney, a pork producer from Adair, Iowa. China has historically been one of the largest markets for U.S. pork, he noted. The NPPC continues to urge U.S. officials to resolve other impediments to trade, including the Chinese ban on pork produced from hogs administered ractopamine, a Food and Drug Administration-approved feed ingredient that improves production efficiency, as well as China's value-added tax on imports, and subsidies on domestically produced pork.

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The Impact of Information Technology on Global Surveillance of A(H1N1) Infection

6 May

The authors of a report published in the New England Journal of Medicine studied the emergence and global spread of the 2009 pandemic influenza A(H1N1) virus and found that it illustrated not only the hazards of an interconnected world, but also the powerful role of new methods for detecting, tracking, and responding to infectious diseases. Furthermore, the authors found that although formal reporting, surveillance, and response structures remain essential for ensuring public health, a new generation of freely accessible, online, and real-time informatics tools for disease tracking are expanding the ability of public health professionals to detect infections earlier as they cross country borders and to raise earlier warnings of emerging disease threats.

The study concluded that in the future, broad-reaching and integrated surveillance techniques may be valuable for situational awareness in a range of rapidly evolving scenarios beyond epidemics of infectious disease. Overall, the 2009 A(H1N1) influenza pandemic presented an important test of new disease-surveillance systems. The authors highlighted the importance of the Journal's HealthMap system (a data mining system that combines automated, around-the-clock data collection and processing with expert review and analysis to aggregate reports according to type of disease and geographic location), which showed how such systems, built largely around readily available informal sources, can provide both early warnings of a disease outbreak and an ongoing operating picture of the patterns of disease spread. The authors further concluded that by providing a highly accessible picture of the emerging pandemic, the Journal's H1N1 Influenza Center played a key role in rapidly disseminating information to the public.

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A(H1N1) Lessons Learned

30 April

CIDRAP News reported that as the biggest public health initiative in the history of the US Centers for Disease Control and Prevention (CDC), the A(H1N1) pandemic vaccination campaign encountered difficult problems due to scarce supplies and complex messaging but nevertheless ended up reaching about a quarter of the US population and, some say, mapping out a path for future wide-scale immunization efforts.

Paul Etkind, senior analyst for immunization with the National Association of City and County Health Officials (NACCHO), said the importance of vaccine partnerships was a valuable lesson, and working with new providers, different state agencies, pharmacies, and social service agencies will pay dividends when future immunization efforts are undertaken. He singled out partnerships with schools as particularly important, especially given recent expansions in seasonal flu vaccine recommendations to include everyone (except babies younger than 6 months) and childrens' role in the spread of the virus.

Kris Ehresmann, immunization director at the Minnesota Department of Health, predicted that the next communication challenge will be how to portray the pandemic flu risk and the need for vaccination to the public during the transition time when the pandemic strain evolves into more of a seasonal flu pattern.

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Pregnant Woman at Greater Risk of Death from A(H1N1) Infection

21 April

According to a new study authored by the Center for Disease Control and Prevention (CDC) and published in the Journal of the American Medical Association, pregnant women have been particularly vulnerable to the effects of A(H1N1) infection, but those who sought early treatment were less likely to die from complications. Pregnant women comprise about 1 percent of the American population, but they accounted for 5 percent of deaths due to A(H1N1) virus during the outbreak. Of pregnant women who waited more than four days to seek treatment, 60 percent ended up in intensive care. Conversely, less than 10 percent of those who sought medical intervention within two days of falling ill required monitoring in intensive care.

Dr. John Carpenter, the division director of infectious disease at Scott & White Healthcare, told Health Day that the uterus is more likely to push on the diaphragm during the later stages of pregnancy, making breathing more difficult. This is one reason why pregnant women should be especially alert for signs of respiratory illness. He also advised that women receive the influenza vaccine if they already are or are planning to become pregnant.

The foregoing are in accord with CDC recommendations that pregnant women who suspect they have influenza, or who come into contact with someone who does, see their doctors. Pregnancy increases the risk that an influenza infection will develop into pneumonia or trigger pre-term labor.

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U.S. Doctors and Minorities Remain Wary of Vaccines

19 April

U.S. Health and Human Services Secretary Kathleen Sebelius said that it became painfully clear during the A(H1N1) pandemic that doctors and minorities have a dangerous mistrust of vaccines. Sebelius told a meeting of vaccine experts at the CDC headquarters in Atlanta, "We shouldn't have to convince health providers that vaccines are safe and that they work. But, despite the fact that we had more health providers than ever getting vaccinated last year, there was still a sizable number who did not." Sibelius said that in an average year, fewer than 40 percent of doctors, nurses and other healthcare workers get flu vaccines.

Regarding minority populations, Sebelius commented, "Too many people in these communities still don't believe that vaccines are safe, or even that they work. But with so many African Americans, Hispanics, American Indians, and others experiencing rising rates of chronic disease, not getting vaccinated is many times more dangerous than even the perceived threat of the vaccine." According to Sebelius, even though 90 million doses of influenza vaccine had been administered of the 162 million doses shipped across the country, a disproportionate number of minorities did not receive the vaccine.

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A(H1N1) Virus Continues to Cause Epidemics

16 April

The U.S. Centers for Disease Control and Prevention (CDC) reported that the A(H1N1) virus continues to cause epidemics, especially in the southeast of the United States. CDC therefore recommends that Americans who have not been vaccinated should seek vaccination.

The CDC reported, "For the week ending March 27, 2010, pneumonia or influenza was reported as an underlying or contributing cause of death for 7.9 percent of all deaths" in the United States. This is slightly above the epidemic threshold of 7.8 percent that the CDC had reported for the last week of March. The CDC's weekly surveillance report on influenza mirrors the WHO's warning that the pandemic continues, although at low levels. Infectious disease specialists warn that as long as the virus continues active passage among people, it could mutate and re-emerge at any time in regions where it in the past caused illness.

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Business Affiliation Could Increase Risk of Transmission of H5N1

5 April

The JHU Gazette reported that Johns Hopkins Bloomberg School of Public Health researchers have examined the potential influence that business connections between broiler-chicken growers may have on the transmission of H5N1. They have found that the risk of between-farm transmission is significantly greater among farms within the same company than it is between farms affiliated with different companies. The study, which appeared in the March 26 edition of PLoS One, is among the first to analyze the impact of company affiliation on the spread of diseases from farm to farm.

Jessica Leibler, a doctoral candidate in the Bloomberg School's Sommer Scholars program, said,

"Our analysis indicates that company affiliation is a major driver of farm-based exposure risk to an infection like avian influenza in regions with high-density food-animal production. Farms within the same integrator group as an infected farm may face as much as a fivefold increase in exposure risk compared to farms affiliated with a different group. H5N1 has never been detected in the U.S., but the absence of the disease does not in and of itself prove that current biosecurity measures have been effective. Low pathogenic avian influenza is detected frequently in U.S. poultry."

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A(H1N1) Prevalent Among Hospital ER Workers

30 March

A study published in the journal Disaster Medicine and Public Health Preparedness found that during last year's A(H1N1) flu pandemic, nearly half of the reported cases involving hospital healthcare workers occurred in emergency medicine, pediatrics, ambulatory care and anesthesiology, with emergency medicine workers having the highest infection rate. Lead author Cynthia Santos of Weill Cornell Medical School said, "The peak of the H1N1 pandemic in healthcare personnel lagged slightly behind the peak of the pandemic in the community, except in the emergency department where the peak closely corresponded to the community." Data on unvaccinated employees from five hospitals were analyzed during the spring 2009 A(H1N1) pandemic. The scientists found that of a total of 123 lab-confirmed cases of A(H1N1), 49% (approximately 60 cases) occurred in hospital emergency departments. Workers in hospital emergency departments comprise 19% of the total healthcare workforce.

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Rapid Development of Drug-Resistant A(H1N1) Influenza Reported in Two Cases

26 March

Doctors from the National Institute of Allergy and Infectious Diseases (NIAID) report that two people with compromised immune systems who became ill with the A(H1N1) virus developed drug-resistant strains of the virus after less than two weeks of therapy. The authors or the report say doctors who treat prolonged influenza infections should be aware that even a short course of antiviral treatment may lead to the development of a drug-resistant virus. Therefore, clinicians should consider this possibility as they develop initial treatment strategies for patients who have impaired immune function. NIAID Director Anthony S Fauci asserted that "While the emergence of drug-resistant influenza virus is not in itself surprising, these cases demonstrate that resistant strains can emerge after only a brief period of drug therapy. We have a limited number of drugs available for treating influenza and these findings provide additional urgency to efforts to develop antivirals that attack influenza virus in novel ways."

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A(H1N1) Virus Similar to 1918 Strains of Influenza

26 March

HealthDay News reported on the findings of two independent research groups demonstrating structural similarities between A(H1N1) virus and virus strains from early in the 20th century. These structural similarities help explain why younger people were disproportionately affected by the A(H1N1) virus, and they also indicate a path for developing better vaccines against the virus.

In one report, published in the March 25 online edition of Science, a team at the Scripps Research Institute discovered that the structure of the hemagglutinin (the influenza virus envelope protein) coating the A(H1N1) virus is very similar to that of the 1918 pandemic flu strain that killed millions worldwide. In particular, one area of hemagglutinin known as antigenic site Sa appears highly similar between the 2009 and 1918 influenza strains. "Parts of the 2009 virus are remarkably similar to human H1N1 viruses circulating in the early 20th century," Ian Wilson, the study's senior author and a Scripps professor, stated in an institute news release. "Our findings provide strong evidence that exposure to earlier viruses has helped to provide some people with immunity to the recent influenza pandemic."

In a separate article published in the March 24 online edition of Science Translational Medicine, scientists report having discovered that both of the 1918 and 2009 pandemic influenza viruses lack a carbohydrate capping group in a certain area, which makes them susceptible to the same antibodies. According to Gary J. Nabel, leader of the research team at the National Institute of Allergy and Infectious Diseases (NIAID), it may be possible to exploit this vulnerability to design new vaccines. Commenting on these findings, Dr. Anthony S. Fauci, director of NIAID, wrote in an agency news release, "This study defines an unexpected similarity between two pandemic-causing strains of influenza. It gives us a new understanding of how pandemic viruses evolve into seasonal strains and, importantly, provides direction for developing vaccines to slow or prevent that transformation."

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CDC Reports Sustained A(H1N1) Viral Activity in Southeastern States

26 March

The US Centers for Disease Control and Prevention (CDC) reported today that there are new indications of increased and sustained A(H1N1) flu activity in some Southeastern states, though rates remain steady at the national level. The CDC report is consistent with reports in the media of a rise in flu hospitalizations this week in Georgia, and increasing numbers of flu-like illnesses in Louisiana and surrounding states. The report of increased activity in the Southeast is also consistent with American College Health Association reports of regional flu activity at college campuses in the Southeast.

Three of the CDC's 10 regions reported increases in doctor visits for flu-like illnesses, including the region encompassing Southeastern states; the region that includes Iowa, Kansas, Missouri, and Nebraska; and the regions that include Arizona, California, Hawaii, and Nevada. The increases were over regional, not national, baselines. On a national level, the rate of flu-related doctor visits remained below the national baseline. The CDC also reported that the A(H1N1) virus remains the dominant flu strain in the United States. Only two of the 3,050 respiratory specimens tested in the United States last week were identified as influenza B.

CDC still recommends that the A(H1N1) flu vaccine be administered to anyone who is age 6 months or older, and add that it is particularly important for people with underlying health conditions, the very young, and people age 65 or older to get vaccinated. Supplies of both A(H1N1) and seasonal vaccines are plentiful and the circulating A(H1N1) virus strain still closely matches the one that constitutes the pandemic vaccine.

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Severe Obesity Raises Risk of Severe Illness from A(H1N1) Infection

17 March

Maryn McKenna of CIDRAP reported that adults with severe obesity are almost five times more likely to be hospitalized if infected with the A(H1N1) virus when compared to a healthy non-obese cohort. According to new research findings by the Centers for Disease Control and Prevention (CDC), these individuals are also more likely to die under certain conditions. The CDC researchers write in the online medical journal PLOS ONE that obesity appears to play such a powerful role that it exerts an effect independent of any underlying chronic conditions that patients may have.

The CDC study reflected data on hospitalizations and deaths gathered by state health departments between April and July 2009. As a control, the researchers compared the cases to a healthy cohort, using data from the National Health and Nutrition Examination Survey, a nationwide representative survey. For each group, the researchers calculated body mass index (BMI), a ratio of height to weight used as a universal measure of whether an individual is under- or overweight. They also recorded whether group members suffered from at least some of the chronic medical conditions that federal health authorities have previously defined as potentially causing complications in A(H1N1)-related illnesses (cardiovascular disease, pulmonary disease, liver disease, cancer, and diabetes). The results showed that obesity appears to influence flu illness and death, though the quality of the data limited researchers'ability to calculate the degree of this influence. Alternatively, obesity did not appear to influence the illnesses and deaths of teenagers and children younger than 20, who were more likely to be very ill and die if they were underweight rather than overweight.

Among adults, morbid obesity—the highest level of obesity, defined as a BMI of 40 or more—played a significant role in the risk of developing a flu infection serious enough to require hospitalization. Morbidly obese adults with chronic medical conditions were 4.9 times more likely than the healthy cohort to be hospitalized; those who did not have such conditions were 4.7 times more likely.

The CDC researchers noted that the specific role played by obesity in severe flu illness has not been extensively studied. It is well-accepted in medicine, though, that obesity complicates severe illness, causing longer stays and greater need for mechanical ventilation in intensive care. Obese patients are also predisposed to wound infections, sepsis, and pneumonia.

A University of North Carolina animal model study may provide preliminary reasons as to why obesity affects the severity of illness in flu patients. Using a study in mice, researchers report in the Journal of Immunology that obesity caused by overfeeding seems to impair the immune system's ability to create the immunologic memory that allows the body to recognize and respond to flu infections. The researchers used a mild lab-adapted flu virus to experimentally infect both lean mice and mice that had been fattened by overfeeding. They then infected both groups of mice a second time with a more lethal flu virus. One fourth of the obese mice, but none of the lean mice used as controls, died as a result of the second infection.

After performing a pathologic exam, researchers found that obese mice had higher rates of lung inflammation along with much higher amounts of flu virus in their lung tissue than found in the lean mice. Further analyses showed that the obese mice produced much lower numbers of influenza-specific memory T cells, which permits the immune system to recognize and mount an attack against subsequent flu infections. Additionally, the T cells present were found to be less effective in mounting a defense against the flu viruses. The findings may suggest that obese people may be less likely to mount adequate immune responses after flu vaccination, but researchers need to perform human studies to obtain conclusive results.

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HHS Prepares to Handle Claims of Harm from A(H1N1) Vaccine

12 March

CIDRAP News reports that according to David Bowman, a spokesman for the Department of Health and Human Service's (HHS's) Health Resources and Services Administration (HRSA), the HSS has as of March 11 received letters from 106 people who plan to seek compensation for injuries caused by the vaccine.

Currently, HRSA only accepts letters of intent to file claims, rather than the claims themselves, because the administrative policies and procedures for handling them have not yet been approved, Bowman reported. He said the agency has no information yet regarding the kinds of injuries people are claiming to have suffered.

According to the agency, people who believe they were injured by the H1N1 vaccine, or by certain other pandemic-related medical treatments such as flu antiviral drugs, must write to HHS within a year after having been vaccinated or treated. Filing a letter of intent to file a claim preserves their right to file a claim later, after regulations for claim processing have been approved.

Injury claims related to the pandemic vaccine are covered by the Countermeasures Injury Compensation Program (CICP), which was created to address claims related to countermeasures for pandemic flu, bioterrorist attacks, and other public health emergencies. The CICP remains separate from the 1980s Vaccine Injury Compensation Program (VICP), which handles claims pertaining to seasonal flu vaccines and routine childhood vaccines.

The CICP was established under the Public Readiness and Emergency Preparedness (PREP) Act, passed in 2005, which shields pharmaceutical companies and medical providers from most lawsuits claiming harm from medical countermeasures for pandemic flu and other public health threats, with the aim of helping to ensure a supply of countermeasures. This law set up the CICP in lieu of the right to pursue damages in court, with few exceptions. The HHS secretary determines which countermeasures are needed to respond to declared threats.

Though it was part of legislation enacted several years ago, the CICP received funding to begin operations only last September, according to Bowman. Claims related to the A(H1N1) vaccine are not covered by the VICP because it is "not currently a vaccine recommended by the CDC [Centers for Disease Control and Prevention] for routine administration to children," Bowman added that seasonal flu vaccines are covered by the older program because it is routinely recommended. "If the H1N1 pandemic vaccine becomes a component of the trivalent seasonal vaccine (as is currently planned for next year's flu season), then it would be covered by the VICP and not the CICP at that time," Bowman said.

According to a presentation given by Vito Caserta, director of CICP, at a recent meeting of the National Vaccine Advisory Committee, the compensation program will cover reasonable medical expenses, lost employment income, and death benefits for injuries caused by the vaccine. Those benefits will be paid only after any payments from other parties, such as insurance companies, have been received by victims. Processing of damage claims must occur only after the administrative policies and procedures are completed. Bowman reports that newly developed draft regulations are currently under review at HHS. After the revue process has been completed, they will be sent to the Office of Management and Budget (OMB). Following OMB approval, they will be published and HHS will accept public comments on them. HHS will then take into account public comments to redo the draft regulations. Bowman said he couldn't predict how long it will take for final regulations to be approved and implemented.

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Officials Regret Vaccine Chaos

5 March

Reuters reports on top U.S. public leaders' agreement that no one anticipated the unpredictability in vaccine production. This unpredictability resulted in people clamoring for A(H1N1) vaccines when there were not enough to satisfy demand, yet by the time vaccines were readily available, most of the public had lost interest in obtaining them.

At a conference addressing influenza regrets sponsored by the Center for Biosecurity at the University of Pittsburgh Medical School, many speakers emphasized that one of the largest challenges to managing the A(H1N1) pandemic was enticing the U.S. public to get vaccinated. Dr. Nicole Lurie, assistant secretary for preparedness and response at the Health and Human Services Department, told the conference "The truth is for this pandemic we had about the longest warning we might ever have for a potential biothreat. And yet we all lament how long it took for vaccine to be made."

Within weeks of the flu outbreak first being detected last April, officials began pressuring flu manufacturers to begin production of a vaccine and based on assurances received from manufactures, CDC spokespersons asserted that more than half of the U.S. population could be quickly vaccinated. Health and Human Services Secretary Kathleen Sebelius said that with 250 million vaccines ordered, any American who wanted to be vaccinated would be able to obtain a flu shot. However, the vaccine did not become available as planned. As Texas state health commissioner David Lakey observed, "We told people to prepare to be vaccinated in October and then we didn't show up with vaccine." Vaccine makers faced many problems at the outset of vaccine production, such as having trouble growing the virus, difficulties with dispensing vaccines into vials, and shipment problems.

The CDC reported that by February 13, as the pandemic waned in the United States, only 97 million A(H1N1) vaccine doses had been administered to 86 million Americans, or 78 percent of the total doses shipped. CDC's Dr. Anne Schuchat told the meeting "The most vaccine we ever shipped in one week was 16 million doses, while initial predictions projected 20 million vaccine doses to be shipped a week." CDC Director Dr. Thomas Frieden added, "All the vaccine in the world is not going to work if you can't deliver it." The initial optimistic predictions on vaccine availability and shipment capability impacted implementation plans. Maryland's Health Secretary John Colmers said, "It had a profound effect on our ability to plan. Supply didn't equal demand. We had a lot of demand, not a lot of vaccine, and then we had a lot of vaccine and not much demand."

A further complication to the vaccine supply was the United States' use of five suppliers, each of whom made vaccine in a slightly different way. For example, MedImmune's nasal spray, while appropriate for children, was inappropriate for high-risk adults. Also, some of the vaccine shots were not indicated for vaccination of young children. Thus, to create and distribute vaccines, the CDC and HHS had to patch together an ad hoc network of private manufacturers, a private distributor and numerous retail clinics, hospitals, doctor's offices, employers, state and city health departments.

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Epidemiologist Explores Dynamics of Mexico's A(H1N1) Influenza Pandemic

21 February

According to Science News, an Arizona State University (ASU) epidemiologist reported that influenza surveillance mechanisms in Mexico were adequate during the fast-spreading A(H1N1) outbreak in 2009, but that Mexico did not have the infrastructure to quickly identify the emergence of this novel strain.

Carlos Castillo-Chavez, director of Mathematical, Computational and Modeling Sciences Center at the ASU College of Liberal Arts and Sciences, discussed his research on factors impacting the influenza dynamics within Mexico during a presentation on February 21 at the annual meeting of the American Association for the Advancement of Science. Castillo-Chavez's presentation, "Life in the Fast Lane: H1N1 Pandemic Dynamics in Mexico's Central Influenza Corridor," was part of a session dedicated to mathematics used for investigating biological hierarchies.

Castillo-Chavez' analysis of Mexico's response to the A(H1N1) virus and the dynamics surrounding the influenza outbreak sought to address such issues as: whether social-distancing measures combined with summer school breaks slowed down the first wave but might have resulted in a less manageable second wave; whether the lack of advanced diagnostic facilities and uniform surveillance systems, common in poor nations, were "good" for the rest of the world; the impacts of the limited access of have-nots (individuals or nations) to adequate supplies of antiviral drugs and A(H1N1) vaccine on the dynamics of A(H1N1) virus spread; and optimal public health policies for non-wealthy nations in times of pandemics.

Castillo-Chavez stated that

"Mexico public health officials took immediate and massive social-distancing measures during the initial outbreak that were effective, but only over a short-time scale. But the second wave hit Mexico and the rate of infections exceeded those over the months of April through June 2009. The combination of large movements of people in Mexico's central influenza corridor and past strict social-distancing measures seemed to have had a dramatic effect on the ongoing influenza dynamics within Mexico. Fortunately, disease severity has not been as devastating as in past pandemics."

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Rapid A(H1N1) Diagnostic Test May Be Most Useful in Young Children

19 February

Laurie Barclay of Medscape Medical News reports that the results of a large pediatric cohort study published in Pediatrics indicate that the rapid influenza diagnostic test (RIDT) for A(H1N1) influenza virus may be most useful in young children who are tested early after symptom onset.

Writes one of the study's researchers, Dr. Michael Hawkes from the University of Toronto in Ontario, Canada:

"Data on the test performance of the RIDT for S-OIV [A(H1N1) influenza virus] have been limited."

"The few available reports in mixed adult-pediatric populations have shown variable sensitivity between 11% and 69%.... The rapidly evolving pandemic of novel 2009 [S-OIV] [A(H1N1) influenza virus] demands that accurate and practical diagnostics be urgently evaluated for their potential clinical utility."

The goal of the study was to assess the diagnostic accuracy of RIDT and direct fluorescent antibody (DFA) assay for S-OIV. Between May 22 and July 25, 2009, the investigators recruited 820 children 17 years of age and younger who were evaluated for influenza-like illness in the emergency department of a pediatric referral hospital (651 children) and a community pediatric clinic (169 children).

Study authors noted that:

"...RIDTs may have a role in clinical practice for diagnosis of S-OIV in young children who present early after symptom onset, for whom the test sensitivity is superior. Our findings support a recent Centers for Disease Control and Prevention interim guidance statement that, when influenza viruses are circulating in a community, a positive RIDT result indicates that influenza infection is likely present; however, a negative test result does not rule out infection."

"Future studies are warranted to examine the clinical utility and cost-effectiveness of RIDTs in the context of the current S-OIV pandemic."

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Doctors' Invention Aids A(H1N1) Infection Victims

19 February

Margaret Buranen of Business Lexington reports that an invention developed by two doctors at the University of Kentucky (UK) may aid some of the most critically ill victims of A(H1N1) influenza. Dr. Joseph B. Zwischenberger, chairman of UK's department of surgery, and Dr. Dongfang Wang, director of UK's Artificial Organ Laboratory, devised an improved double lumen catheter (DLC) for the Extracorporeal Membrane Oxygenation (ECMO) machine, commonly called a lung bypass.

The U.S. Food and Drug Administration approved the UK doctors' DLC in October 2008. In January 2009, UK was the first medical center to have this device available for patients. The device, named Avalon Elite Bi-Caval DLC, is less invasive than the original DLCs used in lung bypass machines because it allows for patient mobility, offers total/more efficient exchange of blood gases, and lessens the chances of nosocomial infection.

While prior versions of the ECMO machine saved the lives of critically ill babies and small children, they had serious limitations. No machine was large enough for adults or older children, tubes tended to kink or collapse, and the machines were not as efficient as they needed to be in the exchange of blood gases.

The sickest A(H1N1) patients often cannot breathe without ventilators, and prolonged use of them can cause lung damage. Sixty-eight A(H1N1) patients who died despite support from ventilators, were given ECMO treatment. However, it must be noted that about 71 percent of the patients who received ECMO treatment survived.

The estimated number of U.S. hospitals that have the ECMO machine varies, but range from 70 to 120. The major drawback to the ECMO machine is its high cost. Zwischenberger said that "ECMO requires dedicated equipment with costs of up to $100,000 start-up and about $20,000 per patient, with increased staffing over and above normal ICU patients (often two caregivers for each patient)."

In addition, the number of patients needing the specialized treatment is relatively small. Zwischenberger explained that "Many centers (are) doing less than five patients per year and only a few busy centers (are) doing more than 20 per year. Most predict ECMO will still be limited to major health care centers in the future." He was cautiously optimistic about the potential benefits of the DLC device. "More experience is necessary to assess cost versus risk, versus benefit, of this new technology. Early results are very promising."

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A(H1N1) Virus Can Cause Severe Heart Inflammation in Children

11 February

John Gever of MedPage Today reports that researchers have announced four children treated for A(H1N1) influenza infection at a San Diego hospital developed acute myocarditis, killing one of them.

"Our observations warrant a high index of suspicion for myocarditis in children with H1N1 influenza A infection," according to András Bratincsák, MD, PhD, and colleagues at Rady Children's Hospital in San Diego, in a research letter published online in the Journal of the American College of Cardiology. "Early detection and aggressive management are paramount," they wrote.

The four children, ranging in age from 3 months to 9 years, were brought to Rady last October. They were among 80 children hospitalized in that month with A(H1N1) flu infections, the researchers said. The single death probably resulted from acute atrioventricular block, the researchers indicated.

These four cases occurred in conjunction with A(H1N1) infection in a single month, which researchers concluded may "raise the possibility that the novel H1N1 influenza A virus is more commonly associated with a severe form of myocarditis than previously encountered influenza strains." They added that "timely intervention with circulatory support" may improve outcomes in such cases.

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Officials Caution that A(H1N1) Virus Still Active

6 February

Reuters reports that health officials say the A(H1N1) virus is still active globally and is still a serious health concern. The A(H1N1) strain is the dominant strain of influenza globally, but some seasonal strains are starting to emerge in China and Africa, the World Health Organization reported.

The United States remains one of the countries most affected by the A(H1N1) pandemic, but many Americans seem unconcerned and many have rejected the vaccine, according to a poll by the Harvard School of Public Health released on February 5th. "Many people believe the outbreak is over and I think it is too soon for us to have that complacency," Dr. Anne Schuchat of the U.S. Centers for Disease Control and Prevention told reporters in a telephone briefing. "This pandemic isn't over yet."

Schuchat said 70 million Americans had been vaccinated against the A(H1N1) virus, which leaves the U.S. government with millions of unused doses. 155 million doses have been shipped and 229 million ordered from five makers: AstraZeneca unit MedImmune, Sanofi Aventis, Novartis, GlaxoSmithKline and CSL.

Schuchat said it is easy to be vaccinated now, and she urged Americans to get the vaccine. "It's just impossible for me to say whether we will have a very large peak in disease," she said. "But we don't seem to be seeing the disappearance of this virus, and we haven't seen the emergence of the seasonal strain ... so I think this virus is going to be finding susceptible people."

The Harvard poll found that 44 percent of Americans believe the H1N1 flu outbreak is over. It also found that 40 percent of parents (with 13 percent more planned) to get the vaccine for their children. Schuchat said only 37 percent of children who needed to get two doses for full protection had received the second dose.

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Sanofi Pasteur's A(H1N1) Vaccines Have Shorter Expiration Times Than Labeled

3 February

Lisa Schnirring of CIDRAP reports that the US Centers for Disease Control and Prevention (CDC) notified healthcare providers that 50 lots of Sanofi Pasteur's A(H1N1) vaccine in pre-filled syringes have a shorter shelf life than recorded on the label.

The CDC noted in its Health Alert Network message that data from Sanofi's routine stability testing of vaccine lots that had already been shipped to providers indicated that while the lots remained potent, they are losing potency more rapidly than expected. The company said the pre-filled syringe doses in the affected lots should be used by Feb 15, 2010, regardless of the expiration date shown on the package. This revised expiration date does not apply to vaccine in multi-dose vials.

There are 50 lots subject to yesterday's expiration change, comprising 12 million doses. Fourteen of the lots are single-dose pediatric flu vaccine, and the remaining 36 are single-dose vaccine for older children and adults. The lots were shipped to providers between November 2009 and January 2010.

The CDC reported there are no safety concerns with the affected lots and that people who were immunized with doses from the lots do not need to be revaccinated.

The CDC reported its notice yesterday applies to the 50 specified lots of vaccine; however that the expiration date change and two earlier non–safety-related recalls apply to all of Sanofi's pandemic pre-filled syringe vaccine doses.

The CDC emphasized that though most of the doses have already been administered, it was almost certain that some haven't yet been used.

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FDA Warns Millipore on A(H1N1) Treatment Promotion

2 February

The FDA issued a warning to Millipore concerning its products purported to diagnose, mitigate, prevent, treat or cure the A(H1N1) virus. In the warning letter, the FDA stated, "These products have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus." The products addressed in the warning letter include the Light Diagnostics™ brand respiratory screens and panels and the SimulFluor® Flu A/B typing kit.

The FDA stated that the marketing of those products violates the Federal Food, Drug, and Cosmetic Act (FFDC Act) and requested that Millipore immediately cease marketing unapproved, uncleared, or unauthorized products for the diagnosis, mitigation, prevention, treatment, or cure of the A(H1N1) virus.

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Researchers Find that Pulmonary Embolism Can be an After-effect of A(H1N1) Infection

27 January 2010

Maureen McFadden of WNDU reports that University of Michigan researchers found that patients who suffered from a severe case of A(H1N1) are at a high risk for serious lung complications. "One interesting thing we found was a high incidence of PE, or pulmonary embolism," says Dr. Prachi Agarwal, cardiothoracic radiologist at the University of Michigan. CT scans revealed one third of A(H1N1) patients in the ICU developed a pulmonary embolism.

A pulmonary embolism (PE) occurs when one or more arteries in the lungs become blocked. Symptoms of PE include difficulty breathing, chest pain and heart palpitations. PE can be treated with blood thinners, but if it is not treated promptly or identified, it can be deadly.

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Hawaiian Laboratory to Test A(H1N1) Specimens from Island Populations Outside Hawaii

21 January 2010

Jim Mendoza of Hawaii News Now reports that the State Laboratories Division, funded with a $471,000 grant, will be receiving and testing specimens from ten laboratories around the Pacific.

"The Federated States of Micronesia, Chuuk, Pohnpei, Kosrae, Yap, Palau, Guam, Commonwealth of Northern Marianas Islands, along with the Marshall Islands and American Samoa" will be included, according to Michael Epp of the Pacific Island Health Officers Association.

The Hawaiian laboratory will turn around test results within 48 hours. The contract duration for these activities is one year.

"The sooner we can report back to disease investigators, the sooner we can identify trends," said Chris Whelen, administrator for the State Laboratories Division. "The good thing about the contract is it allows me to hire people and that's a good thing in a down economy," he added. It also enables the state laboratory to purchase equipment.

As part of this contract, the island nations and territories will become Hawaii's partners in a disease surveillance network.

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USDA Reports that Pork from Pigs Exposed to A(H1N1) is Safe to Eat

21 January 2010

According to a recent study by the USDA Agriculture Research Service, pork from pigs exposed to the A(H1N1) virus is safe to eat.

Researchers noted that sick hogs are not allowed entry into the U.S. food supply as per USDA Food Safety and Inspection Service criteria, but they stated that their findings support the World Health Organization recommendation that pork harvested from A(H1N1)-infected hogs is safe to eat.

In this study, non-respiratory tract tissues were analyzed for the virus following infection of young pigs with the A(H1N1) virus. Researchers found that while the A(H1N1) virus can induce respiratory disease in hogs, no evidence was found for systemic infection that would contaminate meat with the virus.

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Many Children Overdue for Second A(H1N1) Flu Vaccination

15 January 2010

WSYR News reports that many children under age 10 are now overdue for their second dose of the A(H1N1) vaccine. Kids under 10 need a booster vaccine to make enough antibodies to be fully protected from the virus.

Only about one in five people has been vaccinated against the A(H1N1) virus, but that is a good number according to the Centers for Disease Control and Prevention. Among the findings of a new survey published by the CDC today was that 61 million people have been immunized since the vaccination became readily available in October.

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No U.S. State Reported Widespread Cases of A(H1N1) Flu in Past Week

15 January 2010

According to a CDC report released today, no U.S. state reported widespread A(H1N1) flu activity during the first week of 2010. Additionally, visits to doctors for influenza-like illness in the U.S. fell below the national baseline for the first time since late October 2009. "No states reported widespread influenza activity; a decline of one state from last week. Nine states continue to report regional influenza activity. They are: Alabama, Georgia, Hawaii, Maine, Nevada, New Jersey, New Mexico, New York, and Virginia," the CDC reported on its web site. It also stated, "Overall hospitalization rates are declining."

Although the number of A/H1N1 flu cases is declining, health officials stress that there could be a resurgence of the disease and urge people to get vaccinated to protect themselves and their families were this to occur. "Flu is unpredictable, and this flu season is far from over," Kathleen Sebelius, secretary of Health and Human Services, said earlier this week. "Flu season typically lasts until May, and we don't know whether there will be additional waves of flu illness," she explained, adding that the A/H1N1 virus is still circulating, still dangerous, and there are still lives to be saved.

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A(H1N1) Virus Spreads More Easily During Plane Travel

08 January 2010

The Times of India reports that researchers at the University of California, Los Angeles, have used novel mathematical modeling techniques to predict in-flight transmission of A(H1N1) virus. Dr. Sally Blower, Bradley Wagner, and Brian Coburn found that transmission could be significant, particularly during long flights, if the infected individual travels in economy class. Two to five infections could occur during a five-hour flight, five to 10 during an 11-hour flight, and seven to 17 during a 17-hour flight.

"Importantly, we found that the number of infections that would occur on a flight was very dependent on which cabin the infected individual was sitting in. We found that many infections could occur if the infected individual was traveling in economy class but relatively few if the individual was traveling in first class," said Blower.

The researchers also investigated why more infections occur in economy class. "Primarily, it's the more crowded conditions in economy. And unfortunately, there is a very high probability — 75 percent — that if an infected person is on board, they [sic] will be in the economy cabin," said Coburn.

The researchers noted that their results have important implications for understanding and predicting the global dissemination of A(H1N1) virus, suggesting that air-travel restrictions may be useful in controlling influenza pandemics. "Our results imply that one individual traveling by plane, by infecting other travelers on the same flight, could cause multiple simultaneous outbreaks in different geographic locations rather than causing only one outbreak. For that reason, quarantining passengers who travel in economy class on long-haul flights could potentially be an important control strategy this winter, but there is no point quarantining passengers in first class," said Wagner.

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A(H1N1) Virus Could Pose Increased Risk of Severe Illness to Pregnant Women

07 January 2010

Grant Babner of My Way Business reports on a California Department of Public Health study that found that one-third of the pregnant women studied developed risk factors for complications from influenza. Twenty-two percent of pregnant women required intensive care and eight percent died from the illness. The study followed 94 pregnant women, 8 women who were postpartum, and 137 women that were not pregnant, all of which were hospitalized with the A(H1N1) virus during a four month period in 2009.

The most commonly reported symptoms among pregnant patients were cough, fever, sore throat, shortness of breath, muscle aches, and nausea or vomiting. Shortness of breath, muscle aches, and diarrhea were significantly more common among non-pregnant patients than among pregnant patients.

The study, which was published in the New England Journal of Medicine concluded that "H1N1 influenza can cause severe illness and death in pregnant and postpartum women; regardless of the results of rapid antigen testing, prompt evaluation and antiviral treatment of influenza-like illness should be considered in such women."

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A(H1N1) Vaccines Arrive in Mongolia as Outbreak Appears to be Slowing

08 January 2010

P. Shinebayar of the UB Post reports that after several delays, 100,000 WHO-donated A(H1N1) vaccine doses arrived in Mongolia on 7 January 2010, and 170,000 vaccine doses are expected to arrive later this month. The vaccine will be distributed to provincial hospitals.

According to the Health Ministry, there are 1251 laboratory-confirmed cases of A(H1N1), 814 of which were registered in the capital of Ulaanbaatar and 437 in rural provinces. The Khovsgol Province, which is the most northern of Mongolia's 21 provinces, is currently under quarantine due to an increasing number of reported A(H1N1) infections.

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A(H1N1) Vaccine Trials to Start Soon in Hyderabad, India

06 January 2010

The Hindu reports that A(H1N1) vaccine trials, also known as bridging trials, will be conducted at Government Chest Hospital at Erragadda by the end of February. If the trials succeed, the first A(H1N1) vaccine could be available by April. Depending on their success, the Indian government could import 1.5 to 2 million doses of the A(H1N1) vaccine.

Chest Hospital doctors will determine how many people in targeted risk groups like pregnant women, children, healthcare workers and persons with co-existing morbidities will need to be inoculated.

"Bridging trials are needed 'til [an] indigenous H1N1 vaccine is developed. The trial will help assess safety and tolerance among the diverse population in India. Several other hospitals in the country will also take part in the trials," State A(H1N1) Coordinator K. Subhakar told The Hindu.

Top pharmaceutical companies including GSK, Novartis, Sanofi Pasteur, and Baxter have expressed interest in importing the A(H1N1) vaccine into India. However, the A(H1N1) vaccine could only be used in a government-run inoculation program and only after the successful completion of bridging studies.

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Flu Vaccine Ineffective in Arthritis Patients Treated with Rituximab

06 January 2010

Thomas H. Maugh of the Los Angeles Times reports that according to a study published in the journal Arthritis & Rheumatism by Dutch researchers, arthritis patients being treated with the drug rituximab should be given flu vaccinations immediately before treatment begins or several months later, but not in the first two months after treatment.

The vaccine is not dangerous when given after treatment with the drug, but it also provides no benefit because it fails to stimulate the production of antibodies against the flu virus. However, other drugs used to treat arthritis have no effect on immunization.

Dr. Sander van Assen of the University Medical Center Groningen in the Netherlands conducted the study on 23 patients with rheumatoid arthritis who were taking rituximab, 20 patients taking methotrexate, and 29 healthy individuals, all of whom were given the seasonal flu vaccine. Among those taking rituximab, 11 received the vaccine four to eight weeks after treatment and 12 were given it six to 10 months after treatment. The team reported that those given the vaccine in the weeks after treatment developed no protective antibodies, while those given the vaccine later developed some antibodies but not as many as healthy people. Those taking methotrexate developed normal amounts of antibodies. The doctors recommended that patients being treated with rituximab be given the vaccines for seasonal flu and swine flu preemptively before treatment begins.

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CDC disagrees with WHO about influenza A(H1N1) having peaked in the U.S.

25 November 2009

Richard Martin, a St. Petersburg Times reporter, writes that despite a slight decrease in influenza A(H1N1) activity in the United States in recent weeks, the spread of the virus could start increasing again with the beginning of the holiday season as more people congregate at shopping malls, airports, and family gatherings. The article quotes Dr. Anne Schuchat, the director of CDC's National Center for Immunization and Respiratory Diseases, as having said that 43 states continue to report widespread influenza A(H1N1) as compared to 46 states a couple of weeks earlier. Based on these figures, WHO suggests that influenza A(H1N1) may have peaked in the United States, but Dr. Schuchat does not agree with this opinion: "I wish I knew if we had hit the peak. We don't know if these declines will persist, what the slope will be, whether we'll have a long decline or if it will start to go up again." She expects that "the next several weeks will be busy ones as people increase travelling over the holidays."

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Poor response to influenza A(H1N1) demonstrates America's lack of preparedness for bioterrorist events

24 November 2009

Washington Times reporter Tom LoBianco writes that influenza A(H1N1) has become the vehicle for a homeland security message that former Senators Bob Graham and Jim Talent have been trying to deliver over the past year. The Florida Democrat and Missouri Republican, who presided over a congressional panel charged with assessing terrorist threats and weapons proliferation, say that even though bioterrorism — not nuclear proliferation — is the nation's leading terrorist threat, the country is not equipped to respond quickly. "This is an epidemic that didn't just attack us by ambush, we've had much time to prepare, yet many people who want to get the vaccine have been denied so because of inadequate technology," Mr. Graham said, referring to the growth and spread of influenza A(H1N1) virus since April.

Mr. Graham and Mr. Talent have written that "the federal government has established efforts to address the problem but has yet to funnel the money needed into the lead program. To date, the U.S. government has invested the largest portion of its nonproliferation efforts and diplomatic capital in preventing nuclear terrorism. Only by elevating the priority of preventing bioterrorism will it be possible to substantially improve U.S. and global biosecurity." More recently, noting President Obama's trip to Asia and his focus on nuclear capabilities, Mr. Graham stated, "I'm a little concerned that there is this tendency to talk about this threat solely in the nuclear context."

The rush to manufacture millions of doses of A(H1N1) influenza vaccine highlighted problems with a vaccine-manufacturing process developed before the Cold War that has never been updated. Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, is quoted as stating:

"The question is, 'Why do you stick with this fragile, yet time-honored process of growing it in eggs?' The typical vaccination process works well for the seasonal flu — updating the vaccine starting in the winter, then manufacturing it over the course of six to eight months before the next flu season starts. Pharmaceutical manufacturers have not had the financial incentive to spend the billions of dollars necessary to upgrade the manufacturing process (a vaccine is sold and administered far less frequently than other, more profitable medications), which is why the government needs to support any effort. The real endgame is to bring the technology into the 21st century and use molecular biological techniques so you can really have control about making the purified proteins that you want."

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Tamiflu prices vary from state-to-state

18 November 2009

Alison Young, a writer for USA Today, has conducted a survey of prices charged for Tamiflu by more than 100 pharmacies in Pennsylvania, Louisiana, Michigan, Kansas, Colorado, and California. He found that the liquid form of Tamiflu (a form of the drug taken mostly by children) varied from a low of $43 to a high of $130. In Michigan, for instance, pharmacies charge between $49 and $94 per dose, whereas in California charges are between $55 and $130. Due to substantial price variations in their respective states, Attorney Generals in Connecticut and Mississippi have opened investigations on Tamiflu pricing.

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Common cold may interfere with infection by influenza A(H1N1) virus

12 November 2009

Debora MacKenzie, a writer for New Scientist, reports that some French, Swedish, Norwegian, Dutch, and Australian researchers suspect that rhinovirus (a common cold pathogen) infection may block the spread of influenza A(H1N1). According to Ab Osterhaus, a researcher at the University of Rotterdam in the Netherlands, this process, which is called "viral interference," works in the following way: "We think that when you get one infection, it turns on your antiviral defences, and thus excludes other viruses." If suspicions that rhinovirus blocks the spread of influenza A(H1N1) turns out to be true, it would explain why the spread of influenza A(H1N1) has slowed in some European countries.

It remains unclear, however, how important viral interference is in viral epidemics, because interference between two viruses may also not occur, which means that a person could become infected concurrently with both viruses. According to the article, it is normally impossible to observe how rhinovirus affects influenza viruses as flu epidemics usually occurs in winter, whereas rhinoviruses tend to spread during the beginning of the school year.

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FDA expands approved use of influenza vaccines to include infants and children

12 November 2009

The U.S. Food and Drug Administration (FDA) has approved the use of the CSL Limited's (an Australian pharmaceutical company) influenza A(H1N1) and seasonal flu vaccines in children aged six months and older. Previously the vaccine was approved for use only in adults. The approval came after a study involving children demonstrated that CSL Limited's seasonal flu vaccine was safe and efficacious by inducing antibody production against influenza virus. FDA's announcement includes a comment by Commissioner Margaret A. Hamburg stating: "Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children's vaccines available is an important step in responding to the H1N1 outbreak."

According to the FDA, the most common adverse events that affect children having received seasonal and influenza A(H1N1) vaccines are pain, redness, and swelling at the injection site. Rarer side effects are irritability, loss of appetite, and drowsiness. Because CSL's vaccines contain a small amount of egg protein, anyone allergic to eggs or egg products should avoid them. The vaccines will be packaged in pre-filled syringes, each of which contains a single, preservative-free dose. The vaccines will also be available in multi-dose vials that contain thimerosal, which is a mercury derivative preservative. More information about the FDA's approved influenza A(H1N1) vaccines is available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm.

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Google launches a special Maps tool for locating influenza vaccine

10 November 2009

Don Reisinger, the author of a technology column for Cnet, reports that Google has added a new tool to its Maps section that Internet users can use to search for influenza vaccine provider by Zip code or town name. However, Google has not yet received information from 30 states on sites that provide injectable influenza vaccine. Also, depending on the area, Internet users may find clinics listed that actually have run out of influenza vaccine. Google created its flu shot page in collaboration with the CDC, state and local health agencies, U.S. Department for Health and Human Services, Flu.gov, American Lung Association, and Walgreens and CVS pharmacy companies. The tool can be found at: http://www.google.com/flushot.

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Health officials register first Tamiflu-resistant influenza A(H1N1) human-to-human infection

29 October 2009

Health Day News reports that CDC has confirmed the first case in the U.S. of a Tamiflu-resistant A(H1N1) influenza virus passing between two people at a summer camp in North Carolina that had 600 participants. Even though all campers and staff members received Tamiflu to prevent influenza A(H1N1), 65 of them became infected with the virus and thereupon received Tamiflu treatment. Health officials later discovered a mutated version of the virus in two female campers who were sharing a cabin. Since health officials did not discover the mutated influenza A(H1N1) virus in the other 63 sick campers, they believe that it is resistant to Tamiflu.

The article quotes Dr. Natalie Janine Dailey, an epidemic intelligence service officer with the North Carolina Division of Public Health Communicable Disease Branch, as stating: "It is likely that this resistant virus was passed from one camper to the other based on the timing between the illnesses and 2 genetic mutations found in the virus in both campers. This suggests that using oseltamivir to prevent influenza in healthy people may increase the risk of resistance." Therefore, Dailey believes that the influenza A(H1N1) vaccine, instead of antivirals, is a more efficient way of protecting people against the virus, although treatment with antivirals should begin immediately in hospitalized influenza A(H1N1) patients and high risk target populations such as pregnant women, children under the age of two, and people with underlying health conditions.

So far, almost all strains of influenza A(H1N1) virus have responded to both oseltamivir (Tamiflu) and another antiviral called zanamivir (Relenza), while displaying resistance to amantadine, a drug in a different class. As a result, health workers tend to use Tamiflu and Relenza for both the prevention and treatment of influenza A(H1N1).

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Influenza A(H1N1) "pushing hospitals to their limit"

27 October 2009

Steve Sternberg, a writer for USA Today, reports that hospitals throughout America are struggling with the increasing number of influenza A(H1N1) patients who are flooding emergency rooms. Even though only a relatively small number of influenza A(H1N1) patients require intensive care, the few patients who are so ill as to require round-the-clock care for weeks has led to some hospitals cancelling services such as elective surgery.

The article quotes the President's Council of Advisors on Science and Technology as having predicted that if 30 percent of the U.S. population contracts influenza A(H1N1), over 90 million could suffer illness; of these, 1.8 million would be hospitalized and 30,000 or more would die. The Trust for America's Health, a non-profit public-health advocacy group, reported in early October that if the infection rate reaches 35 percent, many states may run out of hospital beds, forcing hospitals to cancel elective procedures. According to Eric Toner of the University of Pittsburgh Center for Biosecurity, at most American hospitals, however, influenza A(H1N1) has had "very little impact on patient care - except in ICUs."

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Best and worst states for influenza A(H1N1) vaccine information

27 October 2009

Courtney Hutchison, a writer for ABC News, after having analyzed influenza-related web sites state-by-state reports that some states are doing a better job than others in informing their inhabitants about vaccine availability. She found, for instance, that New Jersey, Wisconsin and Kansas, are providing their inhabitants with vaccine locating tools, lists of local doctors who are willing to provide the vaccine, and phone numbers for hotlines devoted to helping the public locate a influenza A(H1N1) vaccine clinic or a nearby doctor. Conversely, web sites in Alabama and Mississippi relate little information about influenza A(H1N1) vaccine availability, stating only that people should "contact their health provider" or that information is "coming soon." According to Hutchison, it is up to state and local health departments to inform the public when vaccine will be arriving to their area and where those eligible can obtain it. It is essential that states have means of communicating with the public so that when vaccine supply increases in availability more than it currently is, residents will know how and where to obtain it.

Information about influenza A(H1N1) vaccine availability in Monterey County is located at http://www.co.monterey.ca.us/health/HealthOfficer/IZ/fluSeason.asp

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Why such a shortage of influenza A(H1N1) vaccine?

27 October 2009

In an article, Washington Post reporters Michal D. Shear and Rob Stein discuss reasons for the shortage of influenza A(H1N1) vaccine. In July, Obama administration officials asserted that vaccine manufacturers would produce 80 - 120 million doses by mid-October, but as of October 27 only about 16.5 million doses have become available. The vaccine shortage has caused practical and political problems. On the practical side, local governments have been forced to shift vaccination campaigns and limit access to the vaccine to priority groups. The resulting confusion and frustration at vaccination have led to government officials to pressure vaccine manufacturer executives to explain why their optimistic forecasts about vaccine's availability ended up so far off the mark.

The article quotes Health and Human Services Secretary Kathleen Sebelius as stating that her department has been "relying on the manufacturers to give us their numbers, and as soon as we got numbers we put them out to the public. It does appear now that those numbers were overly rosy." Her deputy Nicole Lurie added that vaccine manufacturers "hit some stumbling blocks, they sometimes thought the fix was around the corner and didn't always feel the need to tell us, and then sometimes it turned out the fix wasn't around the corner." She also refused to make any projections about whether 50 million vaccine doses would become available by November and 150 million by December, as leading health officials have previously promised. Vaccine makers' representatives claim that they have been keeping the government informed about production challenges, including a slower-than-expected growth of vaccine virus in chicken eggs.

The article also quotes David P. Fidler, a professor of health law at Indiana University, as stating that: "Are we going to see this sort of nationwide impact that's also going to be seared in the nation's mind in the way Katrina was? One of the possibilities is that the administration and state governments will lose their credibility, because the response strategies and the promises made about the vaccine, at least in the public's eye, the promises will look again like empty promises."

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AMA launches nation's first comprehensive web-based flu health-assessment program for patients and physicians

22 October 2009

The American Medical Association (AMA) has launched the nation's first comprehensive web-based patient flu health-assessment program, located at www.amafluhelp.org. This program helps patients and physicians better communicate and improve care coordination. It walks patients through a series of questions to help them determine the severity of their influenza symptoms based upon the latest CDC guidelines. Patients can choose to share their information with their physician, as well as family members. It also provides a set of online tools to help physicians monitor their patients' symptoms, facilitate care and treatment decisions, and efficiently manage their practices' patient flow. Furthermore, the program contains a special section for pregnant women to evaluate their need for an influenza vaccination and for all patients to monitor any post-vaccine related symptoms.

Personal information entered into the program is private, secured through Microsoft HealthVault and it is inaccessible without consent from the user. The AMA has collaborated with a broad-based coalition established under the Flu Information & Care System (FiCS) to promote the new portal, including AllOne Health, BlueCross NEPA, CVS Caremark, EMSC, HealthyCircles, HERAE, Merck, MedImpact, Microsoft, Minute Clinic, Schumacher Group, Staywell/Krames, Team Health, and WorldDoc.

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First human-to-ferret influenza A(H1N1) case recorded in the U.S.

20 October 2009

Jacques Von Lunen, a writer for Oregon Live, reports that Oregon has registered its first case of human-animal transmission of the influenza A(H1N1) virus when a pet ferret, whose owner had presented flu-like symptoms, tested positive for influenza A(H1N1). According to the state's public health veterinarian Emilio DeBess, ferrets have been used in labs as an animal model to study how the flu virus affects people, but this may be the first case anywhere of a ferret becoming infected with its owner's flu. DeBess advises pet owners to avoid coughing and sneezing near other people and pets and to wash their hands often. The article also claims that so far no influenza A(H1N1) cases have been recorded in birds, cats, or dogs.

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First case in the U.S. of influenza A(H1N1) confirmed in a hog

19 October 2009

Christopher Doering and Charles Abbott, writers for Reuters, report that a hog has tested positive for the pandemic influenza A(H1N1) virus for the first time. The hog was exhibited at the Minnesota State Fair where four teenagers also became sick with the same virus. The article quotes a U.S. Department of Agriculture's (USDA) announcement "information available at this time would suggest the children were not sickened by contact with the pigs at the fair."

Influenza A(H1N1) is common world-wide in hogs. Until now, the closest to the U.S. where this virus has been detected in hogs was Canada. Since show pigs do not usually come into contact with pigs raised for slaughter in pig factories, spread of A(H1N1) influenza to the pig industry in not necessarily imminent. USDA officials once again emphasized that people cannot become infected with influenza A(H1N1) virus by eating pork products. Despite this fact, however, seven countries, including China, have banned U.S. pork imports.

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Florida plan advises hospitals to bar some patients in event of severe flu pandemic

17 October 2009

Sheri Fink, a writer for Sun Sentinel, reports that Florida health officials are drawing up guidelines that include recommendations for barring patients with incurable cancer, end-stage multiple sclerosis, and other conditions from being admitted to hospitals if the state is overwhelmed by flu cases. The guidelines, which would guide Florida hospitals on how to ration scarce medical care during a severe flu outbreak, calls for doctors to remove patients with poor prognoses from ventilators and use the released ventilators to treat those who have better chances of surviving. The Florida guidelines also call for intensive care unit patients and those using ventilators to be reassessed after 48 to 72 hours. Those whose chances of survival have significantly worsened would be taken off the machines or discharged from critical care to make way for others who may have a better chance of survival. Patients with significantly worsened survival chances would be given palliative care as needed to keep them comfortable. In case of a significantly worsening situation, Florida's draft guidelines call for hospitals to turn away anyone whose doctor has signed a "Do Not Resuscitate" order, which instructs rescuers not to revive a patient whose heartbeat or breathing stops.

The article quotes professor Ken Goodman, Director of the University of Miami bioethics program and the Florida Bioethics Network, stating that Florida's guidelines need to be balanced with an effort to distribute scarce resources in the least discriminatory way and that methods included in the draft are still imperfect: "Among the ways we can do that is to somehow take the evidence about what we think works and bolt it to the values that I think are uncontroversially shared: Namely, life is good, suffering is bad. It's a very difficult problem to figure out how the world of science can help ensure that our strategies for allocating resources are fair and effective."

As the situation now stands, Florida health officials believe that the number of severely ill flu patients will likely remain at a manageable level provided that its residents become vaccinated, they know when to stay home and when to seek medical care, and the currently circulating flu strain does not mutate into a more virulent form.

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Walgreens, CVS shifting efforts from seasonal flu to influenza A(H1N1)

16 October 2009

Bloomberg reports that Walgreen Co. and CVS Caremark Corp will stop providing seasonal flu vaccines at many of their locations and instead will concentrate on influenza A(H1N1) immunizations. According to Bloomberg, some of Walgreen's clinics have already run out of seasonal influenza vaccine and the company has decided not to restock its seasonal flu vaccine once out of stock. The article states that CVS will halt its seasonal flu clinics on October 22nd. CVS will, however, depending on vaccine availability, continue to offer seasonal flu vaccine at its 500 pharmacies throughout the ongoing flu season. The article also highlights the heightened public awareness of seasonal influenza and the fact that drug manufacturers have to produce influenza A(H1N1) and seasonal influenza vaccine simultaneously as main reasons why manufacturers are falling behind in delivering both vaccines.

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FDA warns of unapproved and illegal influenza A(H1N1) drug products purchased over the Internet

15 October 2009

The U.S. Department of Health and Human Services' U.S. Food and Drug Administration (FDA) has warned consumers to be careful when purchasing products over the Internet with claims that they can be used to diagnose, prevent, treat, or cure A(H1N1) influenza. FDA issued this warning because it has recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), but which are not and in fact may pose risks to patients. Among the counterfeit products that the FDA analyzed were Indian-made unlabeled tablets containing talc and acetaminophen, but none of which contained Tamiflu's active ingredient oseltamivir. Furthermore, even if these counterfeit products were to contain oseltamivir, their manufacturers would not have FDA approval to be used in the U.S.

FDA has approved Tamiflu (oseltamivir phosphate) and Relenza (zanamivir) for treatment and prophylaxis of A(H1N1) influenza virus when manufactured by ethical pharmaceutical companies. These products have Emergency Use Authorizations that describe specific authorized uses during this public health emergency. More recommendations about how to protect purchasers of medicines online is available at http://www.fda.gov/Drugs/ResourcesForYou/ucm080588.htm

Commissioner of Food and Drugs Margaret A. Hamburg warns that: "Medicines purchased from Web sites operating outside the law put consumers at increased risk due to a higher potential that the products will be counterfeit, impure, contaminated, or have too little or too much of the active ingredient." The FDA urges consumers to only purchase FDA-approved products from licensed pharmacies located in the United States and to contact their health care provider if they have any questions about medical products.

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State health leaders busy battling myths about influenza A(H1N1) vaccine

14 October 2009

Robert Roos, a writer for CIDRAP, reports on top U.S. health officials' concerns that a significant portion of their current work consists of refuting rumors and myths about the influenza A(H1N1) vaccine. The article quotes Tennessee Health Commissioner Susan Cooper as explaining that: "We've been spending an inordinate amount of time lately saying the vaccine is made just like seasonal flu vaccine. There's this misperception that keeps getting heightened in the media that this vaccine was rushed to market, that corners were cut, that there's some special way this was made that's different from seasonal flu [vaccine], but then you get a talking head saying, 'Well, they're lying to you.' That then complicates the messaging."

Also noted by Roos is that according to recent polls, about 50 percent of parents will allow their children to become vaccinated against influenza A(H1N1) virus and 61 percent of respondents said they would definitely or probably agree to be vaccinated against influenza A(H1N1) if vaccine becomes available to them.

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Most influenza A(H1N1) victims had underlying conditions

13 October 2009

Maggie Fox, a Health and Science editor for Reuters, reports on the largest study yet conducted on influenza A(H1N1) cases in the U.S. The CDC-led study examined detailed data on 1,400 adults and 500 children hospitalized with influenza A(H1N1) in 10 states. Six percent of the observed population groups were pregnant. One of its important findings was that 55 percent of Americans who have died from influenza A(H1N1) had underlying conditions such as asthma, chronic lung disease, chronic heart disease and immunosuppression, or neurological or neuromuscular diseases. The study also found that similarly to seasonal flu, children with sickle cell anemia and other blood diseases are particularly threatened by influenza A(H1N1).

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Psoriasis patients taking immunosuppressive drugs at increased risk from influenza A(H1N1)

13 October 2009

Medical News reported on a National Psoriasis Foundation recommendation urging psoriasis and/or psoriatic arthritis patients who are taking biologic (Amevive, Enbrel, Humira, Remicade, Simponi or Stelara) or non-biologic immunosuppressive medications (cyclosporine-Neoral or methotrexate) to receive both seasonal and influenza A(H1N1) vaccines as soon as possible. According to Medical News, psoriasis patients taking immunosuppressive medication should take care to receive only the inactive version of both seasonal and influenza A(H1N1) vaccines, both of which are available in inactivated and live forms.

The article quotes Mark Lebwohl, Professor and Chairman of Dermatology at the Mount Sinai School of Medicine and Chair of the National Psoriasis Foundation Medical Board: "For most people, flu is an annoying aspect of winter. For people with psoriasis and psoriatic arthritis who are taking immunosuppressive drugs, it can be a much more serious health threat. With the addition of influenza A(H1N1) as a concern this year, we urge everyone on these drugs to take extra precaution." National Psoriasis Foundation also recommends psoriasis patients to discuss the risk and benefits of vaccination with their doctor and follow the immunization information for the general population available on the CDC web site.

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U.S. and other nations stop counting pandemic flu cases

9 October 2009

Mike Stobbe, a Medical Writer for Associated Press, reports on an announcement made by Andrew Pekosz, a flu expert at Johns Hopkins University, claiming that even though the current monitoring system for influenza A(H1N1) is adequate, public health analysts do not have enough information about the spread of the virus after U.S. and other governments stopped counting confirmed influenza A(H1N1) cases. According to Pekosz, the current monitoring system provides too little information about how influenza A(H1N1) affects different population groups. For instance, it is unclear to what extent children, young adults, pregnant women, and other risk groups are likely to become infected with influenza A(H1N1) virus in comparison to other groups.

Currently, methods for recording influenza A(H1N1) cases vary from state to state. For example, some states report only laboratory-confirmed cases to the Centers for Disease Control and Prevention (CDC), whereas others report illnesses that could be influenza A(H1N1), seasonal flu or other respiratory diseases. The CDC itself utilizes nine methods for monitoring influenza. Some methods focus on people who die from flu-like illness, one tracks deaths in children, another records pneumonia and flu deaths of all ages in 122 cities.

The article highlights state budget shortfalls as one of the reasons that explains why monitoring influenza A(H1N1) cases is less than comprehensive. For example, in 2008 state officials cut 7,000 health department jobs and additional 8,000 during January-June 2009.

Difficulties regarding recording influenza A(H1N1) cases are not unique to the U.S. WHO also stopped recording influenza A(H1N1) cases in July, after deciding that tracking individual influenza A(H1N1) cases was too labor-intensive for countries where the virus was spreading widely. WHO has continued to update influenza A(H1N1) reports, but with the disclaimer that since countries are no longer required to report cases, WHO's statistics about influenza A(H1N1) infection rates are underestimates. Great Britain also releases weekly influenza A(H1N1) updates, but these reports include estimates based on how many people visit their doctors with flu-like illness that may be unconnected to A(H1N1).

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U.S. flu study confirms A(H1N1) is more serious for the younger population

8 October 2009

Maggie Fox, a health and science editor for Reuters, reports on a study confirming that the younger population has a greater risk of becoming infected with influenza A(H1N1) and that younger people are also more likely to experience symptoms peculiar to that age group. The study investigated 272 hospitalized influenza A(H1N1) patients, of whom 45 percent were younger than 18 years. (The majority of seasonal flu victims are middle-aged or older.) 40 percent of examined patients experienced diarrhea and vomiting, which seasonal flu victims rarely exhibit.

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Areas hit hard by flu in spring now see little flu activity

8 October 2009

Anemona Hartocollis and Donald G. McNeil Jr., writers for New York Times, report that New York, Boston, Philadelphia, and other areas that experienced large influenza A(H1N1) outbreaks during spring 2009 currently are registering fewer than usual seasonal flu cases for this time of year. New York health officials believe that people who became infected with influenza A(H1N1) in spring have since then developed immunity, and this prevents the virus from spreading. Although it is too early to be sure, as regular flu season usually peaks in January, New York health officials claim that the high level of immunity may lead to a smaller influenza A(H1N1) infection rate than expected during the current flu season. Nevertheless, the city is conducting an extensive influenza A(H1N1) immunization campaign.

Dr. Martin S. Cetron, a flu expert at the CDC and the co-author of a 2007 study describing how the 1918 flu affected 43 American cities, states in the article that it is too early to conclude whether areas that experience high influenza A(H1N1) infection rates in spring will experience low infection rates this winter. Cetron is quoted as stating that "To say, Oh, all of us in New York are immune, we won't have any more disease and we don't need to take vaccine, is a dangerous conclusion to draw."

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Microsoft launches an online influenza A(H1N1) response center to support consumers

7 October 2009

Microsoft announced that it has established the H1N1 (Swine flu) Response Center, which is an online service that aims to help people learn whether they have the symptoms of H1N1 flu (swine flu) and, if they do, gives guidance about next steps. The service is based on self-assessment questions and guidance that were developed by Emory University experts. By effectively "triaging" potential flu cases online, patients, health care providers, and the public can help limit their exposure to the flu virus as well as wait times for health care services.

If a person decides to see a health provider after taking the assessment, a prepare-for-visit tool allows for compilation of an organized health history for providers. This history combines answers from the self-assessment with health information stored in the user's Microsoft HealthVault account (a personal health application platform designed to put consumers in control of their health information). HealthVault enables individuals to act on their assessment through partners such as TelaDoc, which offers telephone consultations, and American Well, which connects individuals to their health plan physicians for video, chat or telephone consultations.

Microsoft launched the H1N1 Response Center (http://www.h1n1responsecenter.com), in response to concerns that hospitals and physicians' offices may experience an overload of patients seeking determine whether they are infected with influenza A(H1N1). The announcement quotes Angela Gardner, president of the American College of Emergency Physicians as saying that: "If current estimates are correct, many emergency departments across the nation could be overwhelmed by two groups of patients — those who have H1N1 and those who believe they have H1N1. It is going to be essential that we use every tool and service at our disposal to contain this illness, and online H1N1 self-assessment tools, such as the one offered by Microsoft, can be helpful in providing people with ways to determine whether they should seek emergency care."

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Survey finds just 40 percent of adults "absolutely certain" they will get A(H1N1) vaccine

2 October 2009

Harvard School of Public Health (HSPH) reports that according to its recent survey, only 40 percent of adults are "absolutely certain" they will agree to receive the A(H1N1) flu vaccine for themselves, and 51 percent of parents are "absolutely certain" that they will permit their children to receive the vaccine. The main reasons why people do not want to vaccinate themselves against the A(H1N1) include: (1) they are concerned about side effects of the vaccine; (2) they do not think they are at risk of contracting a serious case of the illness; (3) they think they could receive medication to treat A(H1N1) if they do become sick, and (4) they do not trust public health officials to provide correct information about the vaccine's safety. However, an additional finding was that if the A(H1N1) pandemic was to become severe, respondents would be likely to change their minds about being willing to receive the vaccine. In view of these findings, Robert J. Blendon, Professor of Health Policy and Political Analysis at HSPH, recommends that public health officials need to be prepared for a surge in demand for the A(H1N1) vaccine if the A(H1N1) flu was to become more severe than it is now.

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Seasonal flu vaccine delayed for some U.S. providers

1 October 2009

David A. Lieb, a writer for Associated Press, reports that Sanofi Pasteur is running behind on its shipping schedule for the seasonal flu vaccine because the company is also simultaneously producing the A(H1N1) influenza vaccine. Sanofi Pasteur, the largest U.S. supplier of seasonal flu vaccine, has so far shipped more than half of the 50.5 million doses of seasonal flu vaccine to U.S. health care providers.

Therefore, some of the company's customers may not get all of their orders before November. As a result, some doctors have been forced to turn away patients who are requesting seasonal flu vaccinations and public health officials have had to cancel scheduled community vaccination clinics. The article quotes Tom Skinner, a spokesman for the Centers for Disease Control and Prevention (CDC), as urging people to be patient and stating that the delay will not cause a big concern because about 70 million of the nation's expected 114 million vaccine doses have already been delivered.

Skinner emphasizes that currently the A(H1N1) flu is the dominant virus, whereas the seasonal flu usually peaks in January or later. Therefore, people should not be concerned about having to receive their flu shot later than planned. Walgreen Co., which has about 16,000 certified immunization providers in more than 7,000 pharmacies nationwide, encourages people who want to get a seasonal flu shot to do it now, even though the company expects its vaccine supplies to run out towards the end of December.

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First packages of A(H1N1) vaccine headed to states, cities

1 October 2009

Robert Roos, news editor for the Center for Infectious Research & Policy, reports that the first 600,000 doses of pandemic A(H1N1) vaccine should arrive to 25 states and major cities by October 6th. The article quotes Dr. Anne Schuchat of the CDC, as saying that the vaccine should become available later, in the week that starts on October 5th. According to Schuchat, the live-virus nasal-spray vaccine, which is made by MedImmune, will be the first to reach health providers. Like MedImmune's seasonal vaccine FluMist, the A(H1N1) vaccine is approved for healthy people aged 2 through 49 years, but not for pregnant women or people with chronic conditions that raise their risk for flu complications.

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A(H1N1) vaccine is top flu concern for U.S. businesses

30 September 2009

CNBC reports on a recent survey of U.S. businesses performed by the Business Roundtable whose main conclusion was that businesses' primary concern is whether A(H1N1) vaccine will be available to their employees. In addition, 35 percent of survey respondents said they need more information about the severity of A(H1N1) pandemic flu compared to seasonal flu. According to Business Roundtable President John Castellani "The findings are a reminder of how it is incumbent on the business community to work together with the government and other key parties to protect the health and well-being of our employees, fellow citizens, and communities in which we live and work."

Business Roundtable's member companies, which employ 10 million workers, represent one third of the U.S. economy. Currently, it is helping companies communicate A(H1N1) prevention advice to workers, using information from several government agencies, including the CDC, the Department of Health and Human Services, the Small Business Administration, the Department of Homeland Security, and the Occupational Safety and Health Administration.

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As A(H1N1) flu spreads among students, many schools lack nurses to respond to H1N1 outbreaks

25 September 2009

Terence Chea, a writer for Associated Press, reports that many school districts in the U.S. have few or no nurses to prevent or respond to A(H1N1) outbreaks, leaving students more vulnerable to a virus that spreads easily in classrooms and infects mostly children and young adults. The article refers to a 2008 survey conducted by the National Association of School Nurses that found that only 45 percent of public schools have their own full-time nurse, another 30 percent have a part-time nurse, and a quarter have no nurses. In California, for instance, roughly half of the state's 1,000 school districts do not have any nurses. According to this survey, the average nurse-to-student ratio nationwide was one nurse for every 1,151 students, but in 14 states there was only one nurse for more than 2,000 students.

School districts that have no nurses are depending on teachers, principals, and secretaries with little medical training to identify, isolate, and send sick children home, as well as monitor absences and illnesses for signs of a wider outbreak. The article refers to statements by Brenda Green, director of school health programs for the National School Boards Association, who has urged school districts without nurses to partner with local health agencies, hospitals, and nursing schools to prepare for A(H1N1) flu.

School districts all over the country that have nurses are developing plans to screen and quarantine sick students, teaching students proper classroom hygiene, urging parents to keep ill children at home, organizing vaccination campaigns, and instructing teachers and school staff how to identify sick students.

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Most parents won't have their children get A(H1N1) flu shots, study finds

25 September 2009

Melissa Healy, a writer for Los Angeles Times, reports on a poll conducted by the University of Michigan's C.S. Mott Children's Hospital that found that only 40 percent of U.S. parents plan to get their children immunized against the A(H1N1) influenza virus. Among those who said they do not intend to have their children vaccinated, 46 percent indicated they are not worried about their children becoming ill with the A(H1N1) virus and 20 percent said they do not believe that A(H1N1) flu is a serious disease. About half of the parents who said they would vaccinate their children against the A(H1N1) flu expressed concern about possible side effects of the vaccine. The Centers for Disease Control and Prevention has said that though serious complications of seasonal flu appear to spare most children and strike the elderly and very young most heavily, the novel A(H1N1) flu appears to hit children and young adults the hardest.

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Most Americans lacking direction from their employers for the H1N1 flu season, survey shows

21 September 2009

Reuters reports on a survey conducted by Mansfield Communications Inc. has found that 69 percent of American workers have not had any direction from their employers about the upcoming flu season, including information related to hand washing or sick leave. The survey also found that 84 percent of workers believe the recession creates more pressure for employees to report to work while being sick. Even though 80 percent of the respondents believe they are knowledgeable about precautions that should be taken if the A(H1N1) virus reached their workplaces, about half of them said that they would still engage in public activities such as riding busses, picking up a prescription, and doing grocery shopping, even when they were infected with A(H1N1) and required to stay home from their office due to a company-imposed quarantine.

The article quotes Rob Ireland, a partner at Mansfield Communications Inc., as saying: "Many workers are understandably concerned about how absenteeism due to sickness will impact their job security in the current economic environment. However, sick employees coming into the office during the H1N1 flu season will undermine the health and productivity of the entire workplace. Clearly, there is much to be done to educate America's workforce and help people act appropriately in order to contain the spread of H1N1."

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A(H1N1) Flu Death Rate Assertedly Similar to that of Seasonal Flu

16 September 2009

Maggie Fox, the Health and Science Editor for Reuters, reports that Dr. Marc Lipsitch of Harvard University claims the death rate from the pandemic A(H1N1) flu is likely lower than earlier estimates, stating that its mortality rate compares to a moderate year's rate of seasonal influenza. "Barring any changes in the virus, I think we can say we are in a category 1 pandemic. This has not become clear until fairly recently," said Lipsitich.

Normally, seasonal flu's mortality rate is less than 0.1 percent. According to Lipsitich's research, the range of mortality from A(H1N1) is between 0.007 and 0.045 percent. The seasonal flu, however, has a far greater affect on the elderly, who constitute 90 percent of the annual flu deaths. In contrast, A(H1N1) flu preferably attacks younger adults and older children, but their mortality rate is much lower than that of the elderly.

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FDA Approves Vaccines for 2009 H1N1 Influenza

15 September 2009

The U.S. Food and Drug Administration (FDA) announced that it has approved four vaccines against A(H1N1) influenza virus. "This vaccine will help protect individuals from serious illness and death from influenza," states Commissioner of Food and Drugs, Margaret A. Hamburg. The vaccines will be distributed nationally after the initial lots become available, which are expected within the next four weeks.

The vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, which is about the same as the seasonal influenza vaccine. Ongoing clinical studies will provide additional information about the optimal dose in children. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated. Potential side effects of the A(H1N1) vaccines are expected to be similar to those of seasonal flu vaccines. For the injected vaccine, the most common side effect is soreness at the injection site. Other side effects may include mild fever, body aches, and fatigue for a few days after the inoculation. For the nasal spray vaccine, the most common side effects are runny nose or nasal congestion for all ages, sore throats in adults, and - in children 2 to 6 years old - fever.

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc. All four firms manufacture the A(H1N1) vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines. Vaccines against three seasonal virus strains are already available to consumers and the U.S. government has recommended that Americans should get vaccinated as soon as possible. As far as is known, seasonal flu vaccine does not protect against the A(H1N1) virus.

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Secretary Napolitano Announces A(H1N1) Preparedness Guide for Small Businesses

14 September 2009

The Department of Homeland Security (DHS) has published a preparedness guide to assist small businesses in planning for the A(H1N1) flu. "Small business owners should take the time to create a plan, talk with their employees and make sure they are prepared for flu season," Small Business Administration (SBA) Administrator Karen Mills stated in the announcement. The preparedness guide offers small business employers tools and information to help them plan for and respond flexibly to varying levels of severity of an A(H1N1) outbreak—which may lead to increased absenteeism, and, if the outbreak becomes more severe, may include restricted service capabilities and supply chain disruptions.

Additional preparations may be necessary if a more serious outbreak evolves during the fall and winter. Employers are encouraged to put strategies in place now to protect their employees and their businesses in advance of the fall flu season. Included in the preparedness guide are tips on how to write a continuity of operations plan, steps for keeping employees healthy, frequently asked questions about the 2009 A(H1N1) flu, and a list of additional resources that employers can access online. To view the preparedness guide, visit http://www.flu.gov/professional/business/smallbiz.html.

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Studies Indicate that A(H1N1) Flu Virus Spreads Long After Fever Stops

14 September 2009

Marilynn Marchione, a medical writer for AP, reports that a new study conducted by the Centers for Disease Control and Prevention (CDC) suggests that the A(H1N1) virus can still spread up to a week after a patient's fever has disappeared. Previously, CDC has been recommending people to stay home from work and school and avoid contact with others until a day after their fever breaks. The agency's advice to stay home for one day after fever breaks does not apply to health care settings. There, confinement for seven days from the start of symptoms — or until they go away, whichever is longer — is still advised. The CDC recommends that persons who have had A(H1N1) flu should cover their mouths when they cough or sneeze and wash their hands frequently once they do return to work and school.

It is unclear whether the new research findings will lead to the CDC rethinking its advice on how long people with A(H1N1) should remain away from public settings when infected. Long breaks from school and work do not seem appropriate for a virus that now seems to cause a mostly mild illness. A(H1N1) flu is spreading so widely now that confining the sick does less good, the article quotes CDC's flu chief Nancy Cox saying. "We tried to have our guidance balance out all of these factors. It's just virtually impossible not to have virus introduced into settings such as schools and universities," she added.

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Sebelius: A(H1N1) Flu Shots May Start in Early October

13 September 2009

AP quotes Health and Human Services Secretary Kathleen Sebelius as saying that America's first round of A(H1N1) flu shots could begin sooner than expected, with some vaccine available as early as the first week of October. She is confident that the vaccine will be available early enough to beat the peak of the expected flu season this fall. As she has stated before, early doses are intended for health care workers and other high-priority groups.

Sebelius said the vaccine doses will be distributed immediately to designated locations across the country once they are available. "Every state has a plan saying these are the sites to get the vaccine as quickly as possible into people's arms. That's where the distribution will go. So, the first week in October, we expect some of the vaccine to begin to roll, and by mid-October, to have the kind of supplies we were talking about. But we may have some available earlier. And we'll get it out to states as fast as it comes off the production lines," Sebelius explains.

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Providers Having Trouble Getting Seasonal Flu Vaccine

9 September 2009

CIDRAP News reports that the desire to complete seasonal flu immunizations before A(H1N1) vaccinations begin has led to a boost in demand for seasonal flu vaccine as vaccinations have begun in many areas. As a result, the demand for seasonal flu vaccine has exceeded the supply. The seasonal flu vaccine supply is, however, likely to improve as the flu season wears on.

The first doses of A(H1N1) vaccine are expected to become available in mid-October. To make way for the H1N1 vaccination campaign, public health officials have been urging people to get their seasonal flu shots early.

"Some [vaccination] providers book more than one product but are not intending to buy both, so some prebooks don't materialize into purchases. So providers should continue to use the supplies they have and then look for opportunities to order additional vaccine as the season goes on. I wish we could say more to people who want to buy vaccine and right now can't buy the vaccine they need," Dr. Jeanne Santoli from the Centers for Disease Control and Prevention (CDC) is quoted regarding the situation.

Santoli said the CDC hasn't heard of "any significant delays that are on the horizon" for seasonal vaccine production. She expects that the vaccine would be ready in August-September. As of her knowledge, no manufacturers are "significantly off" their production schedule.

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NIAID Launches A (H1N1) Influenza Vaccine Trial in Pregnant Women

9 September 2009

National Institutes of Health News reports on an announcement made by the National Institute of Allergy and Infectious Diseases (NIAID), in which it reported that a first round of testing A(H1N1) influenza vaccine in pregnant women has begun. Women are considered to be at higher risk of developing severe illness if they become infected with either seasonal influenza virus or 2009 A(H1N1) while pregnant, NIAID Director Anthony S. Fauci said in the article.

Up to 120 women 18 to 39 years of age who are in their second or third trimester (14 to 34 weeks of pregnancy) will be enrolled in this initial trial. The trial is taking place at the following six medical centers: Baylor College of Medicine VTEU (Vaccine and Treatment Evaluation Unit) in Houston; Group Health Cooperative Center for Health Studies VTEU in Seattle; Saint Louis University VTEU; Vanderbilt University VTEU in Nashville; Duke University in Durham, N.C.; and Scott and White Memorial Hospital and Clinic in Temple, TX.

Researchers from the Centers for Disease Control and Prevention reported a month ago that six out of 45 people who died from A(H1N1) between mid-April and mid-June were pregnant women. According to an earlier study, the rate of hospitalization for A(H1N1) infection in pregnant women was approximately four times higher than it was in the general population.

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CDC Issues Guidance for Early Childhood Programs

8 September 2009

Journal Watch reports that the Centers For Disease Control and Prevention (CDC) has issued guidance to reduce the spread and severity influenza among children in early childhood programs and their providers. The full document, based on an article published in Physician's First Watch, can be accessed at:
http://www.cdc.gov/h1n1flu/childcare/guidance.htm

Some of its recommendations include that children should be immunized against A(H1N1) influenza virus and that those with flu-like illness should stay home until they have been without fever for 24 hours. In addition, it encourages child care providers to check their staff members' and children's health daily. If influenza severity increases, the guidance recommends that children living with ill household members should be allowed to stay home.

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President Obama Urges Americans to be Ready for the Flu Season

1 September 2009

On September 1, U.S. president Barack Obama gave an overview about America's economic situation and national preparedness for the upcoming flu season. The following are excerpts from his speech. Its entire text can be accessed at: http://www.whitehouse.gov/the_press_office/Remarks-by-the-President-on-2009-H1N1-National-Preparedness-and-Response/

"Now, we just had a good meeting about our ongoing efforts to prepare this country for the H1N1 flu virus this fall. And I want to thank John Brennan, our CDC Director Tom Frieden, and Secretaries Sebelius, Napolitano, Duncan, and Locke, for all the good work that they've been doing to get us ready today.

"As I said when we saw the first cases of this virus back in the spring, I don't want anybody to be alarmed, but I do want everybody to be prepared. We know that we usually get a second, larger wave of these flu viruses in the fall, and so response plans have been put in place across all levels of government. Our plans and decisions are based on the best scientific information available, and as the situation changes, we will continue to update the public.

"We're also making steady progress on developing a safe and effective A(H1N1) flu vaccine, and we expect a flu shot program will begin soon. This program will be completely voluntary, but it will be strongly recommended.

"For all that we do in the federal government, however, every American has a role to play in responding to this virus. We need state and local governments on the front lines to make antiviral medications and vaccines available, and be ready to take whatever steps are necessary to support the health care system. We need hospitals and health care providers to continue preparing for an increased patient load, and to take steps to protect health care workers. We need families and businesses to ensure that they have plans in place if a family member, a child, or a co-worker contracts the flu and needs to stay home.

"And most importantly we need everyone to get informed about individual risk factors, and we need everyone to take the common-sense steps that we know can make a difference. Stay home if you're sick. Wash your hands frequently. Cover your sneezes with your sleeve, not your hands. And take all the necessary precautions to stay healthy. I know it sounds simple, but it's important and it works. Finally, for people who want to learn more about this virus, please go to www.flu.gov, or talk to your doctor."

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Drugstores to Provide Early Seasonal Flu Vaccine

31 August 2009

Sarah Mahoney, a reporter for Marketing Daily new service, writes that in an effort to promote public health and win new customers, drugstore chains are raising their competitive activities. CVS says it will give $3 million worth of free flu shots to the unemployed, and rival Walgreens will hand out $1 million worth. CVS' 100,000 free shots will be offered onsite at One-Stop Career Center locations, and it will also hand out vouchers that can be used at CVS stores or many of its MinuteClinics. The company stated that seasonal flu shots will be available for all consumers at 500 of its MinuteClinic locations, beginning September 1, and starting September 15, at about 9,000 flu shot clinics in select stores. A spokesperson announced that each shot costs $30, and are covered by most insurance plans. Walgreens says it will offer flu vaccines at more than 7,000 stores, starting September 1, with 16,000 certified immunizers administering the vaccine, including pharmacists, nurse practitioners, and physicians assistants. Shots are offered on both a walk-in and by-appointment basis between 10 a.m. and 4 p.m., and cost $24.99. (Its Take Care Clinics are also offering the FluMist nasal spray alternatives, for $29.99.)

CVS says it decided to offer the free shots after its research found that only 34% of job seekers say they got a flu shot last year, compared with 49% of the overall population. "CVS Caremark wants to ensure cost and access are not barriers to getting a flu shot this year for one of the most vulnerable populations, the unemployed," the Woonsocket, R.I.-based company says in its release, adding that the large-scale immunization program is "part of our broader efforts to help prevent the spread of seasonal flu, which can lead to more serious and costly health problems."

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Swine Flu Increases Among College Students as Fall Semester Commences

28 August 2009

Dorie Turner, a reporter for the Associated Press, writes that colleges across the country are seeing an increased number of students with suspected cases of swine flu as dorms fill up and classes begin for the fall semester. While the increases were expected and colleges say they were ready for the coughing, sneezing and feverish students before move-in day, health experts say hundreds more are likely to get sick as the virus spreads through college campuses. At Georgia Tech in Atlanta, classes are in full swing for the university's 20,000 students, and so is the highly contagious A(H1N1) virus. The university has had 150 suspected cases of the virus in the two weeks since students moved back to campus. At the University of Kansas, nearly 200 students have reported having flu-like symptoms in the last week or so. University of Tennessee administrators are estimating about 100 suspected swine flu cases on campus. The University of Alabama had more than 50 cases of flu reported on the first day of classes last week. At Texas Christian University, 10 students were diagnosed with swine flu on the first day of class Monday.

CDC spokesman Tom Skinner is quoted as stating: "The mere fact you have lots of people in close proximity with each other results in the virus being transmitted from person to person. I don't think we're surprised by the fact influenza is returning to these campuses. What is concerning to us is people becoming complacent about this and not taking the steps we know can protect them." The CDC recommends that students with flu symptoms — fever, cough, sneezing, chills, aches, sometimes diarrhea or vomiting — stay home from class.

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Judge Denies Group's Bid to Block Flu Vaccine for Pregnant Women

26 August 2009

Nedra Pickler, a reporter for the Associated Press, writes that a judge on 26 July denied the Coalition for Mercury-Free Drugs' bid to prevent the government from giving pregnant women flu vaccines with a preservative that contains mercury. A government advisory committee recently recommended that pregnant women be among the first people to get swine flu vaccinations when the vaccine becomes available this fall.

A small amount of the mercury-containing preservative thimerosal is present in most influenza vaccines, including swine flu vaccines, although some vaccines are packaged without thimerosal. The Coalition argued that pregnant women should receive only the thimerosal-free version because of a risk that the mercury in the shot could poison a fetus and cause medical problems, including autism. But U.S. District Judge Reggie Walton ruled against the group's request for a preliminary injunction because he said the group could not prove that the pregnant women they represent would get vaccines containing thimerosal. Walton said he would consider further written arguments in the next month about whether the lawsuit can continue.

Thimerosal used to be added to many vaccines, but manufacturers began removing the preservative from all routine child vaccines in 2001 as a precaution. However, numerous large studies have shown no link between thimerosal and autism, or other health problems.

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U.S. Department of Defense Prepares for A(H1N1) Flu

26 August 2009

Katherine McIntire Peters, a reporter for the government news service GovernmentExecutive.com, writes that while the Department of Health and Human Services (HHS) plans for the immunizing of millions of Americans against the A(H1N1) flu, Defense officials are working on a parallel track to protect service members and mitigate the flu's effect on military operations. Army Lt. Col. (Dr.) Wayne Hachey, director of preventive medicine and surveillance in the Office of the Assistant Secretary of Defense for Health Affairs is quoted as stating: "We'll be getting vaccine the same time the highest priority groups are receiving their vaccine. That likely will be in October. In the meantime, military officials are working to contain the virus by isolating infected troops and using antiviral drugs whenever A(H1N1) is detected. All the services screen personnel before they deploy overseas and when they arrive at their destination. Earlier this summer, several dozen infected troops en route to Iraq were held in isolation in Kuwait until they were no longer contagious."

During one week in July, more than 100 cases of A(H1N1) flu were reported at the Air Force Academy in Colorado Springs, but by rigorously following public health guidelines, officials quickly contained the virus. Patients were isolated for several days and closely monitored; individuals who had been in contact with them also were watched for signs of infection.

The Department of Defense is purchasing its own supply of vaccine through HHS to meet military operational requirements. It has ordered 2.7 million doses, which it expects will be sufficient to vaccinate 1.35 million people. While all military personnel on active duty or reservists activated for service will be vaccinated, troops and some key civilians determined most vulnerable will receive the vaccine first, including those deployed on missions overseas, recruits in training, sailors and Marines aboard ships that are at sea, and health workers. Military dependents will receive the A(H1N1) vaccine under a separate distribution program managed by HHS through supplies provided to states based on population data. Access to vaccine among military family members living on bases will be the same as it is in civilian communities, with priority given to health care workers and the most vulnerable groups, including pregnant women and children. Defense has been preparing for pandemic influenza for several years now. For the last four years it has maintained significant stockpiles of gowns, gloves, masks, needles and syringes, and has on hand 8 million antiviral treatment courses.

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FDA Authorizes Swine Flu Diagnostic Test for Use by Military Overseas

25 August 2009

Associated Press Writer Christine Simmons writes that the Food and Drug Administration (FDA) has authorized the emergency use of a swine flu test for U.S. troops overseas, allowing the military to speed up diagnoses and treatment of a virus that could cause widespread infections this fall. The FDA emergency authorization lets the Defense Department distribute the swine flu test to its laboratories that are qualified to perform and interpret test results. The FDA authorized the swine flu diagnostic test for the public in April.

The authorization allows for the use of unapproved medical products or unapproved uses of approved medical products during a public health emergency. The FDA said the test will help to speed up diagnosis of H1N1 infections so that deployed troops can quickly begin treatment. According to a statement by the Joint Program Executive Office for Chemical and Biological Defense, the Defense Department will use the test for combat units in the Middle East and on Navy ships, beginning with deliveries next month.

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Estimate of up to 90,000 Deaths in the U.S. From Swine Flu in 2009

25 August 2009

The President's Council of Advisors on Science and Technology issued its "Report to the President on U.S. Preparations for 2009 H1N1 Influenza." Most attention so far has been on the estimates the Council makes. Thus, a "plausible scenario" for the United States is a large-scale outbreak of swine flu later this year, causing possibly 30,000 to 90,000 deaths, mostly among young children and young adults, and perhaps as many as 300,000 sick enough to require treatment at intensive care units in hospitals. Seasonal flu typically causes 30,000-40,000 annual deaths, mainly among people over 65. According to CIDRAP News, Tom Skinner, a CDC spokesman, told reporters that the report presented a worst-case scenario that was used for planning purposes only. He and other CDC officials reiterated that federal experts agree that the virus is unpredictable and that it's impossible to make a reliable projection. "At the end of the day, we just don't know," he said.

The full report can be accessed at: http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report.pdf

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United States to Mount an Unprecedented Vaccine Campaign

24 August 2009

Rob Stein, a reporter for the Washington Post, writes that U.S. government health officials are about to launch a swine flu vaccination campaign this fall that is unprecedented in its scope, and in its potential for generating complications. The campaign aims to vaccinate at least half the country's population within months. Although more people have been inoculated against diseases such as smallpox and polio over a period of years, the United States has never tried to immunize so many so quickly. But even as scientists rush to test the vaccine to ensure it is safe and effective, the campaign is lagging. Officials say only about a third as much vaccine as they had been expecting by mid-October is likely to arrive by then, when a new wave of infections could be peaking. Among the unknowns: how many shots people will need, what the correct dosage should be, and how to avoid confusing the public with an overlapping effort to combat the regular seasonal flu.

Officials stress that they are proceeding cautiously. A final decision to move forward will not be made until they get the results of clinical trials -- testing to determine safety and dosing -- and assess the virus's threat. But officials are confident the vaccine will pass muster and expect a campaign will be launched as soon as manufacturers deliver the first vials. To prepare, more than 2,800 local health departments have begun recruiting pediatricians, obstetricians, nurses, pharmacists, paramedics and even dentists, along with a small army of volunteers from churches and other groups. They are devising strategies to reach children, teenagers, pregnant women and young and middle-aged adults in inner cities, suburban enclaves and the countryside.

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U.S. Government Issues New Guidance for Institutions of Higher Learning

21 August 2009

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius and Department of Education (ED) Secretary Arne Duncan joined with Dr. Beth Bell, Deputy Director, National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention (CDC), to announce new guidance for Institutions of Higher Education (IHE) to plan for and respond to the upcoming flu season. The guidance crafted by the scientists and doctors at the CDC is designed to help colleges and universities start planning and acting now for the impact that seasonal and 2009 H1N1 influenza could have this fall and winter on their students and faculty members, as well as other university employees. Secretary Duncan is quoted as stating: "We can all work to keep ourselves healthy now by practicing prevention, close monitoring, and using common sense. We know that some students may be affected by H1N1. Our top priority is making sure that they have a way to get well, stay well, and keep learning. With this guidance, we're providing a menu of strategies that institutions can use to keep their facilities open, while doing what they can to reduce exposure of students, faculty, and staff -- particularly those at higher risk for complications -- from the flu." Secretary Sebelius stressed the importance of using innovative communications strategies to reach out to students who are some of the people most at risk for H1N1 flu. She highlighted new social media tools and online toolkits that have been created to help faculty, staff, and students at colleges and universities.

Government officials are especially concerned about the impact of H1N1 on schools because the virus appears to disproportionately affect young people. The CDC's Advisory Committee on Immunization Practices recently found that younger Americans, specifically those ages 6 months to 24 years, are one of the top priority groups when it comes to the new H1N1 vaccine.

HHS has created a special toolkit for administrators and students, as well some badges and widgets that can be used on social media sites such as Facebook and Twitter. The Toolkit is available at: http://www.flu.gov/plan/school/higheredtoolkit.html.

For the complete H1N1 guidance for higher education institutions and the special H1N1 Higher Education, please visit: http://www.flu.gov/plan/school/higheredguidance.html.

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Deadly Canine A(H3N8) Influenza Virus Spreading Along East Coast and in Colorado

19 August 2009

Discovery News reports that canine influenza, commonly known as dog flu, is now affecting dogs in at least five states: Colorado, New York, New Jersey, Pennsylvania, and Virginia. During the week of 10 Aug 2009, the infection caused the death of a 15-year-old whippet and sickened 26 dogs at Virginia's Fairfax County Animal Shelter. While the reason for the shelter outbreak remains unknown, it is possible that one or more infected dogs from Philadelphia or Washington, D.C. introduced the illness to Virginia. Edward Dubovi, director of the virology center at Cornell's Animal Health Diagnostic Laboratory, told Discovery News that "Dogs often move in and out of shelter systems over long distances, such as via breed and rescue groups. Boarding kennels and even elite doggie day care centers can also result in cases, since, as for kennel cough spread, the virus is highly contagious and dogs may catch it from one another." Signs in dogs include fever, lethargy, loss of appetite, and a respiratory infection that may last a few weeks. One to five percent of victims die from related hemorrhagic pneumonia.

A scientific team led by Dubovi was the first to determine that the causative virus of canine influenza actually is an A(H3N8) equine flu virus that had jumped from horses to dogs. In addition to spreading from dog to dog, canines can also catch it from humans, who may have come into contact with infected animals. Since dogs are in regular contact with their owners and other people, the illness could potentially spread from dogs to humans in the future. However, the virus has as yet not sickened any people.

Although 30 states have reported cases over the past five years, Dubovi said that outbreaks are "usually sporadic and then die out. For example, we've seen outbreaks in San Diego, Los Angeles, and Pittsburgh, but those all ended."

In July 2009, a vaccine against canine influenza was released. It is administered in two doses, three weeks apart. Dubovi claims that, "in clinical trials, it reduces viral shedding and diminishes signs of the illness." Dubovi would like to see "blanket vaccinations in affected areas, as it would be nice to get this virus out of the dog population."

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New York State Requires Flu Vaccination for Caregivers

19 August 2009

Anemona Hartocollis, a reporter for the New York Times, writes that "the New York State Health Department is requiring tens of thousands of health care workers across the state to be vaccinated for flu, amid fears that swine flu will return in the fall. The new regulation, quietly adopted as an emergency on Thursday, affects workers at hospitals, in home health care agencies and in hospice care, but, because of a technicality in state law, not in nursing homes. Until now, flu vaccination has been voluntary, and fewer than half of health care workers have been vaccinated in a typical season. The new regulation, which requires vaccination against seasonal flu and the H1N1 virus, would affect workers and volunteers who come into direct contact with patients, including nurses, doctors and aides, and even nonmedical staff members like food service workers if they enter a patient's room.

The regulation raised protest on 18 August from New York's largest health care union, 1199 S.E.I.U. United Healthcare Workers East, whose president, George Gresham, is quoted as stating that the policy was "completely unprecedented" and could become punitive if the religious or cultural beliefs of workers prevented them from being vaccinated. He added, "health care workers on the front lines of providing care deserve the dignity and respect of thoughtful consideration before a regulation like this can just be rushed through and put into effect."

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CDC Issues Guidance for Businesses and Employers to Plan and Respond to the 2009 - 2010 Influenza Season

19 August 2009

On 19 August, the CDC published on the federal governments principal flu information site, flu.gov, new guidance that recommends actions that non-healthcare employers should take now to decrease the spread of seasonal flu and A(H1N1) flu in the workplace and to help maintain business continuity during the 2009-2010 flu season. The guidance includes additional strategies to use if flu conditions become more severe and some new recommendations regarding when a worker who is ill with influenza ought to return to work. The CDC notes that guidance in this document may change as additional information about the severity of the 2009-2010 influenza season and the impact of 2009 H1N1 influenza become known. It suggests that all citizens check www.flu.gov periodically for updated guidance. The full guidance can be accessed at: http://www.flu.gov/plan/workplaceplanning/guidance.html.

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Francis S. Collins Sworn in as NIH Director

17 August 2009

NIH News announced that on August 17, Francis S. Collins became the 16th director of the National Institutes of Health. He was nominated to lead the NIH, the nation's premiere biomedical research agency, by President Barack Obama on July 8, and was unanimously confirmed by the U.S. Senate on August 7. In his July 8 nomination announcement, President Obama stated: "The National Institutes of Health stands as a model when it comes to science and research. My administration is committed to promoting scientific integrity and pioneering scientific research and I am confident that Dr. Francis Collins will lead the NIH to achieve these goals. Dr. Collins is one of the top scientists in the world, and his groundbreaking work has changed the very ways we consider our health and examine disease. As a scientist, physician, and passionate visionary, Dr. Collins will further NIH's ultimate mission to improve human health." Kathleen Sebelius, U.S. Health and Human Services Secretary, added "He is an ideal choice to lead the NIH and I look forward to working closely with him."

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Federal Officials Lower Estimates for A(H1N1) Vaccine Availability

14 August 2009

Lisa Schnirring, a staff writer, for CIDRAP News, reports that Dr. Robin Robinson, director of the Biological Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services (HHS), on 14 August said that the latest estimate is that 45 million doses of the A(H1N1) vaccine will be available by mid October, with manufacturers delivering 20 million doses per week after that. This compares to estimates made in July of 120 million doses being available in October, with another 80 million per month in the following months.

Robinson explained that revised, lower estimate is based on several factors expected to slow vaccine delivery from manufacturers. Health officials have already acknowledged that yields of the novel H1N1 antigen are less than for the seasonal flu vaccine. Robinson also said vaccine makers have a limited number of fill-and-finish sites, which are just completing seasonal flu vaccine production. Another factor that has added to the delay in ramping up production of the novel flu vaccine is that one of the companies making seasonal flu vaccine is having problems finishing up production so that it can clear the decks to make novel flu vaccine. This problem has delayed the vaccine timelines by 4 to 6 weeks.

Robinson added that a new seed strain developed to replace the slower-growing strain has shown in laboratory studies that it will produce A(H1N1) antigen yields that are on par with those for the seasonal vaccine, and that federal scientists will be working with manufacturers over the next two weeks to determine whether the improved yields are also seen in commercial production.

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CDC Planners Preparing for Emergency Rooms Being Overwhelmed

13 August 2009

Lauran Neergaard reporting for Associated Press writes that CDC officials are concerned about emergency rooms (ERs) being overwhelmed this autumn by both the so-called "worried well" (people who are well but think they have symptoms of illness) and people who are not so sick. Dr. Arthur Kellermann, an ER specialist at Emory University in Atlanta, stated "There's a clear sense that we can't afford a repetition of the spring experience all over the country. You can't drop millions, much less tens of millions of Americans, into that system willy-nilly because they want to play it safe and get checked. The play-it-safe strategy may be to stay home." Kellermann has been instrumental in stimulating government planning for what he calls "an unprecedented partnership to create the tools in time" to prevent ERs from being overwhelmed should the U.S. be faced with a dire flu situation this coming fall and winter.

With flu season rapidly approaching, the plans aren't finished yet, and it's too soon to know how many people could access such programs. "But," states Dr. Anne Schuchat of the CDC, "we are working on triage systems so people will have good information about, 'What will I need to do?'" Exactly how call centers may work or even how many hasn't been finalized, Schuchat cautions. In the meantime, the CDC has given states and hospitals guidelines on how to open their own — using existing phone-banks like poison-control centers plus the agency's latest information on flu risk and treatment — while exploring whether the government can create a more comprehensive system.

Some local jurisdictions are already implementing programs for ER preparedness. For example, Dallas' health department opened a call center to help doctors decide whether and how to treat sneezy patients, to blunt ER visits, and has begun planning an expanded fall program. According to Dallas preparedness chief Dr. Ira Nemeth, "the main message is, most patients probably won't need the ER."

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Research Explains the H5N1 Virus' Extreme Virulence

11 August 2009

An article titled "Highly pathogenic H5N1 influenza virus can enter the central nervous system and induce neuroinflammation and neurodegeneration" was published on this date in the Proceedings of the National Academy of Sciences of the United States and authored by Haeman Jang, David Boltz, Katharine Sturm-Ramirez, Kennie R. Shepherd, Yun Jiao, Robert Webster, and Richard J. Smeyne. The abstract of the article reads as follows:

One of the greatest influenza pandemic threats at this time is posed by the highly pathogenic H5N1 avian influenza viruses. To date, 61% of the 433 known human cases of H5N1 infection have proved fatal. Animals infected by H5N1 viruses have demonstrated acute neurological signs ranging from mild encephalitis to motor disturbances to coma. However, no studies have examined the longer-term neurologic consequences of H5N1 infection among surviving hosts. Using the C57BL/6J mouse, a mouse strain that can be infected by the A/Vietnam/1203/04 H5N1 virus without adaptation, we show that this virus travels from the peripheral nervous system into the CNS to higher levels of the neuroaxis. In regions infected by H5N1 virus, we observe activation of microglia and alpha-synuclein phosphorylation and aggregation that persists long after resolution of the infection. We also observe a significant loss of dopaminergic neurons in the substantia nigra pars compacta 60 days after infection. Our results suggest that a pandemic H5N1 pathogen, or other neurotropic influenza virus, could initiate CNS disorders of protein aggregation including Parkinson's and Alzheimer's diseases.

The entire article can be accessed at: http://www.pnas.org/content/early/2009/08/07/0900096106.short?rss=1

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Just One Distributor of A(H1N1) Vaccine for Americans

11 August 2009

Robert Roos, news editor at CIDRAP News, writes that the Minnesota McKesson Corporation, based in San Francisco, will be the sole distributor of A(H1N1) vaccines under a contract with the CDC. McKesson currently distributes vaccines under the CDC's Vaccines for Children (VFC) program. The company's press release states "McKesson's role will be to distribute the vaccine to sites designated by state health departments across the country. Each state will designate the providers who will receive and administer the vaccine. The distribution effort will include the centralized distribution of the A(H1N1) vaccine to as many as 90,000 sites across the country, making it the largest public health initiative in the CDC's history."

Jim Blumenstock, chief program officer for public health practice at the Association of State and Territorial Health Officials in Washington, D.C., is quoted as stating "That's different from how seasonal flu vaccines are handled. This is a government-controlled program, so it'll be the state agencies working with local partners and the CDC that will make the determination as to where the public will be able to get vaccine. This is not like your seasonal flu [vaccination] program where healthcare providers decide whether or not they want to do it and then submit private orders."

An explanation released by the CDC states that using a single vaccine distributor will be more efficient than having vaccine manufacturers ship doses directly to customers. One of the key benefits of using a centralized, third-party distributor to support A(H1N1) vaccine distribution is that it allows distribution of doses to a much larger number of provider sites than would be feasible with direct manufacturer distribution. The CDC also repeated previous government predictions that vaccine shipments are likely to begin about mid-October, though a late September start for shipments remains a possibility. It said each person will probably need two doses. The federal government will pay for the vaccine and related supplies, including needles, syringes, and sharps containers.

The CDC also stated that vaccination planners should consider two scenarios for vaccine availability. The first possibility is that about 120 million doses will be released starting in mid-October and continuing over 4 weeks, followed by 80 million doses per month after that. The second scenario envisions about 20 million doses being released starting in late September, followed by 20 million doses a week thereafter.

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Thousands of Americans Involved in A(H1N1) Vaccine Clinical Studies

11 August 2009

The Associated Press reports that 2,800 Americans in eight cities are participating in government-led clinical studies of different combinations of two A(H1N1) vaccines made by drug makers Sanofi Pasteur and CSL Limited, as well as a seasonal flu vaccine. Sharon Frey, an infectious diseases expert who is leading a study at Saint Louis University, is quoted as stating that "...scientists have been working late nights and weekends to organize the studies and recruit volunteers. Typically it takes a year to do this. I can tell you we're working at breakneck speed. The data will be turned around quickly for review by the Food and Drug Administration." Dr. Anne Schuchat, who oversees the flu vaccination programs at the Centers for Disease Control and Prevention (CDC), stated that "It's possible the government will begin a public vaccination campaign before all of the work of the trials is complete."

Saint Louis University will test 200 adults and 200 children. The other study sites are Baylor College of Medicine in Texas, Children's Hospital Medical Center in Cincinnati, Emory University, Group Health Cooperative in Seattle, University of Iowa, University of Maryland School of Medicine, and Vanderbilt University. Also under way are separate studies by five flu vaccine manufacturers under contract with the government. The studies are testing the safety and effectiveness of the newly developed vaccines, will help determine dosage, and make clear whether A(H1N1) vaccines can be safely administered with a seasonal flu shot.

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First Case in U.S. of Humans Contracting Avian Flu from Wild Birds

8 August 2009

The Associated Press reports that a study of duck and geese hunters in Iowa is the first to show that people can contract avian flu from wild birds. Previous cases of people being infected with any form of avian flu involved only domestic poultry, like chickens. The type of avian flu identified in the study is not the H5N1 avian flu, which is the deadly form that emerged in Asia and has led to concerns being voiced about a potential worldwide flu epidemic. Rather, it is the H11N9 avian flu, which has not been associated with human illness.

Dr. James Gill, the University of Iowa researcher who led the study, stated "that one hunter and two state environmental workers tested positive for the H11N9 virus, though none of the three men got sick."

Tom Skinner, a CDC spokesman, stated that the study's findings are noteworthy. Domesticated birds - like chickens - are an established source of bird flu transmission to humans, but this is believed to be the first documented case of a person getting such a virus from a wild bird. Skinner is quoted as stating "This study is evidence that transmission of avian influenza virus from wild birds to humans can occur. However, it's not clear from the paper whether the virus was spread through blood, water or by other methods. But we want to make clear this type of influenza virus should not be confused with H5N1." He also noted that domestic birds are a bigger worry than wild birds when it comes to the deadly bird flu.

The study is published in the August issue of the CDC journal, Emerging Infectious Diseases: http://www.cdc.gov/ncidod/EID/vol12no08/06-0492.htm.

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Minnesota Turkey Flock Infected with H7N9 Avian Flu Virus

8 July 2009

The Associated Press reports that a commercial turkey flock in Meeker County, Minnesota, has been quarantined after routine testing discovered that some of its members were infected with the H7N9 avian influenza virus. The State's Bureau of Animal Health states that the birds appeared healthy and showed no signs of infection and there was no sign of illness among farm workers. The Bureau is following the state's containment plan by quarantining the flock and all other flocks within three miles. They will be repeatedly tested for the virus for six weeks.

Dr. Dale Lauer, the Bureau's assistant director and director of the Minnesota Poultry Testing Laboratory, is quoted as stating that "it's not uncommon to find the bird flu virus in domestic poultry flocks, and Minnesota turkey remains safe. However, if the virus is left unchecked it can change into a form that's lethal to domestic poultry." Minnesota is the nation's top turkey producing state.

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Shorter Home Stays for Those with Flu Symptoms

7 July 2009

Lisa Schnirring, a Staff Writer at CIDRAP News, writes that the CDC has revised its advice for how long those who are sick with the A(H1N1) virus should stay away from other persons. The new exclusion guidance urges people with influenza-like illnesses to stay home at least 24 hours after they are free of a fever (in the absence of fever-reducing medication), defined as 100° F (37.8° C), which in most cases ranges from 3 to 5 days. Earlier recommendations urged people to stay home for 7 days after illness onset or for 24 hours after symptoms resolve, whichever was longer. Besides businesses and schools, the guidance also applies to camps, mass gatherings, and other community settings. However, the new recommendations do not apply to healthcare settings. People working or visiting healthcare facilities should still observe the earlier, longer-period exclusion guidance. CDC also emphasized that more stringent and longer exclusions may be needed for sick people who will return to settings where they have contact with people who have underlying medical conditions, such as camps for children with asthma or daycare centers that children younger than 5 attend. The new advice is expected to reduce the pandemic's absence burden on businesses and schools.

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Nation's Largest Insurer Will Cover Cost of A(H1N1) (Swine Flu) Vaccine

6 July 2009

Bob Graham reporting for the IFAwebnews.com writes that WellPoint, the U.S.' largest health insurance company, has announced that it will cover the administration of the A(H1N1) vaccine for members whose benefit plans provide coverage for vaccines. WellPoint also will continue coverage of seasonal flu vaccine administration for those whose health plans offer vaccine coverage. WellPoint's move is likely to force other, smaller health insurers to provide coverage for the vaccine.

WellPoint operates as Anthem Blue Cross in Virginia (outside of Northern Virginia), and as Empire Blue Cross in 10 New York City metropolitan and surrounding counties, as well as in several upstate counties in New York. In addition, WellPoint, an independent licensee of the Blue Cross Blue Shield Association, serves its members as the Blue Cross licensee for California; the Blue Cross and Blue Shield licensee for Colorado, Connecticut, Georgia, Indiana, Kentucky, Maine, Missouri (excluding 30 counties in the Kansas City area), Nevada, New Hampshire, Ohio, Wisconsin; and through UniCare.

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Vaccine to Protect Against Pneumonia Likely to Prevent Swine Flu Deaths

4 August 2009

Los Angeles Times reporter Thomas H. Maugh II writes that most of the serious consequences linked to flu viruses are the result of pneumonia, and an underused vaccine called Pneumovax can prevent, or at least limit, such complications in many patients. The vaccine, made by Merck & Co., stimulates the body's ability to defend against the bacteria responsible for many cases of pneumonia and has the potential to prevent an estimated one-third of pneumonia deaths linked to swine flu. However, it is not yet clear what proportion of swine-flu-related pneumonia is caused by Streptococcus pneumoniae and thus could be prevented or ameliorated by immunization. But preliminary results presented to the CDC vaccine committee in June by Dr. Matthew R. Moore, a CDC medical epidemiologist, indicated that about 40% of swine-flu-related pneumonia had an unknown cause -- and that about 30% were caused by S. pneumoniae. This suggests that at least a third of flu-related pneumonia deaths could be prevented by vaccination.

Dr. William Schaffner, chairman of preventive medicine at Vanderbilt University School of Medicine, president-elect of the National Foundation for Infectious Diseases, and member of the CDC's advisory committee on vaccines, is quoted as stating: "We would certainly like to see the vaccine used more extensively."

Dr. Linda Rosenstock, dean of UCLA's School of Public Health, believes that Pneumovax has not been promoted more heavily because the A(H1N1) pandemic has so far been perceived to be milder than seasonal flu. However, if the virus mutates to become more deadly, then the recommendations will become stronger. But she argues that increased efforts should be made to vaccinate more people. "As a public health measure, it makes sense to target the groups we would be most worried about, independent of the pandemic."

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Managing Calls and Call Centers during a Large-Scale Influenza Outbreak: Implementation Tool

30 July 2009

The Centers for Disease Control and Prevention (CDC) has published in advisory on "Managing Calls and Call Centers during a Large-Scale Influenza Outbreak: Implementation Tool." It notes that "during a response to a large-scale influenza outbreak such as the current H1N1 outbreak, a community's 9-1-1 and healthcare systems may experience a surge in calls or walk-in visits for care, advice, and information. In fact, call volumes or walk-in visits could reach the point of overwhelming the 9-1-1 and healthcare systems, rendering them unable to respond to other emergencies in an efficient and effective manner. In those instances, community planners should take steps to divert unnecessary calls away from the community 9-1-1 system and non-critically ill patients away from the healthcare system to reserve both for actual emergency situations. This implementation tool provides a step-by-step approach to achieving this objective by focusing on alternative call center resources." The complete advisory can be accessed at: http://www.cdc.gov/h1n1flu/callcenters.htm.

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Recommendations Made for Priorities for Scarce Flu Vaccine Distribution

30 July 2009

Matthew Biggs reporting for the Reuters news service writes that the Health and Human Services Department's Advisory Committee on Immunization Practices met today at CDC headquarters in Atlanta. It learned that up to 160 million doses of flu vaccine probably will be available for the start of a vaccination campaign planned for mid-October. Each person will likely need two flu vaccine doses, but it is not clear exactly how much vaccine would be available when. After the Committee had finished its deliberations on how available vaccines should be apportioned, it recommended that state and local health officials prepare to vaccinate as many as 160 million people. The United States would need 600 million doses to immunize everyone. Kathy Neuzil, the advisory committee's influenza work group chairwoman, said that "...the committee's main message is that it's half the population has priority to be vaccinated. And it's the younger half of the population, as well as healthcare workers." The Health and Human Services Department almost always follows the advice of the committee.

The committee's recommendations are that pregnant women, people who care for babies, and healthcare workers should be the first protected against the virus, which is a total of approximately 41 million people. Children between the ages of 6 months and four years were also included in that group. The vaccine was not recommended for infants under six months. People at risk of serious complications from catching the flu should be next in priority, including those with asthma, diabetes and heart disease. Then, healthy young adults aged 19 to 24. Committee members stated that young adults should be a priority because they are more likely to become infected and tend to work in places that would accelerate the flu's spread. Surveys show that people over 65 are at lower risk of contracting A(H1N1).

The committee also sought to provide clear guidance to state and local health officials attempting to explain to the public who is a priority for H1N1 flu - as opposed to seasonal flu - vaccination. The CDC's Dr. Anthony Fiore is quoted as stating that "at present, only 20 to 25 percent of people in high-risk groups are vaccinated against seasonal flu, which is in an indication of the size of the task facing doctors and clinics."
The Advisory Committee's recommendations and reasons for making them can be accessed at: http://www.cdc.gov/media/pressrel/2009/r090729b.htm.

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The Military May Assist Civilian Authorities in Case of Pandemic Flu

30 July 2009

CNN news service has learned that the U.S. Northern Command's General Victor Renuart has proposed that the military establish regional teams of military personnel to assist civilian authorities in the event of a significant outbreak of the A(H1N1) virus this fall. The proposal is awaiting final approval from Defense Secretary Robert Gates. The plan calls for military teams to work in conjunction with the Federal Emergency Management Agency. There is no final decision on how the military effort would be manned, but one source said it would likely include personnel from all branches of the military. However, it has yet to be determined how many troops would be needed and whether they would come from the active duty or the National Guard and Reserve forces.

Civilian authorities would lead any relief efforts in the event of a major outbreak. The military, as it would for a natural disaster or other significant emergency situation, could provide support and fulfill any tasks that civilian authorities could not, such as air transport or testing of large numbers of viral samples from infected patients.

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Adjuvants May be Needed to Stretch U.S. Supply of A(H1N1) Vaccine

29 July 2009

Tom Randall and Gary Matsumoto reporting for Bloomberg news service write that H1N1 flu vaccine makers may rely on a U.S. emergency declaration to use experimental additives made by GlaxoSmithKline Plc and Novartis AG to boost a limited supply of shots that will be available to fight the pandemic. The ingredients, known as adjuvants, may be added for the first time to flu shots in the U.S. Health officials today are meeting to discuss the additives at the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta, and to recommend who should receive the limited amount of vaccines that will begin being delivering in September or October. Under the U.S. health emergency, the FDA may authorize the use of unlicensed vaccines.

John Treanor, a professor of medicine, microbiology and immunology at the University of Rochester, is quoted as stating "that the U.S. government has been slow to approve the use of adjuvants because of safety concerns, and for fear of giving Americans an excuse to avoid getting the shots. The question is, do you really feel comfortable throwing this new thing into the mix and do you really need to? I myself, if I had to do it, would really wrestle with that decision."

The CDC agreed to pay London-based Glaxo and Novartis, based in Basel, Switzerland, more than $415 million for adjuvants that could be added to the swine flu vaccines. MF59, made by Novartis and sold in Europe, has been given to more than 40 million people, mostly adults, to prevent seasonal flu, according to the company. Glaxo's adjuvant has proven safe and effective in clinical trials with 39,000 people, said Lisa Behrens, a spokeswoman for the company, in an e-mail. Glaxo will conduct more studies and continue to monitor safety after the vaccines are in use, she said.

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New York City Prepares for Swine Flu's Resurgence

20 July 2009

Source: Anemona Hartocollis, New York Times

An article in the New York Times written by Anemona Hartocollis describes how New York City is using lessons learned from the first wave of swine flu during spring 2009 to prepare for the expected second wave this autumn. In particular, health officials are making plans to set up screening facilities at hospitals, clinics, and other buildings to separate worried-well people from genuine sick people before they can overwhelm emergency rooms. The reason for this action is that biggest surprise for hospital and city officials last spring was the surge of visits to emergency rooms by the very large number of people who panicked because they thought they were showing symptoms of flu but actually were well. "I think we were a little surprised at how many people were coming to emergency rooms," said the city's new health commissioner, Dr. Thomas A. Farley. "And the emergency rooms handled them — it wasn't a major problem, but it was a problem."

Hartocollis quotes Dr. Don Weiss, a city epidemiologist, as stating that "on May 25, the worst day of the spring outbreak, 2,500 people visited emergency rooms in the city complaining of influenza-like illness, said. The number on the same day in 2008 was 150. From May 15 to June 15, the worst month-long period of the outbreak, 44,678 people complaining of flulike illness visited the city's emergency rooms, compared with 4,267 the year before. Total visits rose to 428,059, from 325,135. But in an indication of the large numbers of what doctors call the 'worried well,' only 40 to 50 people a day were hospitalized during the worst stretch of that month, including on May 25."

City officials are planning for the possibility that they will have to ration or prioritize vaccinations, because it is unlikely that the city will receive enough for everyone, or 8.3 million doses. If both seasonal and swine flu are circulating, people will be advised to take vaccines for both. But many people resist being vaccinated, and there is a chance that the new H1N1 vaccine could require two doses, making the public persuasion more difficult.

Dr. Farley said it was hard to determine whether closing schools had been medically justified. The pressure from parents, teachers and politicians in some neighborhoods, particularly in Queens, was intense. But Dr. Farley said the health department had not responded to political pressure. "I think it made sense at the time," he said of the closings. "We can't say whether it slowed transmission within that school. It might or might not have." The city is considering, in a worst case, measures like canceling big gatherings and staggering work hours, said Dr. Isaac B. Weisfuse, the city's deputy health commissioner for disease control. In consultation with the Metropolitan Transportation Authority, the health department has concluded that shutting down mass transportation would probably cause more headaches, like leaving hospital workers unable to get to work, than it would solve. But Dr. Weisfuse said he expected many people to walk or drive to work if the flu became severe. He said he thought staggered working hours might be a good idea, though he added that he was not sure it would work.

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President Obama Signs Supplementary Appropriations Act for the H1NI Pandemic

16 July 2009

Source: President Obama

Text of a Letter From the President to the Speaker of the House of Representatives

Dear Madam Speaker:

On June 24, I signed into law the Supplemental Appropriations Act, 2009 (Public Law 111-32). Within the Act, the Congress appropriated $7.65 billion to the Department of Health and Human Services for the 2009-H1N1 influenza outbreak, including a $5.8 billion contingent appropriation for an influenza pandemic. My Administration appreciates the emergency appropriations that the Congress provided and has initiated the development and procurement of 2009-H1N1 vaccines, is expanding the domestic and international surveillance activities, and is preparing for the possibility that a mass immunization campaign may be needed in the fall.

To enhance our Nation's capability to respond to the potential spread of this outbreak, and in accordance with the appropriation, I hereby designate $1.825 billion of the contingent appropriation as emergency funds required to address critical needs related to emerging influenza viruses (specifically, the virus known as 2009-H1N1). These funds will support additional procurement of adjuvant for dose-sparing of vaccine antigen; immunization campaign planning; regulatory activities for H1N1 at the Food and Drug Administration; and funding for the administration of an injury compensation program.

There remains much uncertainty about the outbreak and its potential to return this fall during the northern hemisphere flu season. We continue to watch the evolution of the 2009-H1N1 virus and the worldwide outbreaks and are working diligently to plan and prepare for a national response, should it be necessary.

We will communicate with you further in the future should additional funds be required.
Sincerely,

Barack Obama

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CDC Issues Actions for Novel H1N1 Influenza Planning and Response for Medical Offices and Outpatient Facilities

14 July 2009

Source: Centers for Disease Control and Prevention

The Centers for Disease Control and Prevention (CDC) today published a set of ten activities whose aim is to help medical offices and other outpatient facilities (e.g., outpatient/ambulatory clinics, outpatient surgery centers, urgent care centers, physical therapy/rehabilitation offices or clinics) that provide routine, episodic, and/or chronic healthcare services to manage increased demand for services in the midst of a H1N1 influenza outbreak. The ten activities are as follows:

1. Develop a Business Continuity Plan;
2. Inform employees about your plan for coping with additional surge during pandemic;
3. Plan to operate your facility if there is significant staff absenteeism;
4. Protect your workplace by asking sick employees to stay home;
5. Plan for a surge of patients and increased demands for your services;
6. Care for patients with novel H1N1 flu in your facility;
7. Take steps to protect the health of your workforce during an outbreak of H1N1;
8. Provide immunization against seasonal flu at no cost to your staff;
9. Make sure you know about the pandemic planning and response activities of the hospitals, outpatient facilities and local public health in your community;
10. Plan now so you will know where to turn to for reliable, up-to-date information in your local community.

Detailed explanations of each of the activities can be found on the CDC's H1N1 Flu Page:
http://www.cdc.gov/h1n1flu/10steps.htm.

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The U.S. Will Spend an Additional Billion for H1N1 Vaccine

13 July 2009

Source: Reuters

Reuters news service today quoted U.S. Health and Human Services Secretary Kathleen Sebelius as having said on 12 July that "There'll be another $1 billion worth of orders placed to get the bulk ingredients for an H1N1 vaccination. Congress has agreed with the president that this is the number one priority, keeping Americans safe and secure. We are aggressively working on, first of all, testing the virus strains to get a vaccination ready. It needs to be safe so testing and clinical trials will start this month. We'll know a lot more by the end of the summer and it needs to be effective."

The U.S. Food and Drug Administration has scheduled a July 23 advisory panel meeting to discuss clinical trials of the vaccines against the H1N1 influenza virus and the U.S. Advisory Committee on Immunization Practice wills meet July 29. "FDA is working with the scientists at NIH (National Institutes of Health) to make sure that we have a safe and effective strain and then we're getting ready to make sure that we have a vaccination program," Sebelius said.

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Obesity Might be Risk Factor for Severe Complications Accompanying Swine Flu

11 July 2009

Source: Maggie Fox, Reuters

Maggie Fox, a Reuters news service reporter, writes that Dr. Lena Napolitano of the University of Michigan Medical Center and colleagues studied the cases of 10 patients admitted to the university's intensive care unit with severe acute respiratory distress syndrome caused by infection with H1N1 and found that "Of the ten patients, nine were obese (body mass index of more than 30), including seven who were extremely obese (BMI more than 40)." All had to be put on ventilators. Further, nine of the ten had multiple organ failure, five had blood clots in the lungs, and six had kidney failure. Three of the ten died, and none of the remainder has fully recovered, the researchers said.

The Michigan study was not designed to see if obesity or anything else poses a special risk factor for flu. Nevertheless, "the high prevalence of obesity in this case series is striking," the CDC's commentary accompanying the report reads. "Whether obesity is an independent risk factor for severe complications of novel influenza A(H1N1) virus infection is unknown. Obesity has not been identified previously as a risk factor for severe complications of seasonal influenza." The fact that nine out of the ten patients were male might also prove significant.

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National H1N1 Influenza Preparedness Summit

9 July 2009

Secretaries Kathleen Sebelius (HHS), Janet Napolitano (DHS), and Arne Duncan (ED), along with Homeland Security Advisor John Brennan, are hosting an all-day H1N1 Flu Preparedness Summit with states to further prepare the nation for the possibility of a more severe outbreak of H1N1 flu in the fall. Federal, state and local officials, emergency managers, educators and others will be discussing lessons learned during the spring and summer H1N1 wave, and discuss best practices and preparedness priorities. On behalf of the three secretaries, Secretary Sebelius made the following statement:

"Fellow Americans,
This spring we were confronted with an outbreak of a troubling flu virus called 2009-H1N1. As the fall flu season approaches, it is critical that we reinvigorate our preparedness efforts across the country in order to mitigate the effects of this virus on our communities.
Today, we are holding an H1N1 Influenza Preparedness Summit in conjunction with the White House to discuss our Nation's preparedness. We are working together to monitor the spread of 2009-H1N1 and to prepare to initiate a voluntary fall vaccination program against the 2009-H1N1 flu virus, assuming we have a safe vaccine and do not see changes in the virus that would render the vaccine ineffective.
But the most critical steps to mitigating the effects of 2009-H1N1 won't take place in Washington - they will take place in your homes, schools and community businesses. Taking precautions for this fall's flu season is a responsibility we all share. Visit Flu.gov to make sure you are ready and learn how you can help promote public awareness.
We are making every effort to have a safe and effective vaccine available for distribution as soon as possible, but our current estimate is that it won't be ready before mid-October. This makes individual prevention even more critical. Wash your hands regularly. Take the necessary precautions to stay healthy and if you do get sick, stay home from work or school.
We are doing everything possible to prepare for the fall flu season and encourage all Americans to do the same - this is a shared responsibility and now is the time to prepare. Please visit www.flu.gov to learn what steps you can take to prepare and do your part to mitigate the effects of H1N1."

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Canine influenza outbreak reported in Central Jersey

2 July 2009

Source: The Examiner

The Central New Jersey newspaper The Examiner reports that an outbreak of canine influenza is occurring in the Clarksburg section of Millstone city, NJ. Over the last several weeks, NorthStar VETS, a specialty and emergency trauma hospital located in Millstone, has seen an increasing number of patients being admitted for the treatment of this virus. There have been nine cases in the hospital so far, and because of its contagious nature, more are expected. Canine influenza should be considered a serious disease; infected animals have a 100 percent mortality rate. However, with a rapid and accurate diagnosis, proper treatment can reduce this statistic to a 1-5 percent mortality rate, according to information from the hospital.

Dr. Daniel Stobie, owner of NorthStar VETS, told The Examiner: "It is a new virus. There seems to be a resurgence, with young and older pets being more susceptible." NorthStar VETS is encouraging dog owners to be vigilant and on the lookout for signs such as difficulty breathing, dry coughing, nasal discharge, high fever, severe lethargy or lack of appetite. If any of these signs are displayed, they suggest isolating the dog from other animals and seeking medical treatment immediately. Canine influenza is not contagious to people, cats, or other species, although people can carry the virus in their nasal passages and transmit it to dogs at home.

For brief fact sheets on canine influenza, see the Washington State University College of Veterinary Medicine, Washington Animal Disease Diagnostic Laboratory website and the University of Florida College of Veterinary Medicine website.

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Multiple Shots of Swine Flu Vaccine Needed for Full Immunity

29 June 2009

Source: Tom Randall, Bloomberg

Tom Randall, a reporter for the Bloomberg new service, writes that the vaccine being developed to combat a pandemic of swine flu will require multiple shots to provide immunity from the new virus, and the added immunizations may overwhelm U.S. state agencies. Two injections will be required three weeks apart for H1N1 swine flu, and a third will be needed for seasonal flu. Children younger than 9 years old will need four shots, according to the CDC. William Schaffner, an influenza expert at Vanderbilt University School of Medicine in Nashville, Tennessee, said "One shot probably gives you very little immunity, 10 to 20 percent at most."

Randall also quotes Jeanne Santoli, head of the CDC's routine vaccine distribution activities, stating that vaccinations would be slowed if states are responsible for administering shots instead of doctors' offices and pharmacies. The CDC has not yet determined the role state agencies will play in disseminating the vaccine, and it will be working with states to ensure fast distribution, she said. "Probably each state will decide what works best. There may be some states that lean toward the public sites and others that lean more toward the private," Santoli said.

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Influenza Hits Summer Camps

26 June 2009

Source: Lisa Schnirring, CIDRAP News

Lisa Schnirring, a staff writer with CIDRAP News, reports that "An official from the US Centers for Disease Control and Prevention (CDC) said today that the nation just saw its largest weekly increase in cases since the beginning of the novel flu outbreak and that the virus has so far been detected at 34 summer camps in 16 states." Anne Schuchat, MD, interim deputy director for the CDC's science and public health program, told reporters, "The key point is that this new infectious disease is not going away." Of the nearly 28,000 cases that have been confirmed in the U.S., more than 6,000 were reported over the past week, according to the weekly update that the CDC issued today. She said influenza activity is widespread in 12 states, something very unusual for summer months, but not so unusual for an influenza pandemic. States reporting widespread activity are Arizona, Connecticut, Delaware, Hawaii, Maine, New Jersey, New York, Pennsylvania, Rhode Island, Utah, and Virginia. Nine others are reporting regional activity.

More than 99% of typed influenza isolates are the novel flu strain, Schuchat said. "So virtually all of the influenza that's circulating and getting a diagnosis is this new strain."
Clinical patterns in patients who are sick with the pandemic flu strain are staying constant, with the highest illness rates in people younger than age 25, she said, adding that the median age of those hospitalized with more severe illnesses is 19. However, the median age of people who are dying from novel H1N1 is somewhat older, 37.

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600 Million Doses of Swine Flu Vaccine for Autumn Vaccination Campaign

26 June 2009

Source: Mike Stobbe, Associated Press

Mike Stobbe, reporter for Associated Press, writes that a potential fall swine flu immunization campaign may involve an unprecedented 600 million doses of vaccine. According to Stobbe, CDC officials have yet to figure out how to administer so many doses or accurately track side effects if a seasonal vaccine is given simultaneously. Were this campaign to take place, it would far eclipse the roughly 115 million doses of seasonal flu vaccine distributed each year. Officials said they probably will need to recruit physicians who do not usually give flu shots because local health departments have cut more than 10,000 jobs. Detecting and tracking side effects under these conditions would be difficult.

No final decision has been made about whether a swine flu vaccination campaign will take place or whether all Americans would get immunizations. Health officials told Stobbe that a swine flu vaccination campaign could be only a few months away, and that as many as 60 million doses could be ready by September. The timing depends on how fast a vaccine can be produced and tested, however.

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House Approves $8 Billion for Swine Flu Pandemic

17 June 2009

Source: Jeffrey Levi,Trust for America's Health

The U.S. House of Representatives today approved $7.65 billion in new money to respond to the swine flu pandemic. The money will go toward the purchase of vaccine, antiviral drugs, and other medical needs. Congress also stipulated that the funds be available for surveillance and to help assist international efforts. At least $350 million must be spent on "upgrading State and local capacity."

Jeffrey Levi, a health policy specialist who heads the Washington, D.C.-based Trust for America's Health, applauded Congress's action. "This demonstrates a serious commitment on the part of the Administration and the Congress to ramp up our capacity to respond to the H1N1 pandemic," Levi said.

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Kids First in Line for Swine Flu Shots in Autumn?

16 June 2009

Source: Associated Press

The Associated Press reports that Health and Human Services Secretary Kathleen Sebelius is suggesting that schoolchildren be first in line for swine flu vaccine this fall, and should even be able to get the shot right at school. Sibelius is presenting this scenario to school superintendents around the country, urging them to spend the summer planning what to do if the government decides it needs their buildings for mass vaccinations. "If you think about vaccinating kids, schools are the logical place," Sebelius told the Associated Press today.

Historically, school-based flu clinics have not been common in the U.S. Schools do occasionally team up with local health officials for special flu vaccination clinics. Thus, more than 140 schools around the country scheduled flu vaccination days last fall, with some providing free vaccine. Nevertheless, the turnout of parents with children was disappointing.

Associated Press notes that no decision has been made yet on whether and how to vaccinate millions of Americans against the new flu strain that the World Health Organization last week formally named a phase 6 pandemic, meaning it now is circulating the globe unchecked. But the U.S. government is spending billions of dollars to develop a vaccine in anticipation of it being needed this coming fall.

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FDA. Warns Against Use of Popular Cold Remedy

16 June 2009

Source: New York Times

An article today in the New York Times reports that Federal drug regulators warned consumers to stop using Zicam, a popular homeopathic cold remedy, because it could damage or destroy their sense of smell. The Food and Drug Administration (FDA) has received 130 reports from consumers and doctors of people losing their sense of smell after using one of the Zicam nasal products, which include Zicam Cold Remedy and Zicam Cold Remedy Swabs. The reports date to 1999, when Matrixx Initiatives of Scottsdale, AZ, first introduced the products. In 2006, Matrixx paid $12 million to settle 340 lawsuits from Zicam users who claimed that the product destroyed their sense of smell, a condition known as anosmia. Hundreds more such suits have since been filed.

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Flu onset exposed supply problems

15 June 2009

Source: Stephen Smith, Boston Globe

An article published today on the Boston Globe and written by Stephen Smith states that the swine flu outbreak in the United States exposed gaps in the supply chain that delivers medication, masks, and even testing swabs to hospitals and doctors' offices; shortcomings that could prove vastly more worrisome if a deadlier strain returns in the fall. Smith writes that "across the nation, from sprawling federal agencies to small local health departments, disease trackers are urgently evaluating their response to swine flu, with eyes trained firmly on the autumn months." Further, he quoted James Blumenstock, chief program officer for public health practice at the Association of State and Territorial Health Officials as having averred that "we really didn't have a good handle on how much commercial supplies were out there, who had them, how rapidly were they being drawn down, and how to blend the public and private stockpiles so there would be no disruption of service."

Smith states that some hospitals said shelves usually brimming with surgical masks, used to slow the virus' transmission, turned barren - and suppliers proved unable to replenish supplies in the standard 24-hour timeframe. Hospitals sometimes found themselves in competition with each other for supply reinforcements, and there were instances when departments within the same medical center raced to get their orders in first. Even one of the most low-tech of medical appliances, the basic swab, ran scarce as the state initially asked physicians to collect two nose or throat samples from patients with suspected cases of the disease.

The article ends with a quote from Dr. Jose Montero, New Hampshire's director of public health: "One key assumption is that pandemics will come to us from somewhere else, which basically means we will have time to prepare. Well, this pandemic started in North America. So we were the ones trying to set up a system to assess risk, to assess severity, to assess infectiousness. With flu, you just never know."

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H1N1 flu outbreak may offer Democrats a political opportunity

14 June 2009

Source: Shailagh Murray, Washington Post

An article in Washington Post written by Shailagh Murray states that while "the H1N1 flu outbreak represents a serious public health threat," it may also "offer Democrats a political opportunity." Democrats have added an additional $7.65 billion for flu prevention to a $106 billion emergency war funding bill currently before Congress. House Republicans have opposed the bill "because of an unrelated provision related to the International Monetary Fund, but "if GOP lawmakers follow through with their opposition by voting against the final bill next week, a 'no' vote on flu prevention will appear on the books." A senior Democratic aide "who helped to add funding in the final bill told the Post "if I were a Republican from a marginal district, I would not feel comfortable with that vote." It's happened before. Sen. Susan Collins, R-Maine, was "pummeled by liberal blogs" after she voted to "strip out nearly $900 million in pandemic flu funding from the economic stimulus bill in February," just months before the outbreak of the H1N1 virus.

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CDC Outreach to Industry

12 June 2009

Source: US Centers for Disease Control and Prevention (CDC)

In view of yesterday's pandemic declaration by the WHO, the US Centers for Disease Control and Prevention (CDC) today urged businesses to review their pandemic plans to make sure they're flexible enough to respond to a moderate or severe pandemic. At a teleconference today for the business community, Lisa Koonin, a senior adviser with the CDC's influenza coordination unit, said that because influenza viruses are so unpredictable and the pandemic may change or become more severe in the fall, now is the time for businesses to revise pandemic plans or begin developing one if they don't already have one. "There will be different pictures all around the world," Koonin said. "We need to be nimble and tailor our response based on that picture."

Employers should review their leave, pay, and benefits policies to determine if any adjustments are needed to allow employees to stay home for 7 to 10 days if they are sick with the novel flu or need to stay home to care for a sick family member, she said. Flexibility with policies will be crucial, Koonin said. For example, employers may not want to require a doctor's note when workers have been home sick, because clinics and emergency departments will likely be swamped, making it difficult for sick people to get notes in a timely manner. She advised the group to address business continuity concerns by identifying essential business functions and critical employees, planning for staffing redundancy for key positions, and assessing supply-chain and critical input issues. Koonin added that it's a good idea for businesses to ask suppliers to provide details about their pandemic plans.

Employees who have risk factors for flu complications, such as asthma, cardiac conditions, or pregnancy, should be advised to seek medical care quickly if they have flu symptoms. Those who don't have risk factors but experience severe symptoms should also seek care.

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HHS Secretary Kathleen Sebelius & DHS Secretary Janet Napolitano on WHO Declaration of Novel H1N1 a Pandemic

11 June 2009

Source: Department of Health and Human Services

U.S. Department of Health and Human Services Secretary Kathleen Sebelius and U.S. Department of Homeland Security Secretary Janet Napolitano issued the following statements today in response to the World Health Organization's (WHO) decision to raise the pandemic threat level on the novel H1N1 virus:

"Today's decision by the WHO was expected and doesn't change what we have been doing here in the United States to prepare for and respond to this public health challenge. Once we saw how fast this virus was spreading, we activated our pandemic plans and started doing all the things we needed to do to keep the public as safe and secure as possible. What this declaration does do is remind the world that flu viruses like H1N1 need to be taken seriously. Although we have not seen large numbers of severe cases in this country so far, things could possibly be very different in the fall, especially if things change in the Southern Hemisphere, and we need to start preparing now in order to be ready for a possible H1N1 immunization campaign starting in late September."
--Secretary Sebelius

"We responded to the H1N1 outbreak from the outset with the presumption that a pandemic was likely, so this decision comes as no surprise. We acted aggressively to stay ahead of the virus as it spread across the country. Now our challenge is to prepare for a possible return in the fall. The Obama Administration has been working together across the government and will continue to do so over the weeks and months ahead to keep the American people safe. We are reaching out to our partners in state and local government, in school districts and the private sector to urge them to modify and update their pandemic plans. We are working with our scientists to test and prepare a possible vaccine. And we are working with governments around the world to share what we know and learn from what is happening in their countries."
--Secretary Napolitano

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White House Wants Up to $9 Billion More for H1N1 Preparations

8 June 2009

Source: Washington Post

The Washington Post reports that the White House asked Congress on 2 June for authority to spend up to $9 billion more for an H1N1 flu vaccine and other preparations against the novel flu strain that first appeared in April. Of the total, the administration asked Congress to provide $2 billion in "contingent" funding. Another $3 billion could come from the Project BioShield Special Reserve Fund, created in 2004 to field countermeasures against nuclear, biological or chemical threats; $3.1 billion from stimulus funds appropriated to spur economic recovery; and $800 million from the Department of Health and Human Services. However, on 7 June, this contingency plan was criticized by leaders of a bipartisan commission on weapons of mass destruction because, they claimed, it would "weaken the nation's preparedness for terrorism." The contingency plan will be considered by Congress in the next few months.

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Dr. Thomas Frieden Now CDC Director

8 June 2009

Dr. Thomas Frieden formally assumed the role of Centers for Disease Control and Prevention (CDC) director on June 8. He faces the challenge of helping guide the national response to pandemic influenza, while strengthening the CDC's scientific programs and carving out a sizable role for it in the Obama administration's broader health-care overhaul effort. The new director stated that the CDC will continue to focus intensively on the new H1N1 flu virus as it prepares for the virus's possible return in full force in the fall. The CDC has suffered from having been involved in several controversies in recent years, but has also been credited with a swift and able response to the sudden outbreak of the new flu.

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Nonprofit Trust For America's Health Publishes A(H1N1) Report

4 June 2009

On 4 June, the nonprofit Trust for America's Health published a report that included lessons learned so far in the swine flu outbreak. The Trust's findings included:

• Investments in pandemic planning paid off.
• Public-health departments do not have enough resources to carry out plans.
• Response plans must be adaptable and driven by science.
• Clear, straightforward information is essential to allay the public's fears and build trust.

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