H5N1 Influenza Virus Vaccine

Licensure for the first H5N1 Influenza Virus Vaccine&mdash;a vaccine against H5N1 avian influenza, commonly referred to as avian influenza or 'bird flu', for use with humans&mdash;was approved in April 2007 by the U.S. Food and Drug Administration for use in the United States.

The "current deadly strain of the H5N1 avian virus is not spreading from human to human but only from birds to humans, as well as among birds themselves," Catherine Paddock reported April 17, 2007, in Medical News Today. "But should H5N1 mutate into a human to human version, this vaccine may give limited early protection until a more effective version can be developed that is more tailored to a pandemic strain."

The Associated Press reported April 17, 2007, that the U.S. government "plans to buy and stockpile enough bird flu vaccine for 20 million people, including emergency and health care workers. It also could be given to military personnel before they are deployed abroad."

Fact Sheet: FDA Q&A
The following is according to a Q&A posted online by the FDA about the first approved H5N1 influenza virus vaccine.


 * Indications : "immunization of persons 18 through 64 years of age who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine."
 * Source : A/Vietnam/1203/2004 influenza virus&mdash;"made from an inactivated H5N1 virus isolated in Southeast Asia in 2004" &mdash;containing thimerosal, a mercury containing compound, used as a preservative in the vaccine to prevent the growth of bacteria and fungus in the event that the vaccine is accidentally contaminated, as might occur with repeated puncture of multi-dose vials.
 * Manufacturer : sanofi pasteur (web) of Swiftwater, PA, a vaccines division of France's Sanofi-Aventis, the world's number three company in the pharmaceutical industry, under contract to the National Institute of Allergy and Infectious Diseases (NIAID) (web).
 * Purchaser and Availability : sanofi pasteur "has stated that the vaccine won't be available to the public commercially, meaning it can't be obtained from a doctor's office." The federal government has purchased it "for inclusion within the country's U.S. Strategic National Stockpile, for distribution by the Department of Health and Human Services in case it is ever needed."

In the United States
In November 2006, sanofi pasteur announced an agreement&mdash;"valued at up to $117.9m, dependent on the number of doses that can be formulated from bulk material"&mdash;with the Department of Health and Human Services for "the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine." 

Other production
Although the majority of vaccine production for the U.S. will be at the Pennsylvania plant, "the increased capacity at one of the company's European plants suggests that Sanofi holds out hope for further demands for its vaccine on the other side of the Atlantic." 

Sanofi pasteur "also has several agreements within Europe, including a contract with the French Ministry of Health to produce a 1.4 million dose stockpile of H5N1 vaccine with a clause to be called upon to provide enough vaccine to protect 28 million people in France should a pandemic strike. The firm also has an agreement with the Italian Ministry of Health." 

Sanofi pasteur is not only the "only vaccine manufacturer", but also "the only pharma firm, involved in the Flupan project funded by the European Commission. The project aims to improve pandemic preparedness in the EU by producing and testing experimental vaccines, compiling libraries of reagents and investigating new cell culture vaccine production techniques.

"Sanofi itself is responsible for producing a vaccine to combat another flu strain with pandemic potential, H7N1, that will be used in a Flupan clinical study." 

Single "multi-center, randomized ..." clinical trial
The FDA reports that the National Institutes of Health (NIH) conducted one "multi-center, randomized, double-blinded, placebo-controlled, dose-ranging study in healthy adults, 18 to 64 years of age" as "an exploratory study to look at the amount of antibodies generated in humans from various doses" to investigate "the safety and immunogenicity of the vaccine." The test included a "total of 103 healthy adults [who] received a 90 microgram dose of the vaccine by injection, followed by another 90 microgram dose, 28 days later. In addition, there were approximately another 300 healthy adults who received the vaccine at doses lower than 90 micrograms and a total of 48 who received placebo by injection." 

Licensure was based on a clinical trial conducted between March and July 2005 and carried out at three NIAID-supported Vaccine and Treatment Evaluation Units located at the University of Rochester Medical Center in Rochester, NY; the University of Maryland School of Medicine Center for Vaccine Development in Baltimore; and the Los Angeles Biomedical Research Institute at Harbor-University of California, Los Angeles. The trial was led by UR's "vaccine expert" John Treanor M.D.

The results of the study on the vaccine, published in March 2006 in the New England Journal of Medicine, "showed the vaccine was safe and spurred the immune response considered necessary to protect against the illness, at a dose several times larger than the traditional flu shot and in slightly more than half of people who received the largest dose ...." 

Risks
"It is fortunate to have this vaccine during this 'inter-pandemic' phase. The benefit of having a licensed vaccine against a potential pandemic influenza virus strain, even with limited data, outweighs the risk of having no vaccine at the time of an inevitable influenza pandemic," the FDA states.

Additionally, "because the number of people studied was small, rare safety events may not have been identified, but given the potential risk of a pandemic, this is the only vaccine currently available and its benefits outweigh its risks. In addition, sanofi pasteur has agreed to work with the U.S. government to gather additional information on the safety and effectiveness of the vaccine should it be used in the event of a pandemic." 

Other vaccine manufacturers
Other companies, including Novartis AG and GlaxoSmithKline Plc, "are developing bird flu vaccines with adjuvants, substances that can boost immune response." 

Related SourceWatch Resources

 * avian flu pandemic
 * Bush Administration Plan for Flu Outbreaks

2005

 * Robin Stein, "Vaccine Appears to Ward Off Bird Flu," Washington Post, August 7, 2005.
 * Daniel J. DeNoon, "Bird Flu Vaccine Works in Humans. But if Mutant Flu Comes, Will Vaccine Match?" WebMD, August 8, 2005.
 * Andrew Pollack, "Chiron Hired to Produce Bird Flu Vaccine," New York Times, October 28, 2005.

2006

 * Richard Harris, "U.S. Plan to Stockpile Bird-Flu Vaccine a Big Gamble," NPR, January 6, 2006.
 * Caleb Hellerman, "Bird flu vaccine eggs all in one basket. Researchers: Not sure shots will work but it's all they've got," CNN, March 20, 2006.
 * "H5N1 Avian Flu Virus Vaccine Induces Immune Responses in Healthy Adults," NIAID/NIH News, March 29, 2006.
 * "Study: Bird-flu vaccine safe, but only partly effective," CNN, March 29, 2006.
 * "Bird Flu Vaccine Protects Half The People Who Take It," Medical News Today, March 30, 2006.
 * "Bird Flu Vaccine: Long Way To Go. In Race To Make Bird Flu Vaccine, Finish Line Still Out Of Sight," WebMD (CBS News), March 30, 2006.
 * Fergus Walsh, "Human trials for bird flu vaccine. Human trials of an experimental vaccine against the H5N1 bird flu virus have begun in Belgium," BBC News, March 31, 2006.
 * David Brown, "Bird Flu Vaccine Shows Promise," Washington Post, July 27, 2006.
 * Denise Grady, "Maker Calls New Bird Flu Vaccine More Effective," New York Times, July 27, 2006.
 * Elisabeth Rosenthal, "Method to expand output of bird flu vaccine lauded," International Herald Tribune, September 7, 2006.
 * "Novartis Secures Contract To Supply Additional H5N1 Influenza Vaccine To The US Government," Medical News Today, November 23, 2006.

2007

 * Aaron Smith, "Feds award bird flu vaccine contracts to Novartis, Glaxo ... receive more than $100 million from HHS to help prepare U.S. against bird flu," CNNMoney, January 17, 2007.
 * Slides: "Proposed Pharmacovigilance Plan for H5N1 Influenza Virus Vaccine" by Patrick Caubel, MD, PhD, Head of Pharmacovigilance North America, February 27, 2007. Slides subheaded by sanofi pasteur.
 * "U.S. Advisers Endorse Bird Flu Vaccine. While it has limited effectiveness, it's better than nothing, FDA told," HealthDay/MedlinePlus, February 27, 2007.
 * "Expert panel supports US bird flu vaccine," NewScientist.com and Reuters, February 28, 2007.
 * Anita Manning, "Experimental bird flu vaccine could be doubly promising," USA TODAY, March 5, 2007.
 * "Vaccine may fight different bird flu strains. Broader protection would be valuable if virus mutates, experts say," Associated Press (MSNBC), March 6, 2007.
 * Bruce Japson, "Baxter says bird flu vaccine working for humans in trials," Chicago Tribune, March 29, 2007.
 * Jacob Goldstein, "A Glaxo Bird Flu Vaccine for the Developing World?" Wall Street Journal, April 2, 2007.
 * "Indonesia eyes bird flu vaccine cooperation with Egypt," Reuters AlertNet, April 3, 2007.
 * "Indonesia, Egypt to develop bird flu vaccine," Reuters, April 5, 2007.
 * "H5N1 Influenza Virus Vaccine," USFDA, April 17, 2007.
 * News Release: "FDA Licenses First U.S. Vaccine for Humans Against Avian Influenza. sanofi pasteur receives first U.S. license for a vaccine against avian influenza in humans marking an important milestone in pandemic preparedness," PRNewswire, April 17, 2007.
 * Smriti Jacob, "Vaccine with Rochester roots OK'd," NBC News 10 (Rochester, NY), April 17, 2007.
 * "FDA Licenses Sanofi Bird Flu Vaccine - Quick Facts," TradingMarkets.com, April 17, 2007.
 * Catherine Paddock, "First Vaccine Against H5N1 Avian Flu Approved In The US," Medical News Today, April 17, 2007.
 * Lisa Richwine, "US approves first bird flu vaccine for people," Reuters, April 17, 2007.
 * "Leavitt: Bird Flu Vaccine is a Good Sign," UPI, April 17, 2007.
 * "FDA OKs bird flu vaccine that is considered better than nothing in case of a pandemic," Associated Press (StarTribune.com), April 17, 2007.
 * Gregory Lopes, "FDA approves bird flu vaccine," Washington Times, April 18, 2007.
 * Jia-Rui Chong, "FDA approves bird flu vaccine. The shot, the nation's first, is only modestly effective but could slow a possible pandemic," Los Angeles Times, April 18, 2007.
 * Anna Lewcock, "Sanofi ups production capacity after vaccine go-ahead," In-PharmaTechnologist.com (DrugResearcher.com), April 18, 2007.