H5N1 Influenza Virus Vaccine

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Licensure for the first H5N1 Influenza Virus Vaccine—a vaccine against H5N1 avian influenza, commonly referred to as avian influenza or 'bird flu', for use with humans—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—"made from an inactivated H5N1 virus isolated in Southeast Asia in 2004" [1]—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). [2]
  • 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."

Production

In the United States

In November 2006, sanofi pasteur announced an agreement—"valued at up to $117.9m, dependent on the number of doses that can be formulated from bulk material"—with the Department of Health and Human Services for "the production of bulk concentrate of a new type of H5N1 pre-pandemic vaccine." [3]

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." [4]

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." [5]

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." [6]

Testing & Results

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." [7]

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. [8] The trial was led by UR's "vaccine expert" John Treanor M.D. [9]

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 ...." [10]

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." [11]

Other vaccine manufacturers

Other companies, including Novartis AG and GlaxoSmithKline Plc, "are developing bird flu vaccines with adjuvants, substances that can boost immune response." [12]

Related SourceWatch Resources

External links

2005

2006

2007

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