FDA Licenses First H5N1 Vaccine From Sanofi Pasteur
This article was originally published in The Pink Sheet Daily
Executive Summary
Avian influenza vaccine will not be commercially available but will be included in the national stockpile, FDA says.
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FDA approved the first H5N1 vaccine, manufactured by Sanofi Pasteur, to be licensed by the federal government and included in the U.S. Strategic National Stockpile as part of the country's pandemic preparedness planning. "FDA's approval of this vaccine is an important step in enhancing our nation's readiness against a possible pandemic and enhances our ability to protect those who could be at increased risk of exposure to the H5N1 influenza virus at some point," Center for Biologics Evaluation and Research Office of Vaccines Research and Review Director Norman Baylor said during an April 17 conference call announcing the approval. Health and Human Services Secretary Michael Leavitt said in a statement that HHS has purchased 13 million doses of the vaccine, enough to cover 6.5 million people. While FDA's review of data supporting the vaccine showed the product is safe and effective, Baylor noted it is an interim solution to be used in the case of a pandemic while next-generation lower dose, antigen sparing vaccines are developed. The vaccine is indicated for immunization of people ages 18 to 64 who are at increased risk of exposure to the H5N1 virus. The vaccine includes two intramuscular injections at 90 micrograms each, given approximately one month apart. "You'd like to be able to respond to a pandemic quicker than that. You'd also ideally like to have a vaccine where you could have one dose and you would need less antigen" Baylor said. "That type of vaccine is under study and under development." The approval of Sanofi's BLA, submitted in collaboration with the National Institutes of Health, was based on a clinical trial evaluating the immune responses of vaccine recipients. A total of 103 healthy adults received a 90 microgram dose followed by a second dose 28 days later, while 300 adults received the vaccine at doses lower than 90 micrograms and 48 received placebo. In the trial, the vaccine was generally well tolerated, with the most common side effects including pain at the injection site, headache, ill feeling and muscle pain. The study showed that 45 percent of those who received the 90 microgram dose in two installments developed antibodies at a level that is expected to reduce the risk of getting influenza. Sanofi said it is evaluating new adjuvants, the use of cell culture production processes and vaccine formulations to address other strains of the H5N1 virus. The company is planning to initiate a new clinical trial this spring evaluating an avian flu vaccine with a proprietary adjuvant in France. The existing vaccine will be produced at the company's Swiftwater, Pa., manufacturing facility. In February, FDA's Vaccines and Related Biological Products Advisory Committee recommended licensing Sanofi's H5N1 vaccine despite the fact it failed to meet immunogenicity standards laid out in FDA guidance on pandemic vaccine development (1 (Also see "Clinical Development Of Bird Flu Vaccines For Pre-Pandemic Uses To Be Discussed By Cmte." - Pink Sheet, 26 Feb, 2007.)). FDA announced last year that Sanofi would receive up to $117.9 million worth of a nearly $200 million contract to produce 3.7 million doses of pandemic flu vaccine for the U.S. stockpile. Novartis and GlaxoSmithKline also received $40.1 million and $40.6 million, respectively (2 (Also see "HHS Boosts Pandemic Flu Vaccine Stockpile With Contracts Totaling $200 Mil." - Pink Sheet, 20 Nov, 2006.)). Sanofi was also awarded a $150 million contract in September 2005 for bulk H5N1 vaccine, the firm said. -Jessica Merrill ([email protected]) |