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FDA approves first H5N1 vaccine from Sanofi Pasteur
19th Apr 2007
Sanofi Pasteur's (Sanofi-Aventis) H5N1 inactivated vaccine against avian flu has been granted approval by the US FDA as a "stop-gap" medical measure that could provide some protection against a potential pandemic until more effective vaccines can be developed.
It is the first and only licensed vaccine available in the US against the H5N1 strain, and it is already being stockpiled by the US government in the event that the H5N1 virus, which is mostly spreading among birds, develops the capability to spread efficiently from human to human. It will not be available commercially. Its approval came on the recommendation of an FDA advisory panel, who voted in February that safety data were adequate to support its use (Scrip No 3238, p 16).
During the panel meeting, the advisors generally agreed that the immunogenicity response for the vaccine was lower than they would have liked. However, several experts said that they viewed the vaccine as an important first step in the development of pandemic vaccines.
"We feel that as part of pandemic preparedness, it would be best to have a licensed vaccine and our review has shown that the Sanofi Pasteur vaccine is safe and effective, and it is manufactured by a process that is used for a currently licensed vaccine," said Dr Norman Baylor, director of the office of vaccines research within the FDA's Center for Biologics Evaluation and Research. To date, the HHS has purchased for the federal stockpile 13 million doses, enough to cover 6.5 million people. The H5N1 virus is changing, but the FDA believes that the Sanofi Pasteur vaccine might provide some cross protection.
The vaccine was developed under a contract from the National Institute of Allergy and Infectious Diseases. The FDA said that the highest dose tested, two 90mcg doses given one month apart, elicited a better immune response than lower doses that were tested. The study showed that 45% of individuals who received the higher dose developed antibodies at a level that is expected to reduce the risk of getting influenza. The FDA said it is possible the vaccine would still be able to cut disease severity and influenza-related hospitalisations and deaths among people who do not achieve an optimal response to the vaccine.
Sanofi Pasteur's vaccine is intended for immunising people between 18 and 64 years of age who could be at increased risk of exposure to the H5N1 influenza virus. According to the FDA, additional data on the vaccine are being collected in other age groups and will be available in the near future.
While there have been no reported human cases of H5N1 infection in the US, almost 300 people worldwide have been infected with the virus since 2003, and more than half have died.
Other companies have licensed H5N1 vaccines in preparation for a pandemic. In the EU, two "mock up" pandemic vaccines have been approved for use during a full-blown pandemic (in which the virus strain will be quickly replaced by the exact pandemic strain) including Novartis's Focetria. GlaxoSmithKline is also developing a vaccine for approval for a "mock up" vaccine and for use in the pre-pandemic phase. Baxter is also developing a bird flu vaccine.
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