FDA approves GSK bird flu vaccine for U.S. stockpile

The FDA has approved its first adjuvanted vaccine against a potential outbreak of the deadly bird flu. It just won't be available at the local pharmacy.

The agency said Friday that it has approved the first vaccine for the prevention of H5N1 influenza, or avian or bird flu, for people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus. The agency is getting it from a GlaxoSmithKline ($GSK) subsidiary, ID Biomedical of Quebec, in Canada. The agency earlier this year delayed approval of the vaccine because of reports it might be linked to narcolepsy.

An adjuvant in a vaccine makes it possible to use a smaller amount of influenza protein to get the desired result. The agency said it tested for a response on 2,000 adults and that 91% of those between the ages of 18 and 64 years and 74% of those 65 years and older who received the two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza.

The agency said the vaccine would go into the national stockpile for use in the event of a pandemic and will not be available for commercial use. The stockpile could be used to protect essential personnel like healthcare workers. The agency pointed out that most avian influenza doesn't infect people but that H5N1 has made the leap from poultry to humans, and 60% of those infected die.

There has been an outbreak this year of another avian influenza A called H7N9. The Centers for Disease Control and Prevention reported last week that since the outbreak began in April in China, the virus had infected 139 people and killed 45. Novartis ($NVS) and some other companies have been working on a vaccine for that flu.

- here's the release
- here's the CDC report

Related Articles:
Roche's Tamiflu, GSK's Relenza work against new bird flu strain
Novavax presents positive Phase I data for H7N9 vaccine
UMD scientists test new bird flu vaccine in animals
Novartis, Novavax whip up new bird flu vaccines as pandemic fears flourish

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