The FDA has approved the Influenza A (H5N1) Virus Monovalent vaccine, Adjuvanted, the first adjuvanted vaccine for the prevention of H5N1 influenza (“avian flu”). The vaccine is indicated for use in adults >18 years of age at increased risk of exposure to the H5N1 influenza virus.
The vaccine was developed using an egg-based manufacturing process and contains the adjuvant AS03, an oil-in-water emulsion. An adjuvant is a substance incorporated into some vaccines to enhance or direct the immune response of the vaccinated individual.
In a multi-center safety study, patients’ immune response was evaluated in about 2,000 of the vaccinated adults (n=3,400 vaccine group; n=1,100 placebo group). The results showed that 91% of individuals aged of 18–64 years and 74% of individuals >65 years who received the two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza.
The H5N1 component and the AS03 adjuvant component are supplied as two separate vials, which must be combined prior to intramuscular administration.
The H5N1 avian influenza vaccine is not intended for commercial availability. The U.S. Department of Health and Human Services has purchased the vaccine from ID Biomedical Corporation of Quebec, Quebec City, Canada, for inclusion within the National Stockpile for distribution by public health officials if needed.
For more information call (800) 463-6332 or visit the FDA press release.