GSK’s H5N1 flu vaccine gets green light from FDA

gsk h5n1 avian influenza fda (PeterJBellis

GlaxoSmithKline’s pandemic H5N1 (avian flu) vaccine has been approved by the US FDA for use in the event of an H5N1 avian flu epidemic. The vaccine won’t be available for commercial use, but will be added to the national stockpile for use as directed by BARDA.

The vaccine is the first FDA-approved adjuvanted vaccine for H5N1, which kills about 60% of people it infects. “This vaccine could be used in the event that the H5N1 avian influenza virus develops the capability to spread efficiently from human to human, resulting in rapid spread of disease across the globe,†said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. Clinical trial results showed that 91% of vaccinated individuals between 18 and 64, and 74% of individuals over 65, who received two doses developed antibodies at a level thought to reduce the risk of getting influenza.

The vaccine is adjuvanted with GSK’s AS03 adjuvant, the same adjuvant used in GSK’s H1N1 vaccine, Pandemrix, which generated concerns over a possible link to narcolepsy.

Read more at Reuters and GSK press release >

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