FDA approves GlaxoSmithKline avian flu vaccine

The U.S. Food and Drug Administration recently approved a pandemic influenza vaccine manufactured by GlaxoSmithKline, which could increase pandemic preparedness, according to the U.S. Department of Health and Human Services.

The approval of Q-pan by the FDA means the adjuvanted vaccine is considered effective and safe. Adjuvants can reduce the amount of vaccine antigen needed for an immune response, and less antigen needed in each vaccine dose could allow for the availability of more vaccine doses during a pandemic.

GSK developed the vaccine in partnership with the HHS' Biomedical Advanced Research and Development Authority. GSK and BARDA began working on the vaccine in 2007, with both partners funding the safety and efficacy studies needed to reach FDA approval.

If an H5N1 pandemic were to occur, the U.S. government could have more than 35 million doses of Q-pan available within weeks, and GSK could produce additional doses as needed.

Of the 600 people who became ill with H5N1 avian flu in the last decade, close to 60 percent died from the disease. The approval of Q-pan could protect the health of many people if the H5N1 avian flu virus changes from one that spreads from birds to people into one that spreads between humans.