FDA delays approval of GSK vaccine

Drug maker cites administrative issue; FDA advisory committee voted to recommend approval in November 2012

LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.

The vaccine is designed for adults who are at risk of exposure to the H5N1 influenza virus. The program to develop the vaccine is supported by the Department of Health and Human Services' Biomedical Advanced Development and Research Authority.

GSK said it was working with the agency to resolve the matter, and that the FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to support approval of the vaccine.


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