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H1N1 vaccine licensure depends on adjuvant

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Efforts are under way to expedite H1N1 flu vaccine development for a potential voluntary vaccination campaign in the fall. How FDA handles registration of the vaccine depends on whether an adjuvant is used - if it is manufactured using the same process as the seasonal flu vaccine, the vaccines will be licensed for use as a strain change, the same way FDA approves new strains of the seasonal vaccine. If an adjuvant is used, the products would be registered under an Emergency Use Authorization. FDA announced the licensure of the seasonal flu vaccine for the 2009-2010 flu season on July 20, and clarified that it will not protect against H1N1. The same five manufacturers that produce seasonal vaccine are working on the swine flu vaccine

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