FDA Approves Swine Flu Vaccines

As expected, the U.S. Food and Drug Administration has approved four vaccines against the novel H1N1 virus that is causing the swine flu pandemic. None of the vaccines are yet available to the public, but FDA wanted to make sure that the regulatory process does not cause any delays.

The agency approved the vaccines with scant clinical data, relying instead on the same “strain change” rules that allow manufacturers to change the seasonal vaccine without conducting human studies. The new vaccines include inactivated virus products made by CSL Limited, Novartis Vaccines and Diagnostics, and Sanofi Pasteur Inc., as well as a live, attenuated virus manufactured by MedImmune LLC.

FDA says the first swine flu vaccines will become available within the next 4 weeks, although the U.S. Department of Health and Human Services expects its first major shipment of product to arrive on 15 October.