FDA Licenses Sanofi-Aventis' Avian Flu Vaccine

Filed in archive Corporate and Industrial News , Drugs, Vaccines and Therapeutics on April 19, 2007

The US FDA has licensed Sanofi-Aventis' H5N1 vaccine (pdf file of the press release here), the first Avian influenza vaccine for humans in the U.S.

The licensure of this vaccine was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases. This trial evaluated the safety and ability to generate an immune response of this vaccine when administered in two 90 ug/ml doses in healthy adults 18 through 64 years. The study, which was completed in 2005, showed that the vaccine elicited an immune response against the H5N1 virus and was associated with mild side effects.

This approval implies that the vaccine is no longer considered as exprimental, and this may be dispensed in the advent of a pandemic without requiring patients to sign an informed consent form. The vaccine will not be sold to the general public, however; it will dispensed only by the government. For related info, see the following reports:

International Herald Tribune: U.S. approves limited vaccine for avian flu
Market Watch: FDA approves Sanofi-Aventis H5N1 bird-flu vaccine
The Street: Avian Flu Vaccine Cleared