FDA Licenses Sanofi-Pasteur's H5N1 Vaccine

April 19, 2007
Pharmaceutical Technology Editors
ePT--the Electronic Newsletter of Pharmaceutical Technology

Lyon, France (Apr. 17)-Sanofi Pasteur, the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States.

Lyon, France (Apr. 17)-Sanofi Pasteur (http://en.sanofi-aventis.com), the vaccine division of the Sanofi-Aventis Group, announced that the US Food and Drug Administration (Rockville, MD, www.fda.gov) has licensed its H5N1 vaccine, making it the first avian-influenza vaccine for humans in the United States. The vaccine will be part of the government’s vaccine-stockpile program to prepare for a potential pandemic.

Licensure was based on a clinical trial conducted by the National Institute of Allergy and Infectious Diseases completed in 2005.

Although no human cases of H5N1 infection have been reported in the United States, nearly 300 people worldwide have been infected with the virus since 2003, and more than half have died.

Ensuring sufficient manufacturing capacity to provide an adequate number of doses remains a challenge, however, as worldwide agencies develop strategies for timely development, manufacture, and distribution.

“We are working closely with other government agencies, global partners, and the vaccine industry to facilitate development, licensure, and availability of needed supplies of safe and effective vaccines to protect against the pandemic threat,” said Jesse Goodman, MD, MPH, director of FDA’s Center for Biologics Research and Evaluation, in an FDA release.