Sanofi Pasteur Files H1N1 Vaccine Application

The company began U.S. clinical trials Aug. 6 and plans to test the vaccine's immunogenicity and safety, with about 2,000 people getting it in the trials.

Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced Friday it has submitted a supplemental application to FDA for licensure of its influenza A(H1N1) 2009 monovalent vaccine. In a release datelined Lyon, France and Swiftwater, Pa., the company said it began U.S. clinical trials a day earlier to test the vaccine's immunogenicity and safety, with about 2,000 people to receive the vaccine in the trials. Information on the clinical trials is available at www.clinicaltrials.gov.

"Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1) 2009 virus," said Wayne Pisano, president and CEO of Sanofi Pasteur. "It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time continue the important clinical studies of our vaccine."

The company said the supplemental application follows recommendations by FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process used to approve new viral strains contained in the annual seasonal influenza vaccines. Sanofi Pasteur said its A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a non-adjuvanted vaccine.

The company provided more than 1.6 billion doses of vaccine in 2008. For more information, visit www.sanofipasteur.com or www.sanofipasteur.us.

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