Sanofi Submits A/H1N1 Vaccine Application

Sanofi Pasteur, the vaccine division of Sanofi-Aventis, has submitted a supplemental application to the FDA to license its influenza A/H1N1 2009 monovalent vaccine. The application requests the FDA’s evaluation of the influenza A/H1N1 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.

“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 chief executive officer 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 supplemental application follows recent recommendations by the FDA to evaluate the influenza A/H1N1 2009 monovalent vaccines using the same regulatory process used for new viral strains contained in annual seasonal flu vaccines. The company’s supplemental application specifies the evaluation of a non-adjuvanted vaccine.

These strain change supplements are not required to be supported by new clinical data, but immunogenicity and safety data will be made available through clinical studies. The company will conduct clinical trials testing the immunogenicity and safety of the vaccine. Trials in the U.S., which began August 6, will consist of approximately 2,000 subjects.

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