Sanofi Pasteur submits supplemental application for influenza A(H1N1) 2009 monovalent vaccine to FDA

Sanofi Pasteur announced today the company has submitted to the U.S. Food and Drug Administration (FDA) a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine.

Responding to recent recommendations by the FDA, the company's supplemental 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 by which it approves new viral strains contained in the annual seasonal influenza vaccines. Sanofi Pasteur's influenza A(H1N1) 2009 monovalent vaccine supplemental application specifies the evaluation of a non-adjuvanted vaccine.

While these strain change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began August 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine. More information on the influenza A(H1N1) 2009 vaccine clinical trials is available at www.clinicaltrials.gov.

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