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Sanofi submits FDA application for swine flu vaccine

Published on 10/08/09 at 12:50pm

Sanofi Pasteur has filed with US regulators a supplemental license application for its vaccine to protect against the H1N1 pandemic flu virus.

Responding to FDA recommendations, the company's application requests the evaluation of the influenza A(H1N1) 2009 strain change, which should accelerate the license process for a new pandemic vaccine.

Wayne Pisano, president and chief executive of Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, said: "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.

"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 application follows recommendations by the FDA to evaluate H1N1 flu vaccines using the same regulatory process by which it approves the new viral strains of the annual seasonal influenza vaccines.

Sanofi Pasteur's influenza supplemental application specifies the evaluation of a non-adjuvanted vaccine. This means it is without 'adjuvant', a new type of technology that boosts the potency of antigens in vaccines, which is being used by both Novartis and GSK in the development of their vaccines.

Sanofi Pasteur began testing the immunogenicity and safety of its vaccine in the US on 6 August. The 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.

GSK, another company racing to produce a vaccine, says European and US regulators will also assess a data package including safety information for its own product. However, it has not yet announced it has entered clinical trials, and claims to be in discussions with regulatory authorities to develop appropriate clinical development plans.

More information on the influenza A(H1N1) 2009 vaccine clinical trials is available at

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