Published on September 22, 2009 at 8:57 AM
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that the company has received an additional order from the U.S. Department of Health and Human Services (HHS) to produce vaccine to help protect against the Influenza A (H1N1) 2009 virus. The new order is for the production of bulk antigen equivalent to 27.3 million doses based on 15 mcg of antigen per dose. Specifications for formulation and filling of this new bulk order will be the subject of a separate order. To date, Sanofi Pasteur has committed to the U.S. government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.
"We are pleased to be able to support the U.S. government's pandemic response efforts through the production of additional doses of A (H1N1) vaccine," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "As the only company manufacturing inactivated influenza vaccine in the U.S., we recognize the important role Sanofi Pasteur serves in the country's pandemic response plan and we have committed our resources to responding to our public health needs."
Sanofi Pasteur began commercial production of the new influenza vaccine in June using the novel virus strain to provide doses for clinical trials and to respond to the initial order from HHS. Influenza A (H1N1) 2009 Monovalent Vaccine was licensed by the U.S. Food and Drug Administration on September 15. Sanofi Pasteur is testing the immunogenicity and safety of the Influenza A (H1N1) 2009 Monovalent Vaccine produced in the U.S. through clinical trials, which began in the U.S. on August 6. Final data from these clinical trials will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.
Sanofi Pasteur operates influenza vaccine production facilities in the U.S. and in France. Production of the new A (H1N1) vaccine for HHS is being performed at the company's U.S.-based production facility.
Source: http://www.sanofipasteur.com