Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that the company has received an additional order from the US 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 US government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine.

"We are pleased to be able to support the US 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 US, 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 US 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 US through clinical trials, which began in the US 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 US and in France. Production of the new A (H1N1) vaccine for HHS is being performed at the company's US-based production facility.

The US licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons six months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

The Influenza A (H1N1) 2009 Monovalent Vaccine is manufactured by the same process as Sanofi Pasteur's seasonal trivalent influenza virus vaccine licensed in the US Influenza A (H1N1) 2009 Monovalent Vaccine is formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009 (H1N1) v-like virus. Influenza A (H1N1) 2009 Monovalent Vaccine is licensed for single-dose presentations in syringes and vials and in multi-dose vials. There is no preservative used in the single dose presentations. Multi-dose vials contain a preservative.