Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced that the US Food and Drug Administration (FDA) has approved the company's supplemental biologics license application (sBLA) for licensure of its Influenza A (H1N1) 2009 Monovalent Vaccine.
The US licensed Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. Sanofi Pasteur provides the only influenza vaccine licensed in the US for populations as young as 6 months of age and older.
"Obtaining FDA licensure of this vaccine for A (H1N1) pandemic response is a key milestone that will enable Sanofi Pasteur to provide a licensed vaccine to the US government to support pandemic immunization efforts," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "Development and production of an A (H1N1) influenza vaccine remains a high priority for Sanofi Pasteur and we will continue to focus our vaccine production expertise and resources on addressing this public health challenge."
The sBLA had been filed by Sanofi Pasteur on August 7 in response to recommendations by the FDA for evaluation of Influenza A (H1N1) 2009 Monovalent Vaccine as a strain change using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccine.
Sanofi Pasteur is testing the immunogenicity and safety of its Influenza A (H1N1) 2009 Monovalent Vaccine 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. Similarly, clinical development activities with Sanofi Pasteur's A (H1N1) vaccine manufactured in France are underway in close consultation with the European Authorities.
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.