The FDA has approved Sanofi Pasteur’s supplemental biologics license application (sBLA) for licensure of its Influenza A (H1N1) 2009 Monovalent Vaccine.
Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunisation of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.
Reportedly, 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.
The company said that it is testing the immunogenicity and safety of its Influenza A (H1N1) 2009 Monovalent Vaccine through clinical trials. Final data from these clinical trials will provide additional information to guide recommendations on the optimal dosage, number of doses and schedule.
Additionally, clinical development activities with Sanofi Pasteur’s A (H1N1) vaccine manufactured in France are underway in close consultation with the European Authorities.
Wayne Pisano, president and CEO of Sanofi Pasteur, said: “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 immunisation efforts.
“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.”