LYON, France and SWIFTWATER, Pa., Sept. 15 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group , announced today that the U.S. 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.
“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 U.S. 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.”
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 U.S. 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.
Influenza vaccine should not be administered to anyone with a known severe hypersensitivity to egg proteins, any vaccine component, or life-threatening reactions after previous administration of any influenza vaccine. Recurrence of Guillain-Barre syndrome (GBS) has been temporally associated with the administration of influenza vaccine. The decision to give Influenza A (H1N1) 2009 Monovalent Vaccine to individuals who have a prior history of GBS should be based on careful consideration of the potential benefits and risks. Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.
About Influenza Vaccine Production at Sanofi Pasteur
Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide and more than 45 percent of the influenza vaccines distributed in the U.S. for the 2008-2009 influenza season. More information about Sanofi Pasteur’s pandemic preparedness efforts can be found at www.pandemic.influenza.com.
Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris and in New York .
Forward Looking Statements
SOURCE Sanofi Pasteur
CONTACT: Global Media Relations, Pascal Barollier, +33-(0)4-37-37-50-38,
pascal.barollier@sanofipasteur.com; US Media Relations, Donna Cary,
+1-570-957-0717, donna.cary@sanofipasteur.com
Web site: http://www.sanofipasteur.com/
http://www.sanofipasteur.us/
