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Sanofi Pasteur Receives Additional Order from U.S. Government to Produce Influenza A (H1N1) Vaccine
Date:9/21/2009

ide 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.

About Influenza A (H1N1) 2009 Monovalent Vaccine

The U.S. 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 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 singledose presentations. Multi-dose vials contain a preservative.

Safety Information for Influenza A (H1N1) 2009 Monovalent Vaccine

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.

Before administering Influenza A (H1N1) 2009 Monoval
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