FDA accepts for review Supplemental Biologics License Application for 0.5 mL dose of Fluzone® Quadrivalent (Influenza Vaccine) in children 6-35 months of age

SWIFTWATER, Pa., April 25, 2018 /PRNewswire/ -- The U.S. Food and Drug Administration has accepted for review a supplemental Biologics License Application to expand the age indication of the 0.5 mL dose of Sanofi Pasteur's Fluzone^® Quadrivalent (Influenza Vaccine) to include children 6 through 35 months of age. Per the Prescription Drug User Fee Act, the target action date is January 28, 2019. If approved, physicians will be able to reserve the vaccine for young children for the 2019–2020 flu season.

The application is supported by clinical data from a Phase IV safety and immunogenicity study conducted in nearly 2,000 children. Detailed results from the Phase IV, randomized, observer-blinded, controlled, multicenter study will be presented at medical meetings later this year.   

"We are dedicated to helping protect patients of all ages against the flu, which can be especially severe and life threatening for more vulnerable groups such as younger children," said Dr. David P. Greenberg, Associate Vice President and Regional Medical Head of North America, Sanofi Pasteur. "We are one step closer to potentially offering clinicians the option to use 0.5 mL dose of Fluzone Quadrivalent vaccine with all of their eligible pediatric patients 6 months of age and older."

Fluzone Quadrivalent vaccine is designed to help protect people 6 months of age and older against the four flu viruses that cause the most disease: two influenza A subtypes, A(H1N1) and A(H3N2), and two influenza B lineages, Victoria and Yamagata. A 0.25-mL dose of Fluzone Quadrivalent vaccine is currently approved for use in children 6 through 35 months of age; a 0.5-mL dose is approved for people 36 months of age and older.

About Influenza

Influenza is a leading cause of vaccine-preventable deaths among children in the United States. Children of all ages can get the flu, including those who are otherwise healthy. Each year, young children are admitted to the hospital because of the flu more often than for any other vaccine-preventable disease – including approximately 20,000 children younger than 5 years of age.

Important Safety Information for Fluzone Quadrivalent Vaccine

Fluzone Quadrivalent vaccine should not be administered to anyone who has had a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multidose vial is the only presentation containing thimerosal), or to a previous dose of any influenza vaccine.

If Guillain-Barré syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Quadrivalent vaccine should be based on careful consideration of the potential benefits and risks.

The most common local adverse reactions to Fluzone Quadrivalent vaccine include pain at the injection site (all ages) and erythema and swelling at the injection site (in children). The most common systemic reactions include myalgia, malaise, and headache (irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever in young children). Other adverse reactions may occur. Vaccination with Fluzone Quadrivalent vaccine may not protect all individuals.

Please see full U.S. Prescribing Information.

About Sanofi

Sanofi (EURONEXT: SAN) (NYSE: SNY) is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

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