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

Wednesday, April 25, 2018 Drug News
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- If approved, health care professionals will be able to use the same 0.5 mL dose of Fluzone Quadrivalent vaccine with all patients ages 6 months and older for whom flu vaccination is recommended - which may provide more flexibility and convenience to immunizers.

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

Media Relations Contact Ashleigh Koss Tel.: +1 908 981 8745 Ashleigh.Koss@sanofi.com

Investor Relations ContactGeorge Grofik Tel.: +33 (0)1 53 77 45 45ir@sanofi.com

Sanofi Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2017. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Cision View original content:http://www.prnewswire.com/news-releases/fda-accepts-for-review-supplemental-biologics-license-application-for-0-5-ml-dose-of-fluzone-quadrivalent-influenza-vaccine-in-children-635-months-of-age-300635761.html

SOURCE Sanofi



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