Sanofi Fluzone high-dose quaddrug vaccine approved by FDA for older age group of 65-year-olds

Fluzone ® High-Dose was approved by the FDA in 2009 as a triamcinolone influenza vaccine, including two influenza A and one strain of influenza BFluzone ® High-Dose Quadrivalent contains an additional strain of influenza B virus for the elderly aged 65 and older to help prevent influenza disease caused by the influenza strains of influenza A and B contained in the vaccineThe approval is the final step in Sanofi's full transition to a quadrated flu vaccine in the United StatesFluzone High-Dose Quadrivalent will be available for immunization during the 2020-2021 flu seasonSanofi Pasteur will continue to deliver and deliver Fluzone High-Dose trivalent preparations until the end of the 2019-2020 flu season"The flu is a serious threat, especially for older people who are more at risk for serious complications or even death," said DrJohn Shiver, Senior Vice President of Global Research and Development at Sanofi PasteurOver the past decade, Fluzone High-Dose has helped protect millions of people aged 65 and older from seasonal fluWe are committed to helping as many people as possible from the flu and look forward to the launch of this new formulationThis approval is based on data from a Phase III immunoogenic and safety studyIn this study, Fluzone High-Dose Quadrivalent reached the primary endpoint of non-performance immunoprime compared to fluzone High-Dose, both of which contained one of two influenza B influenza strains recommended for the 2017-2018 flu season vaccineIn terms of secondary endpoints of the trial, each of fluzone High-Dose Quadrivalent's B influenza virus strains induced a superior immune response compared to triassive formulations that did not contain the corresponding B strainIn the study, the local and systemic response rates of Fluzone High-Dose Quadrivalent immunity were similar to those of the Fluzone High-Dose trivalent vaccineThe most common reactions after vaccination were pain at the injection site (41.3%), myalgia (22.7%), headache (14.4%) and discomfort (13.2%), usually in the first three days after vaccination, and most responses were addressed within three days of vaccinationThe findings were published in the September 2019 issue of the journal VaccineFluzone High-Dose is the first and only flu vaccine among adults 65 and older to be shown to be more effective than fluzone ® (flu vaccine), according to a randomized controlled trialThe study assessed nearly 32,000 adults 65 and older during two flu seasons in the United States and CanadaThe results showed that Fluzone High-Dose was 24 percent more likely to have flu cases caused by any circulating flu strain than Fluzone, and more than 51 percent more flu cases than those caused by strains similar to those contained in the vaccineAccording to data from the Fluzone High-Dose vaccine, fluzone High-Dose has slightly higher rates of injection site reactions and systemic adverse reactions than standard dose vaccinesby the end of the 2018-2019 flu season, the U.Shas distributed more than 112 million doses of Fluzone High Dose during the 2018-2019 flu season, and nearly two-thirds of U.Sadults 65 and older who receive the flu vaccine have been immunized against fluzone High Doseoriginal origin: Sanofi : FDA approves Fluzone High--Fluzone High--Influenza Vaccine (Influenza Vaccine) for adults 65 years of age and older