FDA approves Sanofi Fluzone ® High-Dose Quadrivalent's Application for A Supplemental Biologics License
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Sanofi announced that the u.SFood andDrug(http://Administration http://
(http://has approved a supplemental biologic license (sBLA) for fluzone ® High-priced, four-price influenza vaccine for the elderly population aged 65 and overon Fluzone® High-DoseFluzone ® 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 vaccineFluzone 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 seasonthis approval, 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 vaccinefluzone High-Dose Quadrival induced a superior immune response to each of the influenza B influenza strains in the secondary endpoint of thetest(http://, compared to the triamcinal formulation strains 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 aftervaccination 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 vaccination
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