FDA Approves Flu Vaccine for Older Adults

The U.S. Food and Drug Administration (FDA) has approved a new supplemental Biologics License Application for Fluzone High-Dose Quadrivalent, the first and only flu vaccine for adults at least 65 years old, reports MDMag . Sanofi Pasteur's vaccine received initial FDA approval in 2009 as a trivalent influenza vaccine that included two influenza A strains and an influenza B strain, while the new version has an additional influenza B strain. "Increasing protection and delivering improved influenza vaccines are critical to public health," said Sanofi Executive Vice President David Loew. "We are excited to build upon the success of trivalent Fluzone High-Dose with this FDA approval to expand protection for an additional B strain. We have submitted filings with additional regulatory bodies outside the U.S. and anticipate approval in the European Union next spring." The FDA clearance is the last stage Sanofi must make before transitioning to quadrivalent influenza vaccines in the United States during the 2020-2021 flu season. The approval partly stems from a phase 3 immunogenicity and safety study, where the vaccine achieved the primary endpoint of non-inferior immunogenicity compared to two previous trivalent formulations featuring one of the two influenza B strains recommended in 2017-2018.