The FDA has approved Sanofi’s licensure request for vaccine approval for the upcoming 2022-2023 flu season, which would include Fluzone High-Dose Quadrivalent (influenza vaccine), Flublok Quadrivalent (influenza vaccine) and Fluzone Quadrivalent (influenza vaccine).
This approval comes on the heels of the CDC’s Advisory Committee on Immunization Practices’ preferential recommendation for adults 65 years old and older, including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent. Following this licensure, Sanofi will begin to ship their vaccines helping to ensure more people, including vulnerable populations of 65 years old and older, will be immunized with the vaccine best suited for their needs as recommended by the ACIP.
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Influenza disproportionately impacts people over the age of 65 years old and older, underrepresented communities and people with co-morbidities, such as diabetes, asthma, chronic obstructive pulmonary disease and heart disease. Since 2010, it’s estimated by the CDC that between 70% and 85% of seasonal flu-related deaths have occurred in people 65 years old and older, and between 50% and 70% of seasonal flu-related hospitalizations have occurred among people in this age group. ACIP’s June 22 recommendation will undoubtedly help reduce the risk of influenza cases and severe flu-related complications in this population at highest risk, Sanofi said.
“ACIP’s recommendation is a first step to help improve protection against flu and its complications for this 65 years and older high-risk population,” said Michael Greenberg, North America Medial head of vaccines at Sanofi.
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“Not every flu vaccine is created equal and we are pleased with ACIP’s acknowledgment that Fluzone High-Dose Quadrivalent and Flublok Quadrivalent have demonstrated improved protection from flu and its related complications through randomized controlled trials and real-world evidence,” the company said.
“Of note, ACIP recognized that Fluzone High-Dose Quadrivalent had the most data available, including evidence favoring its use over standard dose for all the benefit outcomes within the GRADE analysis, influenza illnesses, outpatient/ER visits, hospitalizations and deaths,” Sanofi said. Nevertheless, we believe even more can be done to provide healthcare providers with clearer guidance. As a leader in flu vaccination, we remain committed to ensure adults 65 years and older have access to flu vaccines, proven to protect them from what really matters, such as flu-related hospitalizations due to cardiovascular events and pneumonia.”