The FDA approved a licensure request for Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent for use in the upcoming 2022-2023 flu season, providing influenza vaccination for adults 65 years of age and older.
The FDA has approved Sanofi’s licensure request for vaccine approval for the 2022-2023 flu season. Approved vaccines include Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent.
The approval follows the CDC’s Advisory Committee on Immunization Practices (ACIP) preferential recommendation for adults 65 years of age and older including Fluzone High-Dose Quadrivalent and Flublok Quadrivalent.
“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,” Michael Greenberg, MD, MPH, North America Medial head of Vaccines at Sanofi, said in a statement. “Not every flu vaccine is created equal and we are pleased with ACIP’s acknowledgement that Fluzone high-Dose Quadrivalent & Flublok Quadrivalent have demonstrated improved protection from flu and its related complications through randomized controlled trials and real-world evidence.”
The licensure approval allows Sanofi to begin shipping their vaccines to be administered to the vulnerable 65 years of age and older population based on their needs as recommended by the ACIP.
The Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent were submitted to the FDA for approval to include new flu strains for the upcoming 2022-2023 flu season. These new flu strains are identified based on FDA, WHO, and CDC predictions for influenza strains likely to cause the most illness in the upcoming flu season.
Fluzone High-Dose Quadrivalent, Flublok Quadrivalent, and Fluzone Quadrivalent are indicated for immunization against disease caused by influenza A and B strains contained in the vaccine. Fluzone Quadrivalent is administered to people 6 months of age and older, whereas Flublok Quadrivalent is administered to those 18 years of age and older.
Flublok Quadrivalent is the first and only recombinant influenza vaccine for adults 18 years of age or older proven to be 30% more effective than a standard dose vaccine at preventing flu infection in more than 9000 adults 50 years of age or older, according to a clinical study. The most common adverse effects (AEs) experienced by adults 50 years of age or older were tenderness and/or pain at injection site, headache, and tiredness.
Fluzone High-Dose Quadrivalent is administered to people 65 years of age and older and provides protection against 4 flu strains. It is the only influenza vaccine licensed for use in adults 65 years of age or older to have demonstrated superior efficacy in a randomized controlled trial versus a standard dose influenza vaccine for the prevention of laboratory-confirmed influenza illness, according to Sanofi.
Additionally, Sanofi asserts that Fluzone High-Dose Quadrivalent is the only influenza vaccine with 10 years of data demonstrating protection from flu and its related complications.
“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,” Greenberg said. “Nevertheless, we believe even more can be done to provide healthcare providers with clearer guidance.”
In a meta-analysis of 15 published reports that included approximately 34 million people, those who received Fluzone High-Dose experienced an 18% reduction in cardiorespiratory hospitalizations and a 28% decrease in pneumonia hospitalizations. Both reductions are above what the standard dose vaccines provided.
Fluzone High-Dose is manufactured according to the same process as and with an overlapping composition with the trivalent formulation, which Sanofi states was clinically proven to be 24.2% more effective at preventing flu than the standard-dose Fluzone vaccine in adults 65 years of age and older.
However, AEs were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard dose vaccine, according to Sanofi.
In a press release, Sanofi suggests that ACIP's recommendation will help reduce the risk of influenza cases and severe flu-related complications in this population with the highest risk.
“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,” Greenberg said.
Sanofi flu vaccines licensed and approved for 2022-2023 influenza season, including CDC preferred higher-dose vaccines for adults 65+ [press release]. Bridgewater, NJ: PR Newswire; July 1, 2022. https://www.news.sanofi.us/2022-07-01-Sanofi-flu-vaccines-licensed-and-approved-for-2022-2023-influenza-season,-including-CDC-preferred-higher-dose-vaccines-for-adults-65. Accessed July 7, 2022.