High-Dose Quadrivalent Vaccine Approved for Seniors

Sanofi Fluzone Quadrivalent vaccine approved by FDA to contain an additional influenza B strain

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The Fluzone High-Dose Quadrivalent Influenza Vaccine for use in adults 65 years of age and older has been approved by the U.S. Food and Drug Administration (FDA) for a supplemental Biologics License Application.

Fluzone was originally approved by the FDA in 2009 as a trivalent influenza vaccine, which included 2 influenza A strains and 1 influenza B strain. 

This new FDA approval on November 4, 2019, is for the Fluzone Quadrivalent vaccine, which will contain an additional influenza B strain. 

"Increasing protection and delivering improved influenza vaccines are critical to public health," said David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur, in a press release. 

"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."

This approval is the final step to complete the transition to quadrivalent influenza vaccines in the U.S. The Fluzone High-Dose Quadrivalent will be available during the 2020-2021 influenza season.

Sanofi Pasteur confirmed it will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season.

This FDA approval was based on data from a Phase 3 immunogenicity and safety study published in Vaccine in September 2019, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to 2 trivalent formulations of Fluzone High-Dose, each containing one of the 2 influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. 

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In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain.

Rates of local and systemic reactions that occurred following immunization with Fluzone High-Dose Quadrivalent were similar to those induced by trivalent formulations of Fluzone High-Dose. 

The most common reactions occurring after administration were injection-site pain (41.3 percent), myalgia (22.7 percent), headache (14.4 percent), and malaise (13.2 percent). Onset usually occurred within the first 3 days after vaccination, and the majority of solicited reactions were resolved within three days of vaccination. 

Fluzone High-Dose is the 1st and only influenza vaccine proven to provide superior efficacy compared to Fluzone® (Influenza Vaccine) in adults 65 years of age and older, based on results in a randomized controlled trial.

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This study evaluated nearly 32,000 adults 65 years of age and older over two influenza seasons in the U.S. and Canada.  

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“With the geriatric population at a higher risk of acquiring influenza and having severe complications from the disease, this vaccine could help provide more protection and lower hospitalization rates,” said Kayla Colunga, Pharmacy Intern, Brookshires Grocery Company. 

“Pharmacists play a major role in advocating for this patient population, and we need to make sure to provide proper patient education about vaccinations,” continued Colunga.

Results showed that Fluzone High-Dose prevented 24 percent more cases of influenza caused by any circulating influenza strain and 51 percent more cases of influenza caused by strains similar to those contained in the vaccine compared to Fluzone. 

Based on data from Fluzone High-Dose, solicited injection site reactions and systemic adverse reactions were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine.

As of the end of the 2018-2019 influenza season, over 112 million doses of Fluzone High-Dose have been distributed in the U.S.

Fluzone High-Dose Quadrivalent should not be given to anyone who has had a severe allergic reaction to any component of the vaccine, including eggs or egg products, or after the previous dose of any influenza vaccine.

Tell your health care provider if you have ever had Guillain-Barré syndrome (severe muscle weakness) after a previous influenza vaccination.

If Fluzone High-Dose Quadrivalent is given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination with Fluzone High-Dose Quadrivalent may not protect all people who receive the vaccine.

For Fluzone High-Dose Quadrivalent, in adults 65 years of age and older, the most common side effects were pain, redness, and/or swelling where you got the shot; muscle ache, headache, and general discomfort. Other side effects may occur.

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Influenza vaccine news is published by Precision Vaccinations.