FDA approves Sanofi’s Fluzone® High-Dose (Influenza Vaccine) for adults 65+

Sanofi announces it’s Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults of 65 years and older, has been given the green light by the FDA. 

Fluzone® High-Dose Quadrivalent FDA approved

The U.S. Food and Drug Administration approved Fluzone® High-Dose (Influenza Vaccine) in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain and is prescribed to the 65+ years age group. The medication can help prevent influenza disease caused by influenza A and B strains contained in the vaccine, according to Sanofi, as per their press release from the 4th November.

Sanofi Pasteur U.S Headquarters (Photo Credit: Google Maps)

Sanofi’s Executive Vice President and head of Sanofi Pasteur stated that:

“Increasing protection and delivering improved influenza vaccines are critical to public health.”  “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.” 

Sanofi Pasteur transition to quadrivalent influenza vaccines

The go-ahead is the last step for Sanofi Pasteur toward achieving a complete transition to quadrivalent influenza vaccines in the United States. Freshly approved, Fluzone High-Dose Quadrivalent will be made available for immunization during the 2020-2021 influenza season. The trivalent formulation of Fluzone High-Dose will continue to be offered by Sanofi Pasteur through the end of the 2019-2020 influenza season.

According to John Shiver, PhD, Senior Vice President, Global Research and Development at Sanofi Pasteur: 

“Influenza is a serious threat, especially for older adults who are more vulnerable to serious complications and even death. For the past 10 years, Fluzone High-Dose has helped protect millions of people 65 years of age and older from seasonal influenza,” and they are “committed to helping protect as many people as possible from influenza and look forward to introducing this new formulation.”

The U.S. Food and Drug Administration approval was based on data from a Phase 3 immunogenicity and safety study. In the study, Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. 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. 

Superior Efficacy

According to the companies press release, based on results in a randomized controlled trial, Fluzone High-Dose has established itself as the first and only influenza vaccine proven to provide superior efficacy in adults 65 years of age and older, compared to the Fluzone® (Influenza Vaccine).

Results of a study evaluating nearly 32,000 65+ years old people in the US and Canada over two influenza seasons showed that Fluzone High-Dose prevented 24% more cases of influenza caused by any circulating influenza strain and 51% more cases of influenza caused by strains similar to those contained in the vaccine compared to Fluzone. 

More than 112 million doses of Fluzone High-Dose have been distributed in the USA, as of the end of the 2018-2019 influenza season, where nearly two-thirds of suitable individuals who received an influenza vaccine received Fluzone High-Dose.


  1. Sanofi – FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older

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