FDA Expands Flu Vaccine Approval to Include Older Adults

The US Food and Drug Administration (FDA) has approved Fluzone High-Dose Quadrivalent influenza vaccine for use in adults aged 65 years and older.

The vaccine was originally approved by the FDA in 2009 as a trivalent vaccine which included 2 influenza A and 1 influenza B strains. The newly approved vaccine incorporates an additional influenza B strain as well.

The safety and efficacy of the vaccine was evaluated in a Phase 3 immunogenicity study in which Fluzone Quadrivalent was shown to be non-inferior compared with 2 trivalent formulations of Fluzone High-Dose, each of which contained the recommended strains for the 2017-2018 season. The B strains included in the quadrivalent vaccine were also shown to induce superior immune response compared with the trivalent vaccine.

The most common adverse reactions associated with use of the vaccine are injection-site pain, myalgia, headache, and malaise.

—Michael Potts

Reference:

FDA approves Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for adults 65 years of age and older [press release]. Paris, France: Sanofi; November 4, 2019. http://www.news.sanofi.us/2019-11-04-FDA-approves-Fluzone-R-High-Dose-Quadrivalent-Influenza-Vaccine-for-adults-65-years-of-age-and-older. Accessed November 6, 2019.