FDA OKs Afluria Quadrivalent Flu Vaccine for Ages 5 and Up

Vaccine protects against two A strain and two B strain viruses

The FDA has approved Afluria Quadrivalent influenza vaccine (Seqirus) for use in people 5 years of age and older. The vaccine was first approved in the U.S. in August 2016 for people ages 18 and older to help protect against two influenza A strain viruses and two B strain viruses.

The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A virus and a single strain of influenza B virus. However, since 1985, two distinct lineages of influenza B virus have co-circulated with varying dominance. The use of a four-strain influenza vaccine may provide protection against both B lineages.

The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone 6 months of age and older. Recently, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to include Afluria influenza vaccine as one of the recommended trivalent influenza vaccine options for people ages 5 years and older for the upcoming 2017–2018 season. The CDC has accepted the ACIP recommendation in its 2017–2018 influenza recommendations.

As a result, both Afluria and Afluria Quadrivalent are now both licensed and recommended for people ages 5 years and older. Both are available in pre-filled syringes as well as multi-dose vials, and they have a needle-free injection delivery option (the PharmaJet Stratis 0.5 mL Needle-Free Jet Injector) for people ages 18 to 64 years.

In a randomized, double-blind, active-controlled clinical trial conducted in 3,395 people ages 18 years and older, Afluria Quadrivalent demonstrated noninferiority to two TIV comparators for all influenza strains contained in the vaccine. Additionally, noninferiority was demonstrated for both endpoints in both age sub-groups—adults ages 18 through 64 years and 65 years and older—for all strains.

In a randomized, observer-blinded, comparator-controlled trial conducted in the U.S. in 2,278 children 5 through 17 years of age, Afluria Quadrivalent demonstrated noninferiority to that of a comparator vaccine containing the same recommended virus strains.

Source: Seqirus; September 14, 2017.