CDC publishes recommendations for immunization practices for the 2015-16 influenza season
The Centers for Disease Control and Prevention published in August its recommendations for immunization practices for the 2015-16 influenza season, including information on new and updated influenza vaccine product approvals.
U.S.-licensed trivalent influenza vaccines will contain hemagglutinin (HA) derived from an A/California/7/2009 (H1N1)-like virus, an A/Switzerland/9715293/2013 (H3N2)-like virus, and a B/Phuket/3073/2013-like (Yamagata lineage) virus. This represents changes in the influenza A (H3N2) virus and the influenza B virus as compared with the 2014-15 season.
Quadrivalent influenza vaccines will contain these vaccine viruses, and a B/Brisbane/60/2008-like (Victoria lineage) virus, which is the same Victoria lineage virus recommended for quadrivalent formulations in 2013-14 and 2014-15.
What’s new?
New and updated influenza vaccine product approvals include the following three: Afluria; an expanded age indication for the use of Flublok; and Fluzone Intradermal Quadrivalent.
Afluria. In August 2014, FDA approved Afluria (inactivated influenza vaccine, bioCSL, Inc.) for intramuscular administration via the Stratis needle-free jet injector (PharmaJet, Inc., Golden, Colo.), for persons aged 18 through 64 years. Adults aged 18 through 64 years may receive Afluria either by the Stratis injector or with a sterile needle and syringe. All other inactivated influenza vaccines are approved for administration by sterile needle and syringe only.
The Stratis injector is a reusable spring-powered device which injects the vaccine through a single-use sterile needle-free syringe into the deltoid muscle. In a prelicensure study of 1,250 adults aged 18 through 64 years, local injection site symptoms were reported more frequently by persons who received Afluria via the Stratis Injector than those who were vaccinated with a sterile needle and syringe; most resolved within three days. Those who received Afluria via the Stratis injector had antibody levels against influenza virus that were noninferior to those who received Afluria by sterile needle and syringe. Data comparing rates of influenza illness in persons vaccinated with the Stratis injector versus needle and syringe are not available.
Flublok expanded age indication. In October 2014, FDA approved an expanded age indication for the use of Flublok (Recombinant Influenza Vaccine, Trivalent [RIV3], Protein Sciences), which was previously approved for persons aged 18 through 49 years. Flublok is now indicated for persons aged ≥18 years. Approval for persons aged ≥50 years is based upon studies of immunogenicity and safety of the vaccine in three randomized trials; data demonstrating a decrease in influenza disease in persons aged ≥50 years after vaccination with Flublok are not available.
Fluzone Intradermal Quadrivalent. In December 2014, FDA approved Fluzone Intradermal Quadrivalent (Sanofi Pasteur), for persons aged 18 through 64 years. It is anticipated that this formulation will replace the previously available trivalent Fluzone Intradermal for the 2015–16 influenza season. In a randomized study of 3,355 adults aged 18 through 64 years comparing safety and immunogenicity of Fluzone Intradermal Quadrivalent with two different trivalent intradermal formulations of Fluzone (each one containing one of the two influenza B viruses contained in the quadrivalent vaccine), the quadrivalent formulation was immunogenically noninferior to the trivalent formulations for the influenza A and matched B viruses, immunogenically superior for the unmatched B viruses, and had a similar adverse event profile. Efficacy data for Fluzone Intradermal Quadrivalent are not available.
For more information, including a list of all influenza vaccine products anticipated to be available during the 2015–16, go to http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm?s_cid=mm6430a3_w