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FDA Approves Afluria Quadrivalent Flu Vaccine for Adults
The FDA has given the green light to the use of Afluria Quadrivalent (Seqirus) in persons 18 years of age and older. The product is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. Both Afluria Quadrivalent and Afluria trivalent vaccine are available in the United States for the 2016–2017 influenza season.
Afluria Quadrivalent is the second quadrivalent flu vaccine from Seqirus; the FDA approved Flucelvax Quadrivalent in May. Afluria Quadrivalent comes in single-dose, preservative-free prefilled syringes, whereas Afluria, indicated for persons 5 years of age and older, is available in both prefilled syringes and multidose vials.
The trivalent formulation of Afluria is the only flu vaccine approved by the FDA to be administered without a needle, using the PharmaJet Stratis needle‐free injector. The device delivers the vaccine through a narrow stream of fluid that penetrates the skin in approximately one-tenth of a second. This method has been shown to provide an immune response that is noninferior to the response to influenza vaccine administered with a needle, according to Seqirus. Anyone 18 through 64 years of age who can receive Afluria is eligible for needle-free Afluria.
In a randomized, double-blind, active-controlled trial involving 3,449 subjects 18 years of age and older, Afluria Quadrivalent demonstrated noninferiority to two trivalent influenza vaccine (TIV) comparators for all influenza strains contained in the vaccine. In addition, noninferiority was demonstrated for both endpoints in both age subgroups: adults ages 18 through 64 years and those 65 years of age and older for all strains. The immune response to each of the influenza B strains contained in Afluria Quadrivalent was shown to be superior to that of the antibody response after vaccination with a TIV formulation not containing B lineage strains in subjects 18 years of age and older. Superiority over the alternate B strain was also demonstrated for each of the influenza B strains in both age subgroups: 18 through 64 years of age, and 65 years of age and older.1
In a randomized, comparator-controlled study that enrolled 1,250 subjects 18 through 64 years of age, the trivalent formulation of Afluria administered by the PharmaJet Stratis needle-free injection system demonstrated noninferiority in the immunogenicity population for all strains compared with the administration of Afluria by needle and syringe. Post hoc analyses of immunogenicity by age showed that younger subjects (ages 18 through 49 years) elicited higher immunological responses compared with older subjects (ages 50 through 64 years).
The traditional seasonal flu vaccine is a trivalent formula consisting of two strains of influenza A viruses 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, such as Afluria Quadrivalent, may provide protection against both B lineages, according to Seqirus.
Source: PR Newswire; August 29, 2016.