Seqirus announced that the Food and Drug Administration (FDA) has approved Afluria Quadrivalent (influenza vaccine) for use in adults aged ≥18 years. Afluria Quadrivalent is an inactivated influenza vaccine indicated for active immunization against influenza A subtype viruses and type B viruses.
A randomized, double-blind, active-controlled clinical trial was conducted in 3,449 subjects aged ≥18 years to determine the efficacy of Afluria Quadrivalent against two other trivalent influenza vaccines (TIV). Non-inferiority was demonstrated by Afluria Quadrivalent to the two TIV comparators for all of the influenza strains in the vaccines. Non-inferiority was also seen within both of the study sub-groups: adults aged 18–64 years and ≥65 years for all strains. Superiority of the immune response to each of the influenza B strains found in Afluria Quadrivalent was seen vs. the antibody response post-vaccination with TIV formulation not containing the B lineage strains for subjects aged ≥18 years. Moreover, superiority against the alternate B strain was seen for each of the influenza B strains in both the age sub-groups.
Quadrivalent vaccines provide additional influenza coverage for patients in comparison to trivalent formulations. TIVs contain two influenza A strains and one influenza B strain. Quadrivalent influenza vaccines contain the same three strains as trivalent formulations but also contain an additional influenza subtype B strain to provide broader influenza protection.
Afluria Quadrivalent and Afluria vaccines are available for the 2016–2017 flu season. Afluria Quadrivalent is supplied as single-dose, preservative-free prefilled syringes. Afluria, indicated for patients aged ≥5 years, is supplied as prefilled syringes and multi-dose vials. 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 about a tenth of a second.
For more information call (855) 358-8966 or visit Seqirus-US.com.