The Food and Drug Administration (FDA) has approved Fluad Quadrivalent (influenza vaccine, adjuvanted; Seqirus) for active immunization in patients 65 years of age and older against influenza disease caused by influenza virus subtypes A and types B contained in the vaccine.
Like Fluad (trivalent, inactivated, influenza vaccine [virus types A and B]), Fluad Quadrivalent contains the MF59 adjuvant, which is designed to enhance and prolong immune responses. The immunogenicity of Fluad Quadrivalent was confirmed in a non-influenza comparator-controlled efficacy study in which elderly patients 65 years and older (mean age: 72 years) received 1 dose of either Fluad Quadrivalent or a US-licensed non-influenza comparator vaccine.
While the vaccine approval was accelerated based on evidence of immune response, continued approval may be contingent upon verification of clinical benefit in a confirmatory trial.
Fluad Quadrivalent is expected to be available for the 2020-2021 influenza season. The product will be supplied in 0.5mL single-dose prefilled syringes.
For more information visit seqirus.com.