Fluad (Seqirus), the first adjuvanted influenza vaccine specifically developed for those aged ≥65, is now available for the 2016/17 flu season. Fluad is an inactivated influenza vaccine indicated for active immunization of adults aged 65 and older caused by influenza virus subtypes A and B contained in the vaccine. It was approved using the accelerated approval regulatory pathway, which allows the FDA to approve products for serious or life-threatening diseases based on evidence that the product has an effect on an outcome that is reasonably likely to predict clinical benefit. In the case of Fluad, the antibody response to the vaccine provided this evidence.
The Food and Drug Administration (FDA) approved the vaccine for person’s ≥65 years in November of last year, based on results from a multicenter international trial which compared the safety and immunogenicity of Fluad to Agriflu.
Results from the 7,082 participant trial (all aged 65 years or older) showed that Fluad induced antibody levels comparable to those induced by Agriful, with no safety concerns identified.
The adjuvant used in Fluad is MF59, an oil-in-water emulsion of squalene oil. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.
Due to weakened immune systems, those aged ≥65 are at a greater risk of the serious complications that come with the flu. The CDC estimates that this age bracket accounts for between 80 and 90% of seasonal flu-related deaths and 50 to 70% of flu-related hospitalizations.
“The availability of an adjuvanted trivalent influenza vaccine provides a new vaccine option to help protect older adults against the flu,” said William Schaffner, MD, Vanderbilt University, in a press release from Seqirus.
For more information visit Fluad.com.