FDA Approves First Seasonal Flu Vaccine with Adjuvant
The Food and Drug Administration (FDA) has approved Fluad (influenza vaccine, adjuvanted; Seqirus) for the prevention of seasonal influenza in patients 65 years and older. Fluad is the first adjuvanted seasonal influenza vaccine approved in the United States; it was specifically developed for the adult population aged 65 and older. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.
The approval was based on the results of a Phase 3 study involving more than 7,000 adults aged 65 and older. Fluad demonstrated a strong immune response and was shown to be non-inferior in relation to the comparator vaccine (Agriflu) for all three vaccine strains on the basis of both seroconversion rates and geometric mean titers; it also demonstrated an acceptable safety profile. The most common adverse events reported included injection site pain and tenderness, muscle aches, headache and fatigue.
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.
"Adults aged 65 years and older are at the greatest risk of serious complications from influenza compared with young, healthy adults because the immune system weakens with age," said William Schaffner, M.D., Medical Director at the National Foundation for Infectious Diseases and Professor of Medicine and Preventive Medicine at Vanderbilt University, Nashville, Tennessee. "The approval of an adjuvanted trivalent influenza vaccine provides a new vaccine alternative."
For more information call (855) 358-8966 or visit Seqirus-US.com.