FDA approved Fluad, the first seasonal influenza vaccine containing an adjuvant. A trivalent vaccine produced from 3 influenza virus strains (2 subtype A and 1 type B), Fluad is approved for the prevention of seasonal influenza in people aged 65 years and older.
“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research. “Immunizing individuals in this age group is especially important because they bear the greatest burden of severe influenza disease and account for the majority of influenza-related hospitalizations and deaths.”
An estimated 80% to 90% of seasonal influenza-related deaths and 50% to 70% of seasonal influenza-related hospitalizations have occurred among people aged 65 years and older, according to the Centers for Disease Control and Prevention.
Here are other facts you should know about Fluad:
1. Fluad has a long history of use globally. It was first approved for use in Italy in 1997 and is currently approved in 38 countries, including Canada and 15 European countries.
2. The vaccine is manufactured by Seqirus, part of the CSL Group, is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis.
3. The vaccine, which is manufactured using an egg-based process, is formulated with the adjuvant MF59, an oil-in-water emulsion of squalene oil. Squalene, a naturally occurring substance found in humans, animals and plants, is highly purified for the vaccine manufacturing process. Adjuvants are incorporated into some vaccine formulations to enhance or direct the immune response of the vaccinated individual.
4. The FDA approval of Fluad was based on the results of the pivotal phase 3 study of more than 7,000 adults aged 65 and older and demonstrated an acceptable safety profile. Fluad demonstrated a strong immune response and was shown to be non-inferior in relation to the comparator vaccine for all 3 vaccine strains on the basis of both seroconversion rates and geometric mean titers (GMTs). Safety was also evaluated in approximately 27,000 additional individuals aged 65 years and older. No safety concerns were identified with Fluad.
5. The most common adverse events reported include injection site pain and tenderness, muscle aches, headache and fatigue.