FDA approves Fluad as first seasonal adjuvant-containing influenza vaccine

The FDA recently approved the first adjuvanted vaccine to prevent seasonal influenza in adults aged 65 years and older, according to a press release.

Fluad (Novartis Vaccines and Diagnostics) is a trivalent vaccine produced from two subtype A and one type B influenza virus strains. It is formulated with the adjuvant MF59, a squalene-based, oil-in-water emulsion. According to the CDC, adults aged 65 years and older account for 80% to 90% of seasonal influenza-related deaths and 50% to 70% of seasonal influenza-related hospitalizations.

Karen Midthun

“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “Immunizing individuals in this age group is especially important because they bear the greatest burden of severe influenza disease.”

The approval was based in part on results of an international, multicenter trial that compared the safety and efficacy of the vaccine in 7,082 participants aged 65 years and older. According to the FDA, the study showed that Fluad induced antibody levels that were similar to those induced by Agriflu (Novartis Vaccines and Diagnostics), an unadjuvanted trivalent seasonal influenza vaccine.

The safety of the vaccine was further demonstrated in nearly 27,000 other adults. The most frequent adverse events were injection site pain and tenderness, muscle aches, headache and fatigue, the FDA said.

Italy approved Fluad in 1997, and 38 other countries also have approved the drug, including Canada, the FDA said.