FDA approves Fluad (MF59 adjuvanted seasonal influenza vaccine) for influenza- NVS Influenza Vaccines

The FDA has approved Fluad (MF59 adjuvanted seasonal influenza vaccine), from NVS Influenza Vaccines, the first seasonal influenza vaccine containing an adjuvant. Fluad, a trivalent vaccine produced from three influenza virus strains (two subtype A and one type B), is approved for the prevention of seasonal influenza in people 65 years of age and older.

Fluad was evaluated in a multicenter clinical trial conducted in the United States and internationally that compared the safety and immunogenicity (ability to generate an antibody response) of Fluad to Agriflu, an FDA-approved unadjuvanted trivalent seasonal influenza vaccine, in individuals 65 years of age and older. In that trial, 7,082 participants received either Fluad or Agriflu. The study showed that Fluad induced antibody levels that were comparable to the levels induced by Agriflu. Safety was also evaluated in approximately 27,000 additional individuals 65 years of age and older. No safety concerns were identified with Fluad. The most common adverse events reported include injection site pain and tenderness, muscle aches, headache and fatigue.