Although much of the east has been enjoying spring-like temperatures while winter storms ravage the Midwest, it is time to remind readers to get their flu-shots. According to the CDC it is estimated that 80%-90% of seasonal influenza-related deaths and 50%-70% of seasonal influenza-related hospitalizations have occurred among people 65 years of age and older.
It is also time to announce that the FDA has just approved Fluad, 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.
While the FDA approved Fluad using the accelerated approval regulatory pathway, the drug was first approved for use in Italy in 1997 and is currently approved in 38.including Canada and 15 European countries.
“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” stated director of the FDA’s Center for Biologics Evaluation and Research Dr. Karen Midthun. “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.”
The drug, however, is not meant for those allergic to eggs, since it is manufactured using an egg-based process 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.
Fluad’s efficacy 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. Both Fluad and Agriflu are manufactured by Novartis Vaccines and Diagnostics Limited, an affiliate of Novartis Vaccines and Diagnostics, Inc., based in Cambridge, Massachusetts.
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.