FDA approves 1st flu vaccine with an adjuvant

SILVER SPRING, Md. — The Food and Drug Administration on Tuesday announced that it had approved the first seasonal influenza vaccine to contain an adjuvant — an ingredient added to improve the body’s immune response. Fluad, made by Novartis, is a trivalent vaccine intended for people aged 65 and older. It contains the adjuvant in MF59, an emulsion of squalene oil in water. 

 

“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” said Dr. Karen Midthun, M.D., director of the 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.”

 

It is estimated that 80% to 90% of deaths related to the flu and between 50% and 70% of flu-related hospitalizations are related to people 65 years of age and older.