FDA OKs Fluad, First Seasonal Influenza Vaccine With an Adjuvant

November 24, 2015

The US Food and Drug Administration (FDA) today approved a new seasonal influenza vaccine designed to provoke a stronger immune response in the elderly.

Fluad (Novartis Vaccines and Diagnostics Limited) is the first seasonal influenza vaccine that contains an adjuvant, a substance that enhances or directs the immune response of the vaccinated person. In the case of Fluad, the adjuvant is an oil-in-water emulsion of squalene oil, a naturally occurring substance in humans, animals, and plants that is highly purified for making vaccines.

The new vaccine is trivalent, produced from three influenza strains: two subtype A and the other type B. It is indicated specifically for people aged 65 years and older.

Public health specialists have long sought special vaccine formulas designed for the elderly, whose immune systems have weakened with age. Their antibody response to a vaccine typically is weaker than that of younger people, leaving them less protected against the influenza.

"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 the FDA's Center for Biologics Evaluation and Research, in a news release. "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."

Because the new vaccine was approved under an accelerated review process, the manufacturer must conduct a postmarket study to verify and describe the clinical benefit of its product.

However, Fluad's safety has already been evaluated in two studies. In one study, approximately 27,000 adults aged 65 years or older received the vaccine. The most common adverse events were injection site reaction, muscle aches, fatigue, and headache. No further safety signal was seen.

In a second study, immunogenicity of Fluad was compared with that of another trivalent influenza vaccine, Agriflu (Novartis), in approximately 7000 adults aged 65 years or older. The antibody responses were similar among the two groups.

Fluad is approved in 38 countries, including 15 European countries and Canada, according to the FDA.

More information about today's decision is available on the FDA website.

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