Seasonal Flu Vaccine Fluad Approved by FDA

The FDA has approved Novartis’ Fluad, the first seasonal influenza vaccine containing an adjuvant.

The vaccine can be used to prevent seasonal flu among patients 65 and older, according to an FDA press release.

The trivalent vaccine was produced from 2 subtype A virus strains and 1 type B strain.

Using an egg-based process, Fluad was formulated with the MF59 adjuvant, which is an oil-in-water emulsion of squalene oil.

Adjuvants are included in some vaccines to enhance the immune response in patients.

In a clinical trial, Fluad induced antibody levels in patients that were comparable to the levels among patients who received Agriflu.

Safety of Fluad was also tested in around 27,000 patients 65 or older, and no serious concerns were reported.

Adverse effects associated with Fluad may include fever, tiredness, headache, and muscle joint pain.

“Fluad provides another alternative for a safe and effective influenza vaccine in people 65 years of age and older,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a press 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.”

Around 90% of influenza deaths in recent years have occurred in the 65 and older demographic, according to the US Centers for Disease Control and Prevention.