FDA Adcom Discusses Safety and Immunogenicity of Flaud Flu Vaccine

The FDA’s Vaccines and Related Biological Products Advisory Committee met last week to discuss the safety and immunogenicity of CSL’s influenza vaccine Fluad to determine if it should be approved through an accelerated approval pathway. The vaccine is proposed for use in people 65 and older as treatment against influenza types A and B.

The vaccine uses an adjuvant — an ingredient that helps create a stronger immune response in the patient’s body.  Fluad uses just a small amount of the flu virus — 15 micrograms each of virus subtype A/H1N1, A/H2N2 and B.

The trial comparator was Novartis’ Agriflu, which is manufactured like Fluad minus the adjuvant. The company claims its trial showed that Fluad had immunologic superiority to Agriflu in treating the H3N2 influenza strain. But it also increased common local and systemic adverse events, including fever or soreness at injection site, by 43 percent versus 33 percent for Agriflu.

On July 31, Australian drugmaker CSL Limited acquired Novartis’ influenza vaccine business. The BLA for Fluad was submitted by Novartis, but is now part of CSL, spokeswoman Monica Galimberti said. — Kellen Owings