FDA Adcom Offers Support for CSL’s Influenza Vaccine Fluad
The FDA’s Vaccines and Related Biological Products Advisory Committee offered nearly unanimous support of CSL’s influenza vaccine Fluad, recommending the agency approve an accelerated pathway for use in people 65 and older against influenza types A and B.
The committee voted 11 to 1 that immunogenicity data is adequate to support the efficacy of Fluad, and voted 10 to 2 that data was adequate to support the vaccine’s safety.
The agency typically follows the advice of its advisory committees. If approved, Fluad would become the first adjuvanted seasonal influenza vaccine for adults 65 and older in the U.S., CSL said.
Trial data showed that the vaccine was particularly effective against the H3N2 influenza strain. This strain is the most severe, especially in older people, said Paul Van Buynder, a principal investigator in a competitive effectiveness study of the vaccine.
Committee member Janet Englund said she found the data reassuring because trials can be difficult with the target patient population, as it includes patients in nursing homes.
The committee was not concerned about Fluad’s use of an adjuvant, saying that the FDA does not consider it an active ingredient, but agency policy requires the applicant to demonstrate added benefit. — Kellen Owings