FDA advisory panel backs approval of NVS influenza candidate vaccine

The US Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted to recommend the licensing of Fluad, a candidate vaccine to help protect against seasonal influenza in those aged 65 years and older via accelerated approval.

The regulatory submission was made by VS Influenza Vaccines, now a subsidiary of Australia’s CSL Limited (ASX: CSL), which recently acquired the influenza vaccines business of Novartis in the USA for $275 million (The Pharma Letter July 31). Currently under review by the FDA and if approved, the candidate vaccine would become the first adjuvanted seasonal influenza vaccine licensed for use in adults aged 65 and older in the USA.

The candidate vaccine is an inactivated influenza vaccine indicated for active immunization of adults aged 65 and older against influenza disease caused by influenza virus subtypes A and B contained in the vaccine. It contains the World Health Organization recommended antigens and the Novartis proprietary adjuvant MF59 designed to help elicit an immune response to vaccine antigens.