The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) has voted to recommend licensure of a candidate vaccine to help protect against seasonal influenza in those aged 65 years and older via accelerated approval.
The vaccine, manufactured by NVS Influenza Vaccines, is currently under review by the FDA and (if approved) would become the first adjuvanted seasonal influenza vaccine licensed for use in adults aged 65 and older in the US.
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 (WHO) recommended antigens and the Novartis proprietary adjuvant MF59 designed to help elicit an immune response to vaccine antigens.
