The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend licensure of NVS Influenza Vaccines’ candidate vaccine to help protect against seasonal influenza in those aged ≥65 years via accelerated approval. Currently under review by the FDA, this investigational vaccine would become the first adjuvanted seasonal influenza vaccine licensed for use in adults aged ≥65 in the US.
The candidate vaccine is an inactivated influenza vaccine indicated for active immunization of adults aged ≥65 against influenza disease caused by influenza virus subtypes A and B contained in the vaccine. In making its recommendation, the Committee examined the results of a pivotal Phase III study comparing the immunogenicity and safety of the candidate vaccine with a US licensed, non-adjuvanted trivalent influenza vaccine in people >65 years of age. The candidate vaccine demonstrated non-inferiority in relation to the comparator vaccine for all three vaccine strains on the basis of both seroconversion rates and geometric mean titers (GMTs). Furthermore, the candidate vaccine demonstrated significantly higher antibody titers versus the comparator vaccine. The safety profile was generally similar to the non-adjuvant comparator.
While the FDA is not bound to the recommendations, the agency typically follows the advice of the advisory committees. The candidate vaccine is currently licensed in more than 30 countries, and approximately 76 million doses have been distributed since first approved.
For more information visit FDA.gov.