FLUAD (Influenza Vaccine, Adjuvanted), a sterile injectable emulsion for intramuscular use, is a trivalent, inactivated influenza vaccine prepared from virus propagated in the allantoic cavity of embryonated hens’ eggs inoculated with a specific type of influenza virus.
12/16/2011 - CBER held a pre-BLA meeting with Novartis
09/20/2013 - type C meeting to discuss the manufacturing, pre-clinical and clinical information to be included in a BLA submission for Fluad.
11/25/2014 - Novartis submitted a BLA for Fluad to CBER, FDA (STN 125510).
11/25/2015 - The PDUFA Action Due date
10/28/2020 - FDA approval date
On September 15, 2015, CBER convened a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review and discuss presentations of safety and immunogenicity data derived from studies conducted with Fluad and submitted in the BLA. The committee voted affirmatively that the available data support the safety (10 yes, 2 no, 1 abstain) and effectiveness (11 yes, 1 no, 1 abstain) of Fluad and approval under the accelerated approval regulations for the proposed indication in adults aged 65 years of age and older.