Proper Name
Influenza Vaccine, Live, Intranasal (Trivalent, Types A and B)
Indication
For active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.
Key Regulatory Milestones
06/2003 - FluMist was approved for use in healthy subjects 5-49 years of age
01/2006 - formulation change was approved
09/17/2007 - Extension of the indication to individuals 2 – < 60 months was approved
07/09/2020 - FDA approval date
Advisory Committee
The Vaccines and Related Biologics Advisory Committee (VRBPAC) was not convened to discuss this supplement. Advice from VRBPAC was not thought to be critical to the review because the data and proposed changes to labeling do not affect the indication or use of the vaccine or reveal major safety concerns
Advanced Facts