MenQuadfi
MenQuadfi is a sterile liquid vaccine administered by intramuscular injection that contains Neisseria meningitidis serogroup A, C, W, and Y capsular polysaccharide antigens that are individually conjugated to tetanus toxoid protein.
Advisory Board:
An Advisory Committee Meeting for MenQuadfi vaccine was not held because there were no issues pertaining to this BLA that required input from the Vaccines and Related Biological Products Advisory Committee.
Indications: Meningococcal (Groups A, C, Y, W) Conjugate Vaccine is indicated for active immunization for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. Meningococcal (Groups A, C, Y, W) Conjugate Vaccine is approved for use in individuals 2 years of age and older.
Key Regulatory Milestones:
04/23/2020 – FDA approval date
04/24/2020 – PDUFA goal date