The US FDA Accepts GSK’s BLA of Meningococcal ABCWY Vaccine for Invasive Meningococcal Disease (IMD)
Shots:
- The US FDA has accepted the BLA of 5-in-1 meningococcal ABCWY (MenABCWY) vaccine based on the P-III study assessing the safety, tolerability & immunogenicity among individuals (n=~3650, 10-25yrs.) for IMD. The decision is anticipated on Feb 14, 2025
- The study reached all the 1EPs showing immunological non-inferiority to 1 dose of Meningococcal Groups A, C, Y & W vaccine & non-inferior immune responses against 110 diverse MenB invasive strains
- The vaccine combines the antigenic parts from Bexsero (Meningococcal Group B Vaccine) & Menveo (Meningococcal [Groups A, C, Y & W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) targeting the IMD causing bacteria Neisseria meningitidis (Men A, B, C, W & Y)
Ref: GSK | Image: GSK
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
