Pfizer Gets FDA Accelerated Approval For Meningococcal Group B Vaccine TRUMENBA

(RTTNews) - Pfizer Inc. (PFE) said Wednesday that the U.S. Food and Drug Administration has granted accelerated approval of TRUMENBA for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Approval of TRUMENBA is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States. The effectiveness of TRUMENBA against diverse serogroup B strains has not been confirmed.

As part of the accelerated approval process, Pfizer will complete its ongoing studies to confirm the effectiveness of TRUMENBA against diverse serogroup B strains.

TRUMENBA was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.

TRUMENBA is to be administered as a 3-dose series at months 0, 2 and 6 in the 10 through 25 year old age group.