OR WAIT null SECS
Pfizer's Trumenba is the first FDA-approved immunization against meningococcal disease for individuals 10-25 years old.
Pfizer announced on Oct. 29, 2014 that FDA had granted Accelerated Approval to Trumenba (meningococcal group B vaccine) for active immunization to prevent meningitis B caused by Neisseria meningitides.Trumenba was reviewed and approved under FDA’s Breakthrough Therapy designation and Priority Review programs. Trumenba is approved for people between the ages of 10-25 years old and will be administered in a three-dose series.
According to FDA, until the approval of Trumenba for the treatment of meningitis B, approved meningitis vaccines only covered four of the five serogroups of N. meningitides: A, C, Y, and W. Three randomized studies were conducted among 2800 adolescents in the United States and Europe to test the vaccine’s efficacy. In the study, after vaccination, 82% of participants had antibodies in their blood that killed four different N. meningitides strains compared with less than 1% before vaccination. These four strains are representative of strains that cause serogroup B meningococcal disease.
“Meningococcal disease can progress from initial symptoms to death within 24 hours, and is often challenging to diagnose and distinguish from diseases that are more common and less serious, making preventative vaccination critically important. In clinical trials, Trumenba demonstrated the ability to induce functional immune responses to four serogroup B strains representative of prevalent strains in the United States,” said study investigator Stanley L. Block, MD, pediatrician at Kentucky Pediatric/Adult Research, in a press release.
In June 2014, Pfizer and Novartis both applied for FDA Breakthrough Therapy for meningitis B vaccines; Novartis for its drug Bexsero (meningococcal group B vaccine). FDA authorized Novartis to manufacture and distribute emergency doses of Bexsero during an outbreak that occurred at Princeton University in 2013, however, Novartis is still awaiting FDA approval of Bexsero