The U.S. Food and Drug Administration (FDA) granted approval on Wednesday of TRUMENBA, a meningococcal group B vaccine produced by Pfizer, for use in people aged 10 through 25 infected with Neisseria meningitidis serogroup B.
The FDA’s Breakthrough Therapy designation and Priority Review programs reviewed and approved the drug, which is to be administered as a three-dose series at months 0, 2 and 6 in the 10- through 25-year-old age group.
“The approval of TRUMENBA is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B,” Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer, said. “Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the U.S. As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations.”
While not proved to be effective against diverse serogroup B strains, Pfizer will continue studies to confirm the effectiveness against said strains.
“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,” study investigator Stanley L. Block, MD, pediatrician at Kentucky Pediatric/Adult Research, said. “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."