Pfizer announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval of TRUMENBA ® (meningococcal group B vaccine) 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.
“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,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer Inc. “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.”
Meningococcal disease can be unpredictable and occur quickly and without warning in otherwise healthy individuals. Outbreaks and cases of meningococcal group B disease occurred in the U.S. in 2013 and 2014.
“Meningococcal meningitis B is a devastating disease, which though rare, significantly impacts affected individuals and families,” said Frankie Milley, Meningitis Angels, Founder/National Executive Director and mother to an only child who died from meningitis. “Vaccines have been available and recommended since 2005 to help protect against four other serogroups of meningococcal disease, and we hope that TRUMENBA will become a recommended vaccine in routine adolescent immunization programs to help prevent meningococcal B 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,” said study investigator Stanley L. Block, MD, pediatrician at Kentucky Pediatric/Adult Research. “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. As a physician, I am pleased that a meningococcal meningitis B vaccine is now available to help protect adolescents and young adults.”
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.