Pfizer's Vaccine For Meningitis B Gets FDA Accelerated Approval

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Trumenba as the first licensed vaccine in the U.S. for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals from 10 through 25 years old.

Trumenba comprises two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and one from subfamily B. The protein fHBP is found on the surface of meningococci bacteria which helps it to slip past the radar of the host’s immune system. The FDA authorized Trumenba under its Accelerated Approval process based on the demonstration of induced immune response against four serogroup B strains prevalent in the U.S. The company has previously received Breakthrough Therapy and Priority Review designations for Trumenba.

Dr. Emilio Emini, SVP of Vaccine R&D for Pfizer, said, “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… As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations.”

The approval was based on positive results from three randomized studies conducted in the U.S. and EU involving 2,800 adolescents. The vaccine was also evaluated in safety studies involving approximately 4,500 individuals in the U.S., EU, and Australia.

Study investigator Stanley L. Block, pediatrician at Kentucky Pediatric/Adult Research, points out, “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.”

Pfizer will continue conducting ongoing efficacy studies for Trumenba against a range of serogroup B strains as part of the FDA’s accelerated approval process.

The New York Times reports that the company has been in a race with fellow big pharma Novartis to deliver a vaccine for serogroup B meningitis. Novartis’ vaccine Bexsero has been approved in the EU, Australia, and Canada but has yet to receive regulatory approval in the U.S.