FDA approves Bexsero, group B meningitis vaccine

the Clinical Advisor take:

The FDA has approved Bexsero as another vaccine for group B meningococcal disease.

The vaccine, manufactured by Novartis, is the second group B meningococcal disease to receive FDA approval. Trumenba, manufactured by Pfizer’s Wyeth subsidiary, was the first vaccine to receive approval last October.

Previously, meningococcal vaccines only provided protection against the A, C, Y, and W serogroups of Neisseria meningitidis.

The FDA approved Bexsero on the basis of three efficacy studies, all of which were conducted in other countries. In total, the studies included approximately 2,600 adolescents, 62% to 88% of whom developed antibody titers that protected against the three most prevalent group B strains.

Safety trials assessed 5,000 participants. The most common side effects included flu-like symptoms as well as pain and swelling at the injection site.

Bexsero was used in an emergency basis in 2013 during a meningitis outbreak at Princeton University and in an additional outbreak at the University of California Santa Barbara. After the outbreak, about 15,000 vaccine recipients underwent follow-up and confirmed the safety profile of the vaccine.

The FDA approved Bexsero under its accelerated approval process. This requires Novartis to put the vaccine through further trials, focusing on protection against other group B meningococcus strains.