FDA Approves Second Meningococcal B Vaccine

The vaccine received accelerated approval status from the FDA.

The FDA has approved a second vaccine, Bexsero (Novartis), for the prevention of serogroup B meningococcal disease for people aged 10 through 25 just three months after approving Trumenba for the same purpose.

The vaccine, which works to prevent meningococcal disease caused by Neisseria meningitidis, is now the second vaccine to cover group B. Prior to the October approval of Trumenba, vaccines in the U.S. only covered four of the five main serogroups of N. meningitidis bacteria: A, C,Y, and W.

“With today’s approval of Bexsero, the U.S. now has two vaccines for the prevention of serogroup B meningococcal disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The approval of these vaccines represents a major public health accomplishment toward preventing this life-threatening disease.”

Bexsero’s effectiveness was evaluated in three studies involving over 2,600 adolescents and young adults. Sixty-two to 88% of those that received two doses of Bexsero had antibodies that killed three different N. meningitidis serogroup B strains after vaccination compared to 0 to 23% before vaccination. The vaccines safety was assessed in over 5,000 people through studies in the U.S. and abroad, as well as in 15,000 people who received Bexsero prior to FDA approval as a result of a breakout on two university campuses.

Common reported side effects included pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

As part of its accelerated approval process, Novartis will continue to test Bexsero for effectiveness against additional strains of N. meningitidis serogroup B.