FDA Approves Second Serogroup B Meningococcal Vaccine

The FDA today approved Bexsero, a vaccine to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in patients aged 10 to 25 years.

With this latest nod, Bexsero becomes the second FDA-approved vaccine to prevent this disease. The first meningococcal serogroup B vaccine, Trumenba, was released in November 2014 following the FDA’s approval in the previous month.

The FDA based their approval on 3 studies evaluating the effectiveness of Bexsero that enrolled approximately 2600 adolescents and young adults. The research team found that, following vaccination, 62-88% of patients who received 2 doses of Bexsero had antibodies in their blood that killed 3 different serogroup B strains known to cause the disease, compared with 0% to 23% of patients prior to vaccination.

Bexsero’s safety was verified in additional studies enrolling about 5000 patients. The vaccine’s safety was also monitored in more than 15,000 patients who were given Bexsero before it was approved in response to 2 university outbreaks of serogroup B meningococcal disease in the United States.

The FDA used an accelerated approval process to approve Bexsero after it determined that then then-investigational vaccine was likely to prove beneficial in preventing a serious or life-threatening disease. After granting Bexsero breakthrough therapy status, the FDA was able to evaluate and approve the vaccine 2 months in advance of its priority review goal date.

“With today’s approval of Bexsero, the US now has 2 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.”

The most common adverse events reported by trial patients who received Bexsero were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills. In accordance with the accelerated approval process, further studies will be conducted to verify the vaccine’s effectiveness against additional serogroup B strains.