Which meningococcal vaccines for serogroup B are approved by the FDA?

Updated: Jul 16, 2019
  • Author: Rodrigo Hasbun, MD, MPH; Chief Editor: Michael Stuart Bronze, MD  more...
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Answer

According to the CDC, in 2012, approximately 500 cases of meningococcal disease were reported; of those, 160 resulted from serogroup B.

In October 2014, the FDA approved the first meningococcal vaccine for serogroup B (Trumenba) under the breakthrough therapy designation and accelerated approval regulatory pathways. Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease.

Approval was based on 3 randomized trials conducted in the United States and Europe in about 2800 adolescents. Among participants who were given 3 doses of the vaccine, 82% developed antibodies against 4 different N meningitidis serogroup B strains representative of those that cause serogroup B meningococcal disease in the United States compared with less than 1% before vaccination. [48]

In January 2015, a second meningococcal serogroup B vaccine was approved (Bexsero). [49]


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