FDA Approves Meningitis B Vaccine
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luiscar/iStockphoto/Thinkstock(NEW YORK) — The U.S. Food and Drug Administration approved the first vaccine to target a strain of meningitis that caused outbreaks at Princeton University and the University of California-Santa Barbara last year.
According to the FDA, Trumenba prevents the disease caused by Neissaria meningitidis serogroup B, one of five main serogroups of the disease. Previously approved vaccines have covered the other four main serogroups.
“Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research.
Three randomized studies looked at about 2,800 adult patients and found that 82 percent of subjects given Trumenba had antibodies that kill four representative strains of the disease in their bloodstream, compared to just one percent beforehand.
Minimal side effects were reported with Trumenba, including headache, diarrhea, muscle pain, fatigue and chills.
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