FDA Approves First Vaccine to Prevent Invasive Meningococcal Disease

The FDA today approved the first vaccine licensed in the United States to prevent invasive serogroup B meningococcal disease in patients aged 10 to 25 years.

“Recent outbreaks of serogroup B meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream and the lining that surrounds the brain and spinal cord. According to the US Centers for Disease Control and Prevention (CDC), roughly 500 total cases of meningococcal disease were reported in the United States in 2012, and of those cases, 160 were caused by Neisseria meningitidis serogroup B.

Meningococcal disease can be treated with antibiotics to reduce the risk of death or serious long-term problems, but vaccination is the most effective way to prevent it. Until today’s approval, meningococcal vaccines approved for use in the United States have only covered 4 of the 5 main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W.

Prior to Trumenba’s approval, 3 randomized studies were conducted in the United States and Europe in approximately 2800 adolescents. Among participants who received 3 doses of Trumenba, 82% had antibodies in their blood that killed the 4 different strains that cause serogroup B meningococcal disease after vaccination, compared with <1% before vaccination.

The safety of Trumenba was assessed in approximately 4500 individuals who received the vaccine in studies conducted in the United States, Europe, and Australia. The most commonly reported side effects among those who received Trumenba were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

To approve Trumenba, the FDA used the accelerated regulatory pathway, which reduces the time it takes for needed medical products to become available to the public. As part of the accelerated process, the drug’s manufacturer, Pfizer subsidiary Wyeth Pharmaceuticals Inc, will conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B.

The FDA previously granted breakthrough therapy status to the vaccine.

“The approval of Trumenba is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the U.S. As a next step, we look forward to participating in discussions with the CDC regarding potential meningococcal group B vaccination recommendations.”