The US Food and Drug Administration (FDA) has approved Trumenba (Wyeth Pharmaceuticals), the first vaccine against invasive meningococcal disease caused by Neisseria meningitides serogroup B to be licensed in the United States. The vaccine is approved for use in individuals aged 10 through 25 years.
Meningococcal disease is a potentially fatal bacterial infection of the bloodstream (sepsis) and the lining around the brain and spinal cord (meningitis). The primary cause of bacterial meningitis is N meningitidis. According to the Centers for Disease Control and Prevention, in 2012, approximately 500 cases of meningococcal disease were reported; of those, 160 resulted from serogroup B.
"Even with appropriate antibiotics and intensive care, invasive meningococcal disease often has devastating consequences," Karen Midthun, MD, director of the FDA's Center for Biologics Evaluation and Research, said in a media briefing. "Between 10 and 15% of people who develop meningococcal disease die from the infection, and another 10% to 20% suffer permanent complications such as brain damage or limb loss."
Antibiotics can reduce the risk for death or serious long-term sequelae, but prompt medical attention is essential. Vaccination is the most reliable method of prevention, but before now, meningococcal vaccines approved in the United States have only covered four of the five primary serogroups of N meningitidis (A, C, Y, and W), according to an FDA statement.
"Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease," Dr Midthun said in the statement. "The FDA's approval of Trumenba provides a safe and effective way to help prevent this disease in the United States."
The decision follows review of three randomized trials conducted in the United States and Europe in about 2800 adolescents. Among participants who were given three doses of the vaccine, 82% developed antibodies against four 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.
Researchers assessed Trumenba's safety in approximately 4500 participants in trials conducted in the United States, Europe, and Australia. The most frequent adverse effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.
The FDA approved Trumenba using the accelerated approval regulatory pathway, which "allows the agency to approve products for serious or life-threatening diseases based on evidence of a product's effectiveness that is reasonably likely to predict clinical benefit, reducing the time it takes for needed medical products to become available to the public," the FDA notes in the statement. The agency granted the vaccine breakthrough therapy status, evaluated its safety and effectiveness, and approved it in less than 6 months, which is the typical timeframe for priority review.
The manufacturer will be required to conduct additional studies to verify the vaccine's "effectiveness against additional strains of N. meningitidis serogroup B."
More information on Trumenba can be found on the FDA's website. Additional information on Meningococcal disease can be found on the Centers for Disease Control and Prevention website.
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Cite this: First Serogroup B Meningococcal Vaccine Approved by FDA - Medscape - Oct 29, 2014.