USFDA approved First vaccine to prevent serogroup B Meningococcal disease...

USFDA announced today the approval of Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). N. meningitidis is a leading cause of bacterial meningitis. The bacteria are transmitted from person to person through respiratory or throat secretions (e.g., by coughing, kissing, or sharing eating utensils). According to the Centers for Disease Control and Prevention, about 500 total cases of meningococcal disease were reported in the United States in 2012; of those cases, 160 were caused by serogroup B.

Meningococcal disease can be treated with antibiotics to reduce the risk of death or serious long-term problems, but immediate medical attention is extremely important. Vaccination is the most effective way to prevent meningococcal disease. Until today, meningococcal vaccines approved for use in the United States have only covered four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W.

The FDA used the accelerated approval regulatory pathway to approve Trumenba. Accelerated approval 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. In the FDA’s evaluation for accelerated approval, evidence of effectiveness was demonstrated by the ability of Trumenba recipients’ antibodies to kill the four representative N. meningitidis serogroup B test strains. As part of the accelerated approval process, the manufacturer will conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B. 

Trumenba was granted breakthrough therapy status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. Working closely with the company, the FDA was able to evaluate Trumenba’s safety and effectiveness and approve it in well under six months, the usual timeframe for a priority review.

Trumenba is manufactured by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc., Philadelphia, Pennsylvania.