Pfizer Receives FDA Approval for Meningitis B Vaccine

Pfizer has received US Food and Drug Administration approval for Trumenba, the first vaccine licensed in the United States to prevent invasive meningococcal disease caused by Neisseria meningitidisserogroup 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. meningitidisis 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 this approval, meningococcal vaccines approved for use in the United States have only covered four of the five main serogroups of N. meningitides 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 also 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.

Trumenba is a sterile suspension composed of two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A, and one from subfamily B (A05 and B01, respectively). fHBP is one of many proteins found on the surface of meningococci and contributes to the ability of the bacterium to avoid host defenses. fHBPs can be categorized into two immunologically distinct subfamilies, A and B. The susceptibility of serogroup B meningococci to complement-mediated, antibody-dependent killing following vaccination with Trumenba is dependent on both the antigenic similarity of the bacterial and vaccine fHBPs, as well as the amount of fHBP expressed on the surface of the invading meningococci.

Source: FDA and Pfizer

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