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Meningitis Vaccine Wins Regulatory Approval

First vaccine to prevent serogroup B disease

The FDA has given the green light to Trumenba (Wyeth/Pfizer), the first vaccine licensed in the U.S. 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 bacterial infection that can result in sepsis and 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, approximately 500 cases of meningococcal disease were reported in the U.S. in 2012; of those cases, nearly a third (160) was caused by serogroup B.

“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. “The FDA’s approval of Trumenba provides a safe and effective way to help prevent this disease in the United States.”

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

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 after vaccination with Trumenba depends both on the antigenic similarity of the bacterial and vaccine fHBPs, and on the amount of fHBP expressed on the surface of the invading meningococci.

Trumenba is administered as a three-dose series at months 0, 2, and 6 in individuals aged 10 through 25 years.

Three randomized studies were conducted in the U.S. and Europe in approximately 2,800 adolescents. Of the subjects that received three doses of Trumenba, 82% had antibodies in their blood that killed four different N. meningitidis serogroup B strains after vaccination compared with less than 1% before vaccination. These four strains represented the strains that cause serogroup B meningococcal disease in the U.S.

The safety of Trumenba was assessed in approximately 4,500 individuals who received the vaccine in studies conducted in the U.S., Europe, and Australia. The most common adverse events associated with Trumenba included injection-site pain and swelling, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

The FDA used its 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, thereby 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 antibodies to kill the four representative N. meningitidis serogroup B test strains in Trumenba recipients.

Trumenba was also granted “breakthrough therapy” status, which is intended to expedite the development and review of medical products that address a serious or life-threatening condition. The FDA was able to evaluate the safety and effectiveness of Trumenba and to approve the product in well under 6 months, the usual time frame for a priority review.

Sources: FDA; October 29, 2014; and Pfizer; October 29, 2014.

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