FDA approves first meningococcal B vaccine

November 4, 2014

The first vaccine licensed in the United States to immunize young persons aged 10 through 25 years against invasive meningococcal disease caused by Neisseria meningitidis serogroup B has been approved by the US Food and Drug Administration.

The first vaccine licensed in the United States to immunize young persons aged 10 through 25 years against invasive meningococcal disease caused by Neisseria meningitidis serogroup B has been approved by the US Food and Drug Administration (FDA).

Until the FDA cleared the new vaccine, Trumenba, meningococcal vaccines approved in the United States covered only 4 of the 5 main N meningitidis serogroups: A, C, W, and Y. Trumenba was granted breakthrough therapy status-which expedites development and review of medical products for serious or life-threatening conditions-and was approved in less than 6 months using the FDA’s accelerated approval regulatory pathway.

The vaccine is given in 3 0.5-mL doses by intramuscular injection on a 0-, 2-, and 6-month schedule.  

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Three randomized studies in the United States and Europe assessed the vaccine’s efficacy in about 2800 adolescents. After 3 doses of Trumenba, 82% of participants had antibodies that killed 4 strains of N meningitidis B that cause meningococcal disease in the United States, compared with fewer than 1% before vaccination. The vaccine’s manufacturer, Wyeth Pharmaceuticals (Philadelphia, Pennsylvania), will conduct further studies to verify Trumenba’s effectiveness against other strains of N meningitidis B, in accordance with the accelerated approval process.

A study of Trumenba’s safety in around 4500 participants in the US, Europe, and Australia found that the most common adverse effects were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue, and chills.

The Centers for Disease Control and Prevention reported around 500 cases of meningococcal disease in the United States in 2012, of which serogroup B caused 160. Several recent outbreaks on college campuses have increased concern about the illness.


 

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