First Meningococcal B Vaccine Approved by FDA

First Meningococcal B Vaccine Approved by FDA
First Meningococcal B Vaccine Approved by FDA

The Food and Drug Administration (FDA) has approved Trumenba (Pfizer), the first vaccine approved in the U.S. to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B. Trumenba vaccine is indicated for patients aged 10–25 years.

The vaccine is composed of two recombinant LP2086 antigens, or factor H binding proteins (fHBP). Antigens from both types of fHBP, subfamily A and subfamily B have been included in the vaccine.

Before Trumenba, previously approved meningococcal vaccines only covered four of the five main serogroups of N. meningitidis bacteria that cause meningococcal disease: A, C, Y, and W.

RELATED: Investigational Meningococcal B Vaccine BLA Under Review

The FDA's approval was based on three randomized trials conducted in the United States and Europe (n=2,800). Eighty-two percent of patients who received three doses of Trumenba demonstrated antibodies in their blood that killed 4 N. meningitidis serogroup B strains, as compared to the <1% before vaccination.

Trumenba was approved through the accelerated regulatory pathway and the manufacturer will conduct additional studies to confirm Trumenba's efficacy against additional N. meningitidis serogroup B strains.

For more information visit FDA.gov.

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