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Pfizer’s Meningitis B Vaccine Trumenba Is CBER’s First ‘Breakthrough’ Approval

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s biologics center grants accelerated approval to the first U.S. vaccine targeting serogroup B meningococcal disease after a 4.5-month review; the vaccine is expected to come up for discussion, but not a vote, at CDC’s Advisory Committee on Immunization Practices meeting Oct. 30.

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