FDA Breakthrough Therapy Designation: Pfizer’s Meningococcal Group B Vaccine Gets Accelerated Approval
Pfizer announces on October 29th, that the FDA grants Accelerated Approval of Trumenba (Meningococcal Group B vaccine) for immunization for people, ages 10 – 25, to prevent invasive disease caused by Neisseria meningitidis serogroup B. Trumenba is to be administered as a 3-dose series at months 0, 2, and 6 in the 10 – 25 year old age group.
Trumenba is the 1st and only FDA approved vaccine in the United States for the prevention of Meningococcal Meningitis B. Trumenba is reviewed and approved under the FDA’s Breakthrough Therapy Designation (BTD) and Priority Review programs. Pfizer receives the FDA BTD in March 2014. Part of the FDA Accelerated Approval process requires Pfizer to conduct further studies to verify Trumenba’s effectiveness against additional strains of N. meningitidis serogroup B.
There are five meningococcal serogroups: A,B,C, W-135, and Y. Serogroup B is the only one for which no broadly-protective vaccine is currently approved in the US. Two existing vaccines, Menactra and Menveo, prevent the other four types of bacterial meningitis and are currently recommended by the CDC for all preteens and adolescents. Many schools and colleges require students to get a meningitis vaccine before starting classes. According to the CDC, in the US in 2012, there were about 500 cases of Meningococcal Disease, with 160 cases or approximately 32%, caused by serogroup B. The CDC said that 10 – 15% of these cases are fatal and that for those who survive, 11 – 19% suffer permanent disabilities.
Pfizer’s competitor for this indication in the US is Novartis’s Bexsero Vaccine that receives the FDA BTD in April 2014. Bexsero is not yet approved of in the US. In Europe, Australia, and Canada, Bexsero is already approved for Meningococcal disease caused by serogroup B. In the UK, the Joint Committee on Vaccination and Immunization (JCVI) recommended in March 2014 including Bexsero in the country’s National Immunization Program (NIP) for “routine use in infants from 2 months of age.”
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