Pfizer, Novartis submit BLAs for meningitis B vaccines

Pfizer Inc. (NYSE:PFE) submitted a BLA and Novartis AG (NYSE:NVS; SIX:NOVN) started submission of a rolling BLA to FDA for their respective meningitis B vaccines, which both have breakthrough therapy designation from the agency. Pfizer submitted a BLA for LP2086 ( rLP2086) to prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in 10-25 year olds. LP2086 is a bivalent meningococcal serogroup B vaccine targeting LP2086 (factor H binding protein).

Novartis began submission of a rolling BLA for Bexsero to vaccinate against invasive meningococcal disease caused by serogroup B in adolescents and young adults from 10-25 year old. Bexsero, a multicomponent meningococcal serogroup B vaccine, has been approved under a treatment IND in the U.S. as part of vaccination programs at two universities. ...