Pfizer Prepares to Submit Biologics License Application for Meningococcal Vaccine
After positive top-line data from phase 3 trials for their meningococcal vaccine, MenABCWY, Pfizer intends to submit a Biologics License Application (BLA) to the FDA.
Pfizer’s investigational meningococcal vaccine, MenABCWY, was demonstrated to be noninferior against other currently approved meningococcal vaccines.
Last week, Pfizer shared positive top-line data from their phase 3 trial (NCT04440163) for MenABCWY. The trial assessed the safety, tolerability, and immunogenicity of the investigational pentavalent meningococcal vaccine in 2400 healthy participants aged 10-25 years old.
Pfizer reported that MenABCWY was not inferior to any of the 5 meningococcal serogroups, A, B, C, W, and Y. The vaccine candidate met all primary and secondary endpoints.
“We are very pleased with these positive phase 3 data, which are the first for a MenABCWY vaccine candidate,” said Annaliesa Anderson, PhD, senior vice president and chief scientific officer of vaccine research and development at Pfizer. “A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the US and improve vaccine coverage. Our goal is to help ensure as many adolescents and young adults as possible are protected against this devastating disease.”
It is significant that MenABCWY has the potential to protect against all 5 serotypes, as there is no approved vaccine that currently does so. MenABCWY is a combination of Trumenba and Nimenrix, a vaccine sold by GSK to Pfizer in 2015.
Trial participants were randomly assigned either 2 doses of MenABCWY or 2 doses of Trumenba and 1 dose of Menveo (both approved meningococcal vaccines). Patients were both naïve and experienced to the serotypes A, C, W, and Y.
Because MenABCWY met pre-established criteria for licensing, Pfizer plans to submit a Biologics License Application (BLA) to the Food and Drug Administration (FDA) by the end of this year. Additionally, Pfizer plans to submit these phase 3 trial data to a peer reviewed scientific journal.