Therapy Areas: Vaccines
US FDA Accepts for Review the Biologics License Application for Pfizer's Investigational Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents
28 December 2022 - - The US Food and Drug Administration accepted for review a Biologics License Application for US-based pharmaceutical company Pfizer Inc's (NYSE: PFE) investigational pentavalent meningococcal vaccine candidate (MenABCWY), the company said.

Pfizer submitted MenABCWY for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October 2023.

Pfizer's MenABCWY vaccine candidate combines the components of two vaccines into one, helping protect against the meningococcal serogroups that cause the majority of invasive meningococcal disease globally.

In the US, approximately 55 m adolescents and young adults are in the age range for meningococcal vaccination (11-23 years old), according to ACIP recommendations.

The regulatory submission is supported by previously announced positive results from a randomized, active-controlled and observer-blinded Phase 3 trial assessing the safety, tolerability, and immunogenicity of the pentavalent vaccine candidate compared to currently licensed meningococcal vaccines, with the goal of determining immunologic noninferiority.

The Phase 3 trial (NCT04440163) evaluated more than 2,400 patients from the US and Europe.

Meningococcal disease is an uncommon but serious illness that can lead to death within 24 hours and, for survivors, can result in life-altering, significant long-term disabilities.

Together, the five most common meningococcal serogroups account for 95 percent of all IMD cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the US and Europe.

In the US, the current meningococcal vaccination platform for adolescents and young adults includes a routine recommendation for MenACWY vaccines (two doses) and a separate, shared clinical decision recommendation for MenB-specific vaccines (two doses) in order to achieve the broadest serogroup protection available against meningococcal disease.

However, less than a third of US adolescents receive even one dose of a MenB vaccine, and fewer complete the series.

If approved and recommended, Pfizer's pentavalent vaccine candidate could be another option for the current routine recommendations in place for MenACWY vaccines.

Pfizer's pentavalent vaccine candidate could potentially reduce the total number of doses needed for individuals to be fully vaccinated against the five serogroups, thereby simplifying meningococcal vaccination and increasing the number of adolescents and young adults vaccinated.

Routine use of a MenABCWY vaccine could reduce IMD cases and associated mortality, the rate of long-term sequelae in survivors, and costs associated with controlling outbreaks.

Pfizer's pentavalent meningococcal vaccine candidate combines the components from its two licensed meningococcal vaccines, Trumenba (meningococcal group B vaccine) and Nimenrix (meningococcal groups A, C, W-135, and Y conjugate vaccine); approvals of Nimenrix and Trumenba vary by country.

Together, the 5 serogroups included in MenABCWY are responsible for the majority of currently circulating meningococcal disease globally.

Top line results from a randomized, active-controlled and observer-blinded Phase 3 trial of Pfizer's pentavalent meningococcal vaccine candidate (NCT04440163) were previously announced in September 2022.
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