MenABCWY Meningococcal Vaccine Description
Pfizer Inc.’s investigational pentavalent meningococcal vaccine candidate MenABCWY (PF-06886992) combines its two approved meningococcal vaccines, Nimenrix™ (meningococcal group A, C, W-135, and Y conjugate vaccine) and Trumenba® (meningococcal group B vaccine). The five serogroups included in MenABCWY are responsible for most currently circulating meningococcal disease globally. Meningococcal disease refers to any illness caused by bacteria called Neisseria meningitidis, says the U.S. Centers for Disease Control and Prevention (CDC).
Pfizer announced on December 28, 2022, that the U.S. Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for MenABCWY for the prevention of meningococcal disease caused by the most common serogroups in individuals 10 through 25 years of age. The FDA Prescription Drug User Fee Act (PDUFA) goal date is in October 2023.
The regulatory submission is supported by previously announced positive results from a randomized, active-controlled, and observer-blinded Phase 3 trial assessing the pentavalent vaccine candidate's safety, tolerability, and immunogenicity with more than 2,400 patients from the U.S. and Europe. compared to currently licensed meningococcal vaccines to determine immunologic noninferiority.
New York-based Pfizer Inc. 'applies science and our global resources to bring therapies to people that extend and significantly improve their lives.'
MenABCWY Meningococcal vaccine candidate is indicated to prevent meningococcal disease, an uncommon but serious disease that can attack without warning and lead to meningitis and serious blood infections. Most invasive meningococcal disease cases worldwide can be attributed to five Neisseria meningitidis groups (A, B, C, W, and Y). Together, these meningococcal groups account for 96% of all invasive meningococcal disease (IMD), with group B accounting for most of the disease in adolescents and young adults in the U.S. and Europe, says the CDC.
December 28, 2022 - Annaliesa Anderson, Ph.D., SVP and Chief Scientific Officer, Vaccine Research and Development, Pfizer., said in a press release, "We believe our investigational MenABCWY vaccine, if approved and recommended, could help simplify the meningococcal vaccination schedule for adolescents and young adults, and in turn improve vaccination rates, and provide the broadest serogroup coverage of any meningococcal vaccine. The pentavalent vaccine candidate was well-tolerated in clinical trials, with a safety profile consistent with currently licensed meningococcal vaccines."
September 15, 2022 - Pfizer Announces Positive Top-Line Results from Phase 3 Trial of Pentavalent Meningococcal Vaccine Candidate (MenABCWY) in Adolescents.
June 22, 2020 - The initiation of the Phase 3 trial is based on positive results from a proof-of-concept study in 543 adolescents and young adults. Detailed results from the proof-of-concept study have been submitted for presentation at ID Week 2020.
MenABCWY Clinical Trials
MenABCWY Meningococcal Vaccine is currently in 4 clinical trials to determine the safety, tolerability, and immunogenicity among various age groups.
The pivotal Phase 3 trial (NCT04440163) assesses the safety, tolerability, and immunogenicity of its investigational pentavalent meningococcal vaccine (MenABCWY) in healthy individuals 10 through 25 years of age. The trial met all primary and secondary endpoints. The investigational vaccine demonstrated noninferiority to licensed vaccines for the five meningococcal serogroups that cause the most invasive meningococcal disease: serogroups A, B, C, W, and Y.