The US Food and Drug Administration (FDA) has accepted for review of Pfizer’s biologics license application (BLA) for its investigational pentavalent meningococcal vaccine candidate, MenABCWY.
The company submitted the vaccine candidate to prevent meningococcal disease, which is caused by the most common serogroups, in individuals aged 10 to 25 years.
MenABCWY combines the two vaccines’ components into one to help protect against the meningococcal serogroups, which cause most of the invasive meningococcal disease (IMD) across the world.
The regulatory body has assigned a Prescription Drug User Fee Act (PDUFA) goal date of October 2023.
Pfizer Vaccine Research and Development senior vice president and chief scientific officer Annaliesa Anderson said: “The FDA’s acceptance of our application for the pentavalent meningococcal vaccine candidate is an essential step toward helping protect individuals and communities against the most common types of meningococcal disease.
“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.”
The company stated that the BLA submitted to the FDA is supported by the data obtained from a Phase III trial, which was conducted in more than 2,400 patients from the US and Europe.
The active-controlled, observer-blinded, and randomised trail evaluated the tolerability, immunogenicity, and safety of the pentavalent meningococcal vaccine candidate compared with the existing licensed meningococcal vaccines.
Its goal was to determine the immunologic noninferiority.