NEW YORK CITY (dpa-AFX) - The U.S. Food and Drug Administration accepted for review a Biologics License Application or BLA for its investigational pentavalent meningococcal vaccine candidate (MenABCWY), Pfizer Inc. (PFE) said in a statement.
The company 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.
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 invasive meningococcal disease or IMD cases worldwide, with serogroup B accounting for the majority of disease in adolescents and young adults in the U.S. and Europe.
Pfizer believes 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.
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