PFE

By Will Feuer

Pfizer Inc. said the Food and Drug Administration has agreed to review a biologics license application for the investigational pentavalent meningococcal vaccine candidate called MenABCWY.

The pentavalent vaccine combines the components of Pfizer's two licensed meningococcal vaccines and is aimed at reducing the total number of doses needed for individuals to be fully vaccinated against the five meningococcal serogroups, the company said.

Meningococcal disease is caused by a bacteria and can include infections of the lining of the brain and spinal cord as well as bloodstream, according to the Centers for Disease Control and Prevention. Rates of the disease in the U.S. have declined in recent decades, the CDC says, and rates of disease are highest in children younger than 1 year, followed by a second peak in adolescence.

In the U.S., the current meningococcal vaccination platform for children and young adults includes a recommendation for the two-dose MenACWY vaccines and a separate recommendation for the two-dose MenB-specific vaccines. However, less than a third of U.S. adolescents receive one dose of a MenB vaccine, and fewer complete the series, Pfizer said.

"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," said Annaliesa Anderson, Pfizer's chief scientific officer of vaccine research and development.

Pfizer submitted its MenABCWY application for people ages 10 through 25. The company said about 55 million people in the U.S. are in the age range for meningococcal vaccination, citing a 2020 evaluation by the CDC's Advisory Committee on Immunization Practices.

Pfizer said the Prescription Drug User Fee Act goal date for a decision by the FDA on the pentavalent meningococcal vaccine application is in October.

The company's application is supported by results from a Phase 3 trial of more than 2,400 patients that compared the vaccine candidate with currently licensed meningococcal vaccines.

Write to Will Feuer at Will.Feuer@wsj.com

(END) Dow Jones Newswires

December 28, 2022 07:35 ET (12:35 GMT)

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