Pfizer Says FDA to Review Meningococcal Vaccine Application
December 28 2022 - 07:50AM
Dow Jones News
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
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
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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