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Pfizer Says Late-stage Study Of Pentavalent Meningococcal Vaccine Candidate Met Primary Goal

Pfizer Inc. (PFE) on Thursday said Phase 3 study of its pentavalent meningococcal vaccine candidate, MenABCWY, in individuals aged 10 through 25 met primary goal.

In the Phase 3 study, MenABCWY showed non-inferiority to licensed vaccines, Trumenba and Menveo, for the five meningococcal serogroups that cause the majority of invasive meningococcal disease.

TRUMENBA is an FDA-approved meningococcal vaccine to protect against B type meningococcal bacteria and Menveo is approved for protection against A,C,W, and Y types of meningococcal bacteria. Currently, there are no single vaccine to protect against all the five types.

Pzier intends to submit an application to the FDA for the approval of the vaccine, in the fourth quarter of this year. Submissions to regulatory authorities outside the U.S. are also planned, the company said.

"A pentavalent vaccine has the potential to help simplify what is currently a complex meningococcal vaccination schedule in the U.S. and improve vaccine coverage," said Annaliesa Anderson, Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer.

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