November 16, 2009 / 6:37 PM / 10 years ago

FDA wants panel to probe Pfizer vaccine efficacy

WASHINGTON (Reuters) - Pfizer Inc’s next- generation Prevnar vaccine missed some key goals in a study of its effectiveness, U.S. reviewers said in documents released on Monday.

The Prevnar 13 vaccine is designed to protect against 13 forms of a bacterium called streptococcus pneumoniae, or pneumococcus, that can cause an array of diseases ranging from ear infections to pneumonia and meningitis.

For three of the types, “the non-inferiority criterion was not met” for a proportion of subjects, Food and Drug Administration reviewers said in an analysis prepared for an outside advisory committee.

The reviewers said they would ask the panel at a meeting on Wednesday about the clinical trial findings.

Prevnar 13 is a successor to the currently marketed Prevnar, which protects against seven types of pneumococcus.

Reporting by Lisa Richwine; editing by Andre Grenon

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