Pfizer's pneumococcal vaccine meets in confirmatory trial

Pfizer Inc. (NYSE:PFE) said Prevnar/ Prevenar 13 met the primary endpoint of reducing the number of first episodes of vaccine-type pneumococcal community-acquired pneumonia (CAP) vs. placebo in the confirmatory Phase IV CAPiTA trial. Vaccine-type pneumococcal CAP was defined as CAP caused by any Streptococcus pneumonia serotype included in the vaccine, which contains 13 serotypes. The double-blind, Dutch trial enrolled about 85,000 adults 65 years of age and older. Detailed data are slated to be presented at the International Symposium on Pneumococci and Pneumococcal Diseases meeting next month.

In 2011, FDA granted the vaccine accelerated approval to prevent pneumococcal disease in adults 50 years of age and older. Pfizer conducted CAPiTA to verify the vaccine's clinical benefit as a requirement under the accelerated approval. The pharma said it will submit the data to FDA and worldwide regulatory authorities, but declined to disclose a timeline. ...