FDA Delays Prevnar Ruling

Pfizer announced on Friday that the FDA had delayed a decision on whether to allow the use of the company’s Prevnar 13 vaccine by adults 50 and older. The review period is now extended to January 2012.

Prevnar 13 protects against pneumococcal disease caused by 13 common strains of Streptococcus pneumonia. It was approved by the FDA in February 2010 for use in infants and children aged six weeks to five years.

The extension of the review is due to additional data provided by Pfizer from two studies that were part of the original application and were submitted to the FDA to evaluate the use of Prevnar 13 in conjunction with the annual flu shot.

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Pfizer Provides U.S. Regulatory Update on Prevnar 13(R) for Use in Adults 50 Years and Older [Press Release]