Pfizer says FDA has not finished reviewing Prevnar 13 vaccine after three-month delay
By APWednesday, December 30, 2009
Pfizer says FDA is still reviewing Prevnar 13
NEW YORK — Pfizer Inc. says the Food and Drug Administration is again extending its review of Prevnar 13, a children’s pneumococcal vaccine.
The FDA’s decision was due Wednesday, but Pfizer says the agency has not completed its review. It did not say when the process might be complete. The FDA was originally scheduled to make a decision by Sept. 30, but decided to extend that review by three months.
Prevnar 13 is intended to reduce the risk of infection by 13 types of pneumococcal disease, which can cause ear infections, meningitis, pneumonia and blood infections. It is a newer version of a vaccine that has been on the market for nine years, and considered one of the most important products Pfizer acquired when it bought rival Wyeth for $68 billion this year.
