Prevnar 13 data addition causes sBLA delays in US for unlucky Pfizer
This article was originally published in Scrip
Executive Summary
Pfizer has been dealt a significant blow by the US FDA issuing a 90-day extension to the action date for the company’s supplemental Biologics License Application (sBLA) for use of Prevnar 13, (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) in adults aged 50 and older.