FDA Delays Prevnar Ruling


The FDA has delayed ruling on whether to allow use of Pfizer's Prevnar 13 vaccine by adults 50 and older until January 2012.

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.

Around the Web

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

Related Videos
Nanette B. Silverberg, MD: Uncovering Molluscum Epidemiology
Reviewing 2023 with FDA Commissioner Robert M. Califf, MD
A Year of RSV Highs and Lows, with Tina Tan, MD
Ryan A. Smith, MD: RSV Risk in Patients with IBD
Cedric Rutland, MD: Exploring Immunology's Role in Molecule Development
Cedric Rutland, MD: Mechanisms Behind Immunology, Cellular Communication
Glenn S. Tillotson, PhD: Treating Immunocompromised Patients With RBX2660
Paul Feuerstadt, MD: Administering RBX2660 With a Colonoscopy
Jessica Allegretti, MD, MPH: Evaluating the First Few Months of RBX2660
© 2024 MJH Life Sciences

All rights reserved.