News Feature | August 13, 2014

EMA Accepts Pfizer's Filing Of New Indication For Prevenar 13

By Estel Grace Masangkay

The European Medicines Agency (EMA) has accepted Pfizer’s application for the indication expansion of its pneumonia vaccine Prevenar 13 in adults to include the prevention of pneumonia caused by the 13 pneumococcal serotypes that the vaccine carries.

Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) is indicated for the prophylaxis of pneumococcal pneumonia and invasive disease induced by 13 Streptococcus pneumonia strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The vaccine was first approved in 2009 by the European Commission and has since received approval in more than 120 countries around the world.

This new filing was supported by the positive results from the CAPiTA trial showing that the vaccine significantly reduced vaccine-type pneumococcal community-acquired pneumonia (CAP) including non-invasive/non-bacteremic CAP, as well as invasive pneumococcal disease (IPD) in patients 65 years old and above.

Dr. Emilio A. Emini, SVP of Vaccine Research and Development at Pfizer, said, “Pneumococcal pneumonia continues to be a serious health problem, causing significant illness and mortality in older adults. The results of the Community-Acquired Pneumonia Trial in Adults (CAPiTA) study underscore the potential benefits of Prevenar 13 in preventing disease in this age group.”

The company has also filed a supplemental Biologics License Application with the U.S. Food and Drug Administration (FDA) pursuing the agency’s accelerated approval program. Pfizer said it expects a decision from the FDA’s Center for Biologics Evaluation and Research (CBER) by the end of September this year.

Pneumococcal disease is a group of diseases caused by S. pneumoniae bacteria. Invasive pneumococcal disease is caused by bacteria penetrating the bloodstream through a normally sterile site, while the non-invasive form of the disease occurs when the bacteria cause lung infection but are not concurrently detected in the patient’s blood. Approximately three cases of non-invasive pneumococcal pneumonia occur for every single invasive pneumococcal pneumonia case in adults.

Last month, Pfizer announced that it would be boosting its vaccine pipeline and vaccine manufacturing capabilities following its acquisition of Baxter’s portfolio of commercialized vaccines, primarily for group C meningococcal meningitis (MenC).