TUESDAY, JUNE 19, 2018

Prevenar 13 approved for preterm infants, weakened immune systems

The European Commission on Thursday approved an updated label for Pfizer's Prevenar 13 that contains information regarding the vaccine's use among preterm infants and individuals with diseases that compromise their immune systems.

The company's decision to expand the summary of product characteristics on the pneumococcal conjugate vaccine's label in the European Union resulted from studies conducted by the European Medicines Agency.

"People with conditions that compromise the immune system (such as HIV), those with sickle cell disease and infants born prematurely are all at an increased risk of pneumococcal disease," Pfizer Vice President of Vaccines, Global Medicines Development Group and Scientific Affairs Dr. Luis Jodar said. "The Prevenar 13 label in the EU now includes important information about appropriate use of the vaccine for the prevention of pneumococcal disease for health care professionals who care for these patients."

Prevenar 13 was approved for use in the EU in July for adults 18 to 49 years old. It was previously approved in the EU for use in infants, young children and adolescents between 6 weeks and 17 years as well as adults 50 and older.

Prevenar 13 is the only pneumococcal vaccine in the EU that offers protection against invasive pneumococcal disease from infancy through adulthood.

"Pfizer is dedicated to improving health through vaccination, and to supporting health care professionals in their efforts to reduce the impact of pneumococcal disease among those most at risk," Pfizer President of Vaccines Susan Silbermann said.