Updated EU labeling for Pfizer’s Prevenar 13

The European Commission has approved updates to the Summary of Product Characteristics (SmPC) for US pharma behemoth Pfizer’s (NYSE: PFE) pneumococcal conjugate vaccine Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), regarding its use in certain populations at high risk of pneumococcal disease.

The updated label now includes information describing the use of the vaccine in preterm infants, children and adolescents with sickle cell disease who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine, and adults with human immunodeficiency virus (HIV) infection who were previously vaccinated with the 23-valent pneumococcal polysaccharide vaccine.

“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,” said Luis Jodar, vice president, Vaccines, Global Medicines Development Group and Scientific Affairs, Pfizer. “The Prevenar 13 label in the European Union 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,” he added.