Pharmaceutical giant Pfizer Inc. (NYSE:PFE) on Wednesday said it received European approval for expanded use of its Prevenar 13 antibacterial vaccine for adults aged 18 to 49 years old. The pneumococcal vaccine was previously approved in Europe for adults 50 years of age and older, as well as for infants, youth, and adolescents aged 6 weeks to 17 years old.
The vaccine is used to protect against 13 strains of the Streptococcus pneumoniae bacterium, which can cause pneumonia and meningitis.
“Prevenar 13 has been administered to millions of individuals around the world, and today’s European approval for the expanded use of Prevenar 13 is a testament to Pfizer’s continued commitment to developing innovative vaccines that can help prevent serious — and sometimes fatal — disease through every stage of life,” Pfizer’s chief scientific officer of vaccine research, Emilio Emini, said in a statement.
Prevenar 13 first gained approval for use in infants and young children in the European Union in 2009. The European Commission OK’d expanded use of the vaccine on Wednesday following an open-label Phase 3 trial of the vaccine, which was conducted on healthy adults between the ages of 18 and 49, according to a press release from Pfizer.
“Adults aged 18 to 49 years with certain underlying medical conditions may benefit in particular from vaccination with Prevenar 13 because of an increased risk of pneumococcal disease,” said Luis Jodar, the company’s vice president of Vaccines Global Medicines Development Group.
Reuters reported that the vaccine is approved for use in adults aged 50 years and older in more than 80 countries, as well as for infants and youth in more than 120 countries.
The vaccine, known as Prevnar 13 in the United States, was approved by the Food and Drug Administration in January and is the drugmaker’s third-largest brand.
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