Pfizer Inc. (NYSE: PFE) announced today the company’s pneumococcal conjugate vaccine, Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), received European approval for an expanded indication to include adults aged 18 to 49 years for active immunization for the prevention of invasive disease caused by vaccine-type
Streptococcus pneumoniae (S. pneumoniae)
Previously approved in the European Union (EU) for use in infants, young children and adolescents aged 6 weeks to 17 years, as well as adults 50 years of age and older, Prevenar 13 is now the only pneumococcal vaccine in the EU that offers protection against invasive disease from infancy through adulthood.
The European Commission is the first to approve Prevenar 13 to offer protection against invasive disease at all stages of life.
“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,” said Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer.
The European Commission’s decision to approve this label expansion for Prevenar 13 followed the submission and review of data from an open-label Phase 3 trial of the vaccine in healthy adults aged 18 to 49 years.
The study – which met all primary and secondary objectives – showed that Prevenar 13 is at least as immunogenic in this age group as it is in adults 60 to 64 years of age, as measured one month after vaccination.
Furthermore, Prevenar 13 showed a favorable safety profile and was generally well tolerated.
“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, Ph.D., vice president, Vaccines Global Medicines Development Group, Pfizer. “Pfizer will continue to partner with health authorities worldwide to seek to provide access to this important vaccine to all those at risk of the disease.”