MONDAY, SEPTEMBER 26, 2016

Pfizer pneumonia vaccine Prevenar 13 gains European approval

Pfizer, Inc., announced on Wednesday that its pneumococcal conjugate vaccine Prevenar 13 was approved in Europe for adults aged 18 to 49 for the treatment of disease caused by vaccine-type Streptococcus pneumonia.

Prevenar 13 was previously approved in the European Union to protect against invasive disease from infants aged 6 weeks up to adolescents aged 17 years old. The vaccine is the only pneumococcal vaccine in the EU that protects against invasive disease from infancy to adulthood.

"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.

Prevanar 13 was approved by the European Commission after the organization reviewed the results of the vaccine's open-label Phase 3 trial. The study met all primary and secondary objectives and proved to be immunogenic for people 18 to 49 years of age and 60 to 64 years of age. The vaccine also proved to be safe and 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," Vice President of Pfizer's Vaccines Global Medicines Development Group Luis Jodar said. "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."