Pfizer Inc announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that the indication for Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) be expanded to include the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults 18 years and older. Prevenar 13 is currently approved in Europe for the prevention of invasive pneumococcal disease (IPD) in the same population. The CHMP’s positive opinion will now be reviewed by the European Commission (EC). The decision on whether to approve Prevenar 13 for this indication will be made by the EC and will be applicable to all European Union member states plus Iceland, Lichtenstein and Norway.
The CHMP opinion was granted following review of the results from the Community-Acquired Pneumonia Immunisation Trial in Adults (CAPiTA). Pfizer conducted this study as part of its regulatory commitments to global regulatory authorities, including the European Medicines Agency. The study achieved its primary and secondary objectives. The primary endpoint evaluated the efficacy of Prevenar 13 for the prevention of a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older. Secondary endpoints were the prevention of a first episode of vaccine-type non-invasive/non-bacteremic CAP, and prevention of a first episode of vaccine-type IPD in adults aged 65 and older.
This study is one of the largest double-blind, randomized, placebo-controlled vaccine efficacy trials ever conducted in older adults. It involved approximately 85,000 subjects aged 65 years and older and was conducted by Julius Clinical, a spin-off of the Julius Center for Health Sciences and Primary Care, a division of the University Medical Center Utrecht in the Netherlands. Fifty-nine sentinel hospitals were used for the surveillance of CAP and IPD.
Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide, including the United States, Canada, Australia and Japan. It is the most widely used pneumococcal conjugate vaccine (PCV) in the world, and more than 750 million doses of Prevenar 7-valent/Prevenar 13 have been distributed worldwide. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 90 countries, and it is also approved in the United States, European Union (EU) and other countries for use in older children and adolescents aged 6 to 17 years. Prevenar 13 is also approved in the EU for use in adults 18 to 49 years of age.
Prevnar 13 is a vaccine approved in the US for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). This indication is based upon immune responses to the vaccine. For children 6 weeks through 17 years of age, Prevnar 13 is approved in the US for the prevention of invasive disease caused by the 13 vaccine strains, and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains.Prevnar 13 is not 100 per cent effective and will only help protect against the 13 strains included in the vaccine. Effectiveness when given less than 5 years after a pneumococcal polysaccharide vaccine is not known.