Wyeth has received a positive opinion from the CHMP for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine).
The CHMP has recommended Prevenar 13 for active immunisation of children aged six weeks to five years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes.
“The CHMP’s positive opinion brings us one step closer to providing infants and young children in Europe with the broadest serotype coverage of any pneumococcal conjugate vaccine,” said Emilio Emini, Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals.
“Prevenar, our currently available vaccine, has both proven clinical efficacy and documented effectiveness, which has resulted in a significant public health benefit. Prevenar 13 builds on the scientific foundation of Prevenar and, if approved, will provide coverage for the 13 most prevalent pneumococcal-disease causing serotypes, including serotype 19A, which has emerged as a serious public health threat in Europe and around the world.”
Prevenar 13 is designed to provide the broadest serotype coverage of any pneumococcal conjugate vaccine. The vaccine contains the seven serotypes included in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), plus six additional serotypes responsible for the greatest remaining burden of invasive disease.
Released in Europe in 2001, Prevenar is now available in 97 countries and more than 265 million doses have been distributed worldwide.
The vaccine is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.