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Wyeth Receives Positive Opinion from European Regulators for Its 13-valent Pneumococcal Candidate Vaccine for Infants & Young Children
Date: 2009-10-01   Read: 92756

Wyeth receives positive opinion from European regulators for its 13-valent pneumococcal candidate vaccine for infants and young children

Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the company's pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent Adsorbed]). The CHMP recommends approval of Prevenar 13 for active immunization of children aged 6 weeks to 5 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 opinion for Prevenar 13 will now be forwarded to the European Commission and a final decision is expected in the coming months.

"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," says Emilio Emini, Ph.D., 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 (4, 6B, 9V, 14, 18C, 19F and 23F) included in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) -- the global standard in pneumococcal disease prevention in infants and young children -- plus six additional serotypes (1, 3, 5, 6A, 7F and 19A) responsible for the greatest remaining burden of invasive disease. Both Prevenar and Prevenar 13 use CRM197 -- an immunological carrier protein with a 20-year history of use in pediatric vaccines. Available in Europe since 2001, Prevenar is currently available in 97 countries and more than 265 million doses have been distributed worldwide.

To date, the company has submitted pediatric regulatory applications for Prevenar 13 in more than 50 countries spanning six continents. Prevenar 13 has been approved in two countries, with Chile being the first in July 2009. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.


Adapted from materials provided by Medical News TODAY

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