Wyeth received approval from the Chilean Ministry of Health, MINSAL (Ministerio de Salud), for Prevenar 13 Valent, (Pneumococcal Conjugate Vaccine 13 Valent (Diphtheria CRM(197) Protein)) for infants and young children. MINSAL is the first government agency to approve the vaccine.

The vaccine is approved for active immunization of children aged 6 weeks through 5 years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes. Pneumococcal disease (PD) is the leading cause of vaccine-preventable death worldwide in children younger than 5.

“The approval of Prevenar 13 in Chile is the first of many regulatory decisions we anticipate receiving around the world this year,” says Emilio Emini, Ph.D., executive vice president, Vaccines R&D, Wyeth. “We believe that Prevenar 13 is an important milestone in Wyeth’s ongoing commitment to public health in the fight against serious pneumococcal disease worldwide.”

The company has submitted regulatory applications for Prevenar 13 in more than 50 countries and has been granted priority review in the U.S., Canada, Australia and South Africa. Prevenar 13 is also being studied in global Phase III trials in adults, with regulatory submissions expected in 2010.