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EU recommends extended indication for Prevenar

Wyeth Pharmaceuticals has received two positive opinions from a European committee recommending an extension of the indication for Prevenar to include immunization against pneumonia and acute otitis media.

Prevenar is currently approved for active immunization of children from 2 months to 5 years of age against sepsis, meningitis, bacteraemic pneumonia and bacteraemia. Pneumococcal disease is a significant concern to children’s health, estimated to result in more than one million deaths each year in young children around the world.

“We welcome the Committee for Medicinal Products for Human Use’s recommendation for both new indications in the EU which, if approved, will underscore the value of Prevenar in helping to protect infants and young children from common pediatric illnesses caused by S. pneumoniae,” commented Peter Paradiso, vice president, Scientific Affairs, Wyeth Vaccines.

Prevenar is the first and only conjugate vaccine shown to be effective in reducing the incidence of pneumococcal disease in infants and toddlers. The recommendations of Prevenar will now be forwarded to the European Commission for final approval, which is anticipated in the second quarter of 2007.