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European Committee Recommends Wyeth’s Prevenar 13

By Pharmaceutical Processing | September 28, 2009

NEW YORK (AP) — Wyeth said Friday European Union regulators are recommending approval for a new version of its children’s pneumococcal vaccine, Prevenar 13. The Madison, N.J., company said the Committee for Medicinal Products for Human Use recommended approval in children 6 weeks to 5 years to prevent pneumococcal disease, as well as pneumonia and middle ear infections caused by related strains of the bacterium. Pneumococcal disease can also cause meningitis and blood infections. A final decision from the European Medicines Agency is expected in the coming months, the company said. The original vaccine is Wyeth’s second best-selling drug, with $2.7 billion in revenue in 2008. The original protects against seven types of disease, the new version includes six more. Wyeth, which is being bought by Pfizer for $68 billion, is seeking U.S. approval for the drug under the name Prevnar 13. The FDA, which delayed its decision last month, is expected to make a ruling by Dec. 30.

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