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The EMEA Committee for Medicinal Products for Human Use (CHMP) has already expressed two positive opinions to Wyeth Pharmaceuticals’ application to extend the indication of PREVENAR™ (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) to include active immunization against pneumonia and acute otitis media (middle ear infection) caused by vaccine serotypes.

PREVENAR is currently approved for active immunization of children from 2 months to 5 years of age against sepsis, meningitis, bacteraemic pneumonia and bacteraemia caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.

PREVENAR™ is the first and only conjugate vaccine that demonstrated efficacy in the reduction of the incidence of pneumococcal disease (PD) in infants and toddlers.

The CHMP recommendations of PREVENAR will now be forwarded to the European Commission (EC) for final approval – expected in the second quarter of 2007. Wyeth Pharmaceuticals (10944776) is a division of Wyeth (NYSE: WYE).

Find more details from the press release.