Pfizer said that The European Commission granted European marketing authorization for its pneumococcal conjugate vaccine, Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]). Prevenar 13 is indicated for active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by 13 Streptococcus pneumoniae serotypes in infants and children from 6 weeks to 5 years of age. Invasive pneumococcal disease includes sepsis, meningitis, bacteremia, bacteremic pneumonia, and empyema. Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer Inc., said, “Although the incidence of pneumococcal disease has been significantly reduced in European countries and elsewhere where Prevenar is routinely used, pneumococcal disease remains a serious threat to children in Europe as strains such as serotypes 19A and 6A are increasing in prevalence and frequently resistant to antibiotics. By providing the broadest serotype coverage of any pneumococcal conjugate vaccine, Prevenar 13 is poised to help reduce the serious public health risk and economic burden associated with pneumococcal disease.” The European Commission’s authorization of Prevenar 13 was based on a clinical trial program of 13 core Phase III studies involving more than 7,000 children. Data from the Phase III trials support the safety and efficacy of Prevenar 13 for the prevention of pneumococcal disease in infants and young children, Pfizer said. Clinical trial data indicate Prevenar 13 has a safety profile similar to that of Prevenar, and can be administered with all routine pediatric vaccines studied.

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