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FDA Approves 13-Valent Pneumococcal Conjugate Vaccine for Infants, Children NEW YORK -- February 24, 2010 -- The US Food and Drug Administration (FDA) has approved a 13-valent pneumococcal conjugate vaccine (diphtheria CRM197 protein; Prevnar 13) for active immunisation of children aged 6 weeks to 5 years for the prevention of invasive disease caused by 13 Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Prevnar 13 is also indicated for the prevention of otitis media caused by serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A. In connection with the approval by the FDA, the manufacturer, Pfizer, has agreed to certain post-marketing commitments involving conducting a study to further evaluate the safety profile of the vaccine, a study to evaluate the prevention of overall invasive pneumococcal disease, and various studies to evaluate reduction in otitis media. The approval is based on the review of 13 phase 3 studies involving more than 7,000 infants and young children. Data from the phase 3 trials support the safety and efficacy of the 13-valent vaccine for the prevention of invasive pneumococcal disease in infants and young children. Clinical trial data indicate that the vaccine can be administered with all routine paediatric vaccines studied. The 13-valent pneumococcal vaccine is recommended to be administered as a 4-dose series at 2, 4, 6, and 12 to 15 months of age. Children aged 15 months to 5 years who have received 4 doses of the 13-valent vaccine may receive 1 dose to elicit immune responses to the 6 additional serotypes. The immune responses induced by this 13 transition schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared with antibody concentrations following 4 doses of the vaccine (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known. SOURCE: Pfizer E-mail this page to a friend or colleague! To print, use this version