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13-Valent Pneumococcal Vaccine for Infants, Children Approved in Chile NEW YORK -- July 14, 2009 -- The Chilean Ministry of Health has approved the 13-valent pneumococcal conjugate vaccine (Prevenar 13) for active immunisation of infants and children aged 6 weeks to 5 years for the prevention of invasive pneumococcal disease (PD), as well as pneumonia and otitis media caused by 13 pneumococcal serotypes. In clinical studies, the most commonly reported adverse events in children were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. As with any vaccine, the 13-valent vaccine may not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. In clinical studies (n = 18,168), the most frequently reported adverse events included injection site reactions, fever, irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhoea, and rash. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. The 13-valent vaccine does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. The decision to administer the vaccine should be based on its efficacy in preventing invasive pneumococcal disease. The frequency of pneumococcal serotypes and serogroups can vary from country to country, which could influence the effectiveness of the vaccine in any given country. SOURCE: Wyeth Pharmaceuticals E-mail this page to a friend or colleague! To print, use this version