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Serological criteria proposed for licensing pneumococcal vaccine in infants.
2003 SEP 10 - (NewsRx.com & NewsRx.net) -- Serological criteria have been recommended for the evaluation and licensure of new pneumococcal conjugate vaccine formulations for use in infants.
According to a study from an international team of researchers, "The World Health Organization (WHO) is undertaking a series of consultations on serological criteria for the evaluation and licensure of new formulations/combinations or different vaccination schedules of pneumococcal conjugate vaccines. The lack of a definitive serological correlate of protection and the multiplicity of antigens involved, especially since the clinical efficacy of most of the individual serotypes represented in the only licensed vaccine has not been established, are hindering the formulation of criteria for licensure of new formulations or combinations of the vaccine."
"This report analyzes the various options with their relative merits and drawbacks and provides preliminary recommendations as guidance to regulatory agencies in evaluating these vaccines for the purposes of licensure," ...
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Source: HighBeam Research, Serological criteria proposed for licensing pneumococcal vaccine in...