Journal
VACCINE
Volume 21, Issue 23, Pages 3265-3272Publisher
ELSEVIER SCI LTD
DOI: 10.1016/S0264-410X(03)00230-5
Keywords
Streptococcus pneumoniae; conjugate vaccine; correlates of protection
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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 analyses 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. More detailed recommendations for production and control of pneumococcal conjugate vaccines, including criteria for evaluation for licensure, are currently being drafted. Published by Elsevier Science Ltd.
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