WHO/Health Canada Consultation on Serological Criteria for Evaluation and Licensing of New Pneumococcal Vaccines

Overview

New pneumococcal vaccine formulations containing more conjugated serotypes are at advanced stages of clinical development and are likely to be subject to regulatory assessment soon. There are also currently a number of initiatives to facilitate the introduction of pneumococcal conjugate vaccines in developing countries. These initiatives are dependent upon the vaccines being satisfactorily licensed and subsequently prequalified by the WHO for use by UN agencies. WHO recommendations for pneumococcal conjugate vaccine production and control were established in 2003 and published in the WHO Technical Report Series (TRS) 927, annex 2.