Recommendations to assure the quality, safety and efficacy of pneumococcal conjugate vaccines, Annex 3, TRS No 977

Overview

These Recommendations provide guidance for the production and control of pneumococcal conjugate vaccines in Part A and for their nonclinical evaluation in Part B. Part C covers the clinical development programme applicable to pneumococcal conjugate vaccines intended primarily for the prevention of invasive pneumococcal disease (IPD) and for administration to infants and toddlers. Clinical assessment of the potential of these vaccines to prevent IPD in older children and adults (including the elderly) or to prevent other types of pneumococcal infection (e.g. pneumonia and otitis media) is not considered in any detail.

Full version of the WHO Technical Report Series N° 977