Immunization, Vaccines and Biologicals


Assessing the Programmatic Suitability of Vaccine Candidates for WHO Prequalification

As part of the WHO vaccine pre-qualification (PQ) process, product summary files (PSFs) are assessed by the WHO PQ Secretariat to determine the suitability of the vaccine for the immunization services where it is intended to be used (p.6, WHO/IVB/05.19). This document aims:

  • To clearly describe the screening process and its set of rules by which all prospective vaccine prequalifications will be judged in terms of their programmatic suitability for developing country public sector immunization programmes. Also, it describes the consequences of not complying with these characteristics on the screening and PQ processes.
  • To indicate very clear preferences for future vaccines that will result in greater compliance with developing country needs and that will facilitate universal immunization without requiring massive and unrealistic investment in additional cold chain capacity, human resources, waste disposal facilities, etc.

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