Procedure for assessing the acceptability, in principle, of vaccines ...

immunization programmes and vaccines regulation. The terms of reference of the
PSPQ Standing Committee can be accessed at
http://www.who.int/immunization_standards/vaccine_quality/ps_pq/en/index.html.
The committee will review the documentation exclusively related to the specific
problem. During its review and discussion which will lead to the formulation of
recommendations, the PSPQ Standing Committee may engage in confidential
discussion with manufacturers and other technical experts approved by WHO and the
manufacturer. All members of the PSPQ Standing Committee will be required to sign
a confidentiality agreement (see section 15 and Appendix 5) and a declaration of
interests form (see section 16 and Appendix 6) prior to taking up their responsibilities.
Note: Under special circumstances, when there is limited access to a vaccine of public health
importance, exceptional consideration will be given regarding the suitability of vaccine
candidates that are noncompliant with the critical characteristics or that present with unique
and innovative characteristics. This decision can be made by the prequalification secretariat
and will take into account the recommendations of the PSPQ Standing Committee, public
health needs and availability of alternative products.
The screening process will be put on hold while the PSPQ Standing Committee
conducts the review. The duration of the review by the PSPQ Standing Committee
will be no longer than three months. In case of rejection following a recommendation
from the PSPQ Standing Committee, the reviewers may include a recommendation
for resubmission after validation by research of the acceptability of specific vaccine
characteristics.
When no review by the PSPQ Standing Committee is required, the manufacturer will
be informed within one month from the submission deadline if the PSF is accepted for
further review or rejected. In case of acceptance, the manufacturer will be informed
by letter of the acceptance of the file for evaluation and of the names of the experts 4
proposed for the evaluation, together with a copy of their curricula vitae. At the same
4 NRA staff, independent consultants or staff from consulting companies may be appointed as external
experts, depending on the specific needs. The manufacturer has the right to reject one or more team
members if justification is provided, in which case WHO will find a replacement. All experts appointed
by WHO to participate in the evaluation of a vaccine evaluation are required to sign a confidentiality
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