Full assessment of a vaccine consists of a scientific evaluation of documentary evidence for quality, safety and efficacy. This assessment process is supported by initial testing performed by WHO-contracted laboratories to assess the consistency of final product characteristics, such as, potency and toxicity of the vaccine. However, depending on the nature of the vaccine, other tests may be performed. The samples subject to testing must comply in all respects with the information and specifications stated in the Vaccines Prequalification Dossier (VPQD).
Inspection of the manufacturing site is also necessary as part of the initial evaluation, to verify that the vaccine candidates for purchase by UN agencies comply with WHO recommendations for good manufacturing practice (GMP) and meet UN tender specifications. Other important elements of on-site inspection may include, but are not limited to, labelling, packaging, verifying whether a post-marketing surveillance system is in place, vaccine vial monitor (VVM) implementation (when required), and the stability programme.
Streamlined procedure for vaccines with marketing authorization from eligible NRAs
As an alternative to full assessment, the streamlined procedure can be applied to vaccines that have been licensed by selected national regulatory authorities (NRAs) who are eligible and willing to share regulatory information with WHO. The procedure is applied through collaboration and confidentiality arrangements, and with the agreement of the manufacturer of the vaccine to which the streamlined prequalification procedure is being applied.
The streamlined prequalification procedure follows the same principles as the full assessment procedure in terms of dossier submission. However, the scientific review will consider and rely on the reports generated by the NRA or the national control laboratory (NCL) of record. In terms of inspection, WHO recognizes the product-related inspections conducted by the responsible NRA and limits its scope of action to a limited site inspection, to verify specific items relevant to UN tender specifications.
Vaccines that are produced for export-only purposes require special consideration and are not eligible for evaluation through the streamlined procedure.
All vaccine applications submitted for evaluation under Article 58, and intended for immediate prequalification after a positive specific opinion, will be assessed according to the streamlined procedure. In these cases, the report of the assessment is drafted in accordance with the full assessment procedure.
For more information related to the streamlined procedure, please refer to Section 4.2 of the WHO vaccines prequalification procedure (TRS 987, Annex 6).
The fast-track procedure is applicable to licensed vaccines (i.e. for which a marketing authorization is available) that are used in routine immunization programmes, or only during an emergency response. This procedure can be considered for application in the following specific situations, in agreement with UN purchasing agencies or other partners:
- during an acute vaccine shortage that may jeopardize global supply for routine immunization programmes
- during emergency situation, such as a disease outbreak or epidemic, for which no prequalified vaccine is yet available
or in the following exceptional circumstances:
- when a pandemic — for which production capacity needs to be established — has been declared
- when an alternative to existing vaccines to be used during an eradication effort is needed.
In cases where the fast-track procedure is followed, the established deadlines for VPQD submission do not apply. Given the need to ensure maximum flexibility during product evaluation, dossier review, initial testing and site inspection are performed simultaneously, optimizing allocation and use of both WHO's and the manufacturer's resources.