A system for the prequalification of vaccines for UN supply
WHO provides a service to UNICEF and other UN agencies that purchase vaccines, to determine the acceptability, in principle, of vaccines from different sources for supply to these agencies. The detailed procedure can be found at the following link and is summarised below.
There is an established procedure used by WHO for the initial evaluation of candidate vaccines. Reassessment at regular intervals ensures the continuing quality of vaccines currently being supplied.
A revised procedure was reviewed and endorsed by the WHO Executive Committee on Biological Standardization in October 2010.
It is expected that the revised procedure will be considered by the WHO Executive Board in January 2012. The target date for implementation of the new procedure is 1 February 2012.
Key elements of the revised procedure are:
Goals
- Vaccines used in immunization programmes are safe and effective.
- Vaccine efficacy data and studies are relevant to the target population.
- Vaccines meet the specific needs of the programme, reflected by the tender specifications: i.e. potency, thermostability, presentation, labeling, shipping conditions, etc.
Principles
- Reliance on the National Regulatory Authority responsible for the regulatory oversight of the vaccine.
- Understanding of production process and quality control (QC) methods.
- Production consistency ensured through good manufacturing practices (GMP) compliance.
- Random testing for compliance with specifications.
- Monitoring of complaints from the field.
Prerequisites
- The National Regulatory Authority responsible for the product is "functional" as per assessment performed using the WHO established indicators.
Process
- Review of general production process and quality control procedures.
- Testing of consistency of lots.
- WHO site audit to manufacturing facilities with observers from the responsible National Regulatory Authority.
Assurance of continued acceptability
- Reassessments at regular intervals.
- Targeted testing programme of lots supplied through UN agencies to monitor continued compliance with specifications.
- Follow up of complaints from the field and reports of adverse events following immunization (AEFI).
Related Links
- WHO prequalification: information and guidance documents for vaccine manufacturers
- WHO list of vaccines for purchase by UN agencies
- UN Prequalification of Medicines, Diagnostics and Vaccines - Sixth consultative stakeholder meeting and second meeting with manufacturers, 4-5 April 2011, Geneva
- Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes, WHO/IVB/07.08 [pdf 476kb]
Last updated 16 September 2011