WHO prequalification: information and guidance documents for vaccine manufacturers
20 March 2006 -
The cost of the activities required to assess the acceptability, in principle, of candidate vaccines for UN agency purchase are as follows:
Screening fee: US$ 500.
Evaluation fee: US$ 25,000 for traditional vaccines and US$ 66,500 for combinations and novel vaccines (see Table 1 below).
Annual fee: US$ 8,000 for traditional vaccines and US$ 14,000 for combinations and novel vaccines (see Table 1 below).
The expenses related to the site audit will be charged on a cost recovery basis.
Vaccine prequalification procedure
A revised procedure was reviewed and endorsed by the WHO Expert Committee on Biological Standardization in October 2010 and is in place as of 1 February 2012.
- Revised procedure for WHO prequalification of vaccines
- Deviation Handling and Quality Risk Management
As described in the procedure referenced above, manufacturers are required to submit a product summary file (PSF). There are a number of guidance documents to assist manufacturers in the preparation of a PSF.
Format requirements for product summary files (PSF)
- Guideline for preparation of the product summary file for vaccine prequalification, WHO/IVB/06.16 [pdf 922kb]
- Points to consider for manufacturers of human vaccines: clinical considerations for evaluation of vaccines for prequalification
- Environmental monitoring of clean rooms in vaccine manufacturing facilities
Submission deadlines for applications for WHO prequalification
There are three deadlines for submission of applications to WHO. These are 31 January, 31 May and 30 September of each year. Applications must arrive at WHO by the submission date to be considered for the following review round.
Acceptance for prequalification depends on the priority assigned for a vaccine type.
WHO model inserts for vaccines
Model inserts have been prepared by WHO for many vaccines to provide guidance to manufacturers on format and content for preparation of package inserts for their vaccines.
The models are relevant for vaccines to be supplied through UN procuring agencies.
The WHO model inserts are not intended to provide information specific to any particular vaccine brand.
Vaccine manufacturers using these models to prepare their own package inserts, should ensure that the information on their vaccine package insert is specific to their vaccine.
The information on specific inserts should be consistent with (does not contradict) the models but can be more comprehensive and detailed.
The package insert is reviewed during the prequalification evaluation.
A copy of the product insert is published with the list of prequalified vaccines.
UN procuring agency tender requirements include that shipped product should comply with the WHO guidelines on the international packing and shipping of vaccines. Annex 1 of the guidelines describes validation of maintenance of appropriate temperature during shipment. This information is reviewed during prequalification.
Vaccine vial monitors
Vaccine vial monitors (VVMs) are recommended for use. During prequalification evaluation, stability data to support the choice of the type of VVM is reviewed. More information on VVMs can be found at the following link.
WHO guidance for expedited national registration of prequalified vaccines in recipient countries
- Procedure for expedited review of imported prequalified vaccines for use in national immunization programmes, WHO/IVB/07.08 [476 kb]