The purpose of the vaccines prequalification annual review is to verify ongoing compliance of each prequalified vaccine with safety and efficacy requirements. Successful completion of the annual review is a prerequisite for maintaining WHO-prequalificed vaccine status.
The first step in the annual review is submission by the manufacturer of an annual report for the prequalified vaccine
Information to be included in the annual report
An annual report must provide the following information:
- A summary of variations to the product(s) that have been implemented since the previous annual report (or, for the first annual report on a product, since initial prequalification). See template below for recording and submitting this information.
- Testing results from the ongoing stability programme since the previous annual report (or, for the first annual report on a product, since initial prequalification).
- Production and distribution data should include a summary table showing the quantity of batches and doses of finished product distributed since the previous annual report. The table should include product used domestically and product exported. Batches supplied to United Nations agencies should be indicated. If more than one presentation is manufactured, these should be listed separately.
- Details of GMP inspections (in which the prequalified product was within the scope of inspection) performed since the previous annual report.
- Summary update on implementation of post-prequalification commitments (if these are indicated in the approval letter or reassessment report). These may be for:
- reports of serious adverse events following immunization
- reports of quality complaints and/or recalls from the field for batches of the prequalified vaccine
- notification of any problem/constraints in production or quality control that might affect the international supply of this vaccine, both in terms of volume and/or lead time
- notification of any problem/constraints in production or quality control that might affect the international supply of this vaccine, both in terms of volume and/or lead times.
- Periodic safety update report (electronic data only).
A manufacturer may already have submitted an annual report to the relevant national regulatory authority. If this annual report contains the information listed above, there is no need to create an additional report for submission to WHO. It can simply be submitted to WHO.
Annual report deadline
The deadline for submission of the first annual report is one year after the date of prequalification, with subsequent submissions due on the same date each year thereafter.
Each prequalified vaccine annual report (PQVAR) must be submitted via the Module for PQVAR submission, screening and evaluation. (Each manufacturer of a prequalified vaccine will have been granted access to this portal.) WHO will thereafter screen and review the report submitted.