Prequalification Procedures and Fees: Vaccines
This section of the website is dedicated to enabling potential applicants to determine how, whether and what information they must compile in order to submit an application for WHO prequalification.
Who can participate in WHO prequalification of vaccines?
Any manufacturer can apply for prequalification assessment of a vaccine provided if that vaccine:
- is included on the vaccines prequalification priority list
- meets the mandatory characteristics for programmatic suitability (PSPQ)
- has received a marketing authorization from the national regulatory authority (NRA) of the country of manufacture
- and for which the NRA responsible for its regulatory oversight is a WHO-listed authority.
What are the steps of the prequalification process?
The following is an overview of the prequalification process for vaccines:
- The manufacturer requests a pre-submission meeting to advise WHO on the intention to submit a vaccine for evaluation. The pre-submission meeting should be requested as early as possible, by sending an email to firstname.lastname@example.org. A predefined agenda and presentation must be proposed by the manufacturer and shared with WHO at least two weeks before the scheduled meeting.
- If the conditions for acceptance are fulfilled, the manufacturer submits an application letter to WHO providing specific details, such as country and manufacturing sites, licensing status, presentations to be made available for procurement and expected deadline for dossier submission.
- A manufacturer whose application letter is accepted submits a Vaccine Prequalification Dossier (VPQD).
- WHO screens the VPQD for completeness and compliance with the required format and contents. The programmatic suitability of the vaccine candidate for WHO prequalification is also assessed at this step.
- The dossier is assessed in accordance with the WHO prequalification procedure for vaccines (WHO TRS 978, Annex 6), as well as verification of compliance of the manufacturing site with WHO Good Manufacturing Practices by means of inspection, where necessary.
- WHO requests the manufacturer to submit vaccines samples for independent and initial testing. Testing is performed by WHO contracted and qualified laboratories.
- An inspection of the vaccines manufacturing site is performed to assess that: the vaccine complies with WHO recommendations for production and quality control; it meets the UN tender specifications; the company has an adequate quality management system in place; and the vaccine is manufactured in compliance with WHO Good Manufacturing Practices.
Dossier submission deadlines
WHO has established three deadlines per years for the submission of a Vaccine Prequalification Dossier (VPQD):
- 31 January
- 31 May
- 30 September.
What happens when a vaccine is prequalified?
Vaccines that are considered to have met prequalification requirements are included on the WHO List of Prequalified Vaccines. On this website, users can find information about the vaccines listed, such as, manufacturer’s name, presentation, prequalification date and other product details. This is complemented with a WHO Public Assessment Report (WHOPAR) and a WHO Public Inspection Report (WHOPIR). The WHOPAR will summarize the assessment of the product information that was submitted in the product dossier. The WHOPIR(s) will provide the date, duration and scope of the inspection, and a summary of inspection observations and findings.
Posting of the WHOPAR and WHOPIR(s) generally occurs sometime after inclusion of the relevant product in the WHO List of Prequalified Vaccines. This is because their contents must be agreed with the manufacturer. In this way, WHO ensures that confidential information is not disclosed.
Ensuring continued acceptability of prequalified vaccines
A rigorous post-prequalification process is also in place to ensure the continued acceptability of prequalified vaccines. It consists of the performance of the vaccine and its manufacturer. This is carried out annually through the evaluation of a Prequalification Annual Report (PQVAR), which includes a summary of changes on the product, report of complaints or adverse events following immunization (AEFIs), etc. Targeted testing of vaccines lots is also carried out to monitor compliance with product standards.