Vaccine manufacturers contribute to the mission of WHO prequalification by ensuring the supply of vaccines that meet WHO standards and supplying information about product performance and vaccine efficacy data, which is relevant to the target population. Manufacturers also engage the national regulatory authority in the country of production, providing them with the requisite information to carry out independent and appropriate regulatory oversight of vaccines.
WHO vaccine prequalification may offer manufacturers a range of benefits, including:
access to new markets
- opportunity to provide vaccines for national immunization programmes of WHO Member States via United Nations procurement agencies
- potential to become market-leaders in technologies for WHO priority vaccines
- engagement with WHO vaccine standards which reflect the programmatic needs strategic priorities of WHO Member States
- receipt of feedback on product suitability, performance and potential areas for improvement
- status associated with producing quality-assured, WHO-prequalified products
- enhanced image through association with UN and national procurement agencies.
Which manufacturers can participate?
Any manufacturer of a vaccine may apply for prequalification of its product(s) provided that the conditions for acceptance of an application can be met, namely that:
- the candidate vaccine is on the current list of priority products for UN prequalification
- the candidate vaccine meets the mandatory characteristics for programmatic suitability
- the national regulatory authority (NRA) responsible for the regulatory oversight of the product is classified as a functional NRA or WHO-listed authority operating at maturity level 3 (at a minimum)
- a marketing authorization has been granted by the relevant NRA and the post-marketing regulatory oversight is under the responsibility of the NRA of the country of manufacture (or the European Medicines Agency in the case of the centralized procedure for marketing authorizations in Europe), or that of the country of finishing and distribution.
Information for manufacturers who wish to participate
Vaccine manufacturers who wish to submit products for prequalification are encouraged to review the following information:
- WHO List of Prequalified Vaccines ― the complete listing of currently prequalified vaccines, including applicant details, pharmaceutical form and NRA responsible for oversight
- Prequalification Procedures and Fees ― information about the prerequisites for prequalification, application and evaluation processes, and application fees
- Post-prequalification procedures ― information on the role and responsibilities of the manufacturer with respect to maintaining product prequalification statu
- WHO Public Inspection Reports ― each report provides information about the manufacturing site of the product concerned and that has passed WHO inspection
- Guidance Documents ― current vaccine standards and other general guidance and UN agency operational specifications on preparation, packaging and shipment
- Market Information ― information and links to WHO partners' market analyses to support commercial decision-making about vaccine product manufacture and development
- Key Contacts – the key persons who can be contacted regarding different aspects of vaccines prequalification or collaborative registration or technical assistance.