WHO Prequalified Vaccines List

The WHO Prequalified Vaccines List is the authoritative database of vaccines that have passed WHO's Prequalification Programme assessment, certifying their quality, safety, and efficacy to the standard required for procurement by UNICEF, the PAHO Revolving Fund, GAVI-financed programmes, and other international immunisation procurement mechanisms.

What is the WHO Prequalified Vaccines List?

Vaccines occupy a distinct position within the pqp because of the complexity of biological manufacturing, the cold chain requirements, and the scale at which international immunisation programmes operate. The WHO Prequalified Vaccines List covers prophylactic vaccines for diseases including measles, polio, pneumococcal disease, rotavirus, typhoid, yellow fever, meningitis, and an expanding range of other preventable conditions. For each vaccine, the listing specifies the manufacturer, product name, formulation, the manufacturing site address, and the national regulatory authority of the producing country, which must be a functional regulatory authority meeting WHO standards.

unicef-supply-division procured 2.787 billion vaccine doses in 2024 and requires WHO prequalification for all vaccines it sources. GAVI, which finances immunisation in 73 lower-income countries and channels most of its vaccine procurement through UNICEF, applies the same standard. The PAHO Revolving Fund, which procures vaccines for Latin America and the Caribbean, similarly restricts its purchases to WHO prequalified products. A vaccine manufacturer without a prequalified product is excluded from these combined markets, which together represent the majority of global public-sector vaccine procurement volume.

Why the WHO Prequalified Vaccines List matters for bidders

For vaccine manufacturers, prequalification is the entry ticket to a global immunisation market worth several billion dollars annually. The prequalification process for vaccines is rigorous and involves inspection of the manufacturing site, review of the product dossier, lot release testing, and post-market surveillance commitments. The process typically takes longer than for small-molecule medicines. Manufacturers should begin engagement with the WHO prequalification team early and prioritise products in high-demand categories where UNICEF and GAVI have identified supply gaps, as these attract the most active procurement interest.

FAQ

What is required for a vaccine to gain WHO prequalification?

The manufacturer must hold a valid marketing authorisation from a functional national regulatory authority, pass a WHO manufacturing site inspection, submit a complete product dossier for review, and commit to ongoing lot release testing and post-market surveillance.

Does WHO prequalification cover both originator and generic vaccines?

Yes. Both originator vaccine manufacturers and biosimilar or generic vaccine producers can apply for and hold WHO prequalification, provided their products and manufacturing sites meet the required standards.

How does GAVI use the WHO Prequalified Vaccines List?

GAVI finances vaccines for eligible countries but channels most purchases through unicef-supply-division. UNICEF requires WHO prequalification for all vaccines it sources, so GAVI-funded procurement is effectively restricted to prequalified products regardless of which agency executes the purchase.