WHO Prequalification

WHO Prequalification is a service provided by the World Health Organization that assesses the quality, safety, and efficacy of vaccines and other health products. Prequalification is essential for vaccines purchased by international organizations like UNICEF, Gavi, and PAHO for distribution in low- and middle-income countries.

What WHO Prequalification Evaluates

• Quality: Manufacturing processes, quality control, consistency
• Safety: Clinical trial data, adverse event profile
• Efficacy: Demonstrated protection against target disease
• Labeling: Appropriate instructions and warnings
• Storage and stability: Cold chain requirements

The Prequalification Process

1. Application: Manufacturer submits comprehensive dossier
2. Documentation review: WHO experts evaluate all submitted data
3. Site inspection: Manufacturing facilities are audited
4. Laboratory testing: Product samples are tested
5. Expert review: WHO Strategic Advisory Group of Experts (SAGE) evaluates
6. Listing: Product is added to WHO list of prequalified vaccines

Why Prequalification Matters

Prequalification enables global vaccine access:

• UNICEF procurement: Required for UNICEF vaccine purchases
• Gavi eligibility: Required for Gavi-funded vaccine programs
• PAHO revolving fund: Required for PAHO vaccine procurement
• National registration: Many countries use prequalification for national registration

Key Statistics

Sources & Citations

• WHO: Prequalification of Medical Products
• UNICEF: Prequalification