RTS,S- the first approved vaccine for malaria
WHO Prequalification pathway- timely access to treatment for life-threatening conditions
The Pre-Qualification Procedure for Vaccines
- has obtained marketing authorization from the manufacturing country’s national regulatory authority (NRA),
- is on the prequalification priority list,
- meets PSPQ requirements
- for which the responsible NRA that oversees the vaccines regulatory activities is a WHO-listed body
The pre-qualification procedure for vaccines involves several steps:
DDReg has provided support to its customers for the prequalification process for vaccines. A general overview on the process is as follows:
- Vaccine manufacturer requests pre-submission meeting with WHO.
- After acceptance, vaccine manufacturer submits application letter to WHO including information on country & manufacturing sites, licensing status, and expected deadline for dossier submission.
- After the application letter is accepted, a vaccine manufacturer must submit a vaccine prequalification dossier.
- WHO evaluates the dossier to ensure it is complete and compliance with the required format and content; vaccine candidate programmatic suitability is also evaluated.
- The dossier is assessed per the WHO prequalification procedure for vaccines and manufacturing site compliance is verified in accordance with WHO Good Manufacturing Practices.
- The vaccine manufacturer would be requested to submit samples for testing
- Vaccine manufacturing site is inspected to ensure:
- The vaccine is compliant with WHO product and quality control recommendations
- The vaccine meets the UN tender specifications
- The vaccine manufacturing processes are compliant with WHO Good Manufacturing Practices
References and Further Reading:
 Hotez PJ, Matshaba M. Promise of new malaria vaccines. bmj. 2022 Oct 14;379.
 WHO. Malaria. World Health Organization. 2023
 Laurens MB. RTS, S/AS01 vaccine (Mosquirix™): an overview. Human vaccines & immunotherapeutics. 2020 Mar 3;16(3):480-9.
 WHO. Prequalified vaccines. World Health Organization. 2023
 WHO. WHO prequalification. WHO Drug Information Volume 31. No. 3. 2017