Assuring quality vaccines for countries that self-procure
This policy outlines how countries opting for self-procurement should only use Gavi funds to purchase vaccines and related injection safety supplies (auto-disable syringes, syringe and needle disposal boxes) that meet international expectations of assured quality.
What is the purpose of Gavi's self-procurement policy and how does it work?
When procuring vaccines and associated injection safety supplies with Gavi funds, countries may select either:
- The supplies in kind from Gavi, procured through UNICEF or PAHO’s Revolving Fund, or
- The equivalent cash grant from Gavi to be used for self-procurement, in lieu of supplies.
Self-procurement of vaccines
Countries that prefer to self-procure vaccines using Gavi support must assure that international expectations of assured quality are met. This can be done by either:
- Selecting vaccines from the list of WHO pre-qualified products; or,
- Ensuring that the vaccines purchased comply with WHO’s definition of quality vaccines (as described in WHO’s Technical Report Series), for which there are no unresolved quality problems reported to WHO, and for which compliance is assured by fully functional National Regulatory Authorities (NRAs), as assessed by WHO in countries both where the vaccines are manufactured and where they are purchased.
Safe procurement of related injection safety supplies
Countries using Gavi’s funds to self-procure auto-disable syringes are required to procure products pre-qualified under WHO’s Performance, Quality and Safety system. Unsafe injections represent a well-established risk and there are no widely-applied national quality assurance mechanisms for these supplies, in the same way as there are NRAs for vaccines. For syringe and needle disposal boxes, countries self-procuring with Gavi funds must either:
- Procure boxes that appear on the relevant WHO list of prequalified products; or,
- Submit to WHO a certificate of quality from a relevant national authority.
Among the steps necessary for a country to self-procure using Gavi funds is a review by Gavi or its designate of the proposed procurement mechanism to assess whether it satisfies generally acceptable procurement methods and to make any recommendations on minimum reporting requirements and improvements.
Gavi strongly encourages countries self-procuring co-financed products (i.e. with national funds) to ensure they are of WHO-defined assured quality, such as those on the WHO list of pre-qualified products or as otherwise described above and that the programmatic suitability of the product has been considered.
Additional information on quality assurance for self-procuring countries is available in a FAQ and in the New and Underused Vaccines Support Guidelines for Applications.