E-DRUG: Establishment of a COVID-19 mRNA vaccine technology transfer hub to scale up global manufacturing
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16 April 2021
Expression of interest
WHO and its partners are seeking to expand the capacity of low- and middle-income countries (LMICs) to produce COVID-19 vaccines and scale up manufacturing to increase global access to these critical tools to bring the pandemic under control.
WHO will facilitate the establishment of one (or more, as appropriate) technology transfer hub(s) (1) that will use a hub and spoke model (REF) to transfer a comprehensive technology package and provide appropriate training to interested manufacturers in LMICs. This initiative will initially prioritize the mRNA-vaccine technology(2) but could expand to other technologies in the future.
The intention is for these hubs to enable the establishment of production process at an industrial or semi-industrial level permitting training and provision of all necessary standard operating procedures for production and quality control. It is essential that the technology used is either free of intellectual property constraints in LMICs, or that such rights are made available to the technology hub and the future recipients of the technology through non-exclusive licenses to produce, export and distribute the COVID-19 vaccine in LMICs, including through the COVAX facility. Preference will be given to applicants who have already generated clinical data in humans, as such clinical data will contribute to accelerated approval of the vaccines in LMICs.
It is anticipated that WHO will work with funders and donors to mobilize financial support to establish the hubs and, as they are being established, to support the transfer of technology to selected manufacturers in LMICs, taking into consideration the need to establish permanent vaccine production capacity in regions where this is currently mostly absent. This broader objective will ensure that all WHO regions will be able to produce vaccines as essential preparedness measures against future infectious threats.
To support this activity, we are seeking expressions of interest from:
Small/middle-sized (public or private) manufacturers of medical products (drugs, vaccines or drug substances) preferably, but not exclusively, in LMICs, which could host a COVID-19 mRNA hub and:
Assemble the technology up to good manufacturing practices-grade pilot lots for clinical trials;
Transfer the appropriate know-how and technology to existing or new manufacturers in LMICs to enable them to develop and produce COVID-19 mRNA vaccines;