Given the urgent need for low- and middle-income countries (LMICs) to be able to respond to the COVID-19 pandemic, and the current critical shortage of COVID-19 vaccines in these countries, WHO and its partners are seeking to expand the capacity of LMICs to produce COVID-19 vaccines and contribute to the success of the global vaccination campaign nationally, regionally and globally. Through this new initiative, WHO will facilitate the establishment of (one or more, as appropriate) technology transfer[1] hub(s) which will be able, using a hub and spoke model (REF), to transfer a comprehensive technology transfer package and provide appropriate training to interested manufacturers in LMICs. This initiative will initially prioritize the mRNA-vaccine technology[2] but will expand this call to other technologies in the future, as appropriate.
Ideally such hubs should be able to establish the production process at an industrial or semi-industrial level permitting training in production processes and provision of all necessary SOPs 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 a non-exclusive license 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 hub(s) and, as it(they) is(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 essentially absent. This broader objective will ensure that all WHO regions will be able to produce vaccines as essential preparedness measure against future infectious threats.
To support this activity, we are seeking expressions of interest from:
- Small/middle-size (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 GMP-grade pilot lots for clinical trials;
- Transfer the appropriate know-how and technology to existing or new manufacturers in LMICs to enable these to develop and produce COVID-19 mRNA vaccines.
- Owners (public or private) of technology and/or Intellectual Property Rights (IPR). These may be academic institutions, pharmaceutical companies, non-governmental organizations or any other entity willing to contribute these to a technology transfer hub, under the auspices of WHO, to enable production of mRNA-based COVID-19 vaccines in LMICs.
For this initial expression of interest, entities willing to be considered as a technology transfer Hub (as briefly described above under 1) or able to provide the necessary know-how, process training, and IPR (as briefly described above under 2), are invited to provide a brief summary of their capacity, and their interest in participating in the establishment of a COVID-19 vaccine technology transfer hub to:
Martin Friede (friedem@who.int) and Raj Long (rlong@who.int)
A call for interest from manufacturers in LMICs interested in receiving the technology developed by the technology transfer hub(s) will be issued by WHO in the coming weeks. Preference will be given to manufacturers of drugs, vaccines or active pharmaceutical substances based in LMICs and capable of producing medical products on a large scale under Good Manufacturing Practices. Another important factor taken into consideration will be prospect for sustainability and experience with WHO Prequalification (PQ) will be an asset.
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[1] Technology transfer hubs have been supported previously by WHO to enable the successful development and transfer of processes for adjuvant production and for influenza vaccine production (ref).
[2] The reasons why WHO decided to advance immediately on mRNA vaccines are as follows:
- They have proven extremely efficacious in protecting against COVID-19, and protection is maintained to a large degree against variants;
- This technology is very flexible and allows relatively rapid adaptation of the vaccine to variants, if needed;
- They can be produced by manufacturers of medicines and medical active substances in addition to vaccines;
Many technical features are free of Intellectual Property Rights in many countries of the world.
Update, 31 May 2021: the call for expressions of interest has now closed, however we welcome any entities still interested in participating in the activity either as technology donors or recipients to contact us.”