World Health Organisation (WHO) will assist pharmaceutical companies in low and middle income countries (LMICs) to mass manufacture mRNA COVID-19 vaccines through non-exclusive licences and technology transfer. The COVID-19 vaccines made using mRNA technology by companies like Pfizer and Moderna are not currently available in India. Such vaccines are considered to be the most effective ones to contain the COVID-19 infection.
The global health agency will issue a call for expression of interest from small- and mid-sized pharmaceutical companies, preferably from LMICs to come forward to set up COVID-19 mRNA hubs and in turn transfer know-how and technology to existing or new manufacturers in LMICs to enable them to develop and produce COVID-19 mRNA vaccines. The WHO itself will assist these hubs to access COVID-19 mRNA technology and assemble the technology up to good manufacturing practices-grade pilot lots for clinical trials.
Expressions of interest have already been invited from academic institutions, pharmaceutical companies, non-governmental organisations and other entity that own mRNA technology and/or intellectual property rights to contribute these to such technology transfer hubs, under the auspices of WHO, to enable production of mRNA-based COVID-19 vaccines in LMICs.
On April 16, a WHO statement said the call for interest from manufacturers in LMICs interested in receiving the technology developed by the technology transfer hubs will be issued 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," it said.
The plan is to facilitate the establishment of one or more technology transfer hubs that will use a hub-and-spoke model to transfer a comprehensive technology package and provide appropriate training to interested manufacturers in LMICs. The initiative will initially prioritise the mRNA-vaccine technology but could expand to other technologies in the future, the statement said.
It explained that 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. The technology used will either be free of intellectual property constraints in LMICs, or rights will be made available to the technology hub and the future recipients of the technology through non-exclusive licences to produce, export and distribute the COVID-19 vaccine in LMICs, including through the COVAX facility. The agency will give preference to applicants who have already generated clinical data in humans, as such clinical data will contribute to accelerated approval of the vaccines in LMICs.
The WHO decided to prioritise mRNA vaccines as they have proven extremely efficacious in protecting against COVID-19, and protection is maintained to a large degree against variants. The WHO also states that the technology is very flexible and allows relatively rapid adaptation of the vaccine to variants, if needed and can be produced by manufacturers of medicines and medical active substances in addition to vaccines. The agency also says many technical features of mRNA vaccines are free of intellectual property rights in many countries of the world.
The move is expected to increase global access to these critical tools to bring the pandemic under control. WHO will work with funders and donors to mobilise 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, the statement said.