[Vaccine-manufacturing] WHO - Establishment of a COVID-19 mRNA vaccine technology transfer hub to scale up global manufacturing

Thiru Balasubramaniam thiru at keionline.org
Fri Apr 16 09:47:39 PDT 2021


https://www.who.int/news-room/articles-detail/establishment-of-a-covid-19-mrna-vaccine-technology-transfer-hub-to-scale-up-global-manufacturing
Establishment of a COVID-19 mRNA vaccine technology transfer hub to scale
up global manufacturing
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 transfer1 hub(s) 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 technology2 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*:

   1. 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;
   2. Owners (public or private) of technology and/or intellectual property
   rights. 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 intellectual
property rights* (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 at who.int) and Raj Long (rlong at 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.

 _______________________

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.




-- 
Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org


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