Extensão de prazo para 15 de outubro de 2021
For the successful establishment of mRNA vaccine manufacturing capacity globally, the World Health Organization (WHO) has launched a new initiative to support transfer of technology to produce mRNA vaccines in low- and middle-income countries (LMICs) (1). The initiative will ensure that all WHO regions will be able to produce vaccines as essential preparedness measure against future infectious threats.
Under this initiative, WHO and the Pan American Health Organization (PAHO) are working together to establish mRNA vaccine manufacturing capacities in LAC. Currently, there is a limited number of global manufacturers able to supply all necessary reagents and/or starting materials (2) needed for manufacturing mRNA vaccines. To ensure sustainability and independence of vaccine production in the Region, access to reagents that are critical to the value chain is fundamental. Hence PAHO/WHO is launching a call for expression of interest to manufacturers in the Region of the Americas that wish to become part of a regional consortium that will ensure that mRNA vaccines can be sourced from starting materials and preparations (including seed lots, cell banks and intermediates) to the finished product.
Through this new initiative, PAHO and WHO will facilitate the establishment of a Regional consortium and support of a comprehensive technology transfer. Ideally, the group of manufacturers that come together for this initiative will include representatives from different geographical areas in the Americas and work towards an integrated regional value chain that will provide sustainability and ease the dependence on imported vaccines from outside the Region.
To support this activity, we are seeking expressions of interest from:
- Public or private manufactures of medical products (drugs, vaccines or drug substances) , and/or starting materials from the Region of the Americas, which could manufacture and supply one or more of the following:
- DNAse 1,
- T7 RNA Polymerase,
- RNase inhibitor,
- Guanyl Transferase,
- s-adenosyl methionine, and
Entities willing to be considered are invited to provide a brief summary that includes, at a minimum, the reagents and/or starting materials they wish to provide, a summary of their capacity, needs, and their interest in participating in this initiative.
Deadline extension from 17 September to 15 October 2021
This information must be sent to:
(2). In accordance with WHO TRS Sixty-sixth report starting materials are: any substances of a defined quality used in the production of a pharmaceutical product but excluding packaging materials. In the context of biological products manufacturing, examples of starting materials may include cryo-protectants, feeder cells, reagents, growth media, buffers, serum, enzymes, cytokines, growth factors and amino acids.