Updated 2 May 2022
Want to learn more about why Médecins Sans Frontières (MSF) launched a global campaign calling on pharmaceutical corporations Moderna, Pfizer and BioNTech – developers of the two World Health Organization (WHO)-listed mRNA vaccines for COVID – to urgently share mRNA technologies with prospective manufacturers in low- and middle-income countries? Read our Q&A below to find out more.
- What is MSF calling for and why?
- Why does this campaign focus on mRNA vaccines?
- What is technology transfer?
- Why is technology transfer needed?
- What is the WHO COVID-19 mRNA Vaccine Technology Transfer Hub?
- What additional capacity may be available to produce COVID-19 mRNA vaccines in low- and middle-income countries?
- What about existing ‘fill-and-finish' deals between Moderna, Pfizer and BioNTech, and manufacturers in other countries?
- What can governments do to support mRNA technology transfer?
- How can I support this campaign?
1. What is MSF calling for and why?
MSF is asking pharmaceutical corporations Moderna, Pfizer and BioNTech – developers of the two WHO-listed mRNA vaccines for COVID-19 – to urgently share mRNA technologies with capable manufacturers in low- and middle-income countries (LMICs). Doing so could facilitate the production of both COVID vaccines and mRNA vaccines for other diseases, and also allow countries to be better prepared for future pandemics.
In addition to calling on Moderna, Pfizer and BioNTech to share mRNA technology with capable manufacturers, MSF is also urging governments that supported the development of mRNA vaccine technology through public funding and other means to demand that these corporations share the technologies.
2. Why does this campaign focus on mRNA vaccines?
The COVID-19 pandemic race to develop new vaccines has brought with it the introduction of revolutionary new technology: mRNA-based vaccines. Not only are mRNA vaccines effective and easy to modify, they are relatively simpler, faster and cheaper to manufacture than traditional vaccines. Moreover, they can be produced by manufacturers with no previous vaccine production experience, like injectable medicines manufacturers (Question 6).
Increasing access to mRNA vaccines has the potential to improve our ability to protect people against COVID-19. The mRNA technology can also be adapted to target other pathogens, meaning the same platform can be ‘switched’ to produce different vaccines or even therapeutics. Thus, in the longer term, building capacity to produce mRNA vaccines within a region may offer benefits for regional public health beyond supplying COVID-19 vaccines.
Having local mRNA-vaccine production capacity in place in low- and middle-income countries would be a lifesaving future prospect for many regions of the world. In the short term, regional mRNA technology can be adapted relatively rapidly to respond to emerging COVID variants and supply needs. In the medium-to-long term, mRNA technology could present a promising option for developing vaccines for other longstanding deadly infectious diseases, such as HIV, tuberculosis and malaria, and could play a major role in future pandemic preparedness.
3. What is technology transfer?
Technology transfer means sharing the knowledge and expertise needed for production of medical tools, like medicines, vaccines and diagnostics, with other manufacturers in a systematic way.
In this case, technology transfer relies on pharmaceutical corporations transferring mRNA vaccine technology knowledge to manufacturers in low- and middle-income countries. To help transfer mRNA vaccines to more manufacturers faster, WHO recently created a technology transfer ‘hub’ for COVID-19 mRNA vaccines (Question 5). Another pathway to diversifying and increasing global vaccine supply would be through direct technology transfer from Moderna, Pfizer and BioNTech to capable manufacturers in low- and middle-income countries.
4. Why is technology transfer needed?
mRNA technology has important potential to beat back not just COVID but possibly other epidemics and even future pandemics. We should refuse to again allow a situation where half of the world gets served first, while the rest of the world looks on empty-handed. The transfer of this technology will contribute to better preparedness for future pandemics and other health needs. This would be a first step to reduce the dependence on imported vaccines for low- and middle-income countries and contribute to future pandemic preparedness.
5. What is the WHO COVID-19 mRNA Vaccine Technology Transfer Hub?
One of the pathways to increasing the production of mRNA vaccines is for originators – Moderna, Pfizer and BioNTech – to transfer technology directly to capable manufacturers in countries in low- and middle-income countries. While none of the mRNA originator companies have shared technology with a manufacturer in a low- or middle-income country, the WHO COVID-19 mRNA Vaccine Technology Transfer Hub was created to develop its own mRNA technology; support and facilitate full technology transfer; and provide staff training, and research and development. The Hub is based in South Africa, but any eligible company based in a low- or middle-income country can apply to benefit from the Hub’s technology transfer and training services. The Hub’s decision to start from the beginning and create a new vaccine is the result of the lack of cooperation exercised by pharmaceutical corporations, and will unfortunately delay the rollout of additional COVID mRNA vaccine doses significantly.
WHO’s COVID-19 mRNA Vaccine Technology Transfer Hub and all technology transfer partners should ensure that the mRNA technology shared is either free of intellectual property constraints, at least in all low- and middle-income countries, or that intellectual property rights are made available through transparent, non-exclusive licenses to produce, export and distribute COVID vaccines in all low- and middle-income countries, including through the COVAX Facility. Additionally, the rights to use, further develop, produce and supply the technology should extend beyond COVID.
Learn more by reading our blog on the WHO COVID-19 mRNA Vaccine Technology Transfer Hub.
6. What additional capacity may be available to produce COVID-19 mRNA vaccines in low- and middle-income countries?
Because mRNA vaccine production does not require prior vaccine manufacturing experience, in addition to traditional vaccine manufacturers, injectable medicines manufacturers based in low- and middle-income countries may also be able to produce mRNA vaccines. In fact, an analysis by MSF and the AccessIBSA project identified more than 100 manufacturers in Africa, Asia and Latin America with the technical requirements and quality standards to produce mRNA vaccines.
Of the 100+ capable manufacturers, at least 8 are based in countries in Africa and are actively producing sterile injectable medical products. These manufacturers meet two basic prerequisites for the quality-assured manufacturing capacity necessary to produce COVID mRNA vaccines, using criteria from previous MSF research:
- Accreditation from a stringent regulatory authority or WHO for the manufacturing of sterile pharmaceutical products.
- Operations based in a country where the national regulatory authority is a Pharmaceutical Inspection Co-operation Scheme (PIC/S) member or has achieved or is likely to achieve WHO’s Maturity Level 3 accreditation for vaccines within the next 12 months. Maturity Level 3 accreditation is a necessary condition for WHO prequalification eligibility for the vaccines produced in the country.
7. What about existing ‘fill-and-finish' deals between Moderna, Pfizer and BioNTech, and manufacturers in other countries?
‘Fill and finish’ describes the process of filling vials with the active pharmaceutical ingredient in a sterile environment, conducting quality control, and sealing, labelling and packaging the final products for distribution. These agreements cover the final phases of vaccine production but do not include technology transfer to enable them to produce the vaccines’ active pharmaceutical ingredients, leaving them dependent on developers (such as Moderna, Pfizer and BioNTech).
Fill-and-finish agreements are a first step, but they are not enough to achieve vaccine independence for low- and middle-income countries. Manufacturers based in regions behind in vaccine access need rights and information for all of the components of vaccine production, from active ingredient production through to finished product. However, instead of sharing their vaccine technology with capable manufacturers in low- and middle-income countries, which could boost production globally, leading mRNA developers (such as BioNTech and Pfizer) have so far opted only for bilateral, restrictive fill-and-finish deals.
8. What can governments do to support mRNA technology transfer?
All governments should utilise all legal, political and policy options to facilitate and diversify vaccine production and supply, and overcome the refusal by technology-holding companies to share technologies and intellectual property. All governments should also provide financial and technical support to the WHO COVID-19 mRNA Vaccine Technology Transfer Hub and support capacity-building in low- and middle-income countries.
Governments that massively funded the development and production of these mRNA vaccines – such as Germany and the United States – must use their influence with Moderna (based in the US), Pfizer (US), and BioNTech (Germany) to demand more from these companies in sharing mRNA technology with the rest of the world.
Additionally, governments hosting manufacturers receiving mRNA technology should work with the WHO to ensure their national regulatory agency is eligible for WHO prequalification of vaccines (Maturity Level 3).
9. How can I support this campaign?
Spread the word and visit ‘Share the Tech - Save Lives’ to learn more and support the campaign.
You can take action by urging Moderna, Pfizer and BioNTech to share the technology, and also demanding that the European Commission as well as the German and US governments engage with these companies to push for complete technology transfer to capable manufacturers around the world.