Want to learn more about why Médecins Sans Frontières (MSF) launched a global campaign calling on pharmaceutical corporations BioNTech, Pfizer and Moderna – developers of the two World Health Organization (WHO)-listed mRNA vaccines for COVID-19 – to urgently share mRNA technologies with prospective manufacturers in countries in Africa? Read our Q&A below.
- 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?
- Why is MSF focusing on countries in Africa?
- What additional capacity may be available to produce COVID-19 mRNA vaccines in countries in Africa?
- What about existing ‘fill-and-finish' deals between BioNTech, Pfizer, Moderna and manufacturers in other countries?
- What can governments do to support mRNA technology transfer?
- How can I support this campaign?
MSF is asking pharmaceutical corporations BioNTech, Pfizer and Moderna – developers of the two WHO-listed mRNA vaccines for COVID-19 – to urgently share mRNA technologies with prospective manufacturers in countries in Africa through the newly established WHO COVID-19 mRNA Vaccine Technology Transfer Hub based in South Africa.
By sharing their know-how now, BioNTech, Pfizer and Moderna could change the course of the pandemic by increasing the global production and supply of COVID-19 vaccines to improve equitable vaccine access for everyone, everywhere.
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.
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 7).
Increasing access to these 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.
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 manufactures in countries in Africa. To help transfer mRNA vaccines to more manufacturers faster, WHO recently created a technology transfer ‘hub’ for COVID-19 mRNA vaccines (Question 5).
Although 12 billion doses of COVID-19 vaccines are projected to be produced by the end of 2021, there is a shortage of doses currently and disproportionately few doses being delivered to countries in Africa. Technology transfer to manufacturers based in countries in Africa could help increase the production and supply of COVID-19 vaccines urgently needed.
Moreover, because mRNA technology has potential to prevent or even treat diseases beyond COVID-19, transfer of this technology will contribute to better preparedness for future pandemics and other health needs. This would be a first step to reduce African countries’ dependence on imported vaccines and contribute to preparedness for future pandemics.
The WHO COVID-19 mRNA Vaccine Technology Transfer Hub was created to support and facilitate full technology transfer for the mRNA vaccine platform by diversifying production capacity and providing staff training, research and development. The Hub is based in South Africa, however any eligible company based in a low- or middle-income country (LMIC) can apply to benefit from the Hub’s technology transfer and training services. Success of the hub will require contributions of technology and know-how from existing mRNA developers.
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 LMICs, or that intellectual property rights are made available through transparent, non-exclusive licenses to produce, export and distribute the COVID-19 vaccine in all LMICs, including through the COVAX Facility. Additionally, the rights to use, further develop, produce and supply the technology should extend beyond COVID-19.
Learn more by reading our blog on the WHO COVID-19 mRNA Vaccine Technology Transfer Hub.
African countries are currently almost entirely dependent on imports for COVID-19 and other vaccines. In the context of a pandemic and vaccine shortages, this means limited and extremely delayed access. While more than 50% of the population has been fully vaccinated in many wealthy countries, less than 3% of people in countries in Africa have been fully vaccinated as of August 2021.
Increasing and diversifying production and supply of mRNA vaccines through additional manufacturers, beginning with those based in countries in Africa, offers an opportunity to urgently and sustainably address vaccine inequity during this pandemic and in the future.
Establishing mRNA vaccine production in at least one African country could create an annual production capacity of up to 100 million COVID-19 vaccine doses within 10 months in one of the regions most affected by vaccine shortages.
Because mRNA vaccine production does not require prior vaccine manufacturing experience, in addition to traditional vaccine manufacturers, injectable medicines manufacturers based in countries in Africa may also be able to produce mRNA vaccines.
At least seven manufacturers that are actively producing sterile injectable medical products and based in African countries meet two basic prerequisites indicating the quality-assured manufacturing capacity necessary to produce COVID-19 mRNA vaccines, based on MSF’s analysis. These prerequisites are:
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.
‘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 BioNTech, Pfizer and Moderna).
Fill-and-finish agreements are a first step, but they are not enough to achieve vaccine independence for countries in Africa. Manufacturers based in regions falling 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 the newly established WHO COVID-19 mRNA Technology Transfer Hub hosted in South Africa, 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.
BioNTech, Pfizer and Moderna should urgently provide full technology transfer via the WHO COVID-19 mRNA Vaccine Technology Transfer Hub to support independent and sustainable vaccine production and supply of mRNA vaccines in countries in Africa.
All governments should utilise all legal, political and policy options to facilitate and diversify vaccine production and supply and overcome the refusal to share technologies and intellectual property by technology-holding companies. All governments should also provide financial and technical support to the WHO COVID-19 mRNA Vaccine Technology Transfer Hub.
Governments that have massively funded the development and production of these mRNA vaccines – such as Germany or the US – must use their influence with BioNTech (based in Germany), Pfizer (US) and Moderna (US) to demand more from these companies.
Additionally, governments hosting manufacturers receiving mRNA technology should work with WHO to ensure their national regulatory agency is eligible for WHO prequalification of vaccines (Maturity Level 3).
Spread the word and visit ‘Share the Tech - Save Lives’ to learn more and support the campaign.
You can take action by urging BioNTech, Pfizer and Moderna to share the technology and also demanding that the European Commission and German and US governments engage with these companies to push for technology transfer to the WHO COVID-19 mRNA Vaccines Technology Transfer Hub.