mRNA Technology Transfer Programme moves to the next phase of its development

• Inauguration of the mRNA technology Hub facility at Afrigen, South Africa.

• Partners gather in Cape Town to discuss the next phase of the mRNA vaccine development and knowledge sharing.

Over 200 international participants working with the mRNA Technology Transfer Programme met in Cape Town this week for their first face-to-face meeting. Joined by World Health Organization (WHO) Director General, Dr. Tedros Adhanom Ghebreyesus and Dr. Joe Phaahla, Minister of Health and Minister of Trade and Industry, Mr. Ebrahim Patel of South Africa together with high-level officials from funding countries, this unique meeting reviewed the progress since WHO and Medicines Patent Pool (MPP) launched it in June 2021.

“I am delighted to be here in Cape Town with our partners to support a sustainable model for mRNA technology transfer to give low- and middle-income countries equitable access to vaccines and other lifesaving health products,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “I am immensely proud of the achievement of all those involved in this project; in less than two years we have shown that when we work collaboratively, we succeed collectively.”

The meeting participants include biomanufacturing partners from 15 countries in the Programme, leading experts, industry, civil society representatives, and funders. During the five-day meeting, participants will share progress and discuss critical enablers for the sustainability of the Programme such as intellectual property issues and regulatory aspects, as well as the science of mRNA technologies and key applications relevant to LMICs in other disease areas such as HIV and tuberculosis.

The COVID-19 pandemic has underscored that gross inequity exists in access to health products, especially vaccines. As of March 2023, more than three years after WHO declared COVID-19 a Public Health Emergency of International Concern (PHEIC), 69.7% of the global population had received at least one dose of a COVID-19 vaccine. Notably, this proportion still remains below 30% in low-income countries (LICs) .This Programme aims to contribute to equitable access to mRNA vaccines by increasing the distribution of sustainable manufacturing capacity across LMICs, enhancing regional and inter-regional collaborations, and developing and empowering a local workforce through tailored and inclusive training and expert support. What is unique in the mRNA Technology Transfer model is the multilateral process that allows sharing of technologies to multiple recipients so that through local and regional production those in need can be reached rapidly.

Dr Phaahla, Minister of Health South Africa, said: “What we see here today, is a moment in history, a Programme that is aimed at empowering LMICs through a global collaborative network. I am thrilled to see the progress made in such a relatively short time and welcome the support from so many different countries – countries like South Africa that have a strong vibrant biomanufacturing capacity and that are willing to work together, learn from and share with each other.”

Minister Blade Nzimande of Higher Education and Science, said: “Ours is the vision of the mRNA Technology Transfer Hub beyond just COVID-19. The capabilities we are building are looking to empower us to deal with other future pandemics whose vaccines could use the same mRNA technology platform. It is a vision that has set its eyes on diseases that are prevalent in our environments such as Malaria, Tuberculosis and HIV and AIDS.”

This occasion also marks an important milestone for the Programme with the inauguration of the mRNA technology Hub facility at Afrigen in Cape Town in the presence of Dr. Tedros and Dr. Matshidiso Moeti WHO Regional Director for Africa, Charles Gore Executive Director of MPP and the Honorable Ministers who took part in a ribbon cutting ceremony at Afrigen.

Professor Petro Terblanche, Executive Director of Afrigen said: “The entire Afrigen team are thrilled to reach this important milestone with the completion of the mRNA technology platform. This platform is housed within the end-to-end mRNA vaccine development and production facility where the mRNA Hub Covid 19 vaccine candidate AfriVac 2121 is currently in scale-up phase. Over the last 18 months, Afrigen has undergone an incredible transformation with the support of a network of partners and mentors enabled by this Programme. We have grown our capability and capacity to meet the highest quality standards of mRNA vaccine development, serving the objective to build sustainable capacity in LMICs to produce mRNA vaccines”.

Afrigen has successfully established a COVID-19 vaccine manufacturing process at a laboratory scale and is currently scaling up that process to a level suitable for manufacturing vaccine batches to be used in Phase I/ II clinical trials to GMP standards. In a parallel process, Afrigen will continue to carry out training and technology transfer to the network partners.

The funders play a crucial role in supporting the Programme with total funding to date at US$ 117 million and France being the first to fund the mRNA technology transfer work. Present at the meeting were representatives from the European Commission, Belgium, Germany, as well as Norway, Canada, African Union, South Africa, and the ELMA Foundation.

Caroline Delany, GlobalAffairs Canada’s Director General for Southern and Eastern Africa said: “Canada reaffirms its continued support of the mRNA Technology Transfer Programme and we are delighted to announce a further contribution of 15 million Canadian dollars at the meeting today. This brings Canada’s total contribution to the Programme up to 45 million Canadian dollars. These funds support the running of the Hub in South Africa as well as network partners around the world. We firmly believe in the importance of building capacity at local and regional level”.

Mr Martin Seychell, Deputy Executive Director European Commission, said. “The EC has already contributed €40 million to the establishment of the mRNA technology transfer Hub and has recently signed another grant with the EIB for €15,5 million to facilitate the expansion of vaccines manufacturing capacity. This is part of the overall investment under the EU Global Gateway strategy, where more than €1 Billion have been mobilised under the Team Europe Initiative on Manufacturing health products. It is now particularly important to also address possible regulatory and demand bottlenecks, to ensure not only production of vaccines of the highest standard in all regions of the world, but also rapid and equitable access to those vaccines.”