The mRNA Technology Transfer Programme supported by WHO, MPP and partners, is designed to encourage the sustainable development of mRNA vaccines and therapeutics against COVID-19 and other diseases that threaten low- and middle-income countries.
Afrigen
The Medicines Patent Pool and Afrigen have signed an agreement to allow the South African biotechnology company to establish itself as the global mRNA vaccine technology transfer hub. The 39 million euros grant will cover the work from 2021 to 2026. As part of the consortium, and through a hub and spoke model, the project aims to boost the vaccine manufacturing capacity of low- and middle-income countries (LMICs) to respond more equitably to COVID-19 and future pandemics.
About Afrigen
Afrigen is a biotechnology company incorporated in South Africa, which established the first adjuvant formulation laboratory in Africa and has a pipeline of vaccines in development. Afrigen has built strong research and development partnerships with leading Universities in South Africa and across Africa.
Biovac
The Medicines Patent Pool (MPP) and Biovac have signed an agreement that will allow the South African biotechnology company to receive the mRNA vaccine manufacturing technology developed by Afrigen at research and development scale. The 19 million USD grant will cover the work from 2022 to 2026. As part of the consortium, and through a hub and spoke model, the project aims to boost the vaccine manufacturing capacity of low- and middle-income countries (LMICs) to respond more equitably to COVID-19 and future pandemics.
The Covid-19 vaccine mRNA technology will be developed by Afrigen at small scale and transferred to Biovac. The signing of the agreement means that equipment procurement and facility modifications can start to ensure that Biovac is ready to receive the technology once developed by Afrigen. As a vaccine manufacturer with GMP production and vaccine product development experience Biovac looks forward to playing it’s part within the hub and advancing mRNA vaccine product develop capability in Africa to serve the world. We are responsible for the scale up of the mRNA technology and the manufacture of product for the phase III clinical trial in South Africa. The scaled-up technology package will be transferred back to Afrigen and MPP for transfer to identified manufacturing spokes across the globe.
About Biovac
Biovac is a biotechnology company that specialises in vaccine product development and aseptic vaccine manufacturing. In collaboration with the South African Government, Biovac was established in 2003 to revive local human vaccine production in Southern Africa. The company currently supplies a comprehensive range of vaccines in support of the South African Department of Health’s Expanded Programme for Immunisation. In addition to supplying millions of doses of vaccines per year, across South Africa and into some neighbouring countries, Biovac has recently entered into partnership with Pfizer and BioNTech to manufacture their Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union. Furthermore, the company is a part of the WHO mRNA technology transfer hub programme, focussed on increasing access to mRNA vaccines in LMICs to ensure greater access to mRNA vaccines in future pandemics. As a member of the mRNA technology transfer programme, Biovac is responsible for scaling up the technology from Afrigen and achieving licensure for the product in South Africa.
SAHPRA
South African Health Products Regulatory Authority (SAHPRA) has signed an agreement for SAHPRA to develop and strengthen its capacity to assess the readiness of facilities for the production of mRNA vaccines and review applications for the authorisation of mRNA vaccines.
This enhancement of SAHPRA’s capacity will enable the implementation of the WHO mRNA technology transfer programme, which is focussed on increasing access to mRNA vaccines in LMICs to ensure greater access to mRNA vaccines for future pandemics. Further, SAHPRA will support the national regulatory authorities of each of the programme partner countries by sharing its expertise and experience.
About SAHPRA
SAHPRA is an entity of the National Department of Health, created by the South African government to ensure the health and well-being of human and animal health. SAHPRA is tasked with regulating (monitoring, evaluating, investigating, inspecting and registering) all health products. This includes clinical trials, complementary medicines, medical devices and in vitro diagnostics. Furthermore, SAHPRA has the added responsibility of overseeing radiation control in South Africa. SAHPRA’s mandate is outlined in the Medicines and Related Substances Act (Act No 101 of 1965 as amended) as well as the Hazardous Substances Act (Act No 15 of 1973).
SAMRC
The Medicines Patent Pool and the SAMRC have signed an agreement for the SAMRC to establish the South African mRNA Vaccine Consortium (SAMVAC) that is tasked to develop and test a variety of mRNA-based vaccine candidates for COVID-19 and, in parallel, mRNA-based vaccine candidates for other diseases of interest in low- and middle-income countries. The 26.6 million South African Rand (ZAR) grant, will support SAMVAC from 2022 to 2025, in addition to local funding support from the South African Government and ELMA Vaccines and Immunization Foundation. The SAMRC co-ordinates the SAMVAC Research consortium which leverages off many leading research units with historic government investments. SAMRC has a long track record in setting up and managing research consortia for drugs and vaccines and managing other large national and international grants and programs.
About SAMRC
The South African Medical Research Council (SAMRC) was established in 1969 with a mandate to improve the health of the country’s population, through research, development and technology transfer, so that people can enjoy a better quality of life. The scope of the organisation’s research projects includes tuberculosis, HIV/AIDS, cardiovascular and non-communicable diseases, gender and health, and alcohol and other drug abuse. With a strategic objective to help strengthen the health systems of the country – in line with that of the Department of Health, the SAMRC constantly identifies the main causes of death in South Africa.
13 Programme Partners have signed a technology Transfer agreement to receive the technology transfer
Announcements
New consortium working to boost vaccine production in South Africa (Published 30 July 2021)
Consortium to establish the first COVID mRNA vaccine technology transfer hub in South Africa
The Medicines Patent Pool (MPP), the World Health Organization (WHO), Afrigen, Biovac, SAMRC and Africa CDC have signed a letter of intent to address the global imbalance of manufacturing capacity for COVID-19 vaccines. The consortium will work together to establish the South African mRNA technology transfer hub that will allow for greater and more diversified vaccines manufacturing capability, strengthen African regional health security, and respond more equitably to the current COVID-19 pandemic and future pandemics.
