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A facility in Cape Town could produce Africa’s first vaccines using messenger RNA, the breakthrough science of the global inoculation effort against Covid-19, within 15 months of signing a technology transfer agreement.
The World Health Organization this week announced it will establish its first-ever mRNA technology transfer hub in the city in an agreement with Afrigen Biologics & Vaccines and the Biovac Institute. The global health body is in talks with potential partners who would work with the South African companies to produce the vaccines to tackle the Covid-19 pandemic in the world’s least-vaccinated continent.
While talks are being held with large companies that already have mRNA Covid-19 vaccines, most negotiations are taking place with smaller firms that are still trialling the shots, Soumya Swaminathan, the WHO’s chief scientist, said. Pfizer, together with its partner BioNTech, and Moderna are the two groups globally with approved mRNA Covid-19 vaccines.
“The target given to us, which is quite ambitious, is 12 months to put the first candidate into clinical trials from the day of technology transfer signing,” and those trials could take about three months, said Petro Terblanche, the managing director of Afrigen, in an interview on Friday. “That’s only possible if the technology partner is one of the big gorillas” and will take a bit longer if it’s a small company, she said.
The push by the WHO is an attempt to boost vaccine manufacturing in Africa as richer nations have hoarded Covid-19 inoculations, leaving few for the continent, which is in the grip of a third wave of coronavirus infections. While the U.S. and the U.K. have fully vaccinated more than 45% of their populations, just more than 1% of Africa’s 1.2 billion people have received a full course of Covid-19 shots.
“There is no vaccine equity,” Terblanche said. “There are no vaccines.”
Once a technology transfer agreement has been signed, Afrigen will perfect the process and make sure the vaccines produced at its laboratory are of acceptable quality. That process will then be transferred to Biovac, which will make the doses on a commercial scale. Other partners may be trained later to make vaccines elsewhere in Africa.
Ideally, Afrigen would want to work with one of the existing mRNA vaccine producers as well as a smaller company whose innoculations can be kept at between 2 and 8 degrees Celsius, making the shots more suitable for distribution across Africa. While working with Pfizer or Moderna would bring vaccines into production more quickly, their shots have to be kept at ultra-cold temperatures.
Afrigen operates the only laboratory in Africa that can produce adjuvants, a substance used to enhance the reaction of the body’s immune response to the presence of an antigen such as a virus.
Tuberculosis vaccine
The company was founded in 2014 as a venture between the South African government’s Industrial Development Corp. and the Infectious Disease Research Institute, a US-based non-profit, with the aim of manufacturing a tuberculosis vaccine in Africa.
It became operational in 2016, and IDRI has since sold its stake to Avacare Health Group. Avacare now owns 51% of the company, while the IDC holds 49%. Avacare operates in 20 African countries as well as a number of other nations.
“Afrigen has infrastructure that could fast-track this project,” Terblanche said, when asked why the company was selected by the WHO. “We have a group of scientists that understand technology transfer.”
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Geneva – The Medicines Patent Pool (MPP) and the World Health Organization (WHO), Afrigen Biologics (PTY) Limited, the Biologicals and Vaccines Institute of Southern Africa (Biovac), the South African Medical Research Council (SAMRC) and Africa Centres for Disease Control and Prevention (Africa CDC) have signed a letter of intent to address the global imbalance of manufacturing capacity for COVID-19 vaccines.
This letter of intent brings together partners 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.
Further to WHO’s announcement in June of the first COVID mRNA vaccine technology transfer hub in South Africa, this letter of intent sets out the terms of the collaboration and responsibilities between our organisations. Through a shared responsibility approach, the organisations will ensure the most suitable platform technologies are selected for the development of COVID-19 vaccines, that technology transfer is in place and that funding is secured for the hub, clinical studies and manufacturing support. It will also ensure that, crucially, this platform for innovation in vaccines is sustainable, inclusive, and will lead to vaccine security for Africa in the future.
“Inequitable manufacturing and distribution of vaccines is behind the wave of death, which is now sweeping across many low- and middle-income countries that have been starved of vaccine supply,” said Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization. “Building vaccine manufacturing capacity in South Africa is the first step in a broader effort to boost local production to address health emergencies and strengthen regional health security.”
The new collaboration brings together key actors from COVAX partners, industry, government, academia, funding agencies, WHO AFRO, which was represented by Regional Director Dr. Matshidiso Moeti and the Africa CDC to collectively provide an enabling environment for the development of the first regional mRNA vaccine manufacturing production facility in Africa.
“At the Medicines Patent Pool, we look forward to offering our intellectual property expertise and experience, and to working closely with WHO and partners”, said Charles Gore, Executive Director, MPP. “Within the consortium, MPP will provide appropriate intellectual property analysis, define and negotiate terms and conditions of the agreements, provide alliance management and make use of our established robust selection process to allow further technology recipients to benefit.”
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.
“We have recently completed a facility suitable for the establishment of a fully integrated mRNA pilot scale production, formulation and fill finish platform,” said Prof. Petro Terblanche, Managing Director of Afrigen. “Our platform and facilities are well positioned to deliver on the hub’s objectives, and Afrigen will focus on ensuring the technical, scientific, quality control and quality assurance and regulatory teams so as to implement the mRNA Hub for Africa.”
Biovac is a South African specialist vaccines company that was established to revive local human vaccine production in Southern Africa. Alongside the development of bacterial vaccine technologies, the company has built modern facilities and secured high profile technology transfers from international vaccine companies.
“Biovac sources and supplies a comprehensive range of vaccines required by the South African government and its neighbouring countries including childhood disease vaccines among others, and more recently COVID-19 vaccines,” said Morena Makhoana, Chief Executive Officer of Biovac. “It is a long-held desire of Biovac to ensure that the full value chain of vaccines is developed in our continent and our aim is to assemble state of the art manufacturing capacity and help ensure the transfer of mRNA technology and know-how as quickly as possible.”
South African Medical Research Council (SAMRC) has decades of experience in managing large research consortia and local and international funding programs, in both the research and innovation domains. The SAMRC is leading South Africa’s research and innovation response to COVID-19.
“Throughout the pandemic, the South African Medical Research Council has been actively funding, conducting and facilitating research and development,” said Dr. Michelle Mulder, Executive Director Grants, Innovation and Product Development (GIPD) of the SAMRC. “As part of this new collaboration our domain will be facilitating product and clinical development so that we can bring new products to market, allowing maximum participation of African countries in developing and testing context appropriate products.”
Africa Centres for Disease Control and Prevention (Africa CDC), is a specialised technical institution of the African Union that strengthens the capacity and capability of Africa’s public health institutions as well as partnerships to detect and respond quickly and effectively to disease threats and outbreaks, based on data-driven interventions and programmes.
“Over the last few weeks there is a worrying increase in the number of cases across Africa and COVID-19 variants are causing a shocking wave of COVID-19 hospitalisation and death,” said Dr. John Nkengasong, Director of the Africa CDC. “Our objective is to ensure Africa has timely access to vaccines to protect public health security, by establishing a sustainable vaccine development and manufacturing ecosystem in Africa. As well as public health social measures, it is critical the world shares vaccine technologies now with African countries while also building up the manufacturing capacity across the region to help battle back against COVID-19 and also to leave a legacy for future pandemics.
Afrigen Biologics and Vaccines is a Cape Town based biotechnology company strategically directed, supported and capitalized by Avacare Healthcare Group and the Industrial Development Corporation (IDC) of South Africa. It was founded in 2014 by Steven G. Reed (PhD) and Erik Iverson (JD, LLM), both of the Infectious Diseases Research Institute (IDRI) www.idri.org in Seattle. Afrigen drives a business strategy focussing on product development, bulk adjuvant manufacturing, and supply and distribution of key biologicals to address unmet healthcare needs. Through international partnerships and local capacity building, Afrigen has established the first ever adjuvant production and formulation technology centre on the African continent. This centre, in partnership with IDRI, a world leader in adjuvant development, focuses on next generation vaccine adjuvants, which are not only geared at preventing disease, but have therapeutic value. These adjuvants confer added potency and durability to vaccines. More recently, Afrigen has ventured into the novel CAM’s space where it aims to bring innovative, differentiated products to market.
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Specialised equipment commonly used in the formulation industry is housed at our R&D laboratories in Cape Town. Afrigen’s highly trained and experienced scientific staff assist with protocol development, validation and analyses. Accurate, reliable and timeous results performed in accordance with GLP principles are provided. Afrigen offers services to collaborators and outside organisations in two key areas:
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August, 2021Comments