AFRICA-GLOBAL
The World Health Organization (WHO) and its COVAX partners are working with a South African consortium comprising Biovac, Afrigen Biologics and Vaccines, a network of universities and the Africa Centres for Disease Control and Prevention (CDC) to establish its first COVID-19 mRNA vaccine technology transfer hub.
COVAX is a global initiative that aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world, including support with the distribution of vaccines in low- and medium-income countries.
The mRNA vaccine technology transfer hub initiative was launched on 22 June, according to a press report issued by South Africa’s Ministry of Higher Education, Science and Innovation.
Professor Hildegund Ertl from the Vaccine and Immunotherapy Centre of the United States-based Wistar Institute told University World News that there was agreement that Africa had to build its vaccine development infrastructure, and “the WHO initiative is a good first step”.
COVID-19 infections and deaths are on the rise in many African countries, and vaccine access is lagging behind. Due to a lack of intensive care resources, Africa as a continent has the highest death rate in the world among adults who become critically ill after contracting COVID-19.
The overall mortality rate of 48.2% is considerably higher than the 31.5% global average, according to a study published in The Lancet on 22 May.
While figures from the research and data collection organisation Our World in Data shows that 22% of the world population has received at least one dose of a COVID-19 vaccine, the Africa CDC Vaccine Dashboard indicates that only 2.55% and 1.09% of Africa’s population has received one and two doses respectively.
It also shows that the top five most COVID-19 vaccinated African countries are Seychelles (67%) followed by Morocco (22%), Equatorial Guinea (7%), Tunisia (3%) and Zimbabwe (2.9%). Seychelles is also the world’s most vaccinated nation, but has a population of only about 99,000.
The dashboard also shows that, as of 28 June, Africa had registered a total of 5,394,709 COVID-19 infections and 140,976 fatalities.
Vaccine tech transfer
The technology hub will be established on an industrial scale and will include clinical development. The hub comprises the Cape Town-based companies Biovac and Afrigen Biologics and Vaccines, along with a network of universities as well as the Africa Centres for Disease Control and Prevention (CDC).
The South African companies Biovac and Afrigen Biologics and Vaccines will be the first recipients of cutting-edge mRNA vaccine know-how under a new technology transfer programme.
Interested manufacturers from low- and low- to middle-income countries can receive training and any necessary licences for the technology.
The WHO initiative will initially prioritise the mRNA vaccine but could expand to other technologies in the future.
The term mRNA technology refers to vaccines that teach cells how to make a protein that triggers an immune response inside the human body. That immune response, which produces antibodies, is what supports those who get infected by real viruses.
Professor Petro Terblanche, managing director of Afrigen Biologics and Vaccines, told University World News that the WHO hub, to be based at Afrigen, is designed to fully explore the knowledge and competencies embedded in universities and the private sector.
“Afrigen has, from its inception, focused on building partnerships with universities in South Africa, Africa and globally, and never allowed ownership of intellectual property (IP) to deter from the potential to create technologies or products for the public good,” Terblanche said.
“We need to apply the values of open innovation more readily when it comes to global pandemics. COVID-19 has a rich learning and reflection value for us,” Terblanche added.
Universities and industry in alliance
According to Terblanche, the Afrigen consortium includes the Centre for Epidemic Response and Innovation at Stellenbosch University, the National Institute of Communicable Diseases, the University of the Witwatersrand, the University of Cape Town’s Centre for Bioprocess Engineering Research, North-West University’s Pre-Clinical Drug Development Platform, the South African Medical Research Council and Biovac.
In addition, the African Centre of Excellence for Genomics of Infectious Diseases based at Redeemer’s University, Nigeria, and the Africa Centres for Disease Control and Prevention (CDC) in Ethiopia are also included.
Afrigen will act as developer, Biovac as manufacturer and South Africa’s consortium of universities and scientific institutions as academic and research supporters providing mRNA know-how and animal models experiments along with the African Centre of Excellence for Genomics of Infectious Diseases and Africa CDC for technical and regional support.
“The hub will not compromise any intellectual property and will operate under licences that provide the required freedom to operate to reach the goal of vaccine security for Africa,” said Terblanche.
With reference to intellectual property management and the issuing of IP licences, the technology transfer hub will benefit from the Medicines Patent Pool’s (MPP) experiences on improving access to high-quality affordable medicines and health technologies, particularly in developing countries, through patent pooling and non-exclusive voluntary licensing.
MPP is also assisting the WHO to negotiate with technical partners and supporting in the governance of the hubs, according to a WHO media statement.
‘The best of both worlds’
Ifeanyi McWilliams Nsofor, director of policy and advocacy for Nigeria Health Watch, told University World News: “The WHO’s COVID-19 vaccine tech transfer is an ideal way to promote universities-industry alliance to scale up COVID-19 vaccines production as universities are research centres and possess the appropriate human resources that can participate and even lead [the process].”
Nsofor says this WHO initiative represents a global North-South partnership and will, therefore, be an opportunity to improve the research capabilities of African university students and faculties from both parts of the world.
Terblanche says the tech transfer hub will benefit African universities in building skills combined with the knowledge of how to develop novel vaccine candidates using a directed market-driven approach.
“It is important that this hub builds research and development capacity as well as vaccine production and delivery capabilities. The best of both worlds.”
However, there are some challenges, Terblanche says. “Can universities train knowledge and skills? We are good at disseminating knowledge and creating a knowledge-intensive society, but what is needed in addition to academic knowledge is the skill to implement and produce a vaccine that meets all quality assurance and quality-control requirements batch after batch.”
At the same time, Terblanche says, “without the inquisitive and deeply specialised knowledge of university researchers, we would not have been able to advance vaccine technology to a level where we can bring a safe and effective vaccine to the market in less than nine months”.
To deal with these challenges, Terblanche said, the goals of the WHO initiative will have to be kept in mind and possible synergies fully explored. Less duplication and more collaboration will be crucial.
Ertl pointed out some of the challenges in the manufacturing of mRNA vaccines.
“Making vaccines that are suitable for use in humans is complicated, as the vaccine has to be produced in mass quantities. Then it has to be purified, formulated, filled and stored, which, for mRNA vaccines, requires freezers.”
At each stage, Ertl added, the vaccine has to undergo numerous tests to ensure its potency, identity and lack of contaminants.
“Not all COVID-19 mRNA vaccines are highly efficacious. While the Moderna and Pfizer vaccines provide nearly complete protection against severe COVID-19, the mRNA vaccine from CureVac gave disappointing results,” Ertl pointed out.
She added: “Academia is great at research and development, but the manufacturing of vaccines takes a different set of skills.”
Therefore, Ertl recommends also enlisting the know-how of vaccine manufacturers where necessary, for a hands-on approach to technology transfer and to ensure that the WHO initiative is successful.
from WordPress https://ift.tt/2UP0ZZW
via IFTTT
No comments:
Post a Comment