As Phase 2 of South Africa’s vaccine rollout is underway, experts are debating the country’s readiness to develop and manufacture vaccines on a large scale. (Photo: Aspen Pharmacare)
Health sector experts say South Africa’s vaccine-manufacturing readiness is at least three years away and hinges on its ability to support vaccine supply and demand.
the Aurum Institute and PATH recently hosted a online seminar titled “South Africa’s desire to develop and manufacture vaccines on a large scale“, moderated by Citizen Maverick editor Mark Heywood.
Heywood preceded the discussion by noting that since the start of vaccine deployment in South Africa, reports were already showing challenges, with demand outstripping the supply of available vaccines. He also argued that there were many issues surrounding local capacity to manufacture vaccines, regulations and timing required.
Professor Helen Rees, President of the South African Health Products Regulatory Authority (Sahpra), started the discussion from a regulatory perspective. She said she thought this discussion was about the ‘way forward’, saying she would approach the discussion from the perspective of asking how to position South Africa to be a player in the vaccine market. .
Rees said South Africans need to keep three key things in mind when discussing manufacturing capability:
- Who will be the future vaccine suppliers?
- What is the demand side of vaccine manufacturing? Are we only talking about covid vaccines, and what is the market, benefits and opportunities in Africa? and
Once a product is approved by the World Health Organization (WHO) for emergency use, it is much easier for Sahpra to approve because Sahpra staff work closely with staff at the Sahpra. ‘WHO when reviewing application records and even inspecting manufacturing sites, Rees said.
Sahpra also requires any pharmaceutical company applying for registration in South Africa to have a local company through which to apply and go through a process of:
- Monitoring of vaccine performance in the field;
- Batch release system – this means evaluating the vaccine by batch that arrives;
- Regular inspections of the manufacturer for compliance with Good Manufacturing Practices (GMP);
- Clinical compliance assessment using authorized clinical trials; and
- Distribution and storage of vaccines. This needs to be well supervised right down to the end user (the health ministry bears this responsibility in South Africa, but not Sahpra).
Rees stressed that monitoring is also important to monitor its effects and effectiveness, and continue to engage the communities in which the products are to be administered with their questions and concerns.
Director of Health Innovation in the Department of Science and Innovation, Glaudina Loots said that bringing “full vaccine manufacturing capabilities to any country is not something you can do in the world. a year or two; in fact, you will need to invest in a period of at least seven years of intense facilities and capacity building ”.
Assessing South Africa’s vaccine production capabilities, Loots said South Africa is capable of conducting research and development (R&D), preclinical toxicology and that “we are excellent at clinical trials ”, using the capacity initially used for HIV and TB.
Loots said the government has invested in funding research at the University of Cape Town and the University of the Witwatersrand and has expertise in places such as Onderstepoort and the National Bioproducts Institute. The challenge, she said, was to bring together all this expertise to enable local manufacture of vaccines. She said the government was a 47.5% shareholder of the Southern African Biologics and Vaccines Institute (Biovac).
Loot projected that South Africa was about three years away from being able to make its own vaccines.
Biovac CEO Dr Morena Makhoana said vaccines have long been part of people’s preventive health care.
“It goes without saying that a lot of people and children, grandchildren have all been vaccinated before and so it’s a not very sexy industry and for good reason because it does preventative health care, but under the radar.
Makhoana took the webinar attendees through the discussions on when it was expected that Africa would be ready to produce its own vaccines, dating back to 2018. At the time, Makhoana said the projection was that manufacturing on a large scale could possibly take place. only between 2027 and 2030.
She explained that the process of becoming a full-fledged vaccine manufacturer involved three steps:
- R&D phase with proof of concept on animals;
- Clinical development and proof of concept in humans; and
- Advanced clinical development and commercial manufacture.
South Africa’s current manufacturing capacity includes only; formulation, filling, freeze-drying, packaging and batch release, which means it can now only complete steps 1 and 3 of the manufacturing process.
In light of this, Makhoana said South Africa needs to rapidly scale up its facilities to respond to pandemics “because there will be another pandemic; we just don’t know when, but the manufacturing sector cannot happen in a pandemic. “
Biovac has done R&D work specifically on bacterial vaccines and on a commercial GMP scale, Makhoana said. Where they hadn’t focused was early clinical development and proof of concept in humans. He said Biovac recognized the need to fill this gap to be more self-reliant when producing vaccines, but the technology did not exist in the country.
Makhoana insisted that for sustainable vaccine manufacturing to happen, there needs to be predictable demand, location-friendly policies, a local ecosystem, access to long-term funding, and willing technology transfer partners. .
“South Africa is halfway to being able to reach its full production capacity,” concluded Makhoana. DM / MC
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This notice was published: 2021-05-24 22:27:21