South Africa is halfway to full-fledged vaccine manufacturing …

With the launch of the second phase of vaccines in South Africa, experts are discussing the country’s willingness to develop and manufacture vaccines on a large scale. (Photo: Aspen Pharmacare)

Health industry experts say South Africa’s readiness to manufacture vaccines is at least three years away and relies on its ability to sustain vaccine supply and demand.

The Gold Institute and PATH recently hosted a Webinar entitled “South Africa’s Readiness to Develop and Manufacture Vaccines on a Large Scale”, moderated by Loner citizen Editor Mark Heywood.

Heywood led the discussion, emphasizing that since the launch of vaccines in South Africa, reports have already shown challenges and demand has exceeded the supply of vaccines available. He also noted concerns about the many issues surrounding the local ability to manufacture vaccines, regulations, and time required.

Professor Helen Rees, Chair of the South African Health Products Regulatory Authority (Sahpra), started the discussion from a regulatory perspective. She said she believed this discussion was about “looking to the future” and that she would approach the discussion from the perspective of asking how South Africa could be positioned as a player in the vaccine market.

Rees said South Africans need to consider three important things when talking about manufacturing capabilities:

  1. Who will be the future vaccine supplier?
  2. What is the demand side of vaccine manufacturing? Are we just talking about covid vaccines and what is the market and benefit and opportunity in Africa? and
  3. Innovation.

Once a product has been approved for an emergency by the World Health Organization (WHO), Sahpra makes approval a lot easier as Sahpra employees work closely with WHO staff to review application documents and even inspect manufacturing facilities.

Sahpra also requires that every pharmaceutical company applying for registration in South Africa has a local company through which it applies and goes through a process:

  • Licensing;
  • Monitoring the field performance of the vaccine;
  • Batch release system – ie evaluation of the vaccine per incoming batch;
  • Regular inspections of the manufacturer for compliance with GMP (Good Manufacturing Practice);
  • Evaluation of clinical compliance through authorized clinical studies; and
  • Distribution and storage of vaccines. This needs to be well monitored up to the end user (the Ministry of Health has this responsibility in SA, but not in Sahpra).

Rees stressed that continued monitoring is also important to monitor impact and effectiveness, and to continue working with the communities where the products will be managed on their questions and concerns.

Glaudina Loots, director of health innovation at the Ministry of Science and Innovation, said it won’t be possible in a year or two to develop full vaccine-making skills in one country. In fact, you need to invest at least seven years of intensive facility and capacity building. “

Loots assessed South Africa’s vaccine manufacturing capabilities, saying South Africa has the ability to conduct research and development (R&D) as well as preclinical toxicology and “we are excellent at clinical trials,” with the capacities originally used for HIV and TB be used.

Loots said the government had invested in research funds at the University of Cape Town and the University of Witwatersrand, and had expertise in places like Onderstepoort and the National Bioproducts Institute. The challenge is to bring all this expertise together to enable local vaccine production. She said the government has a 47.5% stake in the Biologicals and Vaccines Institute of Southern Africa (Biovac).

Loot predicted that South Africa was about three years away from making its own vaccines.

Dr. Morena Makhoana, CEO of Biovac, said vaccines have long been part of people’s health care programs.

“It goes without saying that a lot of people and children, grandchildren, have all been vaccinated before. So it’s been an unsexy industry and for good reason because it’s preventive health care but under the radar.”

Makhoana led attendees through the discussions on when Africa was expected to be ready to produce its own vaccinations, which date back to 2018. At the time, Makhoana said the forecast was that full production might only occur between 2027 and 2030.

She explained that the process of becoming a full-fledged vaccine manufacturer had three stages:

  1. R&D phase with proof of concept on animals;
  2. Clinical development and proof of concept in humans; and
  3. Late clinical development and commercial manufacture.

South Africa’s current production capacity is only included. Formulation, filling, freeze-drying, packaging and batch release, which meant that only stages 1 and 3 of the manufacturing process could be fulfilled.

With this in mind, Makhoana said that South Africa needs to rapidly expand its facilities to respond to pandemics, “because there will be another pandemic; We just don’t know when, but manufacturing can’t just happen in a pandemic. “

Biovac has done research and development, particularly on bacterial vaccines and a commercial GMP, 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 that void in order to be more self-sufficient in making vaccines, but the technology didn’t exist in the country.

Makhoana insisted that making vaccines sustainable requires predictable demand, actions to support localization, a local ecosystem, access to long-term funding, and willing technology transfer partners.

“South Africa is halfway to full production capacity,” concluded Makhoana. DM / MC

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