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South Africa is halfway to fully fledged vaccine manufacturing, says Biovac CEO Morena Makhoana

With South Africa's Phase 2 of vaccines roll-out under way, experts are debating the country's readiness to develop and manufacture vaccines at a large scale. (Photo: Aspen Pharmacare)

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

The Aurum Institute and PATH recently hosted a webinar titled “South Africa’s readiness to develop and manufacture vaccines at a large scale”, moderated by Maverick Citizen editor Mark Heywood.

Heywood prefaced the discussion by highlighting that since the start of vaccine roll-out in South Africa, reports were already showing challenges, with demand exceeding the supply of the available vaccines. He also raised the point that there had been concerns about the many questions on local capacity to manufacture vaccines, regulations and the time required.

Beginning the discussion from a regulations perspective was Professor Helen Rees, chairperson of South African Health Products Regulatory Authority (Sahpra). She said she believed this discussion was about looking “way into the future”, saying that she would approach the discussion from the viewpoint of asking how to position South Africa to be a player in the vaccine market.

Rees said South Africans needed to keep three key things in mind when discussing manufacturing capability:

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

Once a product is approved by the World Health Organization (WHO) for emergency use, it makes it much easier for Sahpra to approve because Sahpra staff work closely with WHO staff during the reviewing of the application dossiers and even the inspection of manufacturing sites, said Rees.

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

  • Licensing;
  • Surveillance of the vaccine’s field performance;
  • System of lot release — which means evaluating the vaccine per lot that arrives;
  • Regular inspections of the manufacturer for Good Manufacturing Practice (GMP) compliance;
  • Evaluation of clinical compliance through authorised clinical trials; and
  • Distribution and storage of vaccines. This must be well supervised down to the end-user, (the department of health bears this responsibility in SA however, not Sahpra).

Rees emphasised that continued surveillance was also important to monitor its effects and efficacy, and continuing to engage with communities into which the products are to be administered on their questions and concerns.

Director for Health Innovation at the Department of Science and Innovation, Glaudina Loots said bringing in “full vaccine manufacturing capabilities to any country is not something that you can do in a year or two; actually, you will need to invest in a period of at least seven years of intense building of the facilities and capacity”.

Assessing South Africa’s capabilities when it came to vaccine production, Loots said South Africa was able to conduct 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 that the government had invested in research funding at the University of Cape Town and the University of Witwatersrand and that it had expertise in places such as Onderstepoort and the National Bioproducts Institute. The challenge, she said, was to bring all this expertise together to enable the local manufacturing of vaccines. She said the government was a 47.5% shareholder in the Biologicals and Vaccines Institute of Southern Africa (Biovac).

Loot projected that South Africa was about three years from being capable of making its own vaccines.

Dr Morena Makhoana, CEO of Biovac, said vaccines had long been part of people’s preventative healthcare.

“It goes without saying that many people and children, grandchildren have all been vaccinated before and so it has been an unsexy industry and with good reason, because it’s been doing preventative healthcare, but under the radar.”

Makhoana took those present at the webinar through the discussions on when it had been anticipated that Africa would be ready to produce its own vaccinations, dating back to 2018. At the time, Makhoana said that the projection was that full-scale manufacturing would possibly happen only between 2027 and 2030.

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

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

South Africa’s present manufacturing capability included only; formulation, filling, freeze-drying, packaging and batch release which meant it could now fulfil only stage 1 and 3 of the manufacturing process.

In light of this, Makhoana said that South Africa needed to quickly ramp up its facilities to respond to pandemics “because there will be another pandemic; we just don’t know when, but manufacturing cannot just come up when there’s a pandemic.”

Biovac has been doing R&D work particularly on bacterial vaccines and on a commercial-scale GMP, said Makhoana. Where they had not been focusing was the early clinical development and proof of concept in humans. He said Biovac recognised the need to plug this gap to be more self-sufficient when producing vaccines, but the technology did not exist in the country.

Makhoana was adamant that for sustainable vaccine manufacturing to happen, there was a need for predictable demand, policies that were supportive of localisation, a local ecosystem, access to long-term funding and willing technology transfer partners.

“South Africa is halfway to being able to be at full manufacturing capacity,” concluded Makhoana. DM/MC

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