On 21 June 2021 President Cyril Ramaphosa announced that South Africa will host the first World Health Organization-backed Covid-19 mRNA vaccine Technology Transfer Hub — an initiative designed to get the production of mRNA vaccines off the ground in Africa. One crucial element to the success of such an initiative is getting companies with existing mRNA vaccine manufacturing know-how to enter into technology transfer agreements that would see them share their know-how with the hub.

The World Health Organization (WHO) is currently negotiating such technology transfer agreements with leading mRNA vaccine producers, Moderna and Pfizer/BioNTech, with deals possibly being announced as soon as next week. This is according to Professor Petro Terblanche, Managing Director of Cape Town-based Afrigen Biologics and Vaccines, a company that forms part of the consortium that makes up the local technology transfer Hub.

If concluded, such deals are anticipated to enable a local Covid-19 vaccine to be developed for safety and efficacy testing and production within 12 months — less than half the time it would take were the consortium to collaborate with a company without an approved mRNA vaccine already on the market. The only two mRNA vaccines so far approved by stringent medicines regulators such as the United States Food and Drug Administration are those made by Pfizer/BioNTech and Moderna. The only mRNA vaccine in use in South Africa is that made by Pfizer/BioNTech.

Hopes for a flying start

“We’re hoping to get feedback on Monday from the WHO and the Medicines Patent Pool, (MPP), who are currently negotiating with Moderna, BioNTech, and Pfizer. If talks succeed, we’ll be off to a flying start and it will accelerate everything,” Terblanche told Spotlight. The MPP is a United Nations-backed body that negotiates voluntary licenses with pharmaceutical companies to increase access to patented life-saving medicines for low-and-middle-income countries. MPP-negotiated licenses have, for example, played a critical role in ensuring access to the antiretroviral medicine dolutegravir, which is part of standard first-line HIV treatment in South Africa.

Terblanche said if no deal could be agreed with Moderna or Pfizer/BioNTech, and the companies supplying know-how and technology to the new technology transfer hub were still in their clinical trial phases, “that timeline would be impossible — it would take another year or two”.

“The key thing here is the technology provided. Once that agreement is in place, we can plan and initialise the road map and absolute detail required to make this hub a sustainable initiative,” she said.

African vaccine independence

The Covid-19 pandemic has focussed the world’s attention on glaring inequities in vaccine access between high-income countries and low-and-middle-income ones, (LMICs).

According to Dr Stavros Nicolaou, Chair of Business For South Africa’s Covid-19 initiative, just 30 million Covid vaccine doses out of 2.3 billion produced worldwide have found their way into arms in Africa. That amounts to about 0.2%.

“That’s an astonishing statistic. The only way to sort this out, for this and any future pandemic of any kind, is to build regional capacity. It’s the only way we can ensure global health security. I understand why every country wants to look after its own — we’d probably do the same if we could — but this virus has been demonstrated to be mutagenic, and because of that, you’ll be chasing variants forever unless there’s vaccine intervention. Access to technology and skills to create local capacity is vital and the funding must follow,” he said.

Pipeline to other vaccines

Terblanche said her company would respect the rights granted and conditions imposed by any mRNA Covid vaccine producer while at the same time hoping they would never stand in the way of social good.

“Once we have the technology and skills transfer in place, we’ll use South Africa’s superb scientific and sequencing capability to develop our own intellectual property for Covid and other disease vaccines. Covid is our first goal but a pipeline to other vaccines will then develop, and we can set up other African tech hubs and distribute across the continent — ours is basically an innovation platform,” she said.

Morena Makhoana, CEO of Biovac, another partner in the consortium and the company that will manufacture any vaccine produced by Afrigen, said Biovac would hopefully be the first of many companies across the continent churning out vaccines. Biovac claims to have the capacity to produce a minimum of up to 30 million Covid-19 doses in the first year of scale-up.

“Afrigen will develop the product and then they’ll need commercial managers to receive it and take it forward. It’s not limited to Biovac. It’s a hub and spoke arrangement. We’re just lucky to be the first in Africa included in this technology transfer project,” Makhoana said.

The South Africa-based initiative is the first in a series of Covid mRNA vaccine technology transfer hubs that the WHO is launching around the world to boost Covid-19 vaccine supplies. The hub includes the South African Medical Research Council, Biovac, Afrigen, and five top universities.

Speaking at the virtual launch of the tech transfer hub last Monday, (21 June), President Cyril Ramaphosa said, “This landmark initiative is a major advance in the international effort to build vaccine development and manufacturing capacity that will put Africa on a path to self-determination.”

Ramaphosa stressed that although the establishment of the technology transfer hub was a step in the right direction, it did not detract from South Africa’s insistence on a waiver of aspects of the WTO Trips agreement relating to the protection of intellectual property rights on Covid-19-related products.

WHO Director-General Dr Tedros Adhanom Ghebreyesus said Covid-19 had highlighted the importance of local production to address health emergencies, strengthen regional health security and expand sustainable access to health products.

Complex, but doable

Terblanche said Afrigen and Biovac were talking to about five other less mature vaccine developers, the main criteria being what formulation they can bring to the party.

“We want a thermo-stable vaccine which we can distribute into other less resourced African countries, ideally one that can be stored at 2-8 degrees Celsius, or even room temperature to optimise access,” she said. This would be a major step up on the current Pfizer/BioNTech Covid-19 vaccine which needs to be stored at very low temperatures and has relatively limited storage times. “We want to vaccinate 1.2 billion people in Africa. That’s a lot of people to reach with a complex cold chain, especially in rural areas,” Terblanche said.

Spotlight put it to her that producing appropriate vaccines for Africa would require complementary manufacturing capacities, alignment of the African Centre for Disease Control, the African Union, the African Vaccine Manufacturing Initiative, plus other stakeholders to steer different companies in different African countries.

Terblanche’s response was phlegmatic.

“It is complex, yes. I’m also aware that objectives may not always converge. That’s the nature of the beast. We know exactly what we need to deliver. We’ll drive hard and build the consortium around that. We can’t control others’ agendas and complex politics.”

She said what her small, agile start-up company had control over was its mindset. “Critical things need to happen. We have a softer, behavioural approach and mindset. These are major tech challenges never tackled before in Africa. Everybody wishes for this continent to have vaccine security. We’ve already built something out of nothing (her facility). Our mindset is that it can be done.”

Will the funding be there?

On the challenge of funding in the current Covid-ravaged economic climate, she said WHO member states, philanthropic organisations, the French government, several SA-based foundations, and President Ramaphosa had pledged their financial support.

“I don’t think it will be an issue. We’re not talking billions of dollars here. It’s more like 30-40 million dollars max, including clinical trials. If we have to do a bridging study for a vaccine, those numbers are included. I’ve had a discussion with the Gates Foundation, while the Elma Foundation here is very keen. I’m meeting with another group of South African philanthropists today. There’s incredible social capital available.”

She said the hub was building on existing infrastructure at Afrigen and Biovac. “This is not a greenfield project — a significant cost factor will be what regulatory trials will be required for vaccine registration, driven by the technology and skills acquired,” she said.

Addressing endemic corruption in South Africa, she said her company had an exemplary record of governance and full compliance with Level One BEE requirements. “We have to be trusted by the donors to be responsible with their money and our record shows that,” she added.

When asked to confirm whether the negotiations are taking place, Pfizer referred us to the WHO. Pfizer did however provide the following brief comment: “As we’ve stated publicly before, from day one of our Covid-19 vaccine development program, we have been working with countries of all income levels and supranational organizations to make sure our Covid-19 vaccine is accessible to all. To date, Pfizer has concluded agreements to supply 122 countries with doses of the Pfizer-BioNTech Covid-19 Vaccine in 2021 – and has supplied doses of the vaccine to multiple countries in Africa, including, South Africa, Rwanda, Cape Verde, Tunisia, Angola, Botswana, Ivory Coast, and Togo. We’ve committed to manufacture 3 billion doses of the Pfizer-BioNTech Covid-19 Vaccine worldwide in 2021 – 1 billion of which will be donated to low- and middle-income countries.”

Spotlight has also asked the World Health Organization and Moderna for confirmation of the negotiations. We will update this article if we receive any responses.DM

Note: The Bill and Melinda Gates Foundation is mentioned in this article. Spotlight receives funding from the Bill and Melinda Gates Foundation.

 *This article was produced by Spotlight – health journalism in the public interest