Africa overcomes hurdles, beats Big Pharma, to produce its own COVID vaccines

Seeking to address vaccine inequities between rich and poor countries, a South African consortium is taking on pharmaceutical giants in its quest to produce Africa’s first Covid-19 mRNA vaccine and share it with countries in the South.

It was sheer determination that drove South African biotechnology company Afrigen Biologics Vaccines, a small fish in the world of big pharma, to fight to produce African vaccines against Covid-19.

Managing Director Petro Terblanche recalls the day they learned that Moderna, the pharmaceutical giant responsible for one of the world’s first mRNA Covid-19 vaccines, would not manufacture vaccines in Cape Town.

“They underestimated the absolute ‘power’ attitude of people in this country,” she says.

Within two months, Afrigen reverse-engineered current mRNA vaccines to create their own.

“Even Moderna underestimated the scientific space in this country,” says Terblanche.

Researchers at the University of the Witwatersrand-based Antiviral Gene Therapy Research Unit were already working on the mRNA technology. Together with Afrigen, they were able to crack the code that could put South Africa on the map to produce the first mRNA vaccine for Covid-19 to be designed and manufactured in Africa.

“I think we surprised a lot of people…we were afraid people would say, ‘those guys, they’re just bullshit.’ So we really had to be fundamentally strong and secure, but once we got the result, we proudly announced it,” says Terblanche.

Their determination to create a vaccine has been fueled by the disparity between access to Covid-19 vaccines in low-income countries and the wealthier world. According to the latest figures from the World Health Organization (WHO), more than 72% of people in high-income countries have received at least one dose, compared to less than 25% in low-income countries.

Vaccine equity

After the pandemic was declared in 2019, pharmaceutical companies rushed to create vaccines that were bought up by wealthy countries, leaving developing countries in Africa and elsewhere in deep trouble. To date, only 20% of the African population is vaccinated against the coronavirus.

The People’s Vaccine Alliance, a global coalition of civil society organizations, described the rush for vaccines and lack of equitable access as “evidence of systematic racism in the global coronavirus response”.

To prevent this from happening again, WHO is committed to producing vaccines by and for low- and middle-income countries in the South.

South Africa, where Afrigen works in partnership with the Biovac laboratory in Cape Town and the Medical Research Council of South Africa, has been chosen by WHO as an international hub to produce local mRNA vaccines. The WHO program includes 15 “spokespersons” from other participating countries who will receive three-part training from Afrigen, which includes technology transfer.

Tunisia, Senegal, Nigeria, Egypt and Kenya make up the African spokespersons, while India, Brazil and Serbia are among the other nations involved.

Scientists from six participating countries have already completed the first cycle of training at the Afrigen facilities. The next step involves transferring technology in an open and collaborative way. And the third stage will focus on producing vaccines in commercial quantities.

An African solution to global problems

This shelf system goes against the business model that drives global pharmaceutical companies. “For us, sustainability is not 200% profit; it’s not our mindset, it’s not our desire,” says Terblanche.

She says a long-term solution is needed not only for Covid-19, but for a range of other diseases on the African continent, such as Lassa fever, Marburg disease, Ebola and tuberculosis – diseases that the West is less likely to invest in.

“Our lot sizes are so small, it gives us unique flexibility; it’s a model that says you don’t have to be big to be sustainable and relevant,” she insists.

South Africa represented in science

While Afrigen creates the batches, the other part of the equation – scaling up vaccine production, manufacturing and distribution – will be handled by Biovac Institute, which has nearly 20 years of expertise. vaccine expertise.

Chief Executive Morena Makhoana is used to hearing naysayers question whether an African company is capable of manufacturing vaccines.

“Why are you trying to do things that are too complex for you in South Africa? is a typical refrain, he says.

His vaccine manufacturing business is currently fulfilling contracts with a number of international pharmaceutical companies, including French giant Sanofi.

Biovac has already started preparing to adopt Afrigen’s technology so they are ready to scale up and manufacture its Covid-19 mRNA vaccines, the head of science and technology told RFI. business innovation, Patrick Tippoo.

They are awaiting the results of Afrigen’s clinical trials. Initial clinical trials in mice have proven successful and it is hoped that clinical trials in humans will begin in May 2023.

“While they are working on it, we make sure that we organize our facilities, that critical equipment is ordered, that will be installed, commissioned and qualified,” says Tippoo.

Preparations include preparing BioVac’s state-of-the-art “freeze farm” – a new facility filled with specialized freezers that will hold vaccines at -80C.

“Biotechnology can exist in South Africa, and all people of all colors can meaningfully participate, even in high-tech environments, and that’s important to us,” Makhoana says.

He gives impressive statistics about the scientists and staff who work at Biovac: 92% of their 584 staff are black, 55% are women and 51% are black women.

“And that for us is important because it essentially represents South African demographics,” he says.

Filling a vaccine gap

Afrigen’s mRNA vaccines have yet to be approved by the South African Health Products Regulatory Authority (SAHPRA), which regulates clinical trials.

In order to get the go-ahead from the WHO to distribute the vaccines, South Africa will need to be registered at least at Maturity Level 3 on the organization’s global classification system for national medical product regulatory authorities. . Classification means that a country’s regulatory system is stable and can guarantee the quality, safety and efficacy of vaccines manufactured, imported or distributed there.

Of all the countries on the African continent, only Egypt is certified at Maturity Level 3 for vaccines, although some countries are rated for other processes.

SAHPRA hopes to present the mRNA project to the WHO as a test case to apply for certification.

“This will be the first vaccine to go through the product development process in South Africa,” says Tippoo.

South Africa has gaps in its vaccine ecosystem, and the hub-and-spokes project is the perfect example to show both the regulatory side and the pharmaceutical manufacturing side, he adds.

This gap can only be filled when a manufacturer starts manufacturing a drug substance, like the South African consortium. Until now, the product has always been developed and manufactured elsewhere.

“There’s still a long way to go in the future, but I believe we’re on a trajectory,” says Tippoo.

“In terms of ability, there’s no doubt in my mind that it can be done.”

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