‘Like copying a Louis Vuitton handbag’: Big pharma tackles Africa’s Covid vaccine replica | Global development

When news broke that scientists had developed an effective Covid vaccine, Emile Hendricks was living in a deprived suburb of Cape Town and studying for a degree in biotechnology.

He believed that he and his community would not have access to such a vaccine, or at the very least would be at the back of the queue.

He was right. By mid-April 2021, more than 32 million people in the UK had received a first dose of a Covid vaccine, compared to just 300,000 in South Africa, where the rollout has been plagued with problems.

“The vaccine was not accessible to me or anyone I knew,” Hendricks says. “It’s something that was given to [people in the west] but not for the rest of us. I pushed it out of my mind, thinking that we in Africa will have to find our own solution.

Two years later, Hendricks is a research technologist at Afrigen Biologics and Vaccines, a pharmaceutical company in Cape Town, and part of a team that successfully replicated small amounts of Moderna’s Covid mRNA vaccine as part of a plan supported by the World Health Organization (WHO). ) to develop vaccines in developing countries.

Scientists from the University of the Witwatersrand worked with Afrigen to deconstruct the Moderna vaccine sequence and build it from scratch. Such reverse engineering is legal under South African law, which contains a provision allowing research and development to be conducted independently of patent protection.

The WHO chose Moderna’s vaccine because of the abundance of public information about it and the pharmaceutical company’s commitment not to enforce Covid-related patents against manufacturers in – or for – certain countries low and middle income during the pandemic.

Afrigen Biologics and Vaccines in Cape Town has replicated small quantities of Moderna’s Covid mRNA vaccine. Photo: Jodi Windvogel/The Guardian

The replica has so far been tested in mice, and strong preliminary results mean human trials could begin in May next year.

The WHO mRNA hub in Cape Town will share know-how with 15-20 “spokes” in Africa, Latin America and Eastern Europe, creating a network of scientists who will collaborate to produce vaccines at mRNA in low- and middle-income countries. Scientists from Brazil, Argentina, Indonesia and Egypt traveled to the center in South Africa to begin their training.

The groundbreaking initiative is built around the idea that mRNA vaccines could have far-reaching applications in the fight against a number of diseases. The hub has the potential to increase manufacturing capacity for other products, such as insulin to treat diabetes; cancer drugs; and mRNA vaccines she hopes to develop for diseases such as malaria and tuberculosis.

It aims to provide a solution to vaccine inequality, ending the dependence of low- and middle-income countries on manufacturers in wealthier countries. The Covid pandemic has glaringly exposed the world’s dependence on big pharma which are mainly located in Europe and the United States.

“The Covid-19 pandemic has shown that reliance on a few companies to deliver global public goods is limiting and dangerous,” WHO Director-General Tedros Adhanom Ghebreyesus said after visiting the hub. in South Africa in February.

Charles Gore, executive director of the Medicines Patent Pool (MPP), which backs the hub, says: “Covid’s silver lining is that it has focused people’s attention on access. The tragedy is that many people died to obtain this concentration.

“People have realized that this model of research and development coming from high-income countries and given to low- and middle-income countries is disempowering, and the need to change that and do things differently. Rather than some kind of donation program, it’s about empowerment.

The Afrigen Formulation Facility in Cape Town, South Africa.
Afrigen hopes to develop mRNA vaccines for diseases such as malaria and tuberculosis. Photo: Jodi Windvogel/The Guardian

The hub’s future is not without obstacles and potential pitfalls, however. For her to succeed, she will have to persuade governments to buy doses from local manufacturers, even if they are initially more expensive.

His freedom of action is also threatened. Moderna has filed several patents in South Africa and refused to cooperate and share technology with the hub in Africa, comparing the vaccine replica to a “copy of a Louis Vuitton handbag”. Additionally, Moderna is suing fellow mRNA vaccine makers Pfizer and BioNTech, which has raised concerns that it could enforce patents against the hub regarding any future vaccines it might develop for diseases other than Covid.

Moderna Chief Executive Stephane Bancel said in August, “We are filing these lawsuits to protect the innovative mRNA technology platform we pioneered, invested billions of dollars in creating, and patented over the past decade. preceding the Covid-19 pandemic”.

In March, Moderna issued a statement saying the company is now “updating its patent commitment never to enforce its patents for Covid-19 vaccines against manufacturers in or for the 92 low- and middle-income countries in the Gavi Covax Advance Market Commitment (AMC), provided that the vaccines manufactured are only intended for use in AMC countries 92”.

He continued, “In non-AMC 92 countries … the company expects those who use Moderna’s patented technologies to respect the company’s intellectual property.”

South Africa is not among the 92 countries on the AMC list, but Moderna has confirmed that the hub will be included in the updated commitment.

Potential issues could arise for any non-Covid vaccine, but the MPP said it will “ensure that the technology used in the hub is not covered by patents or that licenses … are in place to allow freedom to operate”.

Gore thinks Moderna will keep its promise and denies that patents will become an issue. “We’re not going to infringe the patents,” he says. “Obviously we don’t want to come into conflict with the pharmaceutical industry.” He hopes that if there is a patent blocking possible progress, the hub will be licensed.

However, Fatima Hassan, a South African human rights lawyer and founder of the Health Justice Initiative, is skeptical. She says there’s no guarantee that Moderna won’t pursue legal action if and when there are any future breakthroughs or advances, such as any new mRNA vaccine developed at the hub.

“What is plan B? she asks. “You are all naive to assume that [Moderna] will come to the table and things will be fine. If Moderna can sue Pfizer, they won’t hesitate to sue the hub.

She criticizes the fact that the hub is presented as a solution to vaccine inequality and a model of empowerment for low- and middle-income countries, when much of the decision-making about it is made by organizations such as WHO and MPP, both based in Geneva. .

The hub has already been attacked by another branch of big pharma. The kENUP Foundation is a Malta-based consultancy engaged by BioNTech, the company that produces the Pfizer Covid vaccine. In a document sent to South African government officials, the foundation said the hub’s activity should be stopped.

The document said: “It is almost impossible to replicate a vaccine manufacturing process without close cooperation with the inventor. The hub’s plan to copy Moderna’s Covid-19 vaccine manufacturing process should be stopped immediately. »

Managing Director, Professor Petro Terblanche at the Afrigen Formulation Facility in Cape Town, South Africa.
Petro Terblanche, CEO of Afrigen. Photo: Jodi Windvogel/The Guardian

Petro Terblanche, CEO of Afrigen, said of the kENUP report: “It was really damaging. I had to defend this project with my government and my shareholders,” she said. “I was disillusioned. We are a small business; [the hub is] all about access, empowerment and you are [the kENUP Foundation] come here and you try to kill him.

She then reflected on the implications for the pharmaceutical industry if the hub and its partners around the world were successful in developing new drugs and vaccines, and “understood why big pharma was firing on all cylinders for us.”

However, when the BMJ published an article saying that WHO efforts to bring vaccine manufacturing to Africa were being undermined by the pharmaceutical industry, kENUP responded by saying, “The opposite is true… [the foundation] encourages private sector efforts to establish vaccine manufacturing in Africa.

For now, however, work is continuing at Afrigen’s headquarters in Cape Town.

Hendricks prepares for a day of work in the lab. He dreams of developing a vaccine for HIV, which is one of South Africa’s most serious health problems – and Hendricks himself has lost family members to AIDS. He says, “We seek to tackle the burden of disease that is so unique to Africa – something that has never been brought to light or reality. [necessary] Resources. I am delighted to be part of it.

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