‘Like copying a Louis Vuitton handbag’: big pharma hits out at Africa’s replica Covid vaccine
When news broke that scientists had developed an effective vaccine against Covid, Emile Hendricks was living in a deprived suburb of Cape Town and studying for a degree in biotechnology.
He thought 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 with just 300,000 in South Africa, where the rollout was plagued by problems.
“The vaccine wasn’t accessible to me or to anyone I knew,” Hendricks says. “It was something that was given to [people in the west] but not to the rest of us. I pushed it out of my mind, thinking we in Africa will have to find our own solution.”
Two years later, Hendricks is a research technologist at Afrigen Biologics and Vaccines, a Cape Town pharmaceutical company, and part of a team that has successfully reproduced small quantities of Moderna’s mRNA Covid vaccine as part of a plan backed by the World Health Organization (WHO) to develop vaccines in the global south.
Scientists at the University of the Witwatersrand worked with Afrigen to deconstruct the sequence of the Moderna vaccine and build it from scratch. Such reverse engineering is legal in South African law, which contains a provision for carrying out research and development regardless of patent protection.
WHO chose Moderna’s vaccine because of an abundance of public information about it, and the pharmaceutical company’s pledge not to enforce Covid-related patents against manufacturers in – or for – selected low and middle-income countries during the pandemic.
So far, the replica has been tested on mice, and strong preliminary results mean human trials could begin by May next year.
The WHO mRNA hub in Cape Town will share the knowhow with 15 to 20 “spokes” in Africa, Latin America and eastern Europe, creating a network of scientists who will collaborate to produce mRNA vaccines in low and middle-income countries. Scientists from Brazil, Argentina, Indonesia and Egypt have travelled to the hub in South Africa to start training.
The groundbreaking initiative is built around the idea that mRNA vaccines could have far-reaching applications in tackling a number of diseases. The hub has the potential to expand manufacturing capacity for other products, such as insulin to treat diabetes; cancer medicines; and mRNA vaccines it hopes to develop for diseases such as malaria and tuberculosis.
It is intended to provide a solution to vaccine inequity, ending the reliance of low and middle-income countries on manufacturers in richer countries. The Covid pandemic has starkly highlighted the world’s dependence on big pharmaceutical companies that are mostly located in Europe and the US.
“The Covid-19 pandemic has shown that reliance on a few companies to supply global public goods is limiting and dangerous,” said WHO’s director general, Tedros Adhanom Ghebreyesus,
after visiting the hub in South Africa in February.
Charles Gore, executive director of the Medicines Patent Pool (MPP), which supports the hub, says: “The silver lining of Covid is that it has focused people’s attention on access. The tragedy is that a lot of people died to get that focus.
“People have realised 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 programme, this is about empowerment.”
The hub’s future is not without obstacles and potential pitfalls, however. For it to succeed, it will need to persuade governments to buy doses from local manufacturers, even if they are initially more expensive.
Its freedom to operate is also under threat. Moderna has filed several patents in South Africa and has refused to cooperate and share technology with the hub in Africa, likening the replica vaccine to a “copy of a Louis Vuitton handbag”. In addition, Moderna is suing fellow mRNA vaccine manufacturers Pfizer and BioNTech, which has raised fears that it could enforce patents against the hub regarding any future vaccines it may develop for illnesses other than Covid.
Moderna’s chief executive, Stéphane Bancel, said in August: “We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the Covid-19 pandemic.”
In March, Moderna released a statement saying the company was “now updating its patent pledge to never 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 manufactured vaccines are solely for use in the AMC 92 countries”.
It continued: “In non-AMC 92 countries … the company expects those using Moderna-patented technologies will respect the company’s intellectual property.”
South Africa is not one of the 92 countries on the AMC list but Moderna has confirmed the hub will be included in the updated pledge.
Potential issues could arise for any non-Covid vaccines, but the MPP said it “will ensure that technology used in the hub is either not covered by patents or that licences … are in place to enable freedom to operate”.
Gore believes Moderna will stand by its pledge and denies that patents will become a problem. “We’re not going to infringe the patents,” he says. “Clearly, we’re not wanting to enter into disputes with the pharmaceutical industry.” He hopes that if there is a patent blocking possible progress, the hub will be granted a licence.
However, Fatima Hassan, a South African human rights lawyer and founder of the Health Justice Initiative, is sceptical. She says that there is no guarantee Moderna will not take legal action if and when there are possible future breakthroughs or advances, such as any new mRNA vaccines developed at the hub.
“What is plan B?” she asks. “You are all naive to assume that [Moderna] is going to come to the table and things are going to be fine. If Moderna can sue Pfizer, they will have no hesitation to sue the hub.”
She is critical of the hub being pushed as a solution to vaccine inequity and a model of empowerment for low and middle-income countries, when much of the decision-making around it is being done by organisations including WHO and MPP, both based in Geneva.
The hub has already come under attack from another arm of big pharma. The kENUP Foundation is a Maltabased consultancy hired 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 read: “It is close to impossible to replicate a vaccine manufacturing process without close cooperation with the inventor. The hub’s project of copying the manufacturing process of Moderna’s Covid-19 vaccine should be terminated immediately.”
Petro Terblanche, the managing director of Afrigen, says of kENUP’s report: “It was really damaging. I had to defend this project with my government and shareholders,” she says. “I was disillusioned. We are a small company; [the hub is] all about access, empowerment and you’re [the kENUP Foundation] coming in here and you try to kill it.”
She then thought about the implications for the pharmaceutical industry should the hub and its partners worldwide succeed in developing new medicines and vaccines, and “understood why big pharma went all guns blazing for us”.
However, when the BMJ published an article saying WHO’s efforts to bring vaccine manufacturing to Africa were being undermined by the pharmaceutical industry, kENUP responded by saying: “The opposite is true … [the foundation] promotes private sector efforts to establish vaccine manufacturing in Africa.”
For now, though, work continues at Afrigen’s Cape Town headquarters.
Hendricks is preparing for a day’s work in the lab. He dreams of developing a vaccine for HIV, which is one of South Africa’s most serious health concerns – and Hendricks himself has lost family members to Aids. He says: “We’re looking at attacking the burden of disease that is so unique to Africa – something that has never been given the true light of day or the [necessary] resources. I’m excited to be a part of that.”
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Covid focused people’s attention on access. The tragedy is that a lot of people died to get that focus