Activist countries

How Western countries could prevent Africa from manufacturing the vaccines of the future

As Western donors have racked up significant funding for a Covid-19 vaccine manufacturing program in Africa, campaigners say more support is needed to help poor countries secure the intellectual property rights they need to produce mRNA vaccines beyond the pandemic.

Grants and loans from Western countries, including France, gave impetus to a “made in Africa” ​​vaccine.

The World Health Organization’s program to produce mRNA vaccines for the Global South is well funded at 80% of the total needed, says Charles Gore, executive director of the Medicines Patent Pool (MPP ), a public health organization helping the project with licensing and fundraising.

The “hub” of the program is a South African consortium that has developed a Covid mRNA vaccine based on the version produced by the American pharmaceutical giant Moderna. Fifteen other countries, the “spokes”, will eventually receive training and technology to manufacture the vaccine themselves.

Yet without more support for securing intellectual property (IP) rights, the future of vaccine manufacturing in low- and middle-income countries could be in jeopardy, campaigners say.

“There is a certain level of hypocrisy because if they are ready to support this, they are not ready to support other structural changes,” says Anna Marriott, health policy manager at Oxfam, referring to Western donors.

Weakened Waiver

Governments agreed to give up some patents on Covid vaccines in June 2022 after negotiations at the World Trade Organization that lasted more than 20 months.

The five-year agreement allows developing countries to produce vaccines, or the ingredients needed to make them, without the consent of patent holders – and then export them to other low-income countries.

But the European Union and others have worked effectively to water down the deal, according to Marriott, who is also co-policy chief for the People’s Vaccine Alliance, a global coalition of more than 100 organizations working for vaccine access in the world.

While South Africa and India had called for a broader waiver of intellectual property rights for Covid vaccines, tests and treatments, the existing agreement only applies to vaccines.

Critics say the EU and the US – where the pharmaceutical giants are based – have been overprotective of vaccines and other Covid-related technologies to the detriment of poorer countries.

The German government may have mounted the biggest opposition to the waiver, Marriott says – by issuing its own compulsory license for Covid technologies.

“If another country had discovered an effective Covid vaccine that was not available in Germany, they passed national legislation allowing them to override the patent … to produce for the German market.”

In the United States, legal authorizations have also been granted to invalidate patents during the pandemic.

Health is “not truly global while the global south still faces discrimination in terms of access to diagnostics and treatment,” says Barrack Owino of the African Alliance, a group advocating for community-based health care.

Not investing enough in the African continent has led to this inequality, he says.

WHO’s hub-and-spokes project is designed to address two gaping disparities between rich and poor countries: lack of technology and lack of training.

Patent issues

The South African consortium – made up of biotech company Afrigen Biologics and Vaccines, specialist manufacturer Biovac and the South African Medical Research Council – will share its vaccine technology with other low- and middle-income countries and train them to adopt it, ultimately helping them evolve. increase production to commercial quantities.

It is hoped that the partnership can be extended to cover the development and manufacture of future mRNA vaccines for other key diseases.

Yet South Africa’s sweeping patent laws could hamper the process.

The existing patent application system does not thoroughly check whether a submission is really new and the criteria are lax, according to a technical note published by Doctors Without Borders (MSF). Patents also cannot be challenged effectively by the public or civil society organizations under apartheid-era law, says MSF.

“South Africa has granted Moderna very broad patent claims related to mRNA vaccine technology that have been rejected in other countries, such as Japan, Israel and South Korea, due to a lack of technical merit,” MSF’s brief reads.

Moderna has filed at least three mRNA patents in South Africa, which have been automatically accepted and will not expire until 2034.

Although Moderna initially said it would join the WHO program, it later pulled out, leaving Afrigen and partners to develop its own Covid mRNA vaccine based on information about Moderna’s formula that were available in the public domain.

“Moderna will never enforce its Covid-19 intellectual property rights in Gavi-eligible AMC-92 countries, or against manufacturers that produce Covid-19 vaccines for distribution in those markets,” Luke Mircea-Willats, Director of Moderna’s media relations, told RFI.

Gavi-eligible AMC-92 countries are low- and middle-income countries identified by Gavi, the Vaccine Alliance, which works to increase access to immunization in poor countries. South Africa is not on that list, but Moderna promised in media comments that it would not enforce patents related to its coronavirus vaccine there either.

For vaccines beyond Covid, however, “we don’t have Moderna’s blessing,” Afrigen chief executive Petro Terblanche told RFI.

“We’ll have to look at how we’ll get freedom to operate, or we’ll have to get a license. That’s the challenge we’ll have to manage.”

“Protect the mRNA Hub”

Vaccine activists and civil society leaders in South Africa have called on the government to change its legislation to pave the way for South Africa to create and manufacture mRNA vaccines.

“As Moderna’s conditional commitment only covers Covid-19 vaccines, the hub’s work and investment in it remains at risk,” said a letter to South African President Cyril Ramaphosa last month, signed by over 35 individuals and groups in South Africa and across the African continent.

They point out that the program is not just about Covid vaccines but ultimately about making mRNA vaccines against other diseases such as malaria, HIV and tuberculosis.

“Therefore, we urge you to do everything in your executive power to protect the mRNA hub and its spokes and preserve the ability of low- and middle-income countries to research, develop, produce and register mRNA vaccines. “wrote the activists.

But looking beyond South African law, vaccine campaigner Fatima Hassan, founder and director of the Cape Town-based Health Justice Initiative, says it’s up to big biotech companies to allow access – not to not talk about it and then revoke it.

She fears that Moderna could take legal action at any time.

Major vaccine access initiatives such as MPP and Covax, the Covid-19 Vaccines Global Access initiative, tend to “believe in the solidarity and goodwill of pharmaceutical companies, which is not evidence-based”, Hasan says.

She says that if the issue of intellectual property is not addressed, it limits the freedom of operation of the hub. “What we have is a situation where Moderna’s patents could potentially be the biggest stumbling block to the hub’s work, aside from Covid-19.”

Justice, not charity

“We are all aware of the fact that [intellectual property] could become a problem, and of course steps must be taken before it becomes a problem. We all agree on that,” says Marie-Paule Kieny, head of the star steering committee and president of the MPP.

There have been positive comments about addressing vaccine inequality from the United States, most recently at the United Nations General Assembly in September.

“Fairness is not just charity,” acknowledged Loyce Pace, assistant secretary for global affairs at the US Department of Health and Human Services.

“We need to make sure to complement any donations or other support with issues or advancements, like voluntary technology transfer or capacity building or, frankly, decentralizing and distributing local and regional manufacturing.”

Vaccines and drugs could be made on the mainland and distributed for free or at a price set by the government, community health care advocate Owino suggests.

“The system was designed to give us charity, but we don’t want charity,” he says. “We want justice, so we can have autonomy and respect.”