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The covid-19 vaccine patent waiver: a crucial step towards a “people’s vaccine”

BMJ 2021; 373 doi: (Published 17 May 2021) Cite this as: BMJ 2021;373:n1249

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  1. Gregg Gonsalves, associate professor of epidemiology1,
  2. Gavin Yamey, professor of global health and public policy2
  1. 1Public Health Modeling Unit and Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, USA
  2. 2Center for Policy Impact in Global Health, Duke Global Health Institute, Duke University, Durham, NC, USA
  1. gregg.gonsalves{at}

An intellectual property waiver alone will not solve the covid-19 vaccine access challenge, other steps will be needed

In rich nations that have plentiful doses of covid-19 vaccines, including the UK and the US, the public is feeling optimistic that life will return to normal soon, just as it has in Israel, where 56% of the population is fully vaccinated. Tedros Adhanom Ghebreyesus, director general of the World Health Organization, calls this “vaccine euphoria,” a sense among those in rich nations that vaccines have ended the pandemic.

But if the vaccine euphoric nations were to turn their gaze towards the surges in cases and deaths in Brazil, India, Iran, and Nepal, a dose of reality would set in. Worldwide, the number of weekly cases has been steadily rising for 10 weeks and is at its highest ever level. The pandemic is raging out of control.

It did not have to be this way. We have multiple safe, highly efficacious vaccines that we should be deploying worldwide to end the pandemic. And yet only 0.3% of total doses have gone to low income countries, a grotesque inequity that Winnie Byanyima, executive director of UNAIDS, calls “vaccine apartheid.”12

A global pooled solidarity mechanism called Covax was established last year by three agencies: WHO; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations (CEPI). Covax aimed to vaccinate all high risk people and health workers in every single nation, rich and poor equally, in 2021—about one fifth of the planet’s population.

Unfortunately, around three dozen rich nations bypassed this mechanism and went it alone in a vaccine grab, leaving few jabs behind for Covax, the only multilateral mechanism working to get vaccines to poor countries. Rich nations are now moving full steam ahead in vaccinating their low risk citizens ahead of health workers and high risk people in less wealthy nations. In Israel, the UK, and the US, 60%, 52%, and 46% of people, respectively, have received at least one dose.3

Even if Covax succeeds in reaching its targets, only 20% of people in low and middle income countries (LMICs) will be fully vaccinated by the end of 2021. When Covax launched, it set the goal of procuring 2 billion doses for LMICs by the end of 2021, enough to vaccinate one billion people (assuming a two dose regimen). While Covax forecasts that it is on target to reach this goal, it would still mean that just 20% of people in these less wealthy nations would be fully vaccinated this year. The targets lacked ambition because they were based on a “scarcity mindset”—an acknowledgment that total global doses would be limited and rich nations would likely hoard the supply.

And it gets worse. Rich nations have bought more doses than they could ever use and are sitting on them. Canada has procured enough doses to vaccinate all its citizens 10 times over. Britain is not far behind—it could vaccinate everyone in the UK eight times over.

If we are going to bring an end to this pandemic, the most urgent need is for the hoarding to stop. Seth Berkeley, chief executive of Gavi, estimates that rich countries have procured around 1.5 billion excess doses. They should immediately donate these to Covax for urgent distribution to LMICs.

These donations are the quickest way to get shots in arms right away. But they are not enough. Donations are a charity model and once the ‘‘give away’’ is over the vaccine supply dilemma remains. Thus, what is also needed is a sustainable way for LMICs to be able to make their own vaccines to ensure population-wide vaccination by the end of 2021 (or early 2022 at the latest). And for that we need a “people’s vaccine.”

The people’s vaccine campaign, which we both support, is led by the People’s Vaccine Alliance, a global coalition of organisations and activists including UNAIDS, Amnesty International, and Public Citizen. The campaign argues that “pharmaceutical corporations must allow the covid-19 vaccines to be produced as widely as possible by sharing their knowledge free from patents.” We call on Gavi, WHO, and CEPI (the three Covax hosts) to join their close partner UNAIDS and become members of the People’s Vaccine Alliance, which is thinking bigger and more boldly.

We believe that there are three crucial steps towards a people’s vaccine. The first step is a waiver of intellectual property (IP) protections on covid-19 vaccines, including on their components and raw materials. We were thrilled to see the Biden administration throw its support behind the waiver last week. Other countries, with the notable exception of Germany and Switzerland, soon followed. The domino effect continues—even the Bill and Melinda Gates Foundation reversed course. Bill Gates was heavily criticised for initially opposing a waiver, but on 6 May 2021 Mark Suzman, chief executive of the Gates Foundation, said, “No barriers should stand in the way of equitable access to vaccines, including intellectual property, which is why we are supportive of a narrow waiver during the pandemic.”

It is worth reflecting on just how momentous a step it was for the US to back the covid-19 IP waiver. Twenty years ago, when Brazil wanted to make its own generic versions of life saving HIV drugs, the US government took legal action through the World Trade Organisation’s dispute settlement body, claiming that “Brazil’s production of generic HIV drugs breaks international laws on patent protection.” The US has repeatedly used threats of trade action against LMICs, including South Africa and Thailand, to protect its pharmaceutical industry. The pharmaceutical lobby is the largest and richest player in Washington, DC. For a US president to stand up to it, as Biden did last week, is rare and should be celebrated.

An IP waiver would allow other producers to step in and make raw materials for export for all the current vaccines, industrial parts, and components. It would also simplify agreements for eventual production of more doses. But an IP waiver alone will not solve the covid-19 vaccine access challenge. Two further steps will need to be taken to reach a people’s vaccine. Step two is a transfer of technical knowledge from vaccine makers in the global north to regional hubs or directly to manufacturers in the global south. Step three is vast subsidisation of manufacturing in LMICs.

Thousands of lives can be saved immediately through a donation model. But at the same time, we need to get going on a people’s vaccine, since the ramp-up of manufacturing will take time. Companies in LMICs are hungry to get going. When WHO recently announced it was seeking LMIC manufacturers who want to produce mRNA covid-19 vaccines, it was inundated with proposals. Right now, the world’s scientists and politicians need to pull together to figure out how to get the next steps done. Technology will need to be transferred to a set of potential new producers, which will require experts to be mobilised for this task, many at the originator companies themselves. New financial resources must be mobilised to support the building or retrofitting of factories and to coordinate supply chains and other operational tasks at a global scale. The sooner we start, the faster we bring an end to the pandemic.


  • Competing interests: GY is a signatory to the People’s Vaccine campaign and is a funding member of Amnesty International, one of the members of the People’s Vaccine Alliance. He was a member of the Covid-19 Vaccine Development Taskforce, hosted by the World Bank, and participated as an unpaid academic adviser in the consultation process that led to the launch of Covax. He has received grant funding from WHO; Gavi, the Vaccine Alliance; and the Bill and Melinda Gates Foundation. GG has no competing interests to report.

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