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An employee of ALMO, one of the leading manufacturers of disposable syringes worldwide, works at the company's production facility in Bad Arolsen, Germany on December 15, 2020. (Photo: Ina Fassbender/AFP via Getty Images)

An employee of ALMO, one of the leading manufacturers of disposable syringes worldwide, works at the company's production facility in Bad Arolsen, Germany on December 15, 2020. (Photo: Ina Fassbender/AFP via Getty Images)

As EU Tells US to Export Covid Vaccine Doses Before Suspending Patents, Critics Knock Lack of 'Global Leadership'

"The world needs urgent manufacturing investments, regulatory cooperation, and intensive sharing of knowledge to radically expand vaccine supply," said one public health expert.

Kenny Stancil

U.S. President Joe Biden received praise from global health leaders last week for supporting a motion at the World Trade Organization to suspend coronavirus-related intellectual property barriers for the duration of the pandemic, but European Union leaders who have yet to endorse a waiver of Covid-19 vaccine patents are insisting, to the dismay of public health advocates, that the White House should first lift its own restrictions on exporting doses and key ingredients.

"Much more will need to be done to make a 'People's Vaccine' universally available as soon as possible."
—Jayati Ghosh, UMass Amherst

"Patents are not the priority," French President Emmanuel Macron said Friday at the Porto Social Summit. "I call very clearly on the United States to put an end to export bans not only on vaccines but on vaccine ingredients, which prevent production."

"100% of the vaccines produced in the United States are for the American market," he said. The French president also criticized the United Kingdom for curbing vaccine exports.

As The Guardian noted, "Neither the U.K. nor the U.S. has a formal export ban, but Washington has deployed the Defense Production Act to force manufacturers to fulfill domestic contracts ahead of other orders while the British government's contract with AstraZeneca also prioritizes U.K. requirements."

At the summit, European Commission President Ursula von der Leyen claimed that "the IP waiver will not solve the problems, will not bring a single dose of vaccine in the short and medium term."

"The European Union is the pharmacy of the world and open to the world," she added. "Up to today in the European Union, 400 million doses of vaccines have been produced and 50% of them—200 million doses—have been exported to 90 different countries in the world. So we invite others to do the same."

While health justice campaigners agree that the U.S. should stop limiting exports, they argue that defeating the pandemic requires expanding the production of vaccines—a challenge made much more difficult by the E.U.'s continued obstruction of the India and South Africa-led proposal for a temporary waiver of the WTO's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which is backed by more than 100 countries, including, as of last week, the U.S.

Rather than portraying support for the vaccine patent waiver and support for vaccine exports as mutually exclusive alternatives, Rajat Khosla, senior director of research, advocacy, and policy at Amnesty International, asserted that both measures are necessary "if we are serious about addressing" vaccine apartheid.

Yale epidemiologist Gregg Gonsalves tweeted that "other countries understand the importance of vaccine diplomacy, but are simply using exports of their own national vaccines for this purpose."

"No one is marshaling the world's resources [or] providing global leadership," he lamented.

According to public health experts, even a vaccine patent waiver, while necessary, is insufficient by itself to increase global supply. In addition to the TRIPS waiver, they say, stronger measures to facilitate the transfer of technology and know-how, as well as massive public investments in worldwide manufacturing, are necessary to ensure universal access to coronavirus tests, treatments, and vaccines.

As Jayati Ghosh, professor of economics at the University of Massachusetts Amherst, explained Friday:

While the rapid development of Covid-19 vaccines was a truly impressive achievement, it has been tarnished by constraints on global vaccine supply and the related inequities in distribution. As of May 4, less than 8% of the world's population had received even one dose of any Covid-19 vaccine, while just ten rich countries accounted for 80% of all vaccinations. The reason is not just that rich countries have been buying up all available doses; it is also that there simply have not been enough doses to go around.

But this scarcity itself is largely artificial. Vaccine production has been limited by pharmaceutical companies' refusal to share knowledge and technology. Though the companies producing the approved vaccines have benefited from public subsidies and publicly funded research, they nonetheless have taken advantage of patent protections to maintain a monopoly, limiting production to their own factories and a select few other companies to whom they have granted licenses.

"Temporarily waiving IP rights is essential, but it is only the first step," Ghosh wrote. "A waiver agreement would address the previously insurmountable legal side of the problem. But much more will need to be done to make a 'People's Vaccine' universally available as soon as possible."

According to Ghosh, "The next step is to push for concrete measures to facilitate the transfer of knowledge and technology."

"From Canada to Bangladesh, many potential vaccine producers with the required facilities have so far been denied the licenses and technical know-how to proceed," noted Ghosh. "Not a single pharmaceutical company has joined the World Health Organization's voluntary facility for sharing technology, the Covid-19 Technology Access Pool (C-TAP)."

It doesn't have to be this way, Ghosh stressed, pointing out that "governments in the United States, Europe, and elsewhere, having given large subsidies to develop the approved vaccines, can and should pressure the companies to share the knowledge that public money helped provide."

"We know this can be done," she wrote, "because the Biden administration has already persuaded Johnson & Johnson to share its technology with Merck to boost domestic production of its single-dose vaccine. Surely the other companies that have benefited from public support could be pressured to do the same with producers around the world."

In addition to scaling up knowledge and technology transfer, Ghosh argued that "the case for public production of such vaccines is clear... [and] becomes even stronger when one considers that private vaccine producers have little financial incentive to meet current global needs."

Faced with "a near-complete breakdown of overstretched health services [that] is resulting in a catastrophic loss of life" in South America and India as well as the potential emergence of vaccine-resistant variants, "we must build and deploy public manufacturing capacities in the U.S. and other countries," wrote Ghosh.

"World leaders must work together urgently to translate the progress of the WTO waiver into the cooperation needed to produce billions more doses."
—Peter Maybarduk, Public Citizen

Peter Maybarduk, director of Access to Medicines at Public Citizen, made a similar case on Friday.

While Biden's decision to support the TRIPS waiver "is a victory for democratizing technology, for rebalancing power toward governments and away from corporations, and for the power of countries working together to fight the global pandemic," he wrote, "there is much more to be done to get Covid vaccines to the people who need them."

"More than one year into the pandemic, a year of global suffering and death, there still is no plan from world leaders to end it; no plan from national leaders anywhere to vaccinate everyone, everywhere," Maybarduk argued. "A G7 statement this week referenced key steps like technology transfer but stopped short of specific commitments. The world needs urgent manufacturing investments, regulatory cooperation, and intensive sharing of knowledge to radically expand vaccine supply."

According to Maybarduk:

Top officials are reportedly worried about the political consequences of the United States acting globally before the country achieves some unclear measure of security. Yet that moment, if it comes, may come many months from now, too late for the million people who will die in the interim, and likely too late to combat potential virus variants and economic devastation that threaten security everywhere, including the United States.

COVAX, the equitable vaccine access initiative, is not on track to vaccinate its target of one-in-five people in the global south this year. Global health initiatives, struggling with limited resources, are primarily aimed at managing the 'acute phase' of the pandemic in the global south, vaccinating those at the highest risk. The WHO, for all its critical work over the past year, does not, on its own, have the political power to massively expand production or sit across the table from Moderna and Pfizer and establish clear expectations for sharing technology and ensuring global access.

"But President Biden does," he wrote, before outlining specific steps the federal government can take to "immediately launch a vaccine-manufacturing program designed to meet global need and end the pandemic":

  • Modest capital investments (about $2 billion) can retrofit vaccine-manufacturing facilities and install additional mRNA production lines. Doses can then be manufactured for less than $3 each. U.S. leadership is likely to inspire co-funding by other governments and international organizations. A total investment of less than $25 billion, including whole-of-government efforts to source raw materials and provide technical assistance, can support the rapid production of 8 billion doses of mRNA vaccine, enough for more than half the world's population.
  • The United States should support a massive expansion of manufacturing and establish hubs for vaccine production together with the WHO. Hubs would be located not only in North America and Europe but also in Africa, Asia, and Latin America, democratizing production and improving global health security, particularly if they are accountable to the public and equipped with adaptable technologies, such as mRNA platforms, believed critical to defeating the next pandemic.
  • The United States should ensure that technology is shared openly so that scientists and manufacturers worldwide can support vaccine delivery and development. Where necessary, the U.S. government should use its power under existing domestic law to license technology, ensuring its availability and affordability now and for the future. Notably, taxpayers made substantial investments in Covid-19 vaccine research and development, and the U.S. government owns a key patent relied on by the major vaccine makers.

"World leaders must work together urgently to translate the progress of the WTO waiver into the cooperation needed to produce billions more doses," Maybarduk added. "The United States cannot do this alone. But it will take the world much longer to end the pandemic without us."


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