Seven months later, as the U.S. vaccine rollout nears its peak and life veers back toward normal, Washington has reversed its position to support a short-term waiver, angering drug companies while infusing hope into efforts to ramp up vaccine production as severe shortages coincide with enormous waves of virus infections in India, Latin America and other parts of the developing world.
“The notion that ‘no one is safe until everyone is safe’ is true, and the Biden administration seems to have finally taken that to heart,” said Fatima Hassan, a South African human rights lawyer and founder of the Health Justice Initiative, which was part of a global campaign for a generically produced “people’s vaccine.”
“Did it take them seeing people in India dying on television to make this decision?” she asked. “Maybe, but however late this comes, attention now needs to turn immediately to getting other vaccine-producing countries to follow.”
The statement, issued Wednesday by U.S. Trade Representative Katherine Tai, said the United States will move forward with international discussions to waive the protections for the duration of the pandemic.
World Trade Organization Director General Ngozi Okonjo-Iweala said in an interview Thursday that she was pressing member countries to reach an agreement on the waiver no later than December.
“It’s not overnight that we’re going to be able to scale up,” she said, adding that “it is very difficult to say now whether there is going to be a consensus.” She described the U.S. announcement as “helpful” and said it would give momentum to talks.
The U.S. statement did not appear to be a move coordinated with U.S. allies.
The German government voiced opposition to the U.S. proposal in a statement Thursday, saying it would have “significant implications” for vaccine production. The statement said the limiting factor in manufacturing vaccines is production capacity and quality control rather than patents. “The protection of intellectual property is a source of innovation and must remain so in the future,” it said.
Canada and Britain’s trade ministers as well as the European Commission president issued statements indicating their willingness to continue discussions, but they did not commit to any change of stance.
The European Union’s top vaccine czar, Thierry Breton, pointed to concerns about supply chains, expressing skepticism that it made sense to open up the patents immediately. He noted there were many barriers to speeding up production, including access to the raw materials.
“When we will be able to reach this without destabilizing the ramp-up and the supply chain … I could tell you, ‘Yes, the supply chains now are solid, the ramp-up is effective, so yes, it is the time to do it,’” Breton said. “Personally I think it will be good to do it quickly, but as I said always, everything at its time.”
French President Emmanuel Macron took time on the sidelines of a visit to a vaccination center to say that he was in favor of “opening up intellectual property” but that a waiver wouldn’t have much effect without a concrete plan to transfer technology and know-how.
Those technical details — such as how quickly a factory in India, for instance, could actually start churning out vaccine doses based on Pfizer’s formula should it gain access to it — were certain to be tricky if a temporary waiver does eventually come through. And even that is not a given.
It remained unclear whether other countries that had been blocking the waiver, which include almost all of Europe as well as Japan, Canada, Brazil, Australia and Singapore, would follow suit. Those negotiations, which would take place under the auspices of the World Trade Organization, would determine whether Washington’s change of stance leads to the ramping up of production of generic vaccines.
The process to hammer out a deal could take months and result in a narrow interpretation of intellectual property rights. The WTO has met 10 times in the past seven months on the original waiver proposal. The organization’s rules stipulate that any decision has to be made by consensus, meaning any country could hold up a coordinated move on intellectual property waivers.
Ultimately, such a waiver might come into effect only later this year, once vaccine manufacturers in the West have boosted production.
Western pharmaceutical giants such as Pfizer stand to make billions of dollars off coronavirus vaccines alone, and they have received billions more in subsidies from the U.S. government. The industry opposed the short-term waiver, warning of dire consequences for vaccine development and manufacturing going forward.
On Monday, the Pharmaceutical Research and Manufacturers of America condemned the U.S. decision. “In the midst of a deadly pandemic, the Biden administration has taken an unprecedented step that will undermine our global response to the pandemic and compromise safety,” president and CEO Stephen J. Ubl said in a statement.
Wednesday’s news was welcomed in India and South Africa, both hit hard by the pandemic but where vaccination campaigns are far behind those in the United States and Europe.
South African President Cyril Ramaphosa praised the new U.S. stance in a statement and said the “anticipated temporary waiver provides a global response” to the pandemic.
“For countries that do not currently have manufacturing capacity on certain medical technologies, the waiver could open up more supply options and avoid countries being reliant on only one or two suppliers,” he said.
India’s Ministry of External Affairs welcomed the U.S. decision, calling it an “important step for enabling rapid scaling up of manufacture and timely availability of affordable Covid 19 vaccines and essential medical products.”
“We are hopeful that with a consensus based approach, the waiver can be approved quickly at the WTO,” the ministry said in a statement issued Thursday.
The Indian government had been lobbying for a relaxation of the patent regime for coronavirus vaccines for months. Prime Minister Narendra Modi brought up the topic in a call with President Biden in April, and Indian diplomats have reportedly reached out to U.S. senators to appeal for their support.
A spokesman for Serum Institute of India, one of the world’s largest vaccine makers, did not immediately respond to a request for comment on the move. Serum is manufacturing vaccine doses under licensing deals with large U.S. and European pharmaceutical companies.
The vaccine supply crunch has made it difficult for Covax — a World Health Organization-backed effort to equitably distribute vaccine doses — to get off the ground. The program aims to deliver up to 2 billion doses by the end of the year, targeting 20 percent of the population of participating low- and middle-income countries, but under current conditions, some countries could be waiting until 2023 to secure what they need.
So far, Covax has delivered only 53 million doses, with deliveries well behind schedule.
The huge wave of infections in India — where many of Covax’s doses are being manufactured — has slowed the international effort’s timeline, leaving many countries wondering when or if their next doses will arrive. For months now, governments, public health experts and rights advocates have urged policymakers to address the growing gap by focusing not just on sharing available doses but also on dramatically expanding supply.
Many of these voices now stress that a waiver is a helpful but not sufficient step toward ramping up vaccine production.
“The US must also demand that pharma companies that received significant amounts of US taxpayer funding to create these vaccines share the technology and know-how with other capable manufacturers to protect more people worldwide,” Doctors Without Borders said in a statement.
Since October, at least 60 countries became co-sponsors with India and South Africa on the proposal, and at least 40 more voiced their support. Most of them are in the Global South, which includes Latin America, Africa, and South and Southeast Asia.
“This development represents true leadership in a time of need,” said John Nkengasong, director of the Africa Centers for Disease Control and Prevention, the continent’s main public health body. “When the history of the covid-19 pandemic will be written, the decision of this waiver by the U.S. government will be remembered as pivotal in our fight against this terrible virus.”
The U.S. announcement came as a win for South Africa, India and the broad coalition they built at the WTO, where delegations of civil servants, not politicians, persevered against a bloc of the world’s most powerful nations who seemed unready to budge.
“How could we have a situation with a global pandemic, and you keep considering vaccines a commodity?” said Hassan, the South African campaigner. “It was and is absurd. In a sense, it was rich countries and their pharmaceutical companies saying that intellectual property claims and the interests of shareholders on a very narrow set of items mattered more than the lives of millions of people — people in the Global South, in particular.”
Michael Birnbaum in Riga, Latvia; Lesley Wroughton in Cape Town, South Africa; Loveday Morris and Luisa Beck in Berlin; Rick Noack in Paris; Isabelle Khurshudyan in Moscow; and Joanna Slater in New Delhi contributed to this report.