The US is playing to domestic political interests favoring a more diplomatically friendly strategy but also sees broader vaccine distribution as a piece of its global power conflict with Russia and China. Germany appears more concerned about protecting the intellectual property of its manufacturing base so favors donating vaccines to needy countries rather than giving away the IP. JL
Saeed Shah and colleagues report in the Wall Street Journal:
The U.S. said it would support a temporary waiver of provisions protecting the intellectual property associated with Covid-19 vaccines, a move developing countries have pushed forLukewarm reactions in Europe to the U.S. move suggest negotiations could drag on. The government in Germany, home to BioNTech SE and CureVac NV, two of the leading developers of mRNA vaccines, came out against the waiver. Trade officials, health authorities and pharmaceutical executives say lengthy international negotiations required to lift patent protections and technological challenges involved in making new vaccines mean the impact of such a move may not be felt for months or years.
The U.S. decision to back an effort to open up the intellectual property underpinning Covid-19 vaccines is stirring hope that more drug manufacturers, particularly in poor countries, can start churning out shots they sorely lack.
But trade officials, health authorities and pharmaceutical executives say lengthy international negotiations required to lift patent protections and technological challenges involved in making new vaccines mean the impact of such a move may not be felt for months or years.
Instead, in the short term, additional supply could come from extra capacity drug companies are currently adding, as well as new licenses they might extend to more contract manufacturers around the world. Developing-world countries have also been pressing rich countries to release unneeded vaccines to them.
On Wednesday, the U.S. said it would support a temporary waiver of provisions protecting the intellectual property associated with Covid-19 vaccines, a move developing countries have pushed for as coronavirus infections and deaths surge in poor nations.
“On the current trajectory, if we don’t do more, if the entire world doesn’t do more, the world won’t be vaccinated until 2024,” said Secretary of State Antony Blinken on Thursday during an interview on MSNBC. “We can speed this up and get that done, I think, in a much shorter time.”
In early October, India, which is currently at the epicenter of the pandemic, and South Africa introduced a proposal to the World Trade Organization to waive patents linked to Covid-19 vaccines, treatments and diagnostics. They have since gained the support of more than 100 countries.
South Africa and India will present a revised waiver proposal later this month at the WTO, said Mustaqeem de Gama, an official at South Africa’s mission to the trade body. After that, talks on the scope and duration of the waiver could take months.
Lukewarm reactions in Europe to the U.S. move suggest negotiations could drag on. “We are ready to assess how the U.S. proposal could help” increase global vaccinations, Ursula von der Leyen, the president of the European Commission, said Thursday.
The government in Germany, home to BioNTech SE and CureVac NV, two of the leading developers of mRNA vaccines, came out against the waiver on Thursday.
Even with U.S. support, governments might not agree on the details of the waiver for several more months, said WTO Director General Ngozi Okonjo-Iweala. Even then, other challenges remain, she said, such as the terms under which drugmakers would transfer technical know-how to manufacturers who lack the expertise to produce vaccines.
Despite momentum behind a waiver, “it will still take time,” she said. “I think it would be naive to think that all of a sudden this thing is going to be resolved.” It could take six to nine months before plants produce their first doses, she added.
While negotiations continue, the WTO has hosted talks between vaccine manufacturers and drugmakers in Bangladesh, Pakistan, India, Egypt, Indonesia, South Africa and Senegal, that could generate new production agreements.
That, along with less demand in Europe and America, may help ease acute shortages toward the latter half of this year. By August, the World Health Organization expects doses to be more widely available in developing countries. Still, poor countries are concerned that a new coronavirus variant—or another pandemic altogether—could once again spark a global scramble for vaccines made almost exclusively in a small number of mostly wealthier states.
“You can see the concentration of manufacturing in the world and you can see that the politics of that doesn’t work,” said Dr. Okonjo-Iweala. “When countries are caught, it’s very difficult for them to tell their populations, ‘We are going to export.’ ”
“We don’t know whether this pandemic is going anywhere. Nobody knows,” she added.
Drugmakers say that waiving the intellectual property wouldn’t relieve shortages quickly because contract manufacturers aren’t familiar with the know-how required to make the vaccines—technical knowledge that isn’t shielded by patents. Those manufacturers would also need to secure regulatory approval as well as large-scale funding to buy new machinery and adapt their production to the new technology.
Brook Baker, a professor of law at Northeastern University, said that the most immediate impact of the U.S. decision would be to push companies now to cooperate in voluntary transfer of technology globally, before they are compelled.
Vaccine makers also appear to be trying to increase supplies. BioNTech, which developed a Covid-19 shot with Pfizer Inc., said Thursday that it is seeking to establish a network for manufacturers to expand supply of its shot. It also appealed to governments in rich countries to release their own stocks of unneeded vaccines to the developing world.
Novavax Inc., another vaccine manufacturer, has recently struck an agreement to supply 350 million doses to Covax, an initiative backed by the WHO to supply free vaccines to developing nations, starting in the autumn. The shots come from a manufacturing network funded by the Coalition for Epidemic Preparedness Innovations, or CEPI, a foundation that helps finance vaccine research for emerging diseases and is also part of Covax.
Even as some contract manufacturers in the developing world press for licenses to make the vaccines, they acknowledge the challenges in scaling up production.
Abdul Muktadir, chairman of Bangladesh’s Incepta Pharmaceuticals Ltd., said some contract manufacturers already have facilities installed to make vaccines using protein subunit technology. Almost a third of the 96 vaccines for Covid-19 that have reached the clinical phase of development are based on the protein subunit platform. Out of Western vaccines using this technology, the closest to regulatory approval is one developed by Novavax.
Nonetheless, Mr. Muktadir said, regulatory approval for vaccines from new production lines could take time.
“This waiver is going to open up new windows,” he said. “But it’s not like they say ‘yes’ and from tomorrow all the vaccines are churning out from many different factories. It is going to take time.”
In the longer term, a patent waiver could give manufacturers and financial institutions the legal certainty that investments in new machinery and extra staffing won’t go to waste, said Matthew Kavanaugh, an assistant professor for global health at Georgetown University.
Khalid Mahmood, chief executive of Getz Pharma, a medicine manufacturer in Pakistan, plans to establish a vaccine manufacturing plant capable of making mRNA vaccines, and is willing to invest up to $100 million.
Nonetheless, it would take two years before production started, he said. For instance, the waiting time for the delivery of a bioreactor, a tank in which the biological material used to make vaccines is grown, is currently a year.
“The pandemic will stay, we’re betting on that,” said Mr. Mahmood.
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