The U.S. Confronts a Virus ‘That Doesn’t Understand Borders’

https://www.nytimes.com/2021/05/10/us/politics/covid-vaccine-patents-biden.html

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When the Biden administration announced last week that it would support waiving patent protections for Covid-19 vaccines in an effort to fight the coronavirus’s spread around the world, global health advocates hailed the move as a rare challenge to pharmaceutical interests — one that could potentially save a huge number of lives.

But so far, President Biden’s announcement has remained simply that: a statement.

Leaders of some wealthy European nations have pushed back, opposing the relaxation of patents and setting up a showdown among the member nations in the World Trade Organization. Besides, global health experts are saying that even if patents were suspended, vast amounts of international aid would still be needed to effectively disperse the vaccine.

Given the leadership role that Mr. Biden has said he is committed to reasserting on the world stage, the administration now confronts a daunting reality: that no person anywhere is safe until the virus is controlled everywhere. And with vaccine access heavily concentrated in the richest countries, a global solution still appears far off.

“We need to have an end-to-end solution for getting these vaccines to a huge chunk of the global population,” Saad Omer, the director of the Yale Institute for Global Health, said in an interview.

The stakes are high, and not just for the billions of people around the globe who remain unvaccinated. Epidemiologists agree that until the virus is contained everywhere, dangerous variants will continue to develop in infected areas. This will threaten people in all nations, including those that have been widely vaccinated.

“There is a humanitarian reason to help the world, but also a self-interest reason as well, especially when we know there are variants that will develop,” Leana Wen, an emergency physician and public health professor at George Washington University, said in an interview. “This is a virus that doesn’t understand borders.”

With this in mind, Katherine Tai, the U.S. trade representative, announced on Wednesday that Mr. Biden would support suspending patent protections for virus vaccines, allowing those made by pharmaceutical companies in the United States and elsewhere to be replicated by other manufacturers across the globe.

“This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures,” Ms. Tai said in a statement. “The administration believes strongly in intellectual property protections but, in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.”

Some European leaders, including President Emmanuel Macron of France and Chancellor Angela Merkel of Germany, pushed back, saying that American pharmaceutical companies should be compelled to export vaccines around the world in large numbers, but should not be forced to temporarily give up their patents — a nod to an argument from manufacturers that loosening the patents would threaten their profits and de-incentivize research in the future.

Irwin Redlener, the director of the Pandemic Resource and Response Initiative at the Columbia University Earth Institute, said that the argument rang hollow, considering that so much public money was invested last year in researching and developing the Covid-19 vaccines. He also pointed to the fact that the vaccines have already brought in hundreds of millions of dollars in profits for U.S. companies.

“These manufacturers have made fortunes already, and much of the development cost was actually borne by the U.S. government,” Dr. Redlener said. “So I’m a little skeptical about the crocodile tears being shed here by the manufacturers. They’re doing just fine and they will be doing just fine.”

Mr. Biden has always stipulated that he would put domestic distribution first, helping other countries only once all Americans had the chance to be vaccinated. But now, with demand in the United States dropping swiftly and some states even turning away the White House’s offers of more vaccine doses, pressure is building for Mr. Biden to direct more of his attention abroad.

The United States and some other wealthy nations have already offered millions of vaccines to nations in need, but those public displays of good will have only scratched the surface on the overall demand. And less than 1 percent of injections worldwide have gone to people in poor countries; most of the world’s population remains without access to shots.

Mr. Biden has pledged to invest $4 billion in Covax, a global vaccination campaign being partly guided by the World Health Organization, and to aid vaccine production in India specifically, where the virus is spreading aggressively and calls are mounting for a nationwide lockdown.

The W.H.O. last week approved the Sinopharm vaccine, produced by China, for use as part of Covax, which so far has struggled to make a dent in global demand. But that move will only do so much, since China — with its roughly 1.4 billion citizens — is still considerably farther away from meeting its own domestic needs than the United States is.

“Gearing up manufacturing a vaccine is about more than relaxing patents,” said Richard Besser, the president of the Robert Wood Johnson Foundation, who served as acting director of the Centers for Disease Control and Prevention under President Barack Obama. “It’s going to take a concerted effort to transfer technology” to the rest of the world.

Dr. Besser also endorsed sending vaccines made in the United States abroad in large numbers. “Given that we’re hearing that states are turning down some of their doses, that makes me think there could be Pfizer, Moderna or Johnson & Johnson vaccines that could be made available to other places,” he said.

And producing enough vaccines is only part of what’s needed: CARE, an international nonprofit, has estimated that effectively distributing a vaccine dose costs, on average, five times as much as does simply creating that dose. Even in countries where a large number of vaccine doses have been sent, many are going unused because of a lack of distribution infrastructure, including a scarcity of health care professionals to administer shots.

In India, the second-most-populous country in the world behind China, production issues have severely compromised vaccine access; not even 3 percent of India’s population has been fully vaccinated so far. Meanwhile, a relative lack of restrictions on gatherings has led to a spike in cases, with more than 350,000 new infections daily recorded this month (observers say the unofficial count is probably far higher).

Michael Mina, an epidemiologist at Harvard University, said that the United States and other wealthy nations had cornered the market on vaccines without laying the groundwork for equitable distribution.

“We’re talking about a pandemic that is in the process of destroying huge swaths of India — and only now are we talking about, ‘Hey, let’s see if we can release patents so that whole new companies can get started building these from scratch.’ What’s the timeline there?” Dr. Mina said.

He argued that the United States would have been wise to compel pharmaceutical companies to scale their vaccine production to international demand, not just domestic needs, starting last year.

“In the context of a pandemic, foreign aid is domestic aid,” Dr. Mina said. “What’s happening globally in a pandemic is truly a massive risk to ourselves and our livelihood. I would say we should even just consider this U.S. and global security, not necessarily ‘international aid,’ if that’s how we need to justify it.”

Dr. Wen said that loosening patents would not address the core problem of raw materials, specifically the need to produce more of the chemical reagent used to make vaccines. “Based on my understanding, the key limitation is raw materials and manufacturing capability — so I don’t understand how relaxing patent restrictions will overcome these issues,” she said. “The main bottlenecks that we’re seeing now are not about patents.”

Many experts argue that in the grand scheme, the Biden administration’s $4 billion investment in Covax — including $2 billion committed for this year, and another $2 billion pledged for 2022 — was at least as significant as its support for lifting vaccine patents.

Dr. Omer said that the administration should be using its commitment to pressure other wealthy nations to pitch in at commensurate levels, with the goal of investing roughly $20 billion in the global distribution effort.

“For a substantive global access program that targets 50 to 70 percent of the world, you would need approximately $20 billion of investment globally,” Dr. Omer said, adding that the United States’ investment in Covax could allow it to claim “the moral authority to bring other countries in Europe to the table.”

He echoed Dr. Mina’s argument that the global health community was racing against a clock that, in many ways, had already ticked down. “The time to engage seriously at a high magnitude is June 2020. We are already late,” he said. “We need to be strategic, but we are fighting over tactics.”

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