As the number of COVID-19 cases in the United States falls and the economy recovers, India is experiencing a deadly resurgence of the coronavirus, with more than 370,000 new infections and 3,500 deaths every day. Hospitals in Delhi are running out of oxygen, and crematoria have used all of their firewood. Experts predict that the surge is nowhere near its peak.
The Indian crisis is precipitating a global one. One-third of the world currently relies on vaccine exports from a single company in India. However, to meet the overwhelming domestic need, India banned vaccine exports, which means that countries in sub-Saharan Africa are now scrambling for vaccines—leaving their population more vulnerable to resurgences of the virus. Ayoade Alakija, a co-chair of the African Vaccine Delivery Alliance, told the Financial Times, “We’re at the point where we’re rearranging deck chairs on the Titanic.”
President Joe Biden must help, by removing patent barriers and making vaccine technology available to other countries.
We know that the surest path out of the pandemic is vaccinating as many people as possible, as quickly as possible. More than 30 percent of the U.S. population has been fully vaccinated, compared with about 2 percent in India. While the Biden administration’s recent decision to give away 60 million doses of the AstraZeneca vaccine is welcome, that number is not enough to ease the Indian crisis or prevent a similar crisis from occurring in another poor country. Even if more vaccines were promised for overseas use in the future, the gesture would be insufficient: The administration simply does not have enough vaccines under its control to donate its way out of this problem.
We need to be vaccinating billions of people quickly, and to do that we must manufacture more vaccines in India, and also Bangladesh, Indonesia, South Africa, Ghana, Turkey, Brazil, Argentina, the United Arab Emirates, China, Russia, and anywhere else with the capacity to do so. Biden can make that happen by compelling pharmaceutical companies in the U.S. to share their vaccine recipes. Each recipe has two ingredients: the legal rights to make the vaccine, and a guide to manufacturing it. Yet, despite promising in a conversation with the universal-health-care advocate Ady Barkan last year to make the recipes available, and repeating his intention as recently as last week, Biden has not yet followed through.
The path forward is clear. First, the U.S. government can support a proposal made by South Africa and India at the World Trade Organization to temporarily suspend intellectual-property rights. The proposal has been languishing at the WTO since October, despite overwhelming support from developing countries, because of opposition from the U.S., as well as from Canada, Australia, the European Union and the United Kingdom. (The diktat of a few giant corporations, it would seem, takes precedence over the will of the people, even in a global emergency.) The Biden administration should reverse course at the WTO meeting this week and reject claims by the pharmaceutical industry that the proposal is merely a “thinly veiled attempt” to boost the Indian drug industry, never mind the crisis ripping through the country—or that a suspension of intellectual-property rights risks giving China and Russia the ability to "exploit" lifesaving technology, as though that were somehow a bad thing.
Secondly, the Biden administration has the power to require Johnson & Johnson and Moderna, in particular, to share the technology behind their vaccines, because American taxpayers funded them into existence. The U.S. government invested more than $1 billion in J&J’s research, covering a significant portion of the effort. Moderna, by its own admission, had 100 percent of its research costs covered by a $1 billion investment from the government.
Each vaccine has distinct advantages. The J&J vaccine is a single dose, making its use easier in countries with strained resources. The Moderna vaccine is based on novel mRNA technology that does not require the cultivation of biological material, including viruses and proteins, which traditional vaccine technologies rely on, making production relatively simple. (American taxpayers funded a portion of the research behind two other vaccines, Novavax and AstraZeneca, and the government could also consider how to make them more available.)
Although the Trump administration signed away much of the government’s power over the vaccines it funded, the Biden administration retains significant leverage. The president can lift patent barriers through a little-known but powerful law called government patent use. (Moderna, for its part, has already pledged not to enforce its patents during the pandemic, but the problem is that it does not own all the patents on its vaccine.) To share technology globally, the administration can invoke the Defense Production Act, which it reportedly relied on to force J&J to share its technology with a rival, Merck, so more of the vaccine could be made for Americans. The Defense Production Act gives the U.S. government wide authority to address health emergencies, including by providing “critical infrastructure assistance to any foreign nation.”
So what’s behind the administration’s reluctance to make vaccine recipes widely available everywhere in the world? The pharmaceutical industry’s main argument for not sharing the recipes—that every manufacturer capable of making vaccines is already doing so—has gained traction within the administration and elsewhere, including among some surprising people. In an interview with Sky News last week, Bill Gates, the largest private donor to global health efforts through the Bill & Melinda Gates Foundation, was asked whether sharing the recipe would help. “No,” he replied, adding, “There’s only so many vaccine factories in the world, and people are very serious about the safety of vaccines. And so moving something that had never been done, moving a vaccine from, say, a J&J factory into a factory in India—that’s novel.”
This assertion that manufacturers aren’t able to begin making these recipes is simply not true in the West, where, for instance, Biolyse, a Canadian pharmaceutical company, has spare capacity to make the J&J vaccine. But it cannot do so, because J&J won’t allow it. And it’s not true outside the West, where the pandemic has dramatically changed the landscape of vaccine manufacturing, prompting cooperation across governments and private industry and resulting in a spate of new ventures. Cuba’s Soberana 02 vaccine, developed by a state institute, will be manufactured in Iran. Covaxin, a privately developed Indian vaccine, will be produced at three state facilities in the country, after the Indian government forced the company to share its technology. A new private facility in Abu Dhabi, in the United Arab Emirates, will produce hundreds of millions of doses of a vaccine developed by China’s state-owned Sinopharm Group. In Brazil, the Instituto Butantan, a state-funded biologics-research center, is producing CoronaVac in cooperation with a private Chinese company, Sinovac. And in India, the Russian Direct Investment Fund (RDIF) contracted with six pharmaceutical manufacturers to produce the Sputnik V vaccine, which is similar to the J&J vaccine.
We spoke with Hemanth Nandigala, the managing director of one of those manufacturers, Virchow Biotech in Hyderabad. The 20-year-old company produces a range of complex pharmaceuticals, though it had never made vaccines before. Nandigala described the process of obtaining a license for Sputnik V as “kind of like Linux; it’s almost open access.” After signing a technology-transfer agreement with the RDIF, Virchow Biotech took on all of the investment risk. Nandigala repurposed an existing 35,000-square-foot facility and assigned 30 employees to making Sputnik V. The RDIF guaranteed minimal but useful technical help, via a Russian pharmaceutical company, which provided a rotating cohort of 10 people who together serviced all six companies in India that obtained a license. Each company is regulated by Indian law and must adhere to strict approval from both India and any other country that receives the vaccines. Nandigala has made all of the required changes, and received the ongoing approvals he needs, in record time, reflecting the urgency of the moment: He began talks with the RDIF in December and expects to roll out 50 million Sputnik V doses a month by July. His company’s total investment was $11 million.
We asked Nandigala whether he would sign up to make the J&J and Moderna vaccines, if offered the opportunity. “It’s a no-brainer,” he replied. His experience indicates that if the vaccine recipes were available, manufacturing interest would follow.
The United States has the chance to elevate vaccine manufacturing around the world, both by immediately making two World Health Organization–certified vaccine recipes available and by eventually funding the infrastructure to manufacture even more of them. That would be real vaccine diplomacy and would enable, within months, a massive scale-up of vaccination efforts globally.
As the Biden administration looks to match its recovery plans with President Franklin D. Roosevelt’s New Deal, we recall FDR’s appeal from that time. “The test of our progress is not whether we add more to the abundance of those who have much,” he said. “It is whether we provide enough for those who have too little.”
Last year, Donald Trump threw away the opportunity to vaccinate the world. President Biden now has the power to correct that tragic mistake. Doing so immediately is in the United States’ and the world’s best interests.