President Joe Biden announced Monday that the United States would ship its stockpile of millions of Astrazeneca doses overseas to help countries struggling to vaccinate their populations “as the doses become available.” It remains unclear when these doses will become available, and the Biden administration has yet to decide where these vaccines will go.
This is a start, but as cases surge in India, it’s nowhere close to the measures the United States can and should take to get the spread under control.
On April 26, India registered 323,023 new coronavirus cases and more than 2,700 deaths. Between April 20 and 26, more than 2.3 million cases were reported.
While Indian Prime Minister Narendra Modi’s government has continued to downplay the extent of the devastation, the ground reports tell a story of death, chaos, and a collapsing health care system. Hospitals across the country are struggling to stay operational as they face severe shortages of vaccines, essential life-saving medicines, oxygen, ventilators, and beds. They’re turning away patients, and families are pleading for medical help on social media. Crematoriums have been working around the clock with long lines of dead bodies waiting to be cremated; graveyards are running out of space. People looting oxygen cylinders and patients being left on the streets have been widely reported. While the ground reports are alarming, there are rising concerns that even those numbers might be underreported.
To stem the deadly second wave, on April 19, the Indian government announced that all adults would qualify for vaccines starting May 1, but a vaccine shortage threatens to derail this ambition. Adding to the crisis, the Serum Institute of India (SII), which manufactures the AstraZeneca vaccine, announced that it could not produce the required 100 million doses until July.
The crisis unfolding in India will have global ramifications. And so it needs a global approach that dismantles existing patent regimes and listens to the concerns and policy redressals recommended by India, South Africa, and other countries facing vaccine scarcities.
The only way to create equitable access is to declare Covid-19 vaccines a global public good and make this an accessible people’s vaccine by breaking the existing patent regimes, mass production of vaccines, and rapid distribution. In addition to its being the right thing to do, it’s crucial to remember that pharmaceutical giants received vast public investments to develop and produce the vaccines.
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There are immediate steps that the Biden administration can take towards this goal.
1. Renegotiate vaccine contracts that prohibit the US from sharing surplus vaccines with foreign countries.
Beginning with Trump and continuing under Biden, the United States hoovered up whatever vaccines it could get its hands on. It has now bought enough doses to fully inoculate 750 million people—three times the number of American adults. It has bought 100 million doses each from Johnson & Johnson, Novovax, and Sanofi, and 300 million doses each from Pfizer, Moderna, and AstraZeneca.
When the Trump administration signed contracts with Pfizer, Moderna, AstraZeneca, and Janssen, it included this proviso that enables the US government to endlessly stockpile vast vaccine reserves: “The Government may not use, or authorize the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States” or US territories.
The US government could easily have insisted on the ability to protect people across the globe by sharing vaccines; instead, it prioritized the protection and profits of pharma companies instead. Now, over 80 percent of shots worldwide have been administered in high-income countries—one shot per second—while only 0.2 percent of doses have been administered in low-income countries.
Vaccine manufacturers are shielded from liability, with the US government as a guarantor of those sweeping protections thanks to the Public Readiness and Emergency Preparedness Act. No other country protects its pharma companies this extensively, and the Trump administration was not required by law to do so. To the contrary, it had significant leverage and could have told vaccine manufacturers that “if [they] want the billions in procurement dollars then we want the flexibility to send [doses overseas],” as Sam Halabi, a scholar at the O’Neill Institute for National and Global Health Law at Georgetown University, explained to Vanity Fair. But the “America first” doctrine of belligerent nationalism has resulted in a concerted effort to entrench a system of medical apartheid.
President Biden has publicly indicated the United States would stop looking only inward. “If we have a surplus, we’re going to share it with the rest of the world,” Biden said in March. “We are going to start off making sure Americans are taken care of, first, but we’re then going to try to help the rest of the world.”
The time has come for Biden to fulfill that promise. The US government has administered 213 million vaccine doses, with an average daily administration of over 3 million doses. As of today, one in four Americans is fully vaccinated, and the country is safely on track to be fully vaccinated by July. These numbers demonstrate that the United States is in a clear position to donate its stockpile to countries in need—particularly India, Brazil, and South Africa—where deadly variants have developed or are developing.
2. Donate or “loan” Astra-Zeneca, Novovax, and Sanofi surplus to countries in which it has been authorized for use.
To get around the proscription on “donating” vaccines without breaching its contracts, the Biden administration agreed in March to “loan” 4 million doses of AstraZeneca manufactured domestically to Mexico and Canada. But the two countries had to separately negotiate contracts to indemnify AstraZeneca. On Monday, the White House announced that it will share its stockpile of AstraZeneca with foreign countries, once it clears federal safety reviews. While this is welcome news, details of this decision remain obscure, including which countries will have access to this vital stock.
Vaccines produced by AstraZeneca, Novovax, and Sanofi—of which the United States has stockpiled a total of 500 million doses—are not approved for use by the FDA. Even if all of these doses are donated to countries in need, the US would continue to possess more than enough J&J, Moderna, and Pfizer vaccines for its population. And with the American pharmaceutical company Merck repurposing its manufacturing plants to produce Johnson & Johnson vaccines (potentially up to one billion doses a year), the country has a guaranteed supply stream too.
Providing a paltry few million vaccines when it is sitting on hundreds of millions with the potential to produce billions more at this crucial moment in the pandemic is criminal.
3. Permanently remove/repeal Defense Production Act (DPA) export restrictions on raw material required for the production of Covid-19 vaccines abroad.
Immediately after the inauguration, the Biden administration triggered the DPA to ramp up vaccine making. This enabled pharmaceutical companies to more easily procure essential raw material and equipment like 3M filters and plastic tubing. But the DPA requires that these companies “prioritize” domestic vaccine production, placing cumbersome restrictions on the exportability of the suppliers and manufacturers of these high-demand materials. Some are time-consuming bureaucratic impediments, like requiring the government to seek permission before exporting. The law permits the government to bar exports outright, at any time, creating instability and unpredictability in the global market. This embargo has already choked global supply chains.
Last week, Adar Poonawala, CEO and owner of the Serum Institute of India (SII)—the world’s biggest vaccine-producer—tweeted at Joe Biden pleading with him to “lift the embargo of raw material exports out of the United States so vaccine production can ramp up.” On Sunday, the Biden administration announced that it would make raw materials available to India to manufacture the vaccine, including PPE, ventilators, rapid diagnostic tests, and therapeutics.
But the US government has yet to provide how many supplies it intends to export or to give a sense of how many vaccine doses this would enable India to manufacture. There is also no indication of whether an exception was carved out for India, or whether the DPA export controls had been waived—either temporarily or permanently.
4. Waive—and eventually dismantle—WTO intellectual property rules for vaccines.
Health experts in India warn that the catastrophe cannot be contained without ramping up the country’s vaccine manufacturing capacity. Without removing insidious intellectual property protections that keep a vaccine apartheid in place, this will be impossible. These patent protections prevent lower income countries from scaling up production of generic versions of the vaccine and drugs at much cheaper costs. In addition to the patent, all the vaccine know-how, technology, and other components of manufacture can still be protected under IP laws, creating further roadblocks to the creation of affordable vaccines. The Biden administration has remained tight-lipped on the issue of a waiver, sparking concerns about the United States’ grand plans to monopolize the global vaccine supply chain.
Patents and intellectual property laws that have been put in place over the last 40 years inherently benefit wealthier nations and corporations at an enormous human cost for the rest.
If there’s one thing we must constantly bear in mind, it is that we are only as safe as the most vulnerable person. This vaccine apartheid that privileges profits over people will continue to cost countless lives and extend the pandemic as the virus mutates. The death and devastation will have disastrous global ramifications. We need to take steps immediately to make the vaccines available to everyone, everywhere, and free of charge—to treat the Covid vaccine as a global public good. No one is safe unless all of us are vaccinated.
