By Lawrence O. Gostin / Special To The Washington Post
On Sept. 22, at a global covid-19 summit held in conjunction with the meeting of the U.N. General Assembly, President Biden asked the world’s leaders to “go big” on vaccine donations: He announced a goal of vaccinating 70 precent of the world’s population by next September.
The president was responding in part to growing discontent about global vaccine inequities: Some 79 percent of vaccinations have occurred in higher-income countries, compared with 0.5 percent in low-income countries. And Africa has vaccinated only 4 percent of its population.
There’s broad agreement that such a gap is intrinsically unethical, and, what’s more, that the situation could foster the creation of dangerous variants that make their way to the United States. Biden’s plan is a step forward, to be sure, but it’s clear that it will not meet the challenge before us. Fortunately, Biden possesses the authority — under the Defense Production Act — to go a lot further than his current plan. By invoking his full powers to act in the interest of national defense, he could vastly boost vaccine production both domestically and in hubs around the world, which could not only bring this pandemic under control much sooner but also help to prevent the next one.
For context, consider the sheer scale of the vaccine crisis. Reaching Biden’s 70 percent target would take around 11 billion doses (given the two-dose regimen for Pfizer, Moderna and other vaccines). And to get to true containment of the virus, we’d need 80 percent global coverage, around 12.5 billion doses. Yet the United States has so far donated only about 140 million doses. All told, Biden has pledged 1.1 billion doses; which is a long way from meeting the 70 percent goal. Our European, Canadian, and Japanese partners have done much less, donating (by my calculations) about 700 million doses combined. So, how could Biden and U.S. allies meet this vast global demand?
First, the United States is expected to have hundreds of millions of surplus doses by the end of this year. Vaccine doses designated for domestic use are not easily shipped abroad. But the White House could more accurately determine how many vaccines states actually need and arrange to ship excess vaccines overseas well before the doses are about to expire.
A more ambitious plan would involve declaring the global pandemic a threat to national security. That would allow the president — under the Defense Production Act, or DPA — both to order vaccine manufacturers to increase their capacities domestically and to enter into technology-sharing agreements with companies abroad. The DPA explicitly includes actions needed for “emergency preparedness” and to prevent debilitating impacts on “national public health.”
Ramped up charitable donations are urgently needed but they will never be enough to meet global need. That’s why vastly increased manufacturing of vaccines abroad makes more sense than a donations-only approach. Donations — whether of personal protective equipment (PPE), oxygen or vaccines — always seem to come late and in insufficient quantities. Empowering regional hubs to manufacture their own vaccines, in contrast, would amplify supplies globally and enable countries to serve their own needs and that of their regions; whether Africa, Latin America or Asia.
The most likely vaccine candidates for regional production also happen to be the most technologically advanced. That’s because mRNA vaccines can be manufactured more rapidly, and at larger scale, more easily than traditional vaccine technologies, such as that used in the Johnson & Johnson vaccine. (MRNA vaccines are produced by small chemical reactions and don’t need living components, like the weakened or inactivated viruses used in traditional vaccines). They are also more easily adapted to target emerging variants, because it’s possible to replace one sequence of mRNA in the vaccine for another in a matter of weeks. But Pfizer-BioNTech and Moderna have thus far kept their intellectual property and trade secrets close to the chest. (Moderna has said it will not enforce its patents related to its coronavirus vaccine, but that doesn’t mean it will share its patented information with others, let alone its manufacturing know-how.)
The vaccines were hardly developed purely by the private sector: Moderna received $2.5 billion from Operation Warp Speed, both Moderna and Pfizer benefited from over a decade of National Institutes of Health basic research funding for mRNA technologies, and NIH holds several key mRNA patents.
That strengthens the case for forcing the companies — in the name of national defense — to share their technologies. Under the DPA, the government would compensate the companies both for the costs of any additional production and for the technology-sharing arrangements. The government would determine “reasonable” compensation, and the drug companies could challenge the sum in courts, but there is nothing outrageous about this: The Fifth Amendment to the Constitution requires “just compensation” for a “taking,” which is simply the fair market value for the property, including intellectual property.
Some observers might worry that sharing our cutting-edge technologies in this way would lead to its being co-opted by other countries, especially adversaries such as China or Russia. We could hedge against that threat by requiring that foreign producers keep innovative technologies confidential and secure. And these producers would have to pledge to exclusively serve low-income markets, and not usurp richer markets in the United States and Europe. We’ve used that model before to empower foreign manufacturers to make antiretroviral medications for HIV.
Many have argued that foreign manufacturers don’t have the technical competence to produce cutting-edge vaccines. But countries including India, Brazil and Vietnam have a proven track record in vaccine production. And South Africa is already establishing a major mRNA vaccine technology transfer hub, with the support of the World Health Organization. (All it’s waiting for is cooperation from the innovator drug companies.) Countries such as Australia, Singapore and South Korea have invested in advanced vaccine technology but they, too, require cooperation from Pfizer and Moderna.
Increasing vaccine supply won’t be enough. Let’s not forget that delivering vaccine doses into arms in low-resource and rural settings is hard. A U.S.-led coalition would need to fund a strong vaccine infrastructure and train vaccinators and health communicators. MRNA vaccines need cold storage, including during transportation and at local distribution points; a logistical challenge in remote areas.
Changing policies to meet the global vaccine demand in the fashion I’ve described would be a big political lift for the president. He must convince Congress to fund a bold plan, order U.S. pharmaceutical companies to share their innovative technologies and rally the international community. But such an effort would yield immense dividends in saved lives and global economic productivity; and it would prevent ever more dangerous variants from reseeding a covid-19 surge in America.
Perhaps the most enduring accomplishments would be to end the reliance of poor countries on the rich; creating more ample supplies of lifesaving medical resources by diversifying manufacturing globally. That would make the world far more resilient when the next health crisis hits.
Lawrence O. Gostin is professor of global health law, Georgetown University, and directs the World Health Organization Center on Global Health Law. His book “Global Health Security: A Blueprint for the Future” will be published in Oct. 2021.