After months of hoarding coronavirus vaccines in the United States, doses to vaccinate at least 13 million people are now in danger of expiring. Meanwhile, domestic vaccination rates have stagnated, global need has intensified, and dangerous new variants proliferate. In an interconnected world, ensuring that those doses aren't wasted is both humane and prudent — and the United States has several options to avoid that fate.
Vaccines sitting on shelves throughout the country were intended for tens of millions of Americans who are eligible but not fully vaccinated. Efforts to persuade this population to protect themselves and others must continue and are clearly a federal priority, but we cannot risk massive waste in the unrealistic hope that U.S. vaccination rates will suddenly spike with sufficient speed. State governments get it: according to STAT News, many states "started seeking federal assistance in redistributing excess vaccine internationally in April," as India faced a COVID-19 crisis. But no assistance came.
What are the barriers to sending doses abroad? That's not entirely clear, because federal officials haven't been explicit. One set of considerations is logistical. For example, it could be tricky — and expensive — to gather up the extra doses so they can be shipped elsewhere. In addition, states possess but don't own the vaccines that were provided to them by the federal government, necessitating permission from the feds before the states can take action.
Another likely hurdle is the contract language added by vaccine manufacturers and agreed to by the Trump administration. These agreements state: "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 U.S. territories.
Why would vaccine manufacturers care where their products are used? Because they want protection from liability should their vaccines cause harm. U.S. law does just that, while also offering compensation to injured patients. But as any lawyer will tell you, contracts are rarely bulletproof.
For example, the United States previously "loaned" vaccines — language that apparently allowed it to get around contractual limitations — to countries including Mexico and Canada, although those countries still had to work out agreements to indemnify manufacturers from liability. There's no clear reason this couldn't be done again or expanded to other countries willing to make similar agreements, some of which are confident they can use soon-expiring vaccines.
Alternatively, excess vaccines could be provided to foreign nationals on U.S. territory, perhaps in the transit areas of international airports, or — to reach higher-risk populations — at border checkpoints that workers traverse daily. Residents of neighboring countries could be allowed to briefly enter for vaccination, as some Native American tribes have done for Canadian neighbors. Even if these approaches don't use every surplus dose, they are far better than using none.
Another option would be for the United States to breach these restrictive contractual provisions and leave it to vaccine companies to sue. We could have receiving countries agree to indemnify us for the costs of such lawsuits or accept the risk ourselves as a form of international aid. No magical curse befalls someone who breaches a contract. Rather, the manufacturers — who have already been paid for the vaccines — would have to show they suffered damages from vaccine donation.
But that's unlikely if the United States sends vaccines to countries that offer their own liability protections. Remember, too, that the coronavirus vaccines used in the United States for months now are extremely safe, offering further protection against liability. Manufacturers would have to weigh serious public relations concerns if their legal threats resulted in vaccines being trashed. Given the U.S. market share, we're also not worried that breach would inhibit negotiations in future pandemics.
Quickly sending extra vaccines abroad will likely save the most lives, but there are also important domestic possibilities to consider. The most promising of these would be to adopt widespread vaccine mandates. This approach thankfully is garnering increasing support, even as the vaccines remain under emergency use authorization, or EUA.
Making some vaccine doses available to Americans who aren't currently eligible could also boost demand at home. There are a number of ways to do this, some more controversial than others, but none are more extreme than allowing vaccines to go to waste.
For example, consider that existing EUAs bar children under 12 from access, even though there's no sharp biological difference between 12-year-olds and currently ineligible 10- or 11-year-olds. Using doses as boosters for adults also remains unauthorized, despite evidence that they are beneficial to immunocompromised people and may benefit those who received the single-dose Johnson & Johnson vaccine.
The Food and Drug Administration could broaden the terms of the emergency-use authorizations — or better yet, grant full approval, as many have already suggested. Full approval would likely encourage more people to get vaccinated, while also freeing clinicians to offer "off-label" dosing options beyond the specific terms of the approved use and population. Having more data to support extended uses would obviously be best, but off-label prescribing is quite common, including in pediatrics, oncology and HIV/AIDS care.
So what needs to happen to make sure vaccines sitting on American shelves don't expire en masse?
First, the FDA should work with vaccine manufacturers to extend expiration dates as far as scientifically reasonable. Second, the federal government needs to be ready to rapidly take custody of unused supply from states and localities interested in returning it, which may be logistically challenging but no more so than other feats accomplished during this pandemic. Third, the feds need to stop worrying about getting sued and move quickly to share vaccines globally — saving lives is most important and legal risks are manageable. And fourth, as a last resort, we need to seriously consider our domestic options, with vaccine mandates at the top of the list.
Americans owe it to the world and to ourselves to figure this out.
Govind Persad is an assistant professor at the Sturm College of Law at the University of Denver. Holly Fernandez Lynch is the John Russell Dickson, MD presidential assistant professor of medical ethics in the department of medical ethics and health policy at the Perelman School of Medicine, University of Pennsylvania.