Opinion: A solution to the murky legal status of vaccine mandates: rewrite vaccine EUAs

It has been quite a week for vaccine mandates in the United States. The Department of Justice’s Office of Legal Counsel (the president’s lawyer) expressed its opinion that it is legal to mandate vaccination with vaccines distributed under emergency use authorization. The Department of Veterans Affairs became the first federal agency to mandate Covid-19 vaccination for its frontline health care workers. New York City and the state of California declared vaccination or regular Covid-19 testing obligatory for their workforces.

Vaccination is the key weapon in our nation’s battle against Covid-19. Either we quickly get closer to full immunity as a nation or we are doomed to another fall and winter of school shutdowns, business closures, fewer recreational opportunities, and more masking and social distancing, with all the likely deaths that new strains of SARS-CoV-2, the virus that causes Covid-19, entail.

Despite this grim reality, vaccine uptake is inadequate. Leaders have tried begging, pleading, and cajoling, but full vaccination in many states and counties hovers around 30%. Some states and cities have tried incentives such as free meals, drinks, lottery tickets, hunting licenses, vacations, cookies, and even marijuana, but to little avail.

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We believe that the solution to this public health crisis is to institute vaccine mandates, set by government or by private businesses and institutions. A vaccine mandate refers to imposing a consequence for vaccine refusal. The consequence can be a fine or denial of access to a service, job, or venues like hotels, cruise ships, and sports events.

Vaccination has historically been mandated for legal immigration into the U.S., for the military, and for school children and college students and health care workers. So what is holding up mandates for Covid-19 vaccination?

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The biggest obstacle is that the three main vaccines used in the U.S. are not yet fully licensed and there is legal uncertainty surrounding whether a vaccine distributed under emergency use authorization can be mandated.

Many employers, agencies, and schools have been hesitant to impose mandates because they are concerned that courts will find it illegal to mandate a vaccine that is distributed under emergency use authorization, rather than under full Food and Drug Administration authorization.

The opinion from the Department of Justice should give them confidence, but does not really solve the dilemma. Although this opinion is well-reasoned and persuasive, it carries little legal authority outside the federal government, and would likely get limited deference in court. But the opinion includes a way to remove legal hurdles: The FDA can amend the emergency use authorization documents for the Covid-19 vaccines to make it clear that mandates are permitted.

The current law allowing the secretary of Health and Human Services to give emergency use authorization for drugs and vaccines was enacted into law in 2004. Under its provisions, the HHS secretary can, under some circumstances, allow use of an unapproved product on an emergency basis. The secretary has delegated that power to the FDA, and the FDA has given emergency use authorization for the three Covid-19 vaccines.

This is a new situation: It is the first time a vaccine is being given to the entire population. What creates the uncertainty is that the law requires the HHS secretary to make sure vaccine recipients know “of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product …” Some read this language as prohibiting mandates: If someone can legally refuse the product, a mandate is not possible. Others argue — an argument accepted recently by a Texas court — that the provision speaks only to the HHS secretary, not to states, employers, universities and others who may mandate.

So the legal situation is murky. And full licensure of the vaccines is still months away, leaving many entities that could impose mandates hemming and hawing while new strains of SARS-CoV-2 spread rapidly.

But no one needs to wait for licensure. The solution for mandates is obvious: Either the HHS secretary or the FDA commissioner can — and should — edit the emergency use authorizations to say that “refusing the vaccine may lead to one or more of the following consequences: loss of employment, limits on access to education, or limits on access to businesses and private enterprises.”

The FDA has more than enough safety and efficacy evidence to support such a modification, and should act promptly to change the emergency use authorizations. If the FDA won’t do it, HHS Secretary Xavier Becerra should do it.

The nation should not tolerate more deaths, hospitalizations, shutdowns, and economic and personal ruin. The key solution to promptly getting mandates requires our health bureaucracy to act, and act now, to rewrite the emergency use authorizations.

Arthur L. Caplan is professor of bioethics and the founding head of New York University School of Medicine’s Division of Medical Ethics. Dorit R. Reiss is a professor of law at UC Hastings College of Law.

Source: STAT