The claim: Employers, businesses and the government can’t mandate COVID-19 vaccines until they’ve been evaluated for two years
As millions of Americans continue to get vaccinated against COVID-19, some employers, colleges and businesses are weighing whether to make vaccination mandatory. A widely shared claim on social media says those measures are against the law.
An Instagram post published May 10 says Americans “have the right to refuse” coronavirus vaccine mandates.
“Under Emergency Use Authorization, no employer, biz, or govt can make the #COVID19vaccine mandatory until it’s evaluated in 2 yrs,” says text in the post, which is a screenshot of an April 1 tweet.
As evidence, the tweet cites “21 US Code SS 360bbb-3,” a federal law that has to do with “authorization for medical products for use in emergencies.” Instagram posts mentioning that law have received thousands of interactions over the past month, according to CrowdTangle, a social media insights tool.
The law cited in the posts has to do with emergency use authorizations from the U.S. Food and Drug Administration. The law says nothing about a required two-year evaluation period for vaccines approved for emergency use. While there is a legal gray area for mandating vaccines authorized for emergency use, businesses, employers and state governments generally have the power to require vaccination, experts say.
“There is no legal basis for what is being claimed,” said Ana Santos Rutschman, an assistant professor at Saint Louis University who specializes in food and drug law, in an email.
USA TODAY reached out to the Instagram and Twitter users who shared the claim for comment.
What the law does
The law cited in the social media posts is a section of the Federal Food, Drug, and Cosmetic Act that has to do with emergency use authorizations. It does not explicitly limit the ability of private businesses or state governments to require COVID-19 vaccination.
The law spells out how the secretary of Health and Human Services – whose department oversees the FDA – may authorize a “drug, device, or biological product” for use in an emergency, as designated by the HHS, Defense, or Homeland Security secretaries. All three coronavirus vaccines in the United States were approved by the FDA for emergency use, meaning they are technically not approved products, but the agency has permitted their use to prevent the spread of the coronavirus amid the ongoing public health emergency.
The law says nothing about a required two-year evaluation period before states and businesses can require vaccination. That figure may stem from clinical trial protocol for the coronavirus vaccines.
Pfizer and Moderna have both said they will monitor participants from their clinical trials for two years after their second dose. The FDA’s Center for Biologics Evaluation and Research is also monitoring the safety of COVID-19 vaccines that have been distributed to the public.
That process is not related to vaccination mandates, which 21 U.S. Code § 360bbb–3 does not mention.
"The statute says nothing directed at employers or universities," said Tony Yang, executive director of the Center for Health Policy and Media Engagement at George Washington University, in an email. "Instead, it addresses the actions of federal officials, such as the HHS secretary and the president – not private actors."
Businesses, employers, states can require vaccination
States and businesses generally have the right to require vaccines, legal experts say. But there are exemptions for people with disabilities and for people with religious, medical or philosophical objections. Meanwhile, some states have explicitly prohibited COVID-19 vaccine mandates.
Some state vaccination mandates are already on the books. For example, all 50 states have laws that require certain vaccinations for students to attend school, with some exemptions for medical, religious and philosophical reasons. To date, no states have mandated COVID-19 vaccination – but legal experts and public health officials say they could, in theory.
“The FDA does not mandate vaccinations,” said FDA press officer Alison Hunt in an email to USA TODAY. “Whether a state, local government, or employer, for example, may require or mandate COVID-19 vaccination is a matter of state or other applicable law.”
In guidance published Dec. 16, the U.S. Equal Employment Opportunity Commission said employers can set “a requirement that an individual shall not pose a direct threat to the health or safety of individuals in the workplace.” This can include vaccine requirements.
"This is a legal gray area, but there are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs," Yang said.
The Americans with Disabilities Act and the Civil Rights Act of 1964 offer some exemptions for employees with disabilities and “sincerely held” religious beliefs, respectively. In those instances, an employer must “show that an unvaccinated employee would pose a direct threat due to a ‘significant risk of substantial harm to the health or safety of the individual or others that cannot be eliminated or reduced by reasonable accommodation,” according to the EEOC. Employees that don’t receive a required vaccine eventually can be fired.
Businesses are generally free to require that customers show proof of COVID-19 vaccination, sometimes known as a “vaccine passport.” Legal experts have likened the requirement to a “no shirt, no shoes, no service” policy.
However, lawmakers in more than 40 states have introduced legislation – often backed by vaccine skeptics and advanced by Republicans – prohibiting COVID-19 vaccine mandates. Some measures prevent businesses from asking customers for proof of vaccination. The largest number of bills seek to prevent employers from requiring COVID-19 vaccines, USA TODAY has previously reported.
Legal gray area for EUA vaccines
Social media users say one provision of 21 U.S. Code § 360bbb–3 limits the ability of states, employers and businesses to require vaccines that were approved for emergency use. Legal experts say it's a gray area, but there's nothing on the books that would specifically prohibit those mandates.
One section of 21 U.S. Code § 360bbb–3 tells the HHS secretary to inform people of "the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks."
The key phrase in that provision: "the option to accept or refuse." By saying that, the law appears to suggest that requiring people to get vaccines approved for emergency use would be prohibited.
"Federal law treats EUA vaccines more like investigational new drugs when it comes to insisting on consent, and in different ways that complicate public and private efforts to mandate usage," said Lars Noah, a law professor at the University of Florida, in an email.
But that interpretation of the law isn't as certain as social media posts make it seem.
The law is "definitely untested," partially because it's only been around since 2004, said Margaret Foster Riley, a law professor at the University of Virginia, in an email. The FDA also issued relatively few EUAs prior to the coronavirus pandemic.
“The reality is that, because we have never had a mandate for a vaccine under an EUA, we are waiting for a court to weigh in on the debate about whether there is something about EUAs that should change the way we have been applying the law,” Rutschman said. “But there is nothing in the law itself to limit the ability of the government and employers to mandate vaccination."
Other food and drug law experts shared similar views with USA TODAY.
"I think it's only gray in that a court hasn't actually said an EUA makes no difference," said Katharine Van Tassel, a visiting law professor at Case Western University. "That's the only reason why it's gray. It's not because there's anything different about the laws."
Our rating: Partly false
The claim that employers, businesses and the government can’t mandate COVID-19 vaccines until they’ve been evaluated for two years is PARTLY FALSE, based on our research. A section of the Federal Food, Drug, and Cosmetic Act cited on social media does not contain such a provision. Businesses, employers and states generally have a right to require proof of vaccination, with some exemptions for people with disabilities and people with religious, medical or philosophical objections. Some states have explicitly prohibited businesses and employers from requiring COVID-19 vaccination. There is a legal gray area for requiring vaccines approved for emergency use versus those that are FDA-approved, although legal experts say there is no explicit distinction in the law.
Our fact-check sources:
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Alison Hunt, May 11, Email interview with USA TODAY
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Lars Noah, May 15, Email interview with USA TODAY
Margaret Riley, May 16, Email interview with USA TODAY
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This article originally appeared on USA TODAY: Fact check: Federal law doesn't prohibit COVID-19 vaccine mandates