April 9, 2021 -- It's not clear that employers have the legal right to require employees to get vaccinated with a vaccine that has only an emergency use authorization (EUA) from the US Food and Drug Administration, according to a new report by the Kaiser Family Foundation (KFF).

All three of the COVID-19 vaccines available in the United States have EUAs, but none has received full FDA approval yet. Pfizer-BioNTech, however, recently announced it has enough trial data to apply for full approval, according to FiercePharma.

The question of whether employers can mandate COVID-19 vaccination of their workers is important, not only for the workers but also for the drive to vaccinate enough of the US population to create herd immunity. A significant fraction of the population is still reluctant to get vaccinated or refuses to be inoculated against COVID-19.

This resistant cohort includes many employees of healthcare organizations. According to a recent survey, nearly half of frontline healthcare workers had not been vaccinated as of early March. Twelve percent of respondents hadn't decided whether or not to get vaccinated, and 18% said they didn't plan to receive a COVID-19 vaccine.

To date, most healthcare organizations haven't mandated vaccination of their workers. And if the KFF report is accurate, the small number of health systems and post-acute care facilities that do require vaccination may not be on firm legal ground.

Until recently, all employer vaccine mandates, such as flu shots for healthcare workers, have been for fully approved vaccines, the report noted.

The post-9/11 statute that established the EUA process says that individuals must be informed "of the option to accept or refuse administration of the [EUA-approved] 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."

Legal experts are divided on what this directive means for the legality of requiring vaccination with a vaccine authorized for emergency use, the report noted. The courts have not yet interpreted this provision of the statute.

Employers that do require vaccination must abide by the December 2020 guidance of the Equal Employment Opportunity Commission (EEOC), which doesn't address EUA status directly but does say that an employee's disability must be considered when an employer inquires about his or her vaccination status.

The employer must also offer "reasonable accommodations" to employees who say they can't receive a vaccine due to their disabilities, the report pointed out.

Employer vaccine mandates are also subject to religious accommodations under Title VII of the Civil Rights Act, according to the report, although courts have held that state vaccine mandates are not constitutionally required to provide religious exemptions.

Not all observers agree with the KFF report's position on the legality of COVID-19 vaccine mandates while the vaccines are under EUAs. For example, an
April 7 JAMA Viewpoint by three academic experts refers to the recent guidance from the EEOC on COVID-19 vaccinations. The experts noted that the guidance applies to any vaccine "approved or authorized by the Food and Drug Administration," suggesting that employers could require vaccinations under an EUA.

Real-World Experience

That's also the view of Houston Methodist, one of the few healthcare organizations that has mandated that its employees get COVID-19 shots. In an interview with Medscape Medical News, Marc Boom, MD, president and CEO of Houston Methodist, said that the health system's legal counsel had advised the organization that it was on solid legal ground in requiring its staff to get vaccinated as a condition of employment.

This mandate is fairly recent. Houston Methodist has been aggressively vaccinating its workers since January, and it offered them $500 bonuses to get shots by mid-March, Boom noted. To date, 84% of the employees have been vaccinated, and the number continues to rise. But most of those who have still not received the vaccine are "hesitant or reluctant to be vaccinated," he said.

Explaining why Houston Methodist finally required the holdouts to get inoculated, Boom said, "Our sacred duty and obligation is to care for our patients and to care for them in the safest possible manner. Part of that is to make sure that our team is protected and that we minimize the chance of giving COVID to a patient. It's about patients being at the center of everything we do."

The KFF report also noted that there have been discussions about the ethics of requiring employees to get vaccines that are not fully FDA-approved. Boom didn't dismiss that concern, but he said that it's moot now that the COVID-19 vaccines have received widespread acceptance across the country.

"There have been 170 million vaccinations given in the US alone," he noted. "This is massive real-world experience in addition to thoughtful, large clinical trials. The [EUA] process was accelerated, but the studies were no different than they'd ordinarily be."

Legality of Vaccination Mandates

The KFF report also addressed the broader question of whether COVID-19 vaccination mandates are legal and which entities can require people to be vaccinated.

The federal government's authority to mandate vaccinations of any kind is limited, the researchers concluded. The Public Health Service Act authorizes the secretary of Health and Human Services to adopt quarantine and isolation measures to stop the spread of disease among states but doesn't mention vaccine mandates. "General vaccine mandates…are generally within the purview of state and local governments…with the federal government playing a supporting role."

The US Supreme Court upheld a state vaccine mandate over a century ago, based on the state's police power, the report noted. In that case, a local law required all adults to be vaccinated against smallpox during an outbreak. All states today require vaccinations for school attendance, and the Supreme Court has also endorsed those laws.

Some states also require adults to be vaccinated, but these laws are very limited, the report said. "Current state vaccination laws for adults are focused on healthcare workers and patients in healthcare facilities, rather than the general population."

These state mandates generally require that healthcare workers be offered certain vaccines, and some require documentation of employee vaccination status. But the report didn't say that any states require these workers to be vaccinated.

Some private employers require their workers to get vaccines, such as flu shots, in healthcare settings. But states may prohibit vaccine mandates as a condition of employment and instead require that employees have the ability to opt out, the report said.

Medscape Medical News

Sources

Kaiser Family Foundation, "Key Questions About COVID-19 Vaccine Mandates"

Fierce Pharma, "Pfizer, BioNTech eye full FDA approval for COVID-19 vaccine as efficacy stands strong, including against aggressive variant"

JAMA, "Digital Health Passes in the Age of COVID-19Are “Vaccine Passports” Lawful and Ethical?

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