Public and private employers seeking to mandate the COVID-19 vaccines are bolstered by a Department of Justice opinion and high-profile victory in Texas, but their chances in court remain iffy for one big reason: The shots have not been fully approved.
The Food and Drug Administration said a trio of COVID-19 vaccines could be used in the U.S. on an emergency basis, meaning the benefits outweigh potential risks during the crisis.
Regulators are working to grant the drugmakers full biologics licenses, but that process could stretch into the fall. Meanwhile, employers deciding whether to condition jobs on vaccinations are left in a muddled middle.
Public health experts say vaccinations and other measures required to keep workplaces safe have long histories, so the momentum is in employers’ favor.
A Texas judge sided this summer with a Houston hospital, which argued that emergency authorization is good enough for an employment requirement. The Justice Department says the federal government can mandate shots now, but some employers are waiting to see how it all plays out.
“They are just scared of getting into a prolonged legal fight they don’t want,” said Arthur Caplan, director of the division of medical ethics at the New York University Grossman School of Medicine.
Others might not want to vex their employees at a tenuous time in the pandemic fight and economic recovery.
“If they mandate a vaccine, there will be schisms among workers and create a hostile culture. There is a business judgment as well as a health judgment,” said Josh Blackman, a professor at the South Texas College of Law.
The Defense Department said Secretary Lloyd Austin will wait until full federal approval to mandate the shots for troops unless President Biden orders it under an emergency use authorization.
Centura Health told The Colorado Sun that it is not joining other Colorado hospital systems in requiring the shots but “will re-evaluate when the vaccine becomes FDA-approved.”
The debate is unfolding as colleges require vaccinations before the fall semester and governors, mayors and businesses mull get-tough mandates or, in the case of California and New York City, offer the choice between vaccines or regular testing.
Health officials and elected leaders fear a major relapse in the fight against the coronavirus as the delta variant rips through communities, especially places in the South and the Midwest with low vaccination rates.
Mr. Biden is scheduled to announce tougher rules on the federal workforce Thursday. Whatever he announces will be a prominent test case of mandates, especially if unionized workers argue that vaccine or testing rules should be subject to collective bargaining.
White House deputy press secretary Karine Jean-Pierre declined to get ahead of Mr. Biden but said the administration is considering vaccine requirements for certain people within the government. Under one option, she said, employees can either attest to their vaccination status or abide by mask-wearing or virus testing.
“I suspect the courts would uphold a vaccine mandate for federal employees so long as there are reasonable exemptions for workers with religious or disability-based exemptions. People who simply object to the vaccine on health grounds are unlikely to prevail,” Mr. Blackman said. “After the FDA provides full approval, health-based objections will be on even shakier ground. I think many employers will start to require workers to get the shot.”
Stephanie Rapp-Tully, a partner at the Tully Rinckey PLLC law firm, expects a pitched battle. She said she is getting a lot of calls from federal employees who object to a vaccine rule.
“Our phones have been on fire this morning because of the news that came out,” Ms. Rapp-Tully told The Washington Times. “I think it will be bigger when the actual mandate comes out tomorrow, as expected.”
“I think we’re going to see a lot of actions from unions,” she added, “as to whether these mandates violate the current collective bargaining agreement in place.”
The lack of certainty is largely a result of the unprecedented nature of the pandemic.
Some colleges tried to require vaccination for a new strain of meningitis under emergency-use status, and the federal government pushed a trial anthrax vaccine on some government employees during the mid-2000s, Mr. Caplan said.
But COVID-19 has posed a threat to humans everywhere, prompting a scramble to develop and test vaccines and, theoretically, get them into the arms of every eligible human on the planet.
An emergency use authorization allows vaccines and drugs to become available in medical emergencies when no fully approved alternative exists and the benefits of the product outweigh potential risks.
Makers of the COVID-19 vaccines conducted clinical trials with tens of thousands of people before the FDA granted the first emergency use authorization to Pfizer-BioNTech and Moderna in December under the Trump administration.
Americans are still using those vaccines and the one-shot Johnson & Johnson vaccine under this designation.
Pfizer and Moderna have requested full licenses from the FDA, which requires the submission of additional data and involves an exhaustive look beyond safety, such as factory logistics and procurement issues.
Experts say the COVID-19 situation is unique, given its scale. The FDA collected a large trove of data from trials, bolstering confidence in the foundation behind the emergency use authorization.
U.S. District Judge Damon R. Leichty cited the robust data in declining to issue a preliminary injunction against a vaccine mandate at Indiana University.
“Not all EUAs are equal and the one required for COVID-19 vaccines was more robust than usual,” wrote Judge Leichty, an appointee of President Trump.
Dr. David Montefiori, a professor of surgery at Duke University Medical Center, said Pfizer and Moderna could gain full approval by September.
“I think we will see an additional surge in vaccinations when the FDA finally does approve these vaccines for full licensure,” he said.
In the meantime, some experts say, the emergency use authorization should be good enough. Workplaces have wide latitude to impose safety rules so long as they provide enough medical or religious accommodations to avoid running afoul of the Americans with Disabilities Act or other federal laws.
“Employers, even federal employers, have the right to try and make the workplace safe, try and make the workplace functional,” Mr. Caplan said.
But Mr. Biden, he said, “can really only do it for the people who work for him — the feds. He can’t do it for NYU or The Washington Times. People think the president is all-powerful when it comes to this thing. He’s not.”
U.S. District Judge Lynn N. Hughes ruled in June that Houston Methodist Hospital could require its workers to be vaccinated as a condition of employment. That ruling could give confidence to other private employers.
“This is not coercion. Methodist is trying to do their business of saving lives without giving them the COVID-19 virus. It is a choice made to keep staff, patients and their families safer,” said the judge, an appointee of President Reagan. “Every employment includes limits on the worker’s behavior in exchange for his remuneration. That is all part of the bargain.”
The judge said the requirement did not require employees to do anything that runs afoul of state law, a key test for wrongful termination lawsuits in Texas. The ruling also said the part of federal law that requires the health and human services secretary to inform recipients of the “option to accept or refuse administration of the product” does not apply to private employers.
Ms. Rapp-Tully said she expects a more complicated analysis for federal employees, given the range of tasks. For instance, the Department of Veterans Affairs mandated the vaccines for Title 38 employers such as doctors and nurses, but what about federal workers who aren’t involved in health care and object?
Courts will likely be asked to weigh their concerns while being mindful of the COVID-19 crisis, which has killed more than 600,000 Americans and appears to be worsening after an improvement in late spring.
“I think there’s going to be pressure on both sides, pressure on liberties versus personal liberties,” Ms. Rapp-Tully said. “With the delta variant on the rise, it’s a complicated analysis of public safety, public welfare, versus individual rights. I think we’re going to see a split in the courts, to be honest.”
The Justice Department issued an opinion this month that supports a vaccination mandate under emergency use authorization. It says the health secretary must inform recipients about the benefits and risks of a product and their right to refuse the product, but that doesn’t bar public or private entities from inflicting consequences of a decision.
The opinion is just that — an opinion — and not binding on courts.
Mr. Caplan said there is a way around the provision if it becomes a problem. The FDA can rewrite the emergency authorizations to indicate that refusing the vaccine could result in loss of employment or limits on education or access to private businesses.
“I think it’s easy to fix it,” he said. “Why don’t we just change the language?”