COVID-19 Vaccine Mandates: Too Soon, Inevitable, or Both?
Houston Methodist policy prompts lawsuit
By Gary Evans, Medical Writer
Healthcare facilities likely will win the burgeoning legal fight to mandate COVID-19 vaccination as a condition of employment, providing they allow for medical and religious exemptions, says Lawrence Gostin, JD, O’Neill Chair of Global Health Law at Georgetown University in Washington, DC.
The question came to the fore when Houston Methodist was sued recently by a group of healthcare workers for its vaccine mandate policy.
“I have little doubt that healthcare institutions can require COVID-19 vaccinations of all staff,” Gostin tells Hospital Infection Control & Prevention. “The fact that COVID vaccines are under an Emergency Use Authorization (EUA) does not matter. Hospitals still have the power to mandate vaccines as long as they provide appropriate — and narrow — exemptions for medical or religious purposes. The lawsuit against Houston Methodist is unlikely to succeed.”
To that end, the federal Equal Employment Opportunity Commission stated recently that employers can require COVID-19 vaccination of employees “physically entering the workplace” with reasonable accommodations and within existing anti-discrimination laws. (See “Maryland, DC Hospitals Mandate COVID-19 Vaccine.”)
Many states have proposed bans against vaccine mandates by employers, but as of this report, none had been approved and most have gained little traction in state legislatures.
“A state can enact a statute that prohibits hospitals or other businesses from mandating vaccines,” Gostin says. “It requires a statute and not just a governor’s executive order.”
An ‘Experimental Vaccine’
The lawsuit filed against Houston Methodist Hospital by 117 unvaccinated employees on May 28, 2021, claims “for the first time in the history of the United States, an employer is forcing an employee to participate in an experimental vaccine trial as a condition for continued employment.” The lawsuit adds, “The statute granting the Food and Drug Administration (FDA) the power to authorize a medical product for emergency use requires that the person being administered the unapproved product be advised of his or her right to refuse administration of the product.”1
Arguing that the hospital employees were not allowed to refuse an experimental product, the suit compares the mandated immunization of American healthcare workers for COVID-19 to the medical experiments the Nazis conducted on unwilling volunteers. These atrocities led to the Nuremberg Code on Permissible Medical Experiments, which states, “The voluntary consent of the human subject is absolutely essential.”
In a statement, Houston Methodist refuted the charges and said the mandate is within the law. “It is legal for healthcare institutions to mandate vaccines, as we have done with the flu vaccine since 2009,” the statement read. “The COVID-19 vaccines have proven through rigorous trials to be very safe and very effective and are not experimental.”
When the lawsuit was filed, 99% of the hospital’s employees had been vaccinated under a mandate program that began in early March 2021, says Carole Hackett, senior vice president of human resources at Houston Methodist. Although she could not comment further on the legal action, Hackett explained in an earlier interview that every effort was being made to accommodate legitimate exemptions. Overall, the Methodist healthcare system has about 26,000 employees, she says.
“People have been allowed to submit for medical and religious exemptions,” she says. “We have also allowed — since the clinical trials didn’t have any pregnant women in them — all of our pregnant employees to have a choice to defer the vaccine. They do not have to receive the vaccine until they deliver and come back into the organization.”
The hospital also is sensitive to healthcare workers on fertility medications, allowing deferment until treatment is over. “Also, another group to defer [are] those people who got COVID and received monoclonal antibodies,” Hackett says. “You cannot receive the vaccine until three months after you have had that infusion.”
Those who submit a religious deferment must name the religious authority that supports their action. “It doesn’t have to be clergy or a church setting,” she says. “It has to be somebody who knows this person and can be their religious authority.”
“Our policy states if you don’t get the vaccine you will be suspended for two weeks,” she says. “Hopefully during that two weeks, we can answer questions and dispel any myths to make sure that people have accurate information to make the right decision — the decision that they choose to make. We respect everyone’s choice. We hope they choose to get the vaccine, but we understand that some will not.”
The policy called for all employees to be vaccinated by June 7, 2021, with the lawsuit being filed a little more than a week before that deadline.
“We have a committee of our scientists and physicians to help guide us.” Hackett says. “All of our decisions are based on science. Our legal advice was, as long as we had offered accommodations — religious and/or medical exemptions — mandating the vaccine is legal even under EUA. As a healthcare organization, we have to keep our patients safe and not spread this disease.”
More Mandates When EUA Lifted?
Inevitably, this will be settled in the courts, but it does raise the question of whether the same “experimental vaccine” argument could be made after the EUA is lifted, which some expect to be done for at least one COVID-19 vaccine by early July or sooner.
“My hospital is mandating it as soon as it goes from EUA to approval status,” says Monica Gandhi, MD, a human immunodeficiency virus specialist and infectious disease physician at UC San Francisco. “I agree with that.”
She cites the recent report of an unvaccinated healthcare worker in a Kentucky skilled nursing facility (SNF) who set off an outbreak that reached 46 cases. This included 26 residents and 20 staff members, according to the Centers for Disease Control and Prevention (CDC). The COVID-19 vaccination rate among workers at the facility was 53%.
“In a SNF with 90.4% of residents vaccinated, an outbreak of COVID-19 occurred after introduction from an unvaccinated, symptomatic [healthcare worker],” the CDC reports.2 “Attack rates were three to four times as high among unvaccinated residents and healthcare personnel as among those who were vaccinated.” The report adds, “The risk for poor outcomes among unvaccinated SNF residents is highlighted by the hospitalization of four of the six unvaccinated, infected residents, and two subsequent deaths.”
Given the devastating outbreaks that have occurred in long-term care throughout the pandemic, the issue of mandating vaccination of staff in these facilities will be a critical inflection point in the national debate. Recently, the Centers for Medicare & Medicaid Services issued an interim final rule — open for comment through mid-July — that requires education about the COVID-19 vaccines to residents and staff in long-term care and offering the shots to all. It also requires nursing homes to report the COVID-19 vaccination status of residents and staff to the CDC.3
While improving vaccination rates in long-term care remains a formidable challenge, mandated vaccines in hospitals have clear precedent.
“We are mandated to get the flu vaccine every year in most hospitals — with medical and religious exemptions,” Gandhi says. “You have to wear masks all winter long if you decline to get the vaccine. We have to make sure we are up on pertussis and the MMR (measles, mumps, and rubella) vaccine. Honestly, as a healthcare worker I don’t think it has to be mandated in all [worksites and businesses], but I genuinely think that in the healthcare setting it is fair treatment.”
SHEA, APIC Working on Position Paper
Ann Marie Pettis, RN, president of the Association for Professionals in Infection Control and Prevention (APIC), says the association is working on a joint position paper on the mandate issue with the Society of Healthcare Epidemiology of America (SHEA).
“It’s a controversial situation, primarily because we are still under emergency use authorization vs. full FDA approval,” she says. “We still don’t know about the safety during pregnancy. We have some unknowns, so I understand the skepticism that is out there in the public. It is important to acknowledge that and try to address people’s concerns with science the best we can.”
A SHEA board member concurs, saying healthcare messaging aimed at the vaccine-hesitant should be given longer to work before rushing toward mandates. “There are those who still need some convincing and persuading because of the rapid development of the vaccines,” says Rekha Murthy, MD.
The more people in healthcare that are immunized, the better it is for patient safety, worker wellness, and lifting public trust in the vaccines, Pettis says.
“I think there is a certain responsibility when it comes to that,” she says. “Quite honestly, without it being a condition of employment I’m skeptical we will be to get as high [of vaccination rates] as we really would like to.”
Connie Steed, MSN, RN, CIC, director of infection prevention and control at Prisma Health in Greenville, SC, sees more mandatory vaccination policies in hospitals as inevitable — because they work.
“When we are able to require COVID vaccinations [our immunization rates will go up],” she says. “Some hospitals have done that — but many haven’t because it is still under EUA. But I think it will go that way. We have mandatory flu vaccination. We couldn’t get it above 60%, and we are now at 99.6% immunized in a 12-hospital organization. Mandatory is the only way to get it up to speed.”
William Schaffer, MD, a professor at Vanderbilt University and nationally known vaccine advocate, says he expects the EUA designation will be dropped soon for the Pfizer vaccine. That said, he is somewhat doubtful of widespread mandated COVID-19 vaccinations in healthcare immediately thereafter.
“This is still a new, and in many ways, a controversial vaccine,” he says. “I would be surprised if very many institutions move to make it mandatory right away.”
Carrots or Sticks?
The FDA recently expanded Pfizer’s EUA to include COVID-19 immunization of adolescents 12 through 15 years of age. Although school immunization requirements are a time-honored tradition, mandating COVID-19 vaccination of children at this point in the pandemic could be counterproductive, warned Melanie Swift, MD, MPH, occupational medicine specialist at the Mayo Clinic in Rochester, MN.
“I don’t think it would be terribly productive to implement really harsh mandates for things that the kids need — like the ability to go to school — being contingent on being vaccinated,” Swift said at a recent webinar.4 “Discretionary activities, like extracurricular things and trips perhaps, but I think there’d be a lot of pushback — the clinical trials in children have been smaller.”
When a full FDA license is granted and the EUA removed, there will be parents who will be comfortable with immunization and others that remain concerned about things like long-term safety of the vaccines, she adds.
“But other incentives would be sort of the natural consequences of getting vaccinated or not getting vaccinated for the quality of life of that kid in that family,” Swift said. “So, if you get exposed to someone with COVID, and you are not vaccinated, you still have to quarantine. And that means not going to school, that means not going to the soccer game, that means not going on a school trip.”
The incentives to be vaccinated because of these consequences might be more effective at increasing immunization than a mandate in school children.
However, some universities and colleges are requiring faculty and student immunization for fall attendance, including Penn Medicine in Philadelphia, which declined comment for this story. Various employers, such as the transportation industry, may follow suit if the vaccine safety and efficacy data hold. The vaccines have had only extremely rare serious reactions, such as anaphylactic shock in the two-shot vaccines and the blood clotting issue that temporarily shut down the Johnson & Johnson-Janssen one-shot.
“I think it’s really important that we remain humble about what’s not known,” Swift argued. “There are things that we don’t know yet. That’s science. Science is not a set of facts. Science is a process. And what people should be really reassured about is that, even though the clinical trials cannot find one in a million, or one in 5 million side effects, we have incredibly robust vaccine safety monitoring programs in our country.”
Editor’s note: As this issue went to press, a federal judge dismissed the lawsuit against Houston Methodist for mandating the COVID-19 vaccine for all employees. The ruling is expected to be appealed, but suggests that mandated immunization of healthcare workers is going to be hard to stop if healthcare facilities decide to adopt such policies.
REFERENCES
- Jennifer Bridges et al. v The Methodist Hospital. In the District Court of Montgomery County, TX. May 28, 2021. https://assets.documentcloud.org/documents/20792874/methodist-lawsuit-1.pdf
- Cavanaugh AM, Fortier S, Lewis P, et al. COVID-19 outbreak associated with a SARS-CoV-2 R.1 lineage variant in a skilled nursing facility after vaccination program — Kentucky, March 2021. MMWR Morb Mortal Wkly Rep 2021;70:639-643.
- 86 Fed Reg 26,306 (2021).
- Newswise. How to win over vaccine skeptics: Live expert panel for May 20. Published May 21, 2021. https://www.newswise.com/coronavirus/how-to-win-over-vaccine-skeptics-live-expert-panel-for-may-20-3pm-et/?article_id=750762
Healthcare facilities likely will win the burgeoning legal fight to mandate COVID-19 vaccination as a condition of employment, providing they allow for medical and religious exemptions.
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