Houston Methodist Hospital is one of the first institutions in the nation to mandate COVID-19 vaccines for healthcare workers and other employees. Many see such mandates as the wave of the future, but others advise caution and patience to let staff make a willing choice about a controversial vaccine.

While some have praised the CDC for recently allowing vaccinated people to unmask under many formerly restricted conditions, others warn it is premature and could lead to another surge in SARS-CoV-2 infections. (See related story in this issue.) A similar CDC recommendation that vaccinated healthcare workers can take breaks together without masks was viewed with concern by some who questioned the logistics of sorting out the immunized from those who declined the vaccine.

Houston Methodist solved this problem the same way they did in 2009, when the seasonal influenza vaccine was mandated at the facility with limited medical and religious exceptions. The current annual vaccination rate for flu is 99.3% at the healthcare system.

“We were one of the first hospital systems to mandate the flu vaccines,” says Carole Hackett, senior vice president of human resources at Houston Methodist. “We started thinking about when a COVID vaccine might be available in June 2020. We had to make sure of the efficacy and safety, and issues like supply vs. demand. [But with these caveats] we announced at some point that it would be mandatory.”

Leadership First

In March, executives took the first vaccines, followed by management employees. The latter still were receiving vaccines as this report was filed, but management recorded a 95% immunization rate. Executives were at 100%.

“Out of the 1,250 people in management, two have left because they did not want an exemption and they did not want to get vaccinated,” Hackett says.

By late March, about 85% of the entire staff was vaccinated. New hires were immunized as a condition of employment.

“Our policy states if you don’t get the vaccine, you will be suspended for two weeks,” Hackett 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.”

On April 16, the hospital system announced all employees — the remaining unvaccinated 15% — must be fully immunized by June 7.

The Methodist healthcare system includes 26,000 employees, Hackett says. As of May 18, 97% of hospital employees received at least one dose of an mRNA two-shot vaccine or submitted an exemption.

(Editor’s Note: As this issue went to press, a lawsuit was filed by more than 100 employees of the Houston Methodist hospital system against its mandatory COVID-19 vaccination policy for healthcare workers. “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 states. [https://bit.ly/3yTFzKL] The plaintiffs also argue a vaccine under emergency use authorization cannot be mandated. The legal fight to mandate the COVID-19 vaccine likely will play out in many other hospitals and work settings. Look to Hospital Employee Health as we continue to cover this important story.)

“People have been allowed to submit for medical and religious exemptions,” she explains. “Since the clinical trials didn’t include pregnant women, we have also allowed 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 taking fertility medications, allowing deferment until treatment is over. “Also, another group to defer is those 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.”

Some healthcare systems have decided not to mandate SARS-CoV-2 immunization until the FDA lifts the emergency use authorization (EUA) for the COVID-19 vaccines approved in the United States. Hackett says Houston Methodist uses a thorough and expert review process to mandate any vaccine and will continue to follow new developments like the need for boosters or seasonal shots.

“We have a committee of our scientists and physicians to help guide us,” Hackett notes. “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.”

Mandatory Is the Way

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.

“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.”

One issues that brought the topic of vaccine mandates to the fore was a recent recommendation that vaccinated healthcare workers could gather without masks in certain situations.

“In general, fully vaccinated healthcare personnel (HCP) should continue to wear source control while at work,” the CDC stated. “However, fully vaccinated HCP could dine and socialize together in break rooms and conduct in-person meetings without source control or physical distancing. If unvaccinated HCP are present, everyone should wear source control and unvaccinated HCP should physically distance from others.”1

Before vaccines were widely available, Steed was among the first to warn that transmission likely was occurring between healthcare workers in break rooms seeking relief from personal protective equipment (PPE) fatigue by removing masks. Although the vaccines are proving extremely effective, sanctioning these practices now raises questions about breakthrough infections, variant strains that may elude immunization, and whether those who freely chose not to be vaccinated will feel stigmatized.

“I think the CDC guideline for break rooms is concerning,” Steed says. “How do we know who is vaccinated and who isn’t? Even though this CDC guidance is out there, a lot of healthcare organizations are not changing their stance. [Healthcare workers] have to take off their masks to eat, but we still expect them to be careful about the number of people in the space and follow the standards that are in place.”

The mask policy for break rooms remains in effect at Vanderbilt University School of Medicine, says William Schaffner, MD, an epidemiologist at the institution and nationally known vaccine advocate.

“There will still be many institutions — mine, so far — that stipulate we all have to wear masks,” he says. “I think that will continue to be the case for some time because we have such a mix of vaccinated and unvaccinated [employees]. It varies a lot between institutions, especially when you include nursing homes and the like, where the level of vaccination among the personnel has been startlingly low.”

In another recent development that may give mandated or voluntary vaccination some momentum, the CDC reported SARS-CoV-2 airborne viral particles can travel beyond 6 feet, particularly in enclosed, poorly ventilated spaces.2 Moreover, studies also show the early emphasis on environmental surfaces and fomites was off target because the virus mainly transmits through inhaled droplets and particles.3 According to the CDC, factors that increase this risk include exposure of more than 15 minutes and if the infected person is projecting the virus through singing, shouting, or exercising.

Pfizer Might Be First to Drop EUA

Schaffner says he expects the EUA designation will be dropped soon for the Pfizer vaccine, but he is somewhat skeptical of widespread mandated COVID-19 vaccinations in healthcare thereafter.

“Pfizer has put through its biological license application,” Schaffner says. “The anticipation is that will move rather smoothly through the process, so that [EUA] barrier will probably be removed. But this is still a new and, in many ways, controversial vaccine. I would be surprised if very many institutions move to make it mandatory right away.”

The FDA recently expanded Pfizer’s EUA to include COVID-19 immunization of adolescents ages 12 through 15 years. 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, some parents will be comfortable with immunization and others will remain concerned about things like long-term safety of the vaccines.

“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. “If you get exposed to someone with COVID, and you are not vaccinated, you still have to quarantine. 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 take the vaccine to avoid these consequences might be more effective at increasing immunization than a mandate. However, some private colleges and universities have told their students they must take the vaccine to attend this fall. Various employers like the transportation industry may follow suit as long as the vaccine safety and efficacy data hold.

“I think with the COVID vaccine, we will see more types of employers actually mandate vaccines,” Swift said. “University of Pennsylvania Health System has already announced that they are now mandating their healthcare workers take the vaccine. But I think we’ll see more than just healthcare.”

That said, some employers might try novel approaches to increase vaccination rates. “We may see more carrots than sticks at first, but I do think, ultimately, we’ll see some mandates,” Swift said.

Do Not 'Rush to Mandates'

Given the contentious nature of the pandemic — with outsize political interference, record speed on vaccine development, and the painful revisiting of past medical atrocities experienced by people of color — public health officials have tried to craft empathetic vaccine messages from trusted sources. Healthcare messaging aimed at the vaccine hesitant should be given longer to work before “a rush to mandates,” says Rekha Murthy, MD, a board member of the Society for Healthcare Epidemiology of America (SHEA).

“There are those who still need some convincing and persuading because of the rapid development of the vaccines,” she says. “This is a complicated matter that has a lot of focus and attention. SHEA is in the process of evaluating this and will be forthcoming with an assessment and statement in the next few weeks.”

Mandated policies would seem to ride roughshod over the voluntary messaging, but it also is clear that some antivax adherents will never volunteer to take a vaccine. Polls and ballpark estimates suggested that for the COVID-19 vaccine, it may come down to 20%-25% hardcore refuseniks, which could leave herd immunity at a precarious tipping point.

“You have to understand what their particular concern is, and sometimes their concern is that they just believe this is wrong — and you can’t move them,” Swift said. “There’s no fact-based information that can move them.”

These groups also support legal challenges against mandates, citing among other things, the “informed consent” principle used in human research ethics. That would be an uphill battle in a hospital with frail patients — and more than 600,000 people dead — but legal threats could give some conventional workplaces pause.

The vaccines have caused only extremely rare serious reactions, like anaphylactic shock in the two-shot vaccines, and the blood-clotting issue that temporarily shut down the Johnson & Johnson one-shot vaccine.

“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. 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.”

CDC Weighs In

Hospital Employee Health asked the CDC to comment on healthcare vaccine mandates.

“The federal government does not mandate COVID-19 vaccination,” says Tamara Pilishvili, PhD, an epidemiologist at the CDC National Center for Immunization and Respiratory Diseases. “However, whether a state, local government, or employer, for example, may require or mandate COVID-19 vaccination is a matter of state or other applicable laws.”

The historical precedent is seasonal flu shots, which are widely mandated in healthcare, along with measles immunization and shots for other vaccine-preventable diseases. Unlike these illnesses, Murthy echoes Smith in saying too many unknowns with COVID-19 remain.

“We don’t know whether COVID is going to be a seasonal illness or continue ongoing around us,” Murthy says. “Variants remain the unknown variables in terms of pandemic controls.”

Concerning the CDC guidance, both for healthcare workers and the public — who were told they could gather maskless without social distancing if they were vaccinated5 — Murthy noted that CDC recommendations must be subject to state and local regulations.

“It is important that an assessment be made based on local community transmission,” she says. “CDC put out a statement saying it’s possible, but it’s got to be filtered and evaluated based on the local conditions.”

REFERENCES

  1. Centers for Disease Control and Prevention. Updated healthcare infection prevention and control recommendations in response to COVID-19 vaccination. Updated April 27, 2021.
  2. Centers for Disease Control and Prevention. Scientific Brief: SARS-CoV-2 transmission. Updated May 7, 2021.
  3. Lewis D. COVID-19 rarely spreads through surfaces. So why are we still deep cleaning?Nature. Jan. 29, 2021.
  4. How to win over vaccine skeptics: Live expert panel for May 20, 2021. Newswise.
  5. Centers for Disease Control and Prevention. Science Brief: COVID-19 vaccines and vaccination. Updated May 27, 2021.