At a Dec. 1, 2020 meeting, the CDC Advisory Committee on Immunization Practices (ACIP) approved the following recommendation: “When a COVID-19 vaccine is authorized by Food and Drug Administration (FDA) and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) healthcare personnel and 2) residents of long-term care facilities.”1

“We have spent eight months discussing and evaluating the data,” said ACIP Chair José Romero, MD, FAAP, secretary of the Arkansas Department of Health. “Our discussions have been transparent and our motives have been clear. We are using the principles of maximizing benefits and minimizing harms, promoting justice, and mitigating health inequities. Those of us who are in public health see the growing number of cases before us. We see the growing number of healthcare providers that become infected and some of [whom], unfortunately, have passed away. We see that individuals living in long-term care facilities are at exceptional risk for mortality and morbidity due to this virus and disease.”

Approved by the CDC director, the recommendation includes long-term care staff among its broad definition of healthcare workers, “as paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.”

These groups are at clear and present danger. As of Dec. 1, 2020, approximately 245,000 COVID-19 cases and 858 deaths had been reported among U.S. healthcare workers. Despite the concerns raised about the safety of immunizing long-term care residents, clearly they are at greatest risk of death if infected with SARS-CoV-2. Although they represent only 1% of the population, long-term care residents represent 6% of all COVID-19 cases and 40% of all deaths, the CDC reported. Approximately 21 million healthcare personnel work in settings such as hospitals, long-term care, outpatient clinics, home health care, public health clinical services, emergency medical services, and pharmacies. About 3 million people are residents of long-term care facilities.

ACIP member Helen Talbot, MD, MPH, an infectious disease physician at Vanderbilt University in Nashville, TN, cast the lone “no” vote. Talbot expressed concern about the lack of data on immunizing long-term care residents and whether there was a sufficient safety net in place to follow them for adverse effects. She strongly endorsed the recommendation to immunize healthcare workers, including long-term care staff.

“I have spent my career studying vaccines in older adults,” she said. “We have traditionally tried a vaccine in a young, healthy population and then hope it works in our frail older adults. So, we enter this realm of ‘we hope it works and we hope it’s safe.’ That concerns me on many levels, particularly for this vaccine.”

There also is the historic background that the elderly typically have less immune response to vaccines, meaning there may be less benefit despite the risk of side effects and long-term problems associated with immunization.

“We know with flu there is little impact of vaccinating residents and a huge impact in vaccinating [long-term care] workers,” Talbot said. “I’m [the] odd woman out I guess. I struggled with this this was not an easy vote. I really hope this highlights that skilled nursing facilities are a population that needs lots of [better] vaccines not just COVID. We really need to find ways to develop and test these vaccines to prolong quality of life for all long-term care facility residents.”

As this report was filed, FDA advisors were weighing the approval of two COVID-19 vaccines in the United States, and the ACIP meeting was conducted with the general anticipation that at least one of them would be cleared for distribution. If the FDA approves a vaccine, ACIP will meet again to determine whether to formally recommend it for the identified 1a groups. The two vaccines under consideration are both “messenger RNA” platforms developed respectively by Pfizer Inc. (NYC) and BioNTech (Mainz, DEU), and Moderna, Inc. (Cambridge, MA). Totaling more than 70,000 participants in Phase III trials, both vaccines report efficacy of 95%. (See related story, “FDA Approves Pfizer Vaccine for COVID-19.”)

Hard Choices

The initial vaccine allotments are not expected to be in sufficient numbers to cover all targeted recipients, who must receive two doses several weeks apart to achieve immunity with either vaccine. Thus, initially there will be a need for some “subprioritization” among the targeted groups, an issue that was the subject of much ACIP discussion. The general consensus was that the vaccines should not be mandated because of their emergency use status and lack of long-term safety data.

“We anticipate having about 40 million doses so, enough to cover some 15 to 20 million individuals … by the end of December,” said ACIP Executive Secretary Amanda Cohn, MD, of the CDC National Center for Immunization and Respiratory Diseases (NCIRD). “After that, each week we anticipate somewhere between 5 and 10 million [more] doses.”

Healthcare personnel comprise clinical staff members, including nursing or medical assistants and support staff members who work in food service, environmental, and administrative services. “Jurisdictions might consider first offering vaccine to healthcare personnel whose duties require proximity (within six feet) to other persons,” the CDC stated. “If vaccine supply remains constrained, additional factors might be considered for subprioritization.”

ACIP members warned that vaccine supplies could, at some point, be delayed by an unforeseen issue, leading to difficult decisions on who should receive the available vaccine among the designated groups. For example, should healthcare workers with underlying medical conditions, older age, or ethnicity risks be prioritized?

“Each individual healthcare system is going to need to figure out their additional subprioritizations based on doses and the staff that they have,” said Sara Oliver, MD, MPH, an epidemiologist with the CDC NCIRD.

Patricia Stinchfield, RN, MS, CPNP, an ACIP liaison member representing the National Association of Pediatric Nurse Practitioners, said her hospital does not routinely keep medical and demographic information on many employees, particularly those not involved in direct patient care.

“We don’t have birthdates of people in their files,” she said. “We have their month and date but not the year, for age discrimination reasons. We may not have race and ethnicity, and we certainly don’t have medical records their own personal medical histories in the occupational health setting.”

Healthcare workers could be asked to disclose underlying risk factors, but that could lead to unintended consequences, warned ACIP member Grace Lee, MD, MPH, of Stanford University School of Medicine. “If we ask people to self-disclose, that may inherently create unintended inequities,” Lee said. “I worry, by creating that as a construct, we might actually, unintentionally, create more inequity. Lower wage workers may not feel comfortable disclosing medical conditions, but may be faced with higher risk of infections in the community or workplace.”

The CDC recommends staggering immunizations among groups of healthcare workers, since the initial side effects of the vaccine may require a sick day after shots are administered.

“The convenience of vaccinating unit-by-unit would be pretty high within a healthcare system, but that could wipe out that unit for a day if people have reactogenicity,” said Paul Hunter, MD, of the Milwaukee Health Department.

Romero echoed this point. “It goes without saying that this applies to emergency personnel if you have a mass vaccination of [emergency medical technicians] you could be extremely short of these individuals,” he said.

That sounds good in principle, but the logistics are another matter, said Marci Drees, MD, MS, an ACIP liaison member representing the Society for Healthcare Epidemiology of America (SHEA).

“The logistics involved are kind of a disconnect,” she said. “From a large healthcare system, I won’t be able to manage which people on which unit get vaccinated on which days. We’re just going to have to manage that on a unit level as much as possible. The smaller hospitals are going to have a really hard time. If they have a hundred-bed hospital, they don’t have enough staff [for backup].”

Adequate Safety Net?

Although vaccine supplies are limited, skilled nursing homes with high resident acuity should be considered for vaccination priority in long-term care, the CDC recommended. Some of these decisions and allotments will come down to down to state and public health jurisdictions looking at their vaccine supply and populations at need. Regarding long-term care facilities, concerns were expressed that these sites have not routinely used the longstanding Vaccine Adverse Event Reporting System (VAERS), which is passive surveillance in that it relies on clinicians, manufacturers, and public reports.

“I have no concern about the healthcare personnel,” said ACIP member Robert Atmar, MD, of the Baylor College of Medicine in Houston. “I remain a bit concerned about including residents of long-term care facilities in the 1a group because of a lack of both safety and efficacy data in that patient population. I know that plans are in place to do the [safety] monitoring, but there is a potential for a lag of information arising. It will be particularly important to ask the long-term care facilities to vigorously participate in the VAERS program. Staffing to do that may be an issue. I am worried about this group, though I am leaning towards including it.”

Indeed, Atmar did vote in favor of the motion after the CDC outlined the many passive and active surveillance systems that are being brought to bear to detect vaccine adverse events for COVID-19 immunizations.

“I want to reassure the ACIP, public health, healthcare providers, and the public that we have the systems in place to collect safety data,” said Tom Shimabukuro, MD, MPH, MBA, of the CDC’s COVID-19 Vaccine Safety Team. “We have validated methods to rapidly analyze the data. We have processes in place to respond to safety signals when we detect them. And we have trusted partners that we will depend on when we implement the vaccination program.”

The CDC urged clinicians to help them in this effort through vigilant monitoring and rapid reporting of any COVID-19 vaccine side effects and adverse events.

“I want to reiterate the importance that CDC places on the safety of vaccines,” added Nancy Messonnier, MD, director of the CDC NCIRD. “I know that the FDA will not authorize a vaccine and ACIP will not recommend a vaccine unless you are convinced based on the Phase III clinical trials that the vaccines are very safe. We know that vaccine safety doesn’t stop there, especially for these vaccines. We are going to hold ourselves to an extremely high standard for safety monitoring after a vaccine is authorized and rolled out.”

Ultimately, arguments in favor of the motion held the day, as ACIP members argued that they must act in the face of a devastating and expanding pandemic of the novel coronavirus.

“I strongly agree with the recommendations,” said Peter Szilagyi, MD, MPH, a pediatrics professor at the University of California, Los Angeles. “With the assumption that FDA and ACIP will only recommend a vaccine if the best available evidence shows it is effective and safe. I want to emphasize that post-recommendation guidance and support for any implementation and safety monitoring is critical. As we heard today, that is being planned very well by the CDC.”

To underscore the moral imperative, Szilagyi cited Mahatma Gandhi’s observation that “a nation’s greatness is measured by how it treats its weakest members.”

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, noted that the United States was averaging one COVID-19 death a minute as the meeting was taking place. “In the time it takes us to have this ACIP meeting, 180 people will have died from COVID-19,” Bell said. “We would all like to know more, but we go through a process we evaluate carefully every bit of information that we have and then it is time to act.”

Pharmacy Partnership

To deliver the vaccine, the CDC is collaborating with the Pharmacy Partnership for Long-Term Care Program, which has enrolled more than 15,000 skilled nursing facilities across the country. “I would assume that most planning around long-term facilities would have them vaccinate both residents and [their] healthcare personnel at the same time,” Cohn said. “But there will be some jurisdictions that will likely start with healthcare personnel and then vaccinate residents. It is very dependent on [vaccine] supply and local context.”

Questions arose about staff and resident turnover during vaccinations, particularly in the lag period of several weeks after the first dose has been administered.

“It will be a challenge,” said Kathleen Dooling, MD, MPH, a member of the ACIP vaccine work group and a medical officer in the CDC’s division of viral diseases. “The pharmacies that have signed up for this program have agreed to make three separate visits to the facilities in order to vaccinate all persons who wish to be vaccinated. Again, when [the] vaccine is more available in the community this will less of an issue.”

The CDC is planning to produce toolkits with information on vaccinating both healthcare workers and long-term care residents, with the latter being particularly important because a vaccine side effect could be taken for an underlying illness or infection.

“We will need to have a lot of guidance post-vaccination to evaluate symptoms, adverse events, or side effects,” said ACIP member Sharon Frey, MD, of Saint Louis (MO) University Medical School. “Because when the elderly suffer from fatigue and a little fever, people worry about them having an underlying condition.”

There also was discussion of a consent/assent process to be sure long-term care residents and their families understand the risks and benefits of the vaccine.

Concerning medical offices and outpatient practices, the CDC recommended public health authorities and healthcare systems work together to ensure COVID-19 vaccine access to healthcare personnel who are not affiliated with hospitals. However, some ACIP members were concerned that this may not take place, emphasizing the risk faced by small practice physicians and medical offices.

“The outpatient community physician in a small private practice truly is the backbone of the healthcare system,” said Jason Goldman, MD, FACP, a liaison ACIP member representing the American College of Physicians. “I’m pleased to see that it is considered in [the] healthcare first phase, but we really need to look at the outpatient offices at risk.”

He cited a recent study that indicated small-community physicians may be at higher risk of death than their hospital counterparts. “General practitioners, family medicine, and primary care physicians account for 27% of physician deaths, while anesthesiologists, emergency medicine, and critical care physicians account for 7%,” the authors found.2

“For example, an intensive care unit (ICU) physician, while seeing sicker patients, may have greater access to personal protective equipment (PPE) compared to small offices,” Goldman said, adding that it is crucial to vaccinate office staff as well. “[We need to] make sure we are really getting the vaccine to the people on the frontlines who need it the most.”

Other ACIP members seconded this concern, saying home health medical workers and first responders also are at heightened risk.

“On the science front, the transmission dynamics of COVID-19 suggest that those providers who care for patients earlier in their course of illness may be at higher risk,” said Jeffrey Duchin, MD, an ACIP liaison member representing the National Association of County and City Health Officials. “This is supported by information CDC has recently published as well. That would include outpatient healthcare providers.”

REFERENCES

  1. Dooling K, McClung N, Chamberland M, et al. The Advisory Committee on Immunization Practices’ Interim Recommendation for Allocating Initial Supplies of COVID-19 Vaccine — United States, 2020. MMWR Morb Mortal Wkly Rep 2020;69:1857-1859.
  2. Gouda D, Singh PM, Gouda P, et al. The demography of deaths in healthcare workers – an overview of 1004 reported COVID-19 deaths. Journal of the American Board of Family Medicine. https://www.jabfm.org/sites/default/files/COVID_20-0248.pdf