Navigating Aging

With Vaccine Delivery Imminent, Nursing Homes Must Make a Strong Pitch to Residents

Imagine this: Your elderly mother, who has dementia, is in a nursing home and COVID-19 vaccines are due to arrive in a week or two.

You think she should be vaccinated, having heard the vaccine is effective in generating an immune response in older adults. Your brother disagrees. He worries that development of the vaccine was rushed and doesn’t want your mother to be among the first people to get it.

These kinds of conflicts are likely to arise as COVID vaccines are rolled out to long-term care facilities across the country.

“This is a highly politicized environment, not only with respect to vaccines but also over the existence of the virus itself,” said Michael Dark, a staff attorney with California Advocates for Nursing Home Reform. “It’s not hard to imagine disputes arising within families.”

About 3 million people — most of them elderly — live in nursing homes, assisted living centers and group homes, where more than 105,000 residents have died of COVID-19. They should be among the first Americans to receive vaccines, along with health care workers, according to recommendations from the Centers for Disease Control and Prevention and various state plans.

But long-term care residents’ participation in the fastest and most extensive vaccination effort in U.S. history is clouded by a significant complication: More than half have cognitive impairment or dementia.

This raises a number of questions. Will all older adults in long-term care understand the details of the vaccines and be able to consent to getting them? If individual consent isn’t possible, how will families and surrogate decision-makers get the information they need on a timely basis?

And what if surrogates don’t agree with the decision an elderly person has made and try to intervene?

“Imagine that the patient, who has some degree of cognitive impairment, says ‘yes’ to the vaccine but the surrogate says ‘no’ and tells the nursing home, ‘How dare you try to do this?” said Alta Charo, a professor of law and bioethics at the University of Wisconsin-Madison Law School.

Addressing these issues will occur against a backdrop of urgency. Deaths in long-term care facilities are rising dramatically, with new estimates suggesting that 19 residents die of COVID-19 every hour. With viral outbreaks increasing, already-overwhelmed staffers may not have much time to sit down with residents to answer questions or have conversations with families over the phone.

Meanwhile, CVS and Walgreens, the companies operating vaccine programs at most long-term care facilities, have aggressive timetables. Both companies have said the large-scale rollout of the Pfizer-BioNTech vaccine — the first one that the Food and Drug Administration has authorized — will begin on Dec. 21.But facilities in some states may get supplies earlier. Altogether, there are more than 15,000 nursing homes and nearly 29,000 assisted living residences in the U.S.

At a meeting of the federal Advisory Committee on Immunization Practices early this month, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, acknowledged the agency was “very concerned” that information about vaccines be adequately explained to long-term care residents. “It’s very important for the frail elderly not only to ensure that they are understanding the vaccine that they’re getting but also that their family members do,” she said.

Each vaccine manufacturer will be required to prepare a fact sheet describing what’s known about benefits and risks associated with a vaccine, what’s not known, and making it clear that a vaccine has received “emergency use authorization” from the FDA — a conditional endorsement that falls short of full approval. A second vaccine, from Moderna, is poised to receive this kind of authorization after an FDA meeting on Thursday.

Something that will need to be made clear to residents: while vaccines have been tested on people age 65 and older, those tests did not include individuals living in long-term care, according to Dr. Sara Oliver, a CDC expert.

Some operators have crafted communication plans around the vaccines and already begun intensive outreach. Others may not be well prepared.

Juniper Communities operates 22 senior housing communities (a standalone nursing home, multiple memory care and assisted living facilities, and two continuing care retirement communities) in Colorado, New Jersey and Pennsylvania. This week, it is planning an hour-long town hall videoconferencing session for residents and families about coronavirus vaccines. Last week, it held a similar event for staffers.

Juniper has contracted with CVS, which is requiring that every resident and staff member fill out consent forms in triplicate before being inoculated. When written consent can’t be obtained directly, verbal consent, confirmed independently, may substitute. Walgreens has similar requirements.

For residents with memory impairment, two Juniper nurses will reach out by phone to whomever has decision-making authority. “One will ask questions and obtain verbal consent; the other will serve as a witness,” said Lynne Katzmann, Juniper’s founder and chief executive officer. Separately, emails, blog posts and prerecorded voice messages about the vaccines have gone out to Juniper residents and staffers, starting at the end of November.

A key message is “we’ve done this before, not at this scale, mind you, and not at this level of import, but we do flu vaccinations annually,” said Katzmann, who plans to be the first Juniper employee to get the Pfizer vaccine when it comes to New Jersey.

At Genesis Healthcare, crucial messages are “these vaccines have been studied thoroughly, tens of thousands of people have received them already, they’re very, very effective, and no steps have been skipped in the scientific process,” said Dr. Richard Feifer, executive vice president and chief medical officer. Genesis, the nation’s largest long-term care company, operates more than 380 nursing homes and assisted living residences in 26 states, with about 45,000 employees and more than 30,000 residents.

Medical directors at each Genesis facility have been scheduling video conferences with families, residents and staffers during the past few weeks to address concerns. They’ve also distributed a letter and a question-and-answer document prepared by the Society for Post-Acute and Long-Term Care Medicine, in addition to getting information out through closed-circuit TV channels and social media.

In partnership with Brown University researchers, the company will monitor daily the side effects that its long-term care residents experience after getting coronavirus vaccines. Most reactions are expected to be mild or moderate and resolve within a few days. They include fatigue, pain at the injection site, headaches, body aches, fever and, rarely, allergic responses.

Administering the vaccine will occur over three visits for all long-term care facilities. At the first, all Genesis residents and staffers will get inoculations. At the second, three to four weeks later, those same people will get a second dose, and new staffers and residents will get a first dose. At the third, those who still qualify for a second vaccine dose will get one.

What will happen if lots of people experience uncomfortable side effects and employees don’t come in for a couple of days while recovering? “It’s a very difficult problem and we’re making contingency plans to address it,” Feifer said.

And what about continuing care retirement communities — also known as “life plan communities” — where residents in skilled nursing, assisted living and independent living can reside in close proximity?

That’s the case at Bayview in Seattle, which houses 210 residents in a 10-story building. For the moment, independent living residents aren’t on the priority list but “I know there will be a contingent of residents and staff who won’t want to be vaccinated and we’ll see if we can use those vaccines for our independent living people instead,” said Joel Smith, Bayview’s health services administrator.

Logistical challenges are sure to arise, but many operators have an acute sense of mission. “It is critical that we lead the way out of this crisis,” Feifer of Genesis said. “Nursing homes need to go first and be the first ones to address vaccine hesitancy head-on and be successful at generating a high level of acceptance. There is no alternative, no Plan B right now. We have to be successful.”

What Seniors Can Expect When COVID Vaccines Begin to Roll Out

Vaccines that protect against COVID-19 are on the way. What should older adults expect?

The first candidates, from Pfizer and Moderna, could arrive before Christmas, according to Alex Azar, who heads the Department of Health and Human Services.

Both vaccines are notably effective in preventing illness due to the coronavirus, according to information released by the companies, although much of the data from clinical trials is still to come. Both have been tested in adults age 65 and older, who mounted a strong immune response.

Seniors in nursing homes and assisted living centers will be among the first Americans vaccinated, following recommendations last week by a federal advisory panel. Older adults living at home will need to wait a while longer.

Many uncertainties remain. Among them: What side effects can older adults anticipate and how often will these occur? Will the vaccines offer meaningful protection to seniors who are frail or have multiple chronic illnesses?

Here’s a look at what’s known, what’s not and what lies ahead.

Decision-making timetable. Pfizer’s vaccine will be evaluated by a 15-member Food and Drug Administration advisory panel on Thursday. Moderna’s vaccine is expected to go before the panel Dec. 17.

At least two days before each meeting, an analysis by FDA staff will be made public. This will be the first opportunity to see extensive data about the vaccines’ performance in large phase 3 clinical trials, including more details about their impact on older adults.

So far, summary results disclosed in news releases indicate that Pfizer’s vaccine, produced in partnership with BioNTech, has an overall efficacy rate of 95% and efficacy of 94% in people 65 and older. Moderna’s overall efficacy is 94%, with 87% efficacy in preventing moderate disease in older adults, according to Moncef Slaoui, chief science adviser to Operation Warp Speed, the government’s COVID-19 vaccine development program.

If the advisory panel gives a green light, the FDA will decide within days or weeks whether to authorize the Pfizer and Moderna vaccines for emergency use. Distribution of the vaccine has already begun, and health care providers are expected to begin administering it immediately after the FDA acts.

Allocation framework. At a Dec. 1 meeting of the Advisory Commission on Immunization Practices (ACIP), which guides the Centers for Disease Control and Prevention on vaccines, experts recommended that people living in long-term care (primarily nursing homes and assisted living facilities) and health care workers be the first groups to get COVID-19 vaccines.

This recognizes the extraordinary burden of COVID-19 in long-term care facilities. Although their residents represent fewer than 1% of the U.S. population, they account for 40% of COVID deaths — more than 100,000 deaths to date.

The commission’s decision comes despite a lack of evidence that Pfizer’s and Moderna’s vaccines are effective and safe for frail, vulnerable seniors in long-term care. Vaccines were not tested in this population. Federal officials insist side effects will be carefully monitored.

Next in line likely would be essential workers who cannot work from home, such as police, firefighters, teachers and people employed in food processing and transportation, according to commission deliberations Nov. 23 that have not come to a formal vote.

Then would be adults with high-risk medical conditions such as diabetes, cancer, kidney disease, obesity, heart disease and autoimmune diseases and all adults age 65 and older.

Although states typically follow ACIP guidelines, some states may choose, for instance, to vaccinate high-risk older adults before some categories of essential workers.

Left off the list are family caregivers, who provide essential support to vulnerable older adults living in the community — an unpaid workforce of tens of millions of people. “If someone is providing day-to-day care, it makes sense they should have access to the vaccine, too, to keep everyone safe,” said Beth Kallmyer, vice president of care and support for the Alzheimer’s Association.

Further prioritization. The priority groups constitute nearly half of the U.S. population — 21 million health care workers, 3 million long-term care residents, 66 million essential workers, more than 100 million adults with high-risk conditions and 53 million adults age 65 and older.

With initial supplies of vaccines limited, setting priorities will be inevitable. Practically, this means that hospitals and physicians may try to identify older adults who are at the highest risk of becoming seriously ill from COVID-19 and offer them vaccines before other seniors.

A study of more than 500,000 Medicare beneficiaries age 65 and older provides new evidence that could influence these assessments. It found the conditions that most increase older adults’ chances of dying from COVID-19 are sickle cell disease, chronic kidney disease, leukemias and lymphomas, heart failure, diabetes, cerebral palsy, obesity, lung cancer and heart attacks, in that order.

“Out of all Medicare beneficiaries, we identified just under 2,500 who had no medical problems and died of COVID-19,” said Dr. Martin Makary, co-author of the study and a professor of health policy and management at Johns Hopkins Bloomberg School of Public Health in Baltimore. “We knew risk was skewed toward comorbidity [multiple underlying medical conditions], but we didn’t realize it skewed this much.”

Supplies available. Both the Pfizer and Moderna vaccines require two doses, administered three to four weeks apart. The companies have said about 40 million doses of their vaccines should be available this year, enough to fully vaccinate about 20 million people.

After that, 50 million doses might become available in January, followed by 60 million doses in both February and March, according to Dr. Larry Corey, a virologist who heads the COVID-19 Prevention Trials Network.

That translates into enough vaccine for another 85 million people and should be sufficient to vaccinate older adults in addition to medical personnel on the front lines and many other at-risk individuals, Corey suggested at a recent panel on COVID-19 sponsored by the National Academy of Medicine and American Public Health Association.

He acknowledged these were estimates, based on information he has been given. Pfizer and Moderna have not yet specified how much vaccine will be delivered and when. Nor is it clear when other vaccines under investigation will become available — 13 are in phase 3 clinical trials — or what their monthly production capacity might be.

Distribution issues. As Pfizer’s and Moderna’s vaccines are rolled out, a very vulnerable group may have difficulty getting them: 2 million seniors who are homebound and another 5.3 million with physical impairments who have problems getting around.

The reason: handling and cold storage requirements.

Pfizer’s vaccine needs to be stored at minus 70 degrees Celsius, calling for special equipment not available in small hospitals, clinics or doctors’ offices. Moderna’s vaccine needs long-term storage at minus 20 degrees Celsius.

Landmark Health provides in-home medical care to more than 120,000 frail, chronically ill homebound seniors in 15 states. “We don’t have the capabilities to store and distribute these vaccines to our population,” said Dr. Michael Le, the company’s co-founder and chief medical officer.

Instead, he said, Landmark is working to arrange transportation for its patients to centers where COVID-19 vaccines will be administered and educating them about the benefits of the vaccines. “Given the trust, the bond we have with our patients, we can play a big role as advocates,” Le said.

Addressing mistrust. Advocates have a big job ahead of them. According to a recent poll from the University of Michigan, only 58% of older adults (ages 50 to 80) said they were very or somewhat likely to get a COVID-19 vaccine. A significant number of older adults, 46%, thought they’d get the vaccine eventually but wanted others to go first. Only 20% wanted to get it as soon as possible.

Most important in making decisions is knowing how well the vaccine works, according to 80% of the 1,556 older adults surveyed. Just over half (52%) said a recommendation from their doctor would be influential.

Dr. Sharon Inouye, a geriatrician at Hebrew Senior Life in Boston and a professor of medicine at Harvard Medical School, is among the physicians impatiently awaiting the publication of data from Pfizer’s and Moderna’s phase 3 clinical trials.

Among the things she wants to know: How many older adults with chronic health conditions participated? How many participants were 75 and older? Did side effects differ for older adults?

“What I worry about most is the side effects,” she said. “We may not be able to know about serious but rare side effects until millions of people take them.”

But that’s a gamble she’s willing to take. Not only will Inouye get a vaccine, she just told her 91-year-old mother, who lives in assisted living, to say “yes” when one is offered.

“My whole family lives in fear that something will happen to her every day,” Inouye said. “Even though there’s a lot we still don’t know about these vaccines, it’s compelling that we protect people from this overwhelming illness.”

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