Nursing Home Residents May Have Lower Vaccine Immune Response

A COVID-19 vaccine administered to nursing home residents in northeast Ohio was less effective in creating an antibody response in them than in a control group of health care workers, according to a Case Western Reserve-led study.

Some residents responded "reasonably well," but a portion responded "poorly to very poorly," concluded university researchers. What's not yet clear is why, or what the threshold for protection is when measured in terms of antibodies.

"We urgently need better longitudinal evidence on vaccine effectiveness" to inform best practices for nursing home infection control measures, outbreak prevention and potential indication for a vaccine boost, stated the study. Its co-principal investigators include David Canaday, MD, a professor in the School of Medicine’s Division of Infectious Disease, and Mark Cameron, PhD, an associate professor in the school’s Department of Population and Quantitative Health Sciences.

Once COVID-19 reached the United States, nursing homes became hotspots, with a rapid rise of infections and deaths; when vaccines became available, nursing home residents were among the first to receive them.  The study focused on the antibody immune response in residents by comparing a blood sample taken before the first vaccination, with another taken about two weeks after the second one.  It included 149 residents and a younger control group of 110 health care workers. All participants received the Pfizer vaccine.

Researchers examined three measures of antibodies; in all cases, residents had lower levels. For example, residents had a quarter of the anti-virus antibodies as the control group.

Canaday said the study's results can’t be compared to Pfizer’s vaccine efficacy rate of 95% because the Pfizer clinical trial focused on the number of adults of any age who got COVID-19, not the quantity of antibodies in the blood.

"The vaccine does make an immune response in almost every nursing home resident, although the magnitude is lower than in the younger age," Canaday said.

The study was the first outcome from a $2.3 million National Institutes of Health grant focused on COVID-19's spread in nursing homes awarded to Canaday, Cameron and fellow co-principal investigator Stefan Gravenstein, MD, a geriatrician and professor at Brown University.

They are now exploring varying responses to COVID-19 in nursing home residents and what level of antibodies is protective.

"There are so many questions to be answered surrounding the role of one's immune system in determining whether an infected individual has a mild, moderate or very severe form of COVID-19," Cameron said, "especially in people who are older or have underlying health issues that put them more at risk for poor outcomes."

Early COVID-19 Vaccinations Reduce Nursing Home Cases

A new study recently found that facilities that started the COVID-19 vaccination process earlier were less likely to have new cases  compared to providers who started inoculations weeks later. 

"Early group" nursing homes had 2.5 fewer COVID-19 infections per 100 at-risk residents after one week when compared to late group facilities. In addition, they had 5.2 fewer cases per 100 after five weeks. 

The study, led by Brown University researchers, was conducted using data from 280 Genesis HealthCare facilities. Nursing homes in the early group conducted their vaccine clinics from Dec. 18, 2020 to Jan. 2, while the late group’s clinics were between Jan. 3 and 18. 

Rates of hospitalizations and deaths were also down for providers who started the vaccination process earlier. Findings showed that after seven weeks earlier vaccinated facilities five fewer hospitalizations and/or deaths per 100 infected residents. 

Brown University biostatistician and co-author Roee Gutman said the findings reveal just how quickly the vaccine starts to work within long-term care facilities. 

“We see that the mRNA vaccine is useful and has a strong protective effect relatively soon after it is being administered,” Gutman told McKnight’s Long-Term Care News.  The full study was published in the Journal of the American Geriatrics Society.

“It is significant because the original Pfizer trial was not performed on this population and it only examined severe COVID cases. Because residents are tested regularly, we can see that the number of infections is lower than those that vaccinated later and a measure of COVID severity is lower. Second, we see that the mRNA vaccine works on this very old and frail population,” he added. 

Researchers said they hope the findings “make it possible for nursing homes to begin controlled efforts to open up to family visitation and alleviate other restrictions, thus reversing the social isolation which has become virtually universal during the pandemic.”  As previously discussed on this blog, isolation has been devastating to this older vulnerable population:

• Seniors Dying from Isolation Amid Pandemic- One Analysis Suggests Tens of Thousands;
• Heartbreaking Study Finds that Contact with Nursing Home Residents Fell by More than Half;
• Survey Suggests 64% of Residents Don't Leave Rooms to Socialize; More Report Profound Loneliness. 

The statistics also provide even more evidence that the vaccination is effective in reducing the spread of the disease. 

Source: D. Brown, "Nursing homes with early COVID vaccinations less likely to have new COVID cases,"  McKnight’s Long-Term Care News April 20, 2021).

SNF COVID Crisis Over? SNF COVID Deaths Fell 66% in Wake of Vaccine Clinics as Overall U.S. Fatalities Rose 61%

After a year of remarkable tragedy in nursing homes, a new analysis of federal COVID-19 data shows a significant drop in resident deaths in the weeks after vaccine clinics began, a trend made even more striking given the simultaneous spike in U.S. coronavirus deaths over the same period. The detailed analysis, courtesy of the Kaiser Family Foundation (KFF), paints a much-needed portrait of the COVID-19 pandemic as it has impacted, and continues to impact long-term term care facilities (LTCFs).  According to KFF, the final months of 2020 were the deadliest months of the pandemic for many LTCFs across the country, with over 26,000 COVID-19 deaths in LTCFs reported between Thanksgiving weekend and December 31, 2020. 

The end of 2020 saw the approval of the first coronavirus vaccines and the launch of vaccine administrations in LTCFs through the Pharmacy Partnership for Long-Term Care on December 21st, 2020 (Pfizer-BioNTech) and December 28th, 2020 (Moderna). As of February 22, 2021, about 4.5 million residents and staff have received one or more dose through the Partnership; over 2 million residents and staff have received both doses. In addition, some states and some LTCFs have vaccinated residents or staff outside the Partnership. Vaccinations have increased outside of LTCFs as well, though at a significantly lower rate. 

Weekly deaths in nursing homes fell 66% between the last week of December, when the federal government’s long-term care vaccination partnership with CVS and Walgreens ground into gear, and the first week of February, according to the Foundation.  That decline nonetheless represents more than 2,000 fatalities, but it came as nationwide deaths, excluding nursing homes, spiked 61% to nearly 20,000 during the week ended February 7, prompting the Foundation to ponder whether the end of the crisis in LTCFs has finally come into view.

KFF stopped short of definitively concluding that the vaccine clinics were the direct cause of the drop, noting that not every facility started the inoculation process on the same day, but the general association is obvious.

“According to the CDC, there has been strong evidence that the vaccines prevent severe illness and death, and the sharp divergence in deaths inside and outside of LTCFs is consistent with that evidence,” KFF observed. “In addition, given the emerging research around the vaccines’ ability to prevent transmission of the virus, there is reason to believe that the vaccine may be playing a part in reducing virus transmission within nursing homes, contributing to the more rapid decline in new cases in nursing facility residents than in the overall population.”

Total case numbers in nursing homes dropped 83% in the post-clinic period, far outpacing the 45% dip among the general, non-LTC population. “While cases have dropped both within and outside nursing facilities, new nursing facility resident cases peaked earlier (week ending December 20, 2020) as compared to in the general non-nursing facility resident population (week ending January 10, 2021) and declined at a faster rate in nursing facilities than outside nursing facilities,” KFF noted.

The most recent data marks a swift turnaround from record-high death counts seen in LTCFs at the beginning of 2021.  One in every 51 residents of LTCFs died during the four weeks bookending New Year’s Day, for a grim total of nearly 20,000, according to an AARP analysis.

“While the record high death rate in the four weeks ending Jan. 17 represents only a slight increase from the previous month, when 1 in every 53 residents died from COVID-19, it is more than a quadrupling of the resident death rate at the end of the summer,” AARP noted.

The gains also came amid continued concerns about relatively low uptake of vaccines among nursing home staff. Only 37.5% of workers accepted vaccinations during the first month of clinics, according to the Centers for Disease Control & Prevention (CDC), as compared to 77.8% of residents.  Meanwhile the debate regarding mandating vaccines roils. 

Sources:

"Nursing Home COVID Deaths Fell 66% in Wake of Vaccine Clinics — Even as Overall U.S. Fatalities Rose 61%," Skilled Nursing News, February 25, 2021.

Is the End of the Long-Term Care Crisis Within Sight? New COVID-19 Cases and Deaths in Long-Term Care Facilities Are Dropping, KFF, February 24, 2021.  

Vaccine Mandates Threaten Viability of the Long-term Care Industry

Some long-term care facilities are mandating  COVID-19 vaccines among staff.  Mandates divide the industry in profound ways, and threaten a myriad of legal challenges.

Lauren Clason has penned an excellent article for Congressional Quarterly Roll Call, warning that vaccine mandates "have sparked ethical and legal concerns and [already] prompted some nursing home workers to quit."

The Brief History of the Vaccine

It is important, in considering the impact of the vaccine and associated mandates, to appreciate the brief history of the vaccine.  Bluntly, it is neither normal nor organic.  On December 11, 2020, the FDA issued an Emergency Use Authorization ("EUA") for the Pfizer-BioNTech COVID-19 vaccine. Two days later, the first shipment of the vaccine left the manufacturing plant. Vaccinations began on December 14, 2020. Subsequently, on December 18, 2020, the FDA issued an EUA for the Moderna COVID-19 vaccine. The first shipments of the Moderna vaccine left a distribution center on December 20, 2020. An FDA report issued on December 8, 2020, highlights the unknowns that exist when a vaccine receives an EUA, including the limited amount of data to support the effectiveness of the Pfizer-BioNTech vaccine against asymptomatic infection and its unknown effect against transmission of COVID-19 from individuals who are infected despite vaccination. 

While many articles implicitly or explicitly assail workers (or anyone) who expresses doubts or concerns regarding the vaccine, these authors ignore the the "unknowns" that inherently exists when a vaccine receives an EUA.  Whether these "unknowns" merit refusal or delay, is not an objective fact, notwithstanding the narrative of most authors.  Worse, failure to acknowledge rational concerns only substantiates irrational concerns;  the motives of vaccine proponents are more readily assailable when they are not truthful about "unknowns."    

Regardless, long-term care workers have not rushed to receive the vaccine as public health experts battle everything from unsubstantiated conspiracy theories to the simple fears that come with a novel virus and a more novel vaccine. In context, however, the historical success with vaccination utilization by long-term care industry staff is poor; nursing homes historically trail other health care institutions in vaccinations (see CDC Reports That SNF Workers Most Likely Among Health Care Workers to Forego Recommended Vaccinations). 

The Law

At the federal level, the Equal Employment Opportunity Commission ("EEOC") has determined that COVID-19 meets the direct threat standard, meaning that "a significant risk of substantial harm would be posed by having someone with COVID-19, or symptoms of it, present in the workplace at the current time."   The Equal Employment Opportunity Commission (EEOC) issued guidance in December clearing COVID-19 vaccine mandates in accordance with laws like the Americans with Disabilities Act. 

The EEOC's guidance acknowledges without explanation that the FDA has an obligation to "[e]nsure that recipients of [a] vaccine under an EUA are informed … that they have the option to accept or refuse the vaccine." Based on the EEOC's guidance to date, "a mandatory vaccination policy, with appropriate carve-outs for individuals with disabilities and sincerely held religious beliefs, may be permissible under federal law," according to the excellent analysis of one of the most respected firms in America, Jones Day..  

But, even if it is lawful, there are problems: 

"Namely, no federal agency has endorsed employer-mandated COVID-19 vaccinations explicitly, and historically these agencies have stopped short of endorsing mandatory vaccinations outside of certain industries; courts may disagree with a conclusion by the EEOC that mandatory vaccination is lawful; and there is a lack of legal precedent supportive of across-the-board mandatory vaccinations for all job positions in all industries. Moreover, even if mandatory vaccination is found lawful under federal law, such a policy carries additional risks, including potential liability under state law and damage to employee relations. And notwithstanding workers' compensation exclusivity, there is an open question whether tort or similar liability could attach to an employer, and under what circumstances, if employees are harmed by an employer-mandated vaccine.  

Simply, the law pertaining specifically to emergency use authorizations, which require less efficacy and safety data than a full approval, is unclear.  Dorit Reiss, a professor at University of California, Hastings College of the Law told CQ RollCall:

The law requires that recipients be informed of the right to refuse a vaccine under emergency authorizations, but also that they be informed of the consequences. Whether the consequences can include losing one’s job is unclear.  If it goes to court, I think it’s a 50-50." 

While incentives for mandating the vaccine in elderly care setting are strong, so are the disincentives and potential disadvantages.  Employers might expose themselves to tort and negligence claims if something goes wrong, Robin Shea, a Constangy Brooks, Smith and Prophete partner told CQ Roll Call, adding:

“I would be concerned about that, and in a non-health care workplace, I would be thinking about that really hard before mandating it.”

Conclusion?  There is risk everywhere.  

Tearing Apart the Industry

As a result, the vaccine threatens the industry with workforce uncertainty and public mistrust, all amid threats of legal disputes as institutions contend with union agreements, state laws, and the vaccines’ lack of full Food and Drug Administration approval.  A vaccine mandate also raises ethical issues. Clasen writes:

"Distrust in the government is widespread among low-income communities of color, which make up a disproportionate share of the long-term care workforce. Undergoing a mandatory vaccination from whiter, wealthier bosses seems disrespectful of their historic marginalization, worker advocates say. Distrust among white staffers is also widespread."

“Our members deserve to be heard on why they’re hesitant, and there are many reasons for it that aren’t ridiculous,” Lori Porter, CEO of the National Association of Health Care Assistants, which represents 26,000 certified nursing assistants, or CNAs, told CQ RollCall.  

National polls show that as many as 70 percent of long-term care staff are still wary of the vaccine, Porter told CQ RollCall. Polling among NAHCA members is better, with about 50 percent of workers saying they’d take it.

Many CNAs are leaving the centers that are mandating vaccines.  No nursing center in America today can afford to lose CNAs.  According to Porter, there are "more than 170,000 openings for certified nursing assistants in skilled nursing facilities alone. The annual turnover rate stands at 120 percent."  Locally, the Ohio National Guard was dispatched to help staff a nursing home when staff simply failed to show up for work.  The Ohio National Guard served capably in that role, having in certain instances assisted with staffing institutions reeling from infection and self-quarantines.    

Clasen interviewed Shanna Lacy, a 38-year-old nursing assistant at an Iowa nursing home, who is, according to Clasen "opting out of the vaccine over concerns about unknown long-term effects, driven by the vaccine’s fast-tracked timeline coupled with her distrust in government."

“I don’t feel like any corporation or government or whoever should make somebody do something to their body that they don’t want to,” Lacy told CQ Roll Call.

Lacy reportedly enjoys working at her facility and told CQ RollCall that she gets the flu vaccine every year. But, she said, the pandemic is not severe where she lives, and her belief in former President Donald Trump’s claims that he won the 2020 presidential election further undermines her trust in the government’s vaccine operation. 

Lacy’s nursing home offers prize drawings to employees who take the vaccine, she said, while those who don’t are tested three days a week. She has not been told the facility would require her to take the vaccine, but if that happens, she told CQ RollCall she would find work elsewhere, or maybe even leave the field:

“I could work at a McDonald’s flipping burgers, making the same amount and not being made to take this vaccine,” she said. “Do I want to work at McDonald’s? No, I don’t. But if I had to, I would.” 

Mandates for other vaccines like the flu are common, but requiring a vaccine authorized on an emergency basis is new ground. The Atria Senior Living chain is requiring all 14,000 of its staffers to be vaccinated by May 1:  

“We’re very strong in the belief that our residents deserve to live in a vaccinated environment, and our staff deserves to work in a vaccinated environment,” CEO John Moore told CQ Roll Call. “And it’s a privilege to have access to the vaccine early.” 

Moore reported that the number of staffers who had quit since implementing the mandate was low, but that staffers who ultimately refuse the vaccine will be let go.  What constitutes "low" in an industry with 120% turnover, with a deadline still months away is unclear in the CQRollCall article. 

According to Moore and CQ RollCall, dozens of other facilities are implementing vaccine mandates: 

“No one wanted COVID. No one chose COVID,” Moore said. “There are no perfect answers. There’s only the next best answer, and that’s what we keep searching for."

In Pennsylvania, a vaccine mandate in a nursing home operated by Bucks County sparked a union dispute. The American Federation of State, County and Municipal Employees (AFSCME) filed a grievance with Neshaminy Manor, arguing that changes to employment terms are a bargaining issue under state law.

“I really feel as though this is something that can be worked out,” AFSCME District Council 88 Director Tom Tosti told CQ RollCall. “The workers there in that manor — and across every nursing home facility and every facility, whether it has mental health patients or whatever — have been working tirelessly since this pandemic hit. And to turn around and say now you’re mandated to put something into your body or you’re getting terminated isn’t fair at all for what they’ve done this past year.”

Bucks County says the mandate is on solid legal footing, pointing to the toll the coronavirus takes on the elderly. The facility lost 86 patients to the virus.

“Any staff that has not been vaccinated by the end of March could be laid off,” the county said in a statement.  

The emotions of the decision for workers are often overlooked, Pennsylvania COVID-19 task force member Joshua Uy, medical director at Renaissance Healthcare and Rehabilitation Center in Philadelphia told CQ RollCall. Explaining the mechanics of the vaccine doesn’t necessarily erase fear. According to the CQ RollCall article, all of Renaissance’s residents were vaccinated compared with only 50 percent of its staff. Uy focuses on highlighting positive emotions that the vaccine can bring, such as ending isolation. 

“I’ll try to remind them not to ignore what they’re feeling, but to sort of add other emotions, like this vaccine is hope,” he said. 

Porter said NAHCA is considering a project to leverage the families of long-term care patients. 

“CNAs don’t trust government. CNAs don’t trust their employers,” she said. “CNAs trust CNAs. Those two obstacles in the trust run deep.” 

Relying on personal doctors, whom polling shows are a trusted source for many people, doesn’t always work. In Missouri, where NAHCA is based, many doctors weren’t wearing masks as recently as December, she said.

Porter also stresses that receiving priority for a vaccine with the potential to end a pandemic is an unprecedented industry victory:

“We continue to tell our members that this was a win for us,” she said. “Don’t let it be in vain.”

The public watches intently as the drama unfolds.  Perhaps, rather than just feeding a collective fear of institutions, the public will orient its planning toward aging in place, thereby relieving stress upon both the long-term care industry and families seeking to cope with short and long-term care. 

Only 37% of Long-term Care Facilities Staff Vaccinated for COVID-19

While residents of nursing homes and their caregivers have been considered a top priority for COVID-19 vaccination, only 38% of nursing home staff accepted shots when they were offered.  This according a survey conducted by the Centers for Disease Control and Prevention (CDC). 

Anecdotal reports have been circulating for weeks that nursing home staff members were turning down vaccination offers, but these are the first national-level figures.  Of course, historically, nursing homes trail other health care institutions in the staff penetration of vaccines (see CDC Reports That SNF Workers Most Likely Among Health Care Workers to Forego Recommended Vaccinations). 

Dr. Radhika Gharpure, lead author of the study and a member of the CDC’s Vaccine Task Force wrote, "These findings show we have a lot of work to do to increase confidence and also really understand the barriers to vaccination amongst this population." The report cited previous polling data to suggest why employees have been declining vaccines. Many raised concerns about vaccine side effects. Others said they didn't want to be among the first to receive the vaccines, which were first authorized in December. Some said they didn't trust the government, or referenced false claims about the shots.

Residents, meanwhile, have been much more accepting of vaccines, with 78% receiving at least one shot, according to the new report, which examined vaccination rates at more than 11,000 long-term care facilities nationwide between Dec. 18 and Jan. 17.

Source, "Roughly one-third of long-term care staff vaccinated through federal program: CDC," The Hill (2/1/21).

Florida Investigates Nursing Home Reportedly Funneling Vaccines to Rich Donors

The State of Florida is investigating allegations that an upscale West Palm Beach nursing home diverted scarce COVID-19 vaccinations meant for residents and staff to members of the facility’s board of directors and donors.  

Appearing at a press conference in Vero Beach, Governor Ron DeSantis said that the Florida Department of Health was investigating reports that MorseLife Health System chief executive Keith Myers offered vaccinations to some of the long-term care facility’s board members and wealthy donors.  DeSantis said he also directed Florida Inspector General Melinda Miguel to investigate the allegations in stories published this week.

Emily Smith of Page Six reported that real estate moguls Bill and David S. Mack arranged for their “wealthy friends from Manhattan and the ritzy Palm Beach Country Club to get the COVID-19 vaccine at a Florida retirement home.”  The Washington Post reported that MorseLife made the vaccinations “available not just to its residents but to board members and those who made generous donations to the facility, including members of the Palm Beach Country Club, according to multiple people who were offered access, some of whom accepted it.”  DeSantis assured the public that Florida started the investigation “as soon as we found out about it.”

The governor’s remarks came on the heels of U.S. Sen. Rick Scott’s public call for an investigation into the allegation.  "It is absolutely disgusting and immoral that anyone would take vaccines intended for nursing home residents to distribute them to their friends," Scott, a Republican and former Florida governor, said in a statement. "This type of gross mismanagement will not be tolerated, and those responsible must be held accountable."

The federal government inked agreements last year with CVS and Walgreens to provide COVID-19 vaccinations to staff and residents of nursing homes and assisted-living facilities.  Hospital frontline health-care workers and residents of the long-term care facilities were the initial groups of people who qualified for Pfizer Inc. and Moderna vaccinations.

DeSantis on Dec. 23 announced that he was broadening eligibility to include all health care workers as well as people who are 65 or older.  The move led to chaos, resulting in jammed phone lines, overwhelmed websites and, in some instances, lines of seniors camping out over night to be first in line for vaccines.  In other words, it may be that the nursing home was simply providing the vaccine to its donors and others who it thought may have qualified under the broader DeSantis eligibility.  Regardless, the optics couldn't be worse for the nursing home provider.  

DeSantis emphasized Thursday that the vaccinations at the center of the controversy were not supplied by hospitals or county health departments, but were part of the federal arrangement with retail pharmacies.

“The nursing home and long-term care program is for residents and staff of long-term care facilities. That’s who it's for. Look, if you’re not a resident or a member of a long-term care facility but you’re 65 and up, there’s other options for you. We want you to get vaccinated. But to go under that rubric when you are not a resident and you’re not a staff member, that is definitely going outside of what the guidance is and what the program is for,” the governor said.

New Alzheimer’s Vaccine Could Cut Cases In Half

Scientists at the University of Texas, Southwestern have created a DNA vaccine for Alzheimer’s.

It’s thought that the formulation could decrease cases by half.

The vaccine utilizes DNA from Alzheimer’s proteins, from which the immune system learns to fight the compounds and prevent them from collecting in the brain.

The researchers believe human trials are finally in sight.

Dr. Roger Rosenberg, Director of the Alzheimer’s Disease Center at UTS (and also the organization’s founder), said the breakthrough is the result of many years of trial-and-error:

“[It’s] the culmination of a decade of research that has repeatedly demonstrated that this vaccine can effectively and safely target in animal models what we think may cause Alzheimer’s disease.”

According to the Alzheimer’s Association, every 65 seconds, someone in the U.S. develops the disease. 1 in 3 senior citizens die with it or another form of dementia. 5.7 million Americans currently suffer from the terrible condition, for which there are noted risk factors but very little treatment. By 2050, that number is expected to reach nearly 14 million.