For reference, people who didn’t take nirmatrelvir/ritonavir rebounded just 2% of the time, the authors noted. The news comes as the World Health Organization reclassified risk categories for COVID-19, a move that largely affects older adults otherwise thought to have a high risk for the condition.

Virologic rebound is the phenomenon of having a virus, receiving a negative test and then getting the virus again. Virologic rebound included people who tested negative after having the virus but then tested positive again as well as those who had two consecutive increases in viral loads following an initial reduction. 

Nirmatrelvir/ritonavir is an oral medication used to treat COVID-19. Previous research showed that 1% to 2% of people who took it had virologic rebound, but the new study indicates that getting COVID-19 again may be much more common than previously known.

Despite the findings, the team from Mass General Brigham said that the results don’t change the fact that the drug works to prevent hospitalizations and death. The study gives people who take the medicine valuable insights to understand how long they may be contagious, the authors said.

Their study was published Monday in Annals of Internal Medicine.

“We conducted this study to address lingering questions about Paxlovid and virologic rebound in COVID-19 treatment,” Mark Siedner, MD, an infectious disease clinician and one of the authors in the Division of Infectious Diseases at Massachusetts General Hospital, said in a statement. 

“We found that the virologic rebound phenomenon was much more common than expected — in over 20% of people taking Paxlovid — and that individuals shed live virus when experiencing a rebound, implying the potential for transmission after initially recovering from the virus.”

For the research, the team used data from the Post-vaccination Viral Characteristics Study, or POSITIVES. Data came from 142 people between March 2022 and May 2023. The researchers compared people who took nirmatrelvir/ritonavir with those who didn’t. They tracked the peoples’ symptoms and viral loads and conducted genome sequencing.

Of the participants, 20.8% who took nirmatrelvir/ritonavir had virologic rebound compared with 1.8% of those who didn’t take it.

People who had rebound had viral shedding — meaning they still were contagious — for an average of 14 days compared with five days in people who didn’t experience rebound. There wasn’t evidence of drug resistance among the people with prolonged shedding. 

In related news, the WHO announced updated COVID-19 treatment guidelines on Friday. The new guidance includes the addition of a moderate risk category and may include some people formerly thought to be at high risk. It includes older adults as well as those with chronic conditions, comorbidities and disabilities.

A study released Monday in JAMA Internal Medicine found there was a small reduction in long COVID, or post-COVID condition (PCC), in people over the age of 65 who got either nirmatrelvir (Paxlovid) or molnupiravir (Lagevrio).

The data was derived from people who were part of the Medicare program and were diagnosed with COVID-19 from January to September 2022. Of the 313,262 participants in the study, 51,658 took nirmatrelvir during acute infection, and 8,089 took molnupiravir. 

For the study, long COVID was defined as any new occurrence (not present prior to COVID-19 diagnosis) of 11 noted symptoms from 4 to 12 weeks after the person had the COVID-19 infection. Symptoms included fatigue, difficulty breathing, heart palpitations and memory issues.

The incidence of long COVID was 11.8% in people who took nirmatrelvir and 13.7% for those taking molnupiravir. The incidence of long COVID was 14.5% in people who didn’t take either medication. The effect was smaller among females, as well as people who were Asian, Black and Hispanic race. The protection against long COVID was also reduced in people with lower incomes. 

“The current approved use of the two drugs is for the prevention of severe acute COVID-19,” the authors wrote. “Our findings suggest that they may also have a role in preventing PCC.”

The news comes as Paxlovid’s manufacturer Pfizer announced the drug is going on the commercial market and would cost more than double what the company charged the federal government. Paxlovid will still be free for some populations through 2028, including older adults on Medicare.

The authors noted that the research didn’t include details on whether or not people who took the medications were vaccinated.

The study on 6,866 people from British Columbia with COVID-19 found that taking the drug was linked to having a lower risk for being hospitalized for, or dying from, COVID-19 if people were especially vulnerable to COVID-19. The biggest benefit researchers saw was in people who were immunocompromised. 

Lower-risk people didn’t have a reduction in death from any cause or emergency hospitalization with COVID-19 within 28 days of taking the medication. That included people over the age of 70 with serious comorbidities. The researchers say that was the finding regardless of age. 

The study, which was published in JAMA Network Open on Monday, occurred between Feb. 1, 2022, and Feb. 3, 2023. The researchers looked at death from any cause, or hospitalization with COVID-19, within a 28-day span.

Researchers put people into high-risk groups. Some were clinically extremely vulnerable or moderately immunocompromised. A third group wasn’t immunocompromised but had medical conditions that put them at a high risk for complications from COVID-19. A fourth group included people at a lower risk for severe infection, including those who were over 70 years old or unvaccinated.

In short, people who had high risk, moderate risk or those considered immunocompromised lowered their risk for COVID-19 hospitalization or death when taking Paxlovid, but people at a lower risk didn’t seem to benefit. Also Monday, the Centers for Disease Control and Prevention (CDC) released a report from the week ending Sept. 23  that showed that COVID-19 activity fell with the exception of deaths, which rose by 8%. New hospital admissions slipped by 3.1%. The percentage of deaths from COVID-19 was 2.7% that week.

The US Centers for Disease Control and Prevention (CDC) shared its National Health Interview Survey results on Tuesday that contained data on Americans and long COVID. The survey data came from 27,651 people who reported data in 2022.

According to the survey results, 6.9% of adults said they had COVID symptoms for at least three months after testing positive for COVID-19 or being diagnosed by a doctor. The estimate is lower than previous CDC survey data from 2022 and 2023, which has stated that about 14% to 15% of adults in the country have had long COVID.

The report said that 18 million Americans said they have had long COVID, and 8.8 million said they currently had it at the time survey data was gathered.

Adults between the ages of 35 and 49 were most likely to ever have or currently have long COVID, according to the new data. People in that age group reported that 8.9% have had it, and 4.7% had it when the data was collected. Women were more likely than men to ever have or have long COVID when the survey was taken.

In a separate briefing, the CDC reported that 1.3% of children in the US have had long COVID. At the time the survey data was collected, 0.5% of children had symptoms that persisted for at least three months. Children ages 12 to 17 years were more likely than those ages up to five years old and those 6 to 11 years old to ever have it, or have it when the data was collected.

The news comes after a report found that the risk of developing long COVID was higher for the alpha, delta and wild-type variants of COVID-19 — and lower with the omicron variant. Those with long COVID are more likely to require long-term care services.

COVID-19 and respiratory syncytial virus cases are increasing, and the height of influenza season is on the horizon, but older adults and long-term care staff members are entering the first virus season in which vaccines are available for all three viruses responsible for the most hospitalizations.

The Centers for Disease Control and Prevention Office of Readiness and Response laid out the agency’s recommendations for flu, COVID-19 and RSV vaccines for older adults during a clinician outreach and communication activity call on Tuesday.

Influenza vaccines

Flu vaccination is recommended for everyone aged more than 6 months. Studies show older adults account for 54% to 70% of flu-related hospitalizations and 71% to 85% of flu-related deaths, said Lisa Grohskopf, MD, MPH, medical officer of the influenza division of the CDC’s National Center for Immunization and Respiratory Diseases.

This year, recommendations were updated regarding vaccine composition for 2023-2024, and changes were made to recommendations for people allergic to eggs.

Specifically, preferred vaccinations for older adults include the standard-dose adjuvanted or high-dose inactivated quadrivalent vaccines, or the recombinant quadrivalent vaccine — the latter being the only preferred vaccine that is not egg-based.

Experts also recommend flu vaccines in September or late fall due to the potential waning of immunity. The updated recommendations also indicate that individuals with egg allergy should be treated no differently than other recipients of any other vaccine, with no additional safety measures required. 

COVID-19 vaccines

Although the burden of COVID-19 varies by age and underlying conditions, older adults and those who have multiple underlying conditions have the highest risk of severe outcomes. Megan Wallace, DrPH, MPH, a CDC epidemiologist, said that the number of COVID cases is lower than at previous points in the pandemic, but experts continue to see thousands of hospitalizations and hundreds of deaths weekly from the virus, particularly in those 75 and older.

Vaccination with the updated COVID-19 vaccine is recommended, according to the CDC, because vaccine and infection-induced immunity wanes and because new variants continue to emerge, suggesting that susceptibility remains and may increase over time. Millions of COVID-19 vaccines have been administered over three years, proving their safety profile, Wallace added.

Key changes to the 2023-2024 mRNA vaccine recommendations include that anyone aged five or more years receive a single dose regardless of prior vaccination history, although additional doses may be recommended in the future based on epidemiology and vaccine effectiveness.

Under general best practice guidelines for immunization, routine administration of all age-appropriate doses of vaccines — COVID-19, flu and RSV — simultaneously is recommended if no contraindications exist at the time of vaccination. 

This year’s COVID-19 vaccines are the first to be available directly from the manufacturers as part of the commercial market rather than through the federal government. 

RSV vaccines

Although RSV is a familiar viral infection, Amadea Britton, MD/SM, medical officer of the CDC’s Coronavirus and Other Respiratory Viruses Division, said that it is an important cause of respiratory illness in older adults.

Older adults typically account for 60,000 to 160,000 RSV-related hospitalizations annually, and 6,000 to 10,000 deaths. Chronic underlying conditions are associated with increased risk of severe RSV disease, along with living in a senior living community or nursing home, frailty and advanced age.

In June, the CDC signed off on a recommendation from the Advisory Committee on Immunization Practices for a single dose of RSV vaccines for older adults. Studies found the vaccines to be generally well-tolerated, with common side effects similar to other vaccines, including pain at injection site, fatigue, headache, muscle pain and joint pain.

The ACIP and CDC recommend that adults aged 60 or more years receive a single dose of the RSV vaccine using shared clinical decision-making with their healthcare provider. RSV vaccination should be administered as soon as the vaccine is offered each summer. 

Vaccine hesitancy

Talking about vaccines can be a challenge, said Joellen Wolicki, BSN, RN, a nurse educator with the National Center for Immunization and Respiratory Diseases. 

“The biggest challenge is, knowledge does not equal behavior,” she said. “And it matters who the message is coming from and how it’s communicated.”

A broad range of socio-psychological determinants contribute to vaccine hesitancy, including attitudes, past experiences, trust, social norms, moral values and world views, Wolicki said.

The CDC recommends that healthcare providers give a strong recommendation for vaccination using the presumptive approach, which assumes that someone will choose to get vaccinated. In some cases, motivational interviewing — collaborative communication to guide people toward change or action — might be more effective. Studies using motivational interviewing with vaccination decisions showed increased intent to vaccinate and improved vaccination rates, Wolicki said.

A team from the Beth Israel Deaconess Medical Center (BIDMC) in Boston used Medicare data from 883,394 Medicare beneficiaries over the age of 65. They were admitted and then discharged between March 2020 and August 2022. The team compared the results to that of 56,409 Medicare beneficiaries who were hospitalized and then sent home for having the flu between March 2018 to August 2019. The study was funded by the National Health, Lung, and Blood Institute.

Though people with COVID-19 had lower rates of comorbidities, they had a 10.9% risk of dying within 30 days of being discharged compared to people who had the flu, who had a 3.9% rate. That same higher death rate was 15.5% in people with COVID-19 compared to 7.1% with the flu at 90 days after being discharged. At 180 days post-discharge, people with COVID-19 had a 19.1% death rate compared to people with the flu, who had a 10.5% rate.  

“The 30-day risk of death after hospital admission with COVID-19 peaked at 17.9% in May 2020 but decreased to 7.2% by the end of the study period,” the authors wrote. “Although this finding may be due to differences in the biology of SARS-CoV-2 and influenza viruses, it may also reflect differences in baseline immunity between cohorts, either from previous infection or from vaccination, though we were unable to evaluate the underlying mechanism in this study.”

People who had COVID-19 had a sixfold higher rate of in-hospital deaths. Of those studied, 16.6% of Medicare enrollees died while they were in the hospital for COVID-19. That compares to 2.7% of those hospitalized for flu.

“Our findings suggest the continued need to evaluate clinical and societal interventions that address the glaring inequities in post-discharge outcomes among older adults hospitalized with COVID-19,” the study said.

Connecticut’s highest court has offered a mixed ruling for a nursing home that sought dismissal of a wrongful death suit under a state provision limiting COVID-era liability.

The court backed the provider’s interpretation that operators were protected in cases where short staffing due to COVID-19 conditions affected the ability to care for any patients in a healthcare facility. Coverage applies even when the affected patient doesn’t have COVID.

But the Supreme Court also ruled last week that a lower court was correct in denying Regency House of Wallingford’s motion, explaining that the provider should have presented more evidence of the effect of COVID on its operations to benefit from protections granted under an executive order.

In a companion ruling last week, the state Supreme Court also decided in Mills v. Hartford HealthCare Corp. that the immunity granted by Gov. Ned Lamont’s (D) 2020 order broadly applies to services meant to prevent, diagnose or treat COVID, but not to those taken after the virus had been ruled out.

The ruling comes as state courts grapple with how to interpret various immunity provisions and a federal liability statute. Many of the protections expired with the end of the public health emergency,  but cases from when they were in place continue to wind their way through appeals.

In denying the motion to dismiss the case involving Regency and its management company, National Health Care Associates, a Connecticut trial court cited the Mills case. A lower court had earlier interpreted the executive order to apply only in ‘‘instances involving the treatment of COVID-19 patients.’’ National sought to appeal its case to the state Supreme Court to help determine whether that ruling was too limited.

The state Supreme Court published rulings on the companion cases simultaneously Aug. 8.

“We are pleased with the court’s interpretation of the governor’s executive order within the opinions, which acknowledges the importance of protecting providers in the early days of the pandemic,” the company said in a statement emailed to McKnight’s Long-Term Care News Thursday. “Otherwise, we cannot comment on litigation that remains pending.”

Lack of resources may include ‘staffing’

Much of the court’s unanimous decision in Manganelli vs. Regency House centered around language in Lamont’s order regarding the “lack of resources” as providers responded to the pandemic.

The court found that cases involving a lack of resources — including a staff shortage — attributable to the pandemic that led to sub-par care should be covered under the immunity clause. But it also said the language clearly requires defendants to show evidence that COVID conditions caused that lack of resources.

In the Regency case, executor Kimberly Manganelli is seeking damages following the December 2020 death of Darlene Matejek. Matejek had lived at the 4-star nursing home since 2014 but fell during a bed transfer on April 26, 2020. She fractured both legs but when she returned, Manganelli alleged, she did not receive adequate physical therapy and developed other complications.

Regency argued that Matejek’s fall occurred during the height of the facility’s first COVID outbreak. A former director of nursing outlined detailed administrative challenges including staff shortages due to virus exposure, shortages of personal protective equipment, increased phone call volume, the weakened condition of Regency House residents, and increased requests for nurse evaluations. 

Court: More needed from provider

But the court said that was not enough, and that the facility’s attorneys should have sought an evidentiary hearing to argue how those operational challenges affected Matajek’s care specifically.

“The defendants provided no evidence regarding how the lack of these resources led to the defendants’ failing to implement Matejek’s health program, leading to her fall,” Associate Justice Gregory T. D’Auria wrote. “They also supplied no evidence regarding how the lack of these resources related to the defendants’ failure to provide Matejek treatment for two days. Finally, the defendants advanced no evidence regarding how the lack of these resources connects to the defendants’ alleged failure to provide Matejek with proper treatment after she left the hospital and returned to Regency House.”

The court, however, affirmed repeatedly that such arguments could be valid in future cases given proper evidence.

“This interpretation of the ‘‘lack of resources’ clause is consistent with the language of the immunity provision as a whole,” D’Auria wrote. “Specifically, the clause at issue goes on to clarify that the alleged acts and/or omissions are caused by the lack of resources when the lack of resources ‘renders the healthcare professional or healthcare facility unable to provide the level or manner of care that otherwise would have been required in the absence of the COVID-19 pandemic . . . .’ This language eliminates any possibility that the governor intended the immunity afforded by Executive Order No. 7V to apply only to the diagnosis and treatment of COVID-19 patients.”

Long-term care operators might be forgiven for giving a similarly mixed review to the disease caused by SARS-CoV-2.

Fortunately, the most damaging wrecking ball to ever hit this sector appears to be moving on. And the facilities that survived the carnage are starting to feel a bit better.

But lest we forget how bad COVID-19 was, some clear if obvious documentation appears in a recent issue of JAMA Network Open. While the findings will probably not surprise anyone, they do point to how dire staffing challenges were during the storm.

For the mixed-methods study, investigators conducted 156 interviews with 40 nursing home administrators in eight markets. To determine staffing practices, they used Centers for Medicare & Medicaid Services Long-term Care Facility Staffing Payroll Based Journal (PBJ) data.

And what did they find? Facility coping tactics during COVID-19 included additional overtime payments, greater reliance on staffing agencies and reductions in resident admissions.

The major takeaway: Higher staffing costs and fewer customers can lead to financial difficulties. Imagine that.

Still, it’s useful to have some documentation of the damage. After all, future generations may simply not believe how bad facilities had it during COVID-19.

In fact, by the looks of things, many observers don’t believe nursing homes are suffering much these days. Or at least, not enough.

Consider:

·      Currently, CMS is putting the finishing touches on a first-ever requirement: mandatory staffing levels.

·      In recent weeks, we have also seen lawmakers send correspondence to CMS demanding the agency keep a closer eye on nursing home practices.

·      We’ve also seen a proposal from two Senators to set up a national advisory commission for long-term care. One slight problem: long-term care providers need not apply. Perhaps it should more accurately be called a national advisory commission for long-term care oversight?

Talk about trading one bag of guano for another.

Which reminds me of something else Mama used to say. People who think they can’t fall off the floor never lived through an earthquake.

John O’Connor is editorial director for McKnight’s.

Opinions expressed in McKnight’s Long-Term Care News columns are not necessarily those of McKnight’s.

Of more than 6 million people in the study, the Moderna vaccine had a 4% lower risk for producing pulmonary embolism and a 2% lower risk for clotting. The vaccine also was 15% better at preventing COVID-19 infections compared with the Pfizer vaccine.

The results are only based on the first dose of the mRNA vaccine. 

The study was published yesterday in JAMA Network Open.

“The results of this study can help public health experts weigh which mRNA vaccine might be preferred for older adults and older subgroups, such as those with increased frailty,” said Daniel Harris, PhD, lead author, an epidemiologist and research scientist at Brown University’s School of Public Health.

“The slightly reduced risk of pulmonary embolism and other adverse events that we saw in individuals who received Moderna may be because the Moderna vaccine was also more effective at reducing COVID-19 risk,” he added. 

The study was important because it let researchers see how the vaccines performed in more people, Harris said. The average study participant was 76 years old. It is important to look at vaccine effectiveness in older adults, who tend to have more chronic conditions. Also, older adults who live in nursing homes and senior living communities have a higher risk for severe COVID infections.

This risk of experiencing adverse events from the virus is much higher than the risk of adverse events from either vaccine, Harris explained.

“In an ideal world where we can have a choice between which vaccine product is used, we wanted to see whether one vaccine was associated with better performance for older adults and those with increased frailty,” Harris said.

In related news, the CEO of Pfizer said that the Food and Drug Administration could give approval to the updated COVID-19 booster by the end of this month. The shot targets the XBB.1.5 subvariant, which began to spread in the winter.