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FDA authorizes updated COVID boosters to target newest variants
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
Children and COVID: New cases increase; hospital admissions could follow
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
New cases of COVID-19 in children were up again after 2 weeks of declines, and preliminary data suggest that hospitalizations may be on the rise as well.
based on data collected by the American Academy of Pediatrics and the Children’s Hospital Association from state and territorial health departments.
A similar increase seems to be reflected by hospital-level data. The latest 7-day (Aug. 21-27) average is 305 new admissions with diagnosed COVID per day among children aged 0-17 years, compared with 290 per day for the week of Aug. 14-20, the Centers for Disease Control and Prevention reported, while also noting the potential for reporting delays in the most recent 7-day period.
Daily hospital admissions for COVID had been headed downward through the first half of August, falling from 0.46 per 100,000 population at the end of July to 0.40 on Aug. 19, the CDC said on its COVID Data Tracker. Since then, however, admissions have gone the other way, with the preliminary nature of the latest data suggesting that the numbers will be even higher as more hospitals report over the next few days.
Vaccine initiations continue to fall
Initiations among school-age children have fallen for 3 consecutive weeks since Aug. 3, when numbers receiving their first vaccinations reached late-summer highs for those aged 5-11 and 12-17 years. Children under age 5, included in the CDC data for the first time on Aug. 11 as separate groups – under 2 years and 2-4 years – have had vaccine initiations drop by 8.0% and 19.8% over the 2 following weeks, the CDC said.
Through their first 8 weeks of vaccine eligibility (June 19 to Aug. 15), 4.8% of children under 5 years of age had received a first vaccination and 1.0% were fully vaccinated. For the two other age groups (5-11 and 12-15) who became eligible after the very first emergency authorization back in 2020, the respective proportions were 25.0% and 16.0% (5-11) and 33.8% and 26.1% (12-15) through the first 8 weeks, according to CDC data.
How do you live with COVID? One doctor’s personal experience
Early in 2020, Anne Peters, MD, caught COVID-19. The author of Medscape’s “Peters on Diabetes” column was sick in March 2020 before state-mandated lockdowns, and well before there were any vaccines.
She remembers sitting in a small exam room with two patients who had flown to her Los Angeles office from New York. The elderly couple had hearing difficulties, so Dr. Peters sat close to them, putting on a continuous glucose monitor. “At that time, we didn’t think of COVID-19 as being in L.A.,” Dr. Peters recalled, “so I think we were not terribly consistent at mask-wearing due to the need to educate.”
“Several days later, I got COVID, but I didn’t know I had COVID per se. I felt crappy, had a terrible sore throat, lost my sense of taste and smell [which was not yet described as a COVID symptom], was completely exhausted, but had no fever or cough, which were the only criteria for getting COVID tested at the time. I didn’t know I had been exposed until 2 weeks later, when the patient’s assistant returned the sensor warning us to ‘be careful’ with it because the patient and his wife were recovering from COVID.”
That early battle with COVID-19 was just the beginning of what would become a 2-year struggle, including familial loss amid her own health problems and concerns about the under-resourced patients she cares for. Here, she shares her journey through the pandemic with this news organization.
Question: Thanks for talking to us. Let’s discuss your journey over these past 2.5 years.
Answer: Everybody has their own COVID story because we all went through this together. Some of us have worse COVID stories, and some of us have better ones, but all have been impacted.
I’m not a sick person. I’m a very healthy person but COVID made me so unwell for 2 years. The brain fog and fatigue were nothing compared to the autonomic neuropathy that affected my heart. It was really limiting for me. And I still don’t know the long-term implications, looking 20-30 years from now.
Q: When you initially had COVID, what were your symptoms? What was the impact?
A: I had all the symptoms of COVID, except for a cough and fever. I lost my sense of taste and smell. I had a horrible headache, a sore throat, and I was exhausted. I couldn’t get tested because I didn’t have the right symptoms.
Despite being sick, I never stopped working but just switched to telemedicine. I also took my regular monthly trip to our cabin in Montana. I unknowingly flew on a plane with COVID. I wore a well-fitted N95 mask, so I don’t think I gave anybody COVID. I didn’t give COVID to my partner, Eric, which is hard to believe as – at 77 – he’s older than me. He has diabetes, heart disease, and every other high-risk characteristic. If he’d gotten COVID back then, it would have been terrible, as there were no treatments, but luckily he didn’t get it.
Q: When were you officially diagnosed?
A: Two or 3 months after I thought I might have had COVID, I checked my antibodies, which tested strongly positive for a prior COVID infection. That was when I knew all the symptoms I’d had were due to the disease.
Q: Not only were you dealing with your own illness, but also that of those close to you. Can you talk about that?
A: In April 2020, my mother who was in her 90s and otherwise healthy except for dementia, got COVID. She could have gotten it from me. I visited often but wore a mask. She had all the horrible pulmonary symptoms. In her advance directive, she didn’t want to be hospitalized so I kept her in her home. She died from COVID in her own bed. It was fairly brutal, but at least I kept her where she felt comforted.
My 91-year-old dad was living in a different residential facility. Throughout COVID he had become very depressed because his social patterns had changed. Prior to COVID, they all ate together, but during the pandemic they were unable to. He missed his social connections, disliked being isolated in his room, hated everyone in masks.
He was a bit demented, but not so much that he couldn’t communicate with me or remember where his grandson was going to law school. I wasn’t allowed inside the facility, which was hard on him. I hadn’t told him his wife died because the hospice social workers advised me that I shouldn’t give him news that he couldn’t process readily until I could spend time with him. Unfortunately, that time never came. In December 2020, he got COVID. One of the people in that facility had gone to the hospital, came back, and tested negative, but actually had COVID and gave it to my dad. The guy who gave it to my dad didn’t die but my dad was terribly ill. He died 2 weeks short of getting his vaccine. He was coherent enough to have a conversation. I asked him: ‘Do you want to go to the hospital?’ And he said: ‘No, because it would be too scary,’ since he couldn’t be with me. I put him on hospice and held his hand as he died from pulmonary COVID, which was awful. I couldn’t give him enough morphine or valium to ease his breathing. But his last words to me were “I love you,” and at the very end he seemed peaceful, which was a blessing.
I got an autopsy, because he wanted one. Nothing else was wrong with him other than COVID. It destroyed his lungs. The rest of him was fine – no heart disease, cancer, or anything else. He died of COVID-19, the same as my mother.
That same week, my aunt, my only surviving older relative, who was in Des Moines, Iowa, died of COVID-19. All three family members died before the vaccine came out.
It was hard to lose my parents. I’m the only surviving child because my sister died in her 20s. It’s not been an easy pandemic. But what pandemic is easy? I just happened to have lost more people than most. Ironically, my grandfather was one of the legionnaires at the Bellevue-Stratford Hotel in Philadelphia in 1976 and died of Legionnaire’s disease before we knew what was causing the outbreak.
Q: Were you still struggling with COVID?
A: COVID impacted my whole body. I lost a lot of weight. I didn’t want to eat, and my gastrointestinal system was not happy. It took a while for my sense of taste and smell to come back. Nothing tasted good. I’m not a foodie; I don’t really care about food. We could get takeout or whatever, but none of it appealed to me. I’m not so sure it was a taste thing, I just didn’t feel like eating.
I didn’t realize I had “brain fog” per se, because I felt stressed and overwhelmed by the pandemic and my patients’ concerns. But one day, about 3 months after I had developed COVID, I woke up without the fog. Which made me aware that I hadn’t been feeling right up until that point.
The worst symptoms, however, were cardiac. I noticed also immediately that my heart rate went up very quickly with minimal exertion. My pulse has always been in the 55-60 bpm range, and suddenly just walking across a room made it go up to over 140 bpm. If I did any aerobic activity, it went up over 160 and would be associated with dyspnea and chest pain. I believed these were all post-COVID symptoms and felt validated when reports of others having similar issues were published in the literature.
Q: Did you continue seeing patients?
A: Yes, of course. Patients never needed their doctors more. In East L.A., where patients don’t have easy access to telemedicine, I kept going into clinic throughout the pandemic. In the more affluent Westside of Los Angeles, we switched to telemedicine, which was quite effective for most. However, because diabetes was associated with an increased risk of hospitalization and death from COVID, my patients were understandably afraid. I’ve never been busier, but (like all health care providers), I became more of a COVID provider than a diabetologist.
Q: Do you feel your battle with COVID impacted your work?
A: It didn’t affect me at work. If I was sitting still, I was fine. Sitting at home at a desk, I didn’t notice any symptoms. But as a habitual stair-user, I would be gasping for breath in the stairwell because I couldn’t go up the stairs to my office as I once could.
I think you empathize more with people who had COVID (when you’ve had it yourself). There was such a huge patient burden. And I think that’s been the thing that’s affected health care providers the most – no matter what specialty we’re in – that nobody has answers.
Q: What happened after you had your vaccine?
A: The vaccine itself was fine. I didn’t have any reaction to the first two doses. But the first booster made my cardiac issues worse.
By this point, my cardiac problems stopped me from exercising. I even went to the ER with chest pain once because I was having palpitations and chest pressure caused by simply taking my morning shower. Fortunately, I wasn’t having an MI, but I certainly wasn’t “normal.”
My measure of my fitness is the cross-country skiing trail I use in Montana. I know exactly how far I can ski. Usually I can do the loop in 35 minutes. After COVID, I lasted 10 minutes. I would be tachycardic, short of breath with chest pain radiating down my left arm. I would rest and try to keep going. But with each rest period, I only got worse. I would be laying in the snow and strangers would ask if I needed help.
Q: What helped you?
A: I’ve read a lot about long COVID and have tried to learn from the experts. Of course, I never went to a doctor directly, although I did ask colleagues for advice. What I learned was to never push myself. I forced myself to create an exercise schedule where I only exercised three times a week with rest days in between. When exercising, the second my heart rate went above 140 bpm, I stopped until I could get it back down. I would push against this new limit, even though my limit was low.
Additionally, I worked on my breathing patterns and did meditative breathing for 10 minutes twice daily using a commercially available app.
Although progress was slow, I did improve, and by June 2022, I seemed back to normal. I was not as fit as I was prior to COVID and needed to improve, but the tachycardic response to exercise and cardiac symptoms were gone. I felt like my normal self. Normal enough to go on a spot packing trip in the Sierras in August. (Horses carried us and a mule carried the gear over the 12,000-foot pass into the mountains, and then left my friend and me high in the Sierras for a week.) We were camped above 10,000 feet and every day hiked up to another high mountain lake where we fly-fished for trout that we ate for dinner. The hikes were a challenge, but not abnormally so. Not as they would have been while I had long COVID.
Q: What is the current atmosphere in your clinic?
A: COVID is much milder now in my vaccinated patients, but I feel most health care providers are exhausted. Many of my staff left when COVID hit because they didn’t want to keep working. It made practicing medicine exhausting. There’s been a shortage of nurses, a shortage of everything. We’ve been required to do a whole lot more than we ever did before. It’s much harder to be a doctor. This pandemic is the first time I’ve ever thought of quitting. Granted, I lost my whole family, or at least the older generation, but it’s just been almost overwhelming.
On the plus side, almost every one of my patients has been vaccinated, because early on, people would ask: “Do you trust this vaccine?” I would reply: “I saw my parents die from COVID when they weren’t vaccinated, so you’re getting vaccinated. This is real and the vaccines help.” It made me very good at convincing people to get vaccines because I knew what it was like to see someone dying from COVID up close.
Q: What advice do you have for those struggling with the COVID pandemic?
A: People need to decide what their own risk is for getting sick and how many times they want to get COVID. At this point, I want people to go out, but safely. In the beginning, when my patients said, “can I go visit my granddaughter?” I said, “no,” but that was before we had the vaccine. Now I feel it is safe to go out using common sense. I still have my patients wear masks on planes. I still have patients try to eat outside as much as possible. And I tell people to take the precautions that make sense, but I tell them to go out and do things because life is short.
I had a patient in his 70s who has many risk factors like heart disease and diabetes. His granddaughter’s Bat Mitzvah in Florida was coming up. He asked: “Can I go?” I told him “Yes,” but to be safe – to wear an N95 mask on the plane and at the event, and stay in his own hotel room, rather than with the whole family. I said, “You need to do this.” Earlier in the pandemic, I saw people who literally died from loneliness and isolation.
He and his wife flew there. He sent me a picture of himself with his granddaughter. When he returned, he showed me a handwritten note from her that said, “I love you so much. Everyone else canceled, which made me cry. You’re the only one who came. You have no idea how much this meant to me.”
He’s back in L.A., and he didn’t get COVID. He said, “It was the best thing I’ve done in years.” That’s what I need to help people with, navigating this world with COVID and assessing risks and benefits. As with all of medicine, my advice is individualized. My advice changes based on the major circulating variant and the rates of the virus in the population, as well as the risk factors of the individual.
Q: What are you doing now?
A: I’m trying to avoid getting COVID again, or another booster. I could get pre-exposure monoclonal antibodies but am waiting to do anything further until I see what happens over the fall and winter. I still wear a mask inside but now do a mix of in-person and telemedicine visits. I still try to go to outdoor restaurants, which is easy in California. But I’m flying to see my son in New York and plan to go to Europe this fall for a meeting. I also go to my cabin in Montana every month to get my “dose” of the wilderness. Overall, I travel for conferences and speaking engagements much less because I have learned the joy of staying home.
Thinking back on my life as a doctor, my career began as an intern at Stanford rotating through Ward 5B, the AIDS unit at San Francisco General Hospital, and will likely end with COVID. In spite of all our medical advances, my generation of physicians, much as many generations before us, has a front-row seat to the vulnerability of humans to infectious diseases and how far we still need to go to protect our patients from communicable illness.
A version of this article first appeared on Medscape.com.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts; three books on diabetes; and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
Early in 2020, Anne Peters, MD, caught COVID-19. The author of Medscape’s “Peters on Diabetes” column was sick in March 2020 before state-mandated lockdowns, and well before there were any vaccines.
She remembers sitting in a small exam room with two patients who had flown to her Los Angeles office from New York. The elderly couple had hearing difficulties, so Dr. Peters sat close to them, putting on a continuous glucose monitor. “At that time, we didn’t think of COVID-19 as being in L.A.,” Dr. Peters recalled, “so I think we were not terribly consistent at mask-wearing due to the need to educate.”
“Several days later, I got COVID, but I didn’t know I had COVID per se. I felt crappy, had a terrible sore throat, lost my sense of taste and smell [which was not yet described as a COVID symptom], was completely exhausted, but had no fever or cough, which were the only criteria for getting COVID tested at the time. I didn’t know I had been exposed until 2 weeks later, when the patient’s assistant returned the sensor warning us to ‘be careful’ with it because the patient and his wife were recovering from COVID.”
That early battle with COVID-19 was just the beginning of what would become a 2-year struggle, including familial loss amid her own health problems and concerns about the under-resourced patients she cares for. Here, she shares her journey through the pandemic with this news organization.
Question: Thanks for talking to us. Let’s discuss your journey over these past 2.5 years.
Answer: Everybody has their own COVID story because we all went through this together. Some of us have worse COVID stories, and some of us have better ones, but all have been impacted.
I’m not a sick person. I’m a very healthy person but COVID made me so unwell for 2 years. The brain fog and fatigue were nothing compared to the autonomic neuropathy that affected my heart. It was really limiting for me. And I still don’t know the long-term implications, looking 20-30 years from now.
Q: When you initially had COVID, what were your symptoms? What was the impact?
A: I had all the symptoms of COVID, except for a cough and fever. I lost my sense of taste and smell. I had a horrible headache, a sore throat, and I was exhausted. I couldn’t get tested because I didn’t have the right symptoms.
Despite being sick, I never stopped working but just switched to telemedicine. I also took my regular monthly trip to our cabin in Montana. I unknowingly flew on a plane with COVID. I wore a well-fitted N95 mask, so I don’t think I gave anybody COVID. I didn’t give COVID to my partner, Eric, which is hard to believe as – at 77 – he’s older than me. He has diabetes, heart disease, and every other high-risk characteristic. If he’d gotten COVID back then, it would have been terrible, as there were no treatments, but luckily he didn’t get it.
Q: When were you officially diagnosed?
A: Two or 3 months after I thought I might have had COVID, I checked my antibodies, which tested strongly positive for a prior COVID infection. That was when I knew all the symptoms I’d had were due to the disease.
Q: Not only were you dealing with your own illness, but also that of those close to you. Can you talk about that?
A: In April 2020, my mother who was in her 90s and otherwise healthy except for dementia, got COVID. She could have gotten it from me. I visited often but wore a mask. She had all the horrible pulmonary symptoms. In her advance directive, she didn’t want to be hospitalized so I kept her in her home. She died from COVID in her own bed. It was fairly brutal, but at least I kept her where she felt comforted.
My 91-year-old dad was living in a different residential facility. Throughout COVID he had become very depressed because his social patterns had changed. Prior to COVID, they all ate together, but during the pandemic they were unable to. He missed his social connections, disliked being isolated in his room, hated everyone in masks.
He was a bit demented, but not so much that he couldn’t communicate with me or remember where his grandson was going to law school. I wasn’t allowed inside the facility, which was hard on him. I hadn’t told him his wife died because the hospice social workers advised me that I shouldn’t give him news that he couldn’t process readily until I could spend time with him. Unfortunately, that time never came. In December 2020, he got COVID. One of the people in that facility had gone to the hospital, came back, and tested negative, but actually had COVID and gave it to my dad. The guy who gave it to my dad didn’t die but my dad was terribly ill. He died 2 weeks short of getting his vaccine. He was coherent enough to have a conversation. I asked him: ‘Do you want to go to the hospital?’ And he said: ‘No, because it would be too scary,’ since he couldn’t be with me. I put him on hospice and held his hand as he died from pulmonary COVID, which was awful. I couldn’t give him enough morphine or valium to ease his breathing. But his last words to me were “I love you,” and at the very end he seemed peaceful, which was a blessing.
I got an autopsy, because he wanted one. Nothing else was wrong with him other than COVID. It destroyed his lungs. The rest of him was fine – no heart disease, cancer, or anything else. He died of COVID-19, the same as my mother.
That same week, my aunt, my only surviving older relative, who was in Des Moines, Iowa, died of COVID-19. All three family members died before the vaccine came out.
It was hard to lose my parents. I’m the only surviving child because my sister died in her 20s. It’s not been an easy pandemic. But what pandemic is easy? I just happened to have lost more people than most. Ironically, my grandfather was one of the legionnaires at the Bellevue-Stratford Hotel in Philadelphia in 1976 and died of Legionnaire’s disease before we knew what was causing the outbreak.
Q: Were you still struggling with COVID?
A: COVID impacted my whole body. I lost a lot of weight. I didn’t want to eat, and my gastrointestinal system was not happy. It took a while for my sense of taste and smell to come back. Nothing tasted good. I’m not a foodie; I don’t really care about food. We could get takeout or whatever, but none of it appealed to me. I’m not so sure it was a taste thing, I just didn’t feel like eating.
I didn’t realize I had “brain fog” per se, because I felt stressed and overwhelmed by the pandemic and my patients’ concerns. But one day, about 3 months after I had developed COVID, I woke up without the fog. Which made me aware that I hadn’t been feeling right up until that point.
The worst symptoms, however, were cardiac. I noticed also immediately that my heart rate went up very quickly with minimal exertion. My pulse has always been in the 55-60 bpm range, and suddenly just walking across a room made it go up to over 140 bpm. If I did any aerobic activity, it went up over 160 and would be associated with dyspnea and chest pain. I believed these were all post-COVID symptoms and felt validated when reports of others having similar issues were published in the literature.
Q: Did you continue seeing patients?
A: Yes, of course. Patients never needed their doctors more. In East L.A., where patients don’t have easy access to telemedicine, I kept going into clinic throughout the pandemic. In the more affluent Westside of Los Angeles, we switched to telemedicine, which was quite effective for most. However, because diabetes was associated with an increased risk of hospitalization and death from COVID, my patients were understandably afraid. I’ve never been busier, but (like all health care providers), I became more of a COVID provider than a diabetologist.
Q: Do you feel your battle with COVID impacted your work?
A: It didn’t affect me at work. If I was sitting still, I was fine. Sitting at home at a desk, I didn’t notice any symptoms. But as a habitual stair-user, I would be gasping for breath in the stairwell because I couldn’t go up the stairs to my office as I once could.
I think you empathize more with people who had COVID (when you’ve had it yourself). There was such a huge patient burden. And I think that’s been the thing that’s affected health care providers the most – no matter what specialty we’re in – that nobody has answers.
Q: What happened after you had your vaccine?
A: The vaccine itself was fine. I didn’t have any reaction to the first two doses. But the first booster made my cardiac issues worse.
By this point, my cardiac problems stopped me from exercising. I even went to the ER with chest pain once because I was having palpitations and chest pressure caused by simply taking my morning shower. Fortunately, I wasn’t having an MI, but I certainly wasn’t “normal.”
My measure of my fitness is the cross-country skiing trail I use in Montana. I know exactly how far I can ski. Usually I can do the loop in 35 minutes. After COVID, I lasted 10 minutes. I would be tachycardic, short of breath with chest pain radiating down my left arm. I would rest and try to keep going. But with each rest period, I only got worse. I would be laying in the snow and strangers would ask if I needed help.
Q: What helped you?
A: I’ve read a lot about long COVID and have tried to learn from the experts. Of course, I never went to a doctor directly, although I did ask colleagues for advice. What I learned was to never push myself. I forced myself to create an exercise schedule where I only exercised three times a week with rest days in between. When exercising, the second my heart rate went above 140 bpm, I stopped until I could get it back down. I would push against this new limit, even though my limit was low.
Additionally, I worked on my breathing patterns and did meditative breathing for 10 minutes twice daily using a commercially available app.
Although progress was slow, I did improve, and by June 2022, I seemed back to normal. I was not as fit as I was prior to COVID and needed to improve, but the tachycardic response to exercise and cardiac symptoms were gone. I felt like my normal self. Normal enough to go on a spot packing trip in the Sierras in August. (Horses carried us and a mule carried the gear over the 12,000-foot pass into the mountains, and then left my friend and me high in the Sierras for a week.) We were camped above 10,000 feet and every day hiked up to another high mountain lake where we fly-fished for trout that we ate for dinner. The hikes were a challenge, but not abnormally so. Not as they would have been while I had long COVID.
Q: What is the current atmosphere in your clinic?
A: COVID is much milder now in my vaccinated patients, but I feel most health care providers are exhausted. Many of my staff left when COVID hit because they didn’t want to keep working. It made practicing medicine exhausting. There’s been a shortage of nurses, a shortage of everything. We’ve been required to do a whole lot more than we ever did before. It’s much harder to be a doctor. This pandemic is the first time I’ve ever thought of quitting. Granted, I lost my whole family, or at least the older generation, but it’s just been almost overwhelming.
On the plus side, almost every one of my patients has been vaccinated, because early on, people would ask: “Do you trust this vaccine?” I would reply: “I saw my parents die from COVID when they weren’t vaccinated, so you’re getting vaccinated. This is real and the vaccines help.” It made me very good at convincing people to get vaccines because I knew what it was like to see someone dying from COVID up close.
Q: What advice do you have for those struggling with the COVID pandemic?
A: People need to decide what their own risk is for getting sick and how many times they want to get COVID. At this point, I want people to go out, but safely. In the beginning, when my patients said, “can I go visit my granddaughter?” I said, “no,” but that was before we had the vaccine. Now I feel it is safe to go out using common sense. I still have my patients wear masks on planes. I still have patients try to eat outside as much as possible. And I tell people to take the precautions that make sense, but I tell them to go out and do things because life is short.
I had a patient in his 70s who has many risk factors like heart disease and diabetes. His granddaughter’s Bat Mitzvah in Florida was coming up. He asked: “Can I go?” I told him “Yes,” but to be safe – to wear an N95 mask on the plane and at the event, and stay in his own hotel room, rather than with the whole family. I said, “You need to do this.” Earlier in the pandemic, I saw people who literally died from loneliness and isolation.
He and his wife flew there. He sent me a picture of himself with his granddaughter. When he returned, he showed me a handwritten note from her that said, “I love you so much. Everyone else canceled, which made me cry. You’re the only one who came. You have no idea how much this meant to me.”
He’s back in L.A., and he didn’t get COVID. He said, “It was the best thing I’ve done in years.” That’s what I need to help people with, navigating this world with COVID and assessing risks and benefits. As with all of medicine, my advice is individualized. My advice changes based on the major circulating variant and the rates of the virus in the population, as well as the risk factors of the individual.
Q: What are you doing now?
A: I’m trying to avoid getting COVID again, or another booster. I could get pre-exposure monoclonal antibodies but am waiting to do anything further until I see what happens over the fall and winter. I still wear a mask inside but now do a mix of in-person and telemedicine visits. I still try to go to outdoor restaurants, which is easy in California. But I’m flying to see my son in New York and plan to go to Europe this fall for a meeting. I also go to my cabin in Montana every month to get my “dose” of the wilderness. Overall, I travel for conferences and speaking engagements much less because I have learned the joy of staying home.
Thinking back on my life as a doctor, my career began as an intern at Stanford rotating through Ward 5B, the AIDS unit at San Francisco General Hospital, and will likely end with COVID. In spite of all our medical advances, my generation of physicians, much as many generations before us, has a front-row seat to the vulnerability of humans to infectious diseases and how far we still need to go to protect our patients from communicable illness.
A version of this article first appeared on Medscape.com.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts; three books on diabetes; and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
Early in 2020, Anne Peters, MD, caught COVID-19. The author of Medscape’s “Peters on Diabetes” column was sick in March 2020 before state-mandated lockdowns, and well before there were any vaccines.
She remembers sitting in a small exam room with two patients who had flown to her Los Angeles office from New York. The elderly couple had hearing difficulties, so Dr. Peters sat close to them, putting on a continuous glucose monitor. “At that time, we didn’t think of COVID-19 as being in L.A.,” Dr. Peters recalled, “so I think we were not terribly consistent at mask-wearing due to the need to educate.”
“Several days later, I got COVID, but I didn’t know I had COVID per se. I felt crappy, had a terrible sore throat, lost my sense of taste and smell [which was not yet described as a COVID symptom], was completely exhausted, but had no fever or cough, which were the only criteria for getting COVID tested at the time. I didn’t know I had been exposed until 2 weeks later, when the patient’s assistant returned the sensor warning us to ‘be careful’ with it because the patient and his wife were recovering from COVID.”
That early battle with COVID-19 was just the beginning of what would become a 2-year struggle, including familial loss amid her own health problems and concerns about the under-resourced patients she cares for. Here, she shares her journey through the pandemic with this news organization.
Question: Thanks for talking to us. Let’s discuss your journey over these past 2.5 years.
Answer: Everybody has their own COVID story because we all went through this together. Some of us have worse COVID stories, and some of us have better ones, but all have been impacted.
I’m not a sick person. I’m a very healthy person but COVID made me so unwell for 2 years. The brain fog and fatigue were nothing compared to the autonomic neuropathy that affected my heart. It was really limiting for me. And I still don’t know the long-term implications, looking 20-30 years from now.
Q: When you initially had COVID, what were your symptoms? What was the impact?
A: I had all the symptoms of COVID, except for a cough and fever. I lost my sense of taste and smell. I had a horrible headache, a sore throat, and I was exhausted. I couldn’t get tested because I didn’t have the right symptoms.
Despite being sick, I never stopped working but just switched to telemedicine. I also took my regular monthly trip to our cabin in Montana. I unknowingly flew on a plane with COVID. I wore a well-fitted N95 mask, so I don’t think I gave anybody COVID. I didn’t give COVID to my partner, Eric, which is hard to believe as – at 77 – he’s older than me. He has diabetes, heart disease, and every other high-risk characteristic. If he’d gotten COVID back then, it would have been terrible, as there were no treatments, but luckily he didn’t get it.
Q: When were you officially diagnosed?
A: Two or 3 months after I thought I might have had COVID, I checked my antibodies, which tested strongly positive for a prior COVID infection. That was when I knew all the symptoms I’d had were due to the disease.
Q: Not only were you dealing with your own illness, but also that of those close to you. Can you talk about that?
A: In April 2020, my mother who was in her 90s and otherwise healthy except for dementia, got COVID. She could have gotten it from me. I visited often but wore a mask. She had all the horrible pulmonary symptoms. In her advance directive, she didn’t want to be hospitalized so I kept her in her home. She died from COVID in her own bed. It was fairly brutal, but at least I kept her where she felt comforted.
My 91-year-old dad was living in a different residential facility. Throughout COVID he had become very depressed because his social patterns had changed. Prior to COVID, they all ate together, but during the pandemic they were unable to. He missed his social connections, disliked being isolated in his room, hated everyone in masks.
He was a bit demented, but not so much that he couldn’t communicate with me or remember where his grandson was going to law school. I wasn’t allowed inside the facility, which was hard on him. I hadn’t told him his wife died because the hospice social workers advised me that I shouldn’t give him news that he couldn’t process readily until I could spend time with him. Unfortunately, that time never came. In December 2020, he got COVID. One of the people in that facility had gone to the hospital, came back, and tested negative, but actually had COVID and gave it to my dad. The guy who gave it to my dad didn’t die but my dad was terribly ill. He died 2 weeks short of getting his vaccine. He was coherent enough to have a conversation. I asked him: ‘Do you want to go to the hospital?’ And he said: ‘No, because it would be too scary,’ since he couldn’t be with me. I put him on hospice and held his hand as he died from pulmonary COVID, which was awful. I couldn’t give him enough morphine or valium to ease his breathing. But his last words to me were “I love you,” and at the very end he seemed peaceful, which was a blessing.
I got an autopsy, because he wanted one. Nothing else was wrong with him other than COVID. It destroyed his lungs. The rest of him was fine – no heart disease, cancer, or anything else. He died of COVID-19, the same as my mother.
That same week, my aunt, my only surviving older relative, who was in Des Moines, Iowa, died of COVID-19. All three family members died before the vaccine came out.
It was hard to lose my parents. I’m the only surviving child because my sister died in her 20s. It’s not been an easy pandemic. But what pandemic is easy? I just happened to have lost more people than most. Ironically, my grandfather was one of the legionnaires at the Bellevue-Stratford Hotel in Philadelphia in 1976 and died of Legionnaire’s disease before we knew what was causing the outbreak.
Q: Were you still struggling with COVID?
A: COVID impacted my whole body. I lost a lot of weight. I didn’t want to eat, and my gastrointestinal system was not happy. It took a while for my sense of taste and smell to come back. Nothing tasted good. I’m not a foodie; I don’t really care about food. We could get takeout or whatever, but none of it appealed to me. I’m not so sure it was a taste thing, I just didn’t feel like eating.
I didn’t realize I had “brain fog” per se, because I felt stressed and overwhelmed by the pandemic and my patients’ concerns. But one day, about 3 months after I had developed COVID, I woke up without the fog. Which made me aware that I hadn’t been feeling right up until that point.
The worst symptoms, however, were cardiac. I noticed also immediately that my heart rate went up very quickly with minimal exertion. My pulse has always been in the 55-60 bpm range, and suddenly just walking across a room made it go up to over 140 bpm. If I did any aerobic activity, it went up over 160 and would be associated with dyspnea and chest pain. I believed these were all post-COVID symptoms and felt validated when reports of others having similar issues were published in the literature.
Q: Did you continue seeing patients?
A: Yes, of course. Patients never needed their doctors more. In East L.A., where patients don’t have easy access to telemedicine, I kept going into clinic throughout the pandemic. In the more affluent Westside of Los Angeles, we switched to telemedicine, which was quite effective for most. However, because diabetes was associated with an increased risk of hospitalization and death from COVID, my patients were understandably afraid. I’ve never been busier, but (like all health care providers), I became more of a COVID provider than a diabetologist.
Q: Do you feel your battle with COVID impacted your work?
A: It didn’t affect me at work. If I was sitting still, I was fine. Sitting at home at a desk, I didn’t notice any symptoms. But as a habitual stair-user, I would be gasping for breath in the stairwell because I couldn’t go up the stairs to my office as I once could.
I think you empathize more with people who had COVID (when you’ve had it yourself). There was such a huge patient burden. And I think that’s been the thing that’s affected health care providers the most – no matter what specialty we’re in – that nobody has answers.
Q: What happened after you had your vaccine?
A: The vaccine itself was fine. I didn’t have any reaction to the first two doses. But the first booster made my cardiac issues worse.
By this point, my cardiac problems stopped me from exercising. I even went to the ER with chest pain once because I was having palpitations and chest pressure caused by simply taking my morning shower. Fortunately, I wasn’t having an MI, but I certainly wasn’t “normal.”
My measure of my fitness is the cross-country skiing trail I use in Montana. I know exactly how far I can ski. Usually I can do the loop in 35 minutes. After COVID, I lasted 10 minutes. I would be tachycardic, short of breath with chest pain radiating down my left arm. I would rest and try to keep going. But with each rest period, I only got worse. I would be laying in the snow and strangers would ask if I needed help.
Q: What helped you?
A: I’ve read a lot about long COVID and have tried to learn from the experts. Of course, I never went to a doctor directly, although I did ask colleagues for advice. What I learned was to never push myself. I forced myself to create an exercise schedule where I only exercised three times a week with rest days in between. When exercising, the second my heart rate went above 140 bpm, I stopped until I could get it back down. I would push against this new limit, even though my limit was low.
Additionally, I worked on my breathing patterns and did meditative breathing for 10 minutes twice daily using a commercially available app.
Although progress was slow, I did improve, and by June 2022, I seemed back to normal. I was not as fit as I was prior to COVID and needed to improve, but the tachycardic response to exercise and cardiac symptoms were gone. I felt like my normal self. Normal enough to go on a spot packing trip in the Sierras in August. (Horses carried us and a mule carried the gear over the 12,000-foot pass into the mountains, and then left my friend and me high in the Sierras for a week.) We were camped above 10,000 feet and every day hiked up to another high mountain lake where we fly-fished for trout that we ate for dinner. The hikes were a challenge, but not abnormally so. Not as they would have been while I had long COVID.
Q: What is the current atmosphere in your clinic?
A: COVID is much milder now in my vaccinated patients, but I feel most health care providers are exhausted. Many of my staff left when COVID hit because they didn’t want to keep working. It made practicing medicine exhausting. There’s been a shortage of nurses, a shortage of everything. We’ve been required to do a whole lot more than we ever did before. It’s much harder to be a doctor. This pandemic is the first time I’ve ever thought of quitting. Granted, I lost my whole family, or at least the older generation, but it’s just been almost overwhelming.
On the plus side, almost every one of my patients has been vaccinated, because early on, people would ask: “Do you trust this vaccine?” I would reply: “I saw my parents die from COVID when they weren’t vaccinated, so you’re getting vaccinated. This is real and the vaccines help.” It made me very good at convincing people to get vaccines because I knew what it was like to see someone dying from COVID up close.
Q: What advice do you have for those struggling with the COVID pandemic?
A: People need to decide what their own risk is for getting sick and how many times they want to get COVID. At this point, I want people to go out, but safely. In the beginning, when my patients said, “can I go visit my granddaughter?” I said, “no,” but that was before we had the vaccine. Now I feel it is safe to go out using common sense. I still have my patients wear masks on planes. I still have patients try to eat outside as much as possible. And I tell people to take the precautions that make sense, but I tell them to go out and do things because life is short.
I had a patient in his 70s who has many risk factors like heart disease and diabetes. His granddaughter’s Bat Mitzvah in Florida was coming up. He asked: “Can I go?” I told him “Yes,” but to be safe – to wear an N95 mask on the plane and at the event, and stay in his own hotel room, rather than with the whole family. I said, “You need to do this.” Earlier in the pandemic, I saw people who literally died from loneliness and isolation.
He and his wife flew there. He sent me a picture of himself with his granddaughter. When he returned, he showed me a handwritten note from her that said, “I love you so much. Everyone else canceled, which made me cry. You’re the only one who came. You have no idea how much this meant to me.”
He’s back in L.A., and he didn’t get COVID. He said, “It was the best thing I’ve done in years.” That’s what I need to help people with, navigating this world with COVID and assessing risks and benefits. As with all of medicine, my advice is individualized. My advice changes based on the major circulating variant and the rates of the virus in the population, as well as the risk factors of the individual.
Q: What are you doing now?
A: I’m trying to avoid getting COVID again, or another booster. I could get pre-exposure monoclonal antibodies but am waiting to do anything further until I see what happens over the fall and winter. I still wear a mask inside but now do a mix of in-person and telemedicine visits. I still try to go to outdoor restaurants, which is easy in California. But I’m flying to see my son in New York and plan to go to Europe this fall for a meeting. I also go to my cabin in Montana every month to get my “dose” of the wilderness. Overall, I travel for conferences and speaking engagements much less because I have learned the joy of staying home.
Thinking back on my life as a doctor, my career began as an intern at Stanford rotating through Ward 5B, the AIDS unit at San Francisco General Hospital, and will likely end with COVID. In spite of all our medical advances, my generation of physicians, much as many generations before us, has a front-row seat to the vulnerability of humans to infectious diseases and how far we still need to go to protect our patients from communicable illness.
A version of this article first appeared on Medscape.com.
Anne L. Peters, MD, is a professor of medicine at the University of Southern California, Los Angeles, and director of the USC clinical diabetes programs. She has published more than 200 articles, reviews, and abstracts; three books on diabetes; and has been an investigator for more than 40 research studies. She has spoken internationally at over 400 programs and serves on many committees of several professional organizations.
Autoimmune disease patients’ waxing, waning response to COVID vaccination studied in-depth
A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.
The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.
This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.
“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
What was studied?
For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.
A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.
Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.
Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.
“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.
One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
Need to take care
“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”
It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”
These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.
“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.
“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.
“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”
Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”
The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.
The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.
This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.
“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
What was studied?
For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.
A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.
Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.
Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.
“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.
One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
Need to take care
“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”
It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”
These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.
“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.
“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.
“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”
Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”
The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A new study in The Lancet Rheumatology examines the strength and duration of SARS-CoV-2 vaccine–induced immunoglobulin-G antibody responses over time for patients with a variety of autoimmune diseases, compared with healthy controls.
The presence of humoral antibodies to SARS-CoV-2 has been shown to correlate with protection against COVID infection. But for patients with immune-mediated inflammatory diseases (IMIDs), host response to COVID infection or to vaccination is affected by the immune dysfunction imposed by the IMID and by the use of immune-modulating drugs to treat it.
This new study finds a weaker – as shown previously – and less sustained immune response to SARS-CoV-2 vaccines in patients with a variety of IMIDs, including rheumatoid arthritis, spondyloarthritis, psoriasis, inflammatory bowel diseases, and other systemic autoimmune diseases such as lupus. It also points toward the possibility of adjusting treatment and vaccination schedules and strategies for these patients based on their antibody levels, among other factors, to preserve best protection against severe COVID.
“It is important to assess immune response in these patients to see if they still have protection against severe COVID infection,” said lead author David Simon, MD, senior clinical scientist in clinical immunology and rheumatology at University Hospital Erlangen (Germany). “We know that antibody response is an immune correlate. Therefore, it is important to see how large and durable the immune response is to the coronavirus vaccine in these IMID patients, and whether specific drugs or therapies have negative effects on their immune response.”
What was studied?
For this large prospective cohort study, researchers registered 5076 coronavirus-vaccinated individuals. They analyzed serum samples obtained between December 15, 2020, and December 1, 2021, from 2,535 patients diagnosed with IMIDs and participating in a prospective coronavirus study program at the Deutsches Zentrum Immuntherapie in Erlangen. The IMID patients had a mean age of 55.0 years, and 58.9% were women.
A healthy control group of 1,198 individuals without IMID who had a mean age of 40.7 years, including 53.8% men, was also recruited for the analysis. All approved coronavirus vaccines were included, following standard vaccination schedules. Antibody response was measured over time by an enzyme-linked immunosorbent assay from 8 weeks after first vaccination to week 40.
Among the findings, the healthy controls had higher postvaccine antibody levels than did those with IMIDs. But the majority of vaccinated patients with IMID were able to build up a humoral immune response to SARS-CoV-2. Patients who were taking B-cell inhibitors like rituximab (Rituxan, Genentech; and biosimilars) and T-cell inhibitors like abatacept (Orencia, Bristol Myers Squibb) for IMIDs had significantly poorer antibody response.
Greater age and the use of combination therapies for IMIDs, compared with monotherapy, further reduced immune response to the vaccine. In terms of vaccination modality, messenger RNA–based vaccines induced higher antibody levels than did vector-based vaccines. The researchers noted that patients with IMID who were given a third vaccine dose could actually catch up well with the antibody responses observed in healthy controls.
“We looked at whether different IMIDs had a different humoral response, and we also assessed if there are effects from different therapeutic strategies,” Dr. Simon explained. “It doesn’t matter so much what kind of IMID patients have; much more important is the specific drug treatment and its impact on their antibody response.” Some participants were advised to briefly stop taking some immunosuppressive treatments before or after vaccination.
One of Dr. Simon’s coauthors, statistician and rheumatologist Koray Tascilar, MD, added, “This research is important because we looked not only at who responded less, which has been previously established, but who are at greater risk of losing their immune response, and how quickly.”
Need to take care
“Most treatments we as rheumatologists give to our patients don’t affect their SARS-CoV-2 humoral response,” Dr. Simon said. “However, there are specific drugs that are associated with lower antibody response. With respect to those drugs, we have to be more careful.”
It is important to be able to tell patients which drugs are safe and won’t have a negative impact on their immune response to vaccinations, Dr. Tascilar said. “But it would be too strong to say we’re ready to choose therapies based on their potential impact on protection against COVID. Yes, there is a risk from catching COVID, but we need to balance that risk with the risk of not giving patients the medications that are necessary to treat their rheumatologic condition.”
These diseases are serious, sometimes life-threatening. “We might think of strategies for how to mitigate the risk of underprotection from COVID that is brought about by these treatments,” he said. For example, offering boosters sooner or more frequently, or prophylactically treating with monoclonal antibodies.
“This study, along other recent studies, has found that antibody levels in patients with immune-mediated diseases wane more rapidly than in healthy controls, and this is especially true of those on medications that interfere with the B and T cells and anticytokine therapies,” Rebecca Haberman, MD, assistant professor, division of rheumatology, New York University Langone Health, noted in an email to this news organization.
“While there is no known antibody level that specifically correlates with clinical protection, and each patient needs to be thought of individually, these findings support the use of supplemental booster dosing in patients with immune-mediated inflammatory diseases,” Dr. Haberman said, adding that her own research in this area has shown similar results.
“As a rheumatologist, I would be more likely to encourage my patients – especially those on immunomodulatory medications – to get boosted.”
Dr. Tascilar said his study does not directly answer the question of whether an earlier booster shot would be an effective strategy for patients with IMID. “In our department, we have an early boosting strategy, based on level of immune response.” But the decision of revaccination or not, and when, is based on a number of factors, not only on the level of antibodies. “It’s just part of the instruments we are using.”
The study was supported by the Deutsche Forschungsgemeinschaft. Dr. Simon and Dr. Tascilar declared no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET RHEUMATOLOGY
Paxlovid reduces risk of COVID death by 79% in older adults
The antiviral drug Paxlovid appears to reduce the risk of dying from COVID-19 by 79% and decrease hospitalizations by 73% in at-risk patients who are ages 65 and older, according to a new study published in The New England Journal of Medicine.
The pill, which is a combination of the drugs nirmatrelvir and ritonavir, received FDA emergency use authorization in December 2021 to treat mild to moderate disease in ages 12 and older who face high risks for having severe COVID-19, hospitalization, and death.
“The results of the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from COVID-19,” Doron Netzer, MD, the senior study author and a researcher with Clalit Health Services, Tel Aviv, told The Jerusalem Post.
“We are the country’s leader in the provision of giving Paxlovid to relevant patients,” he said. “It was given to patients all over the country, with medical teams monitoring the patients who took the pills.”
, the news outlet reported. The research team analyzed information from Clalit’s electronic medical records. The health care organization covers about 52% of the Israeli population and almost two-thirds of older adults. More than 30,000 COVID-19 patients in Israel have been treated with the drug so far.
Dr. Netzer and colleagues looked at hospitalization and death data for at-risk COVID-19 patients ages 40 and older between Jan. 9 and March 31, when the original Omicron variant was the dominant strain in Israel. During that time, more than 1.1 million Clalit patients were infected with COVID-19, 109,000 patients were considered at-risk, and 3,900 patients received the drug.
The average age of the patients was 60, and 39% of the patients were 65 and older. Overall, 78% of the patients had previous COVID-19 immunity due to vaccination, prior infection, or both.
Among ages 65 and older, the rate of COVID-19 hospitalization was 14.7 cases per 100,000 person-days among treated patients, compared with 58.9 cases per 100,000 person-days among untreated patients. This represented a 73% lower chance of being hospitalized.
Among ages 40-64, the rate of hospitalization due to COVID-19 was 15.2 cases per 100,000 person-days among treated patients, compared with 15.8 cases per 100,000 person-days among untreated patients. The risk of hospitalization wasn’t significantly lower for this age group.
Among ages 65 and older, there were two deaths from COVID-19 in 2,484 treated patients, compared with 158 in the 40,337 untreated patients. This represented a 79% lower chance of dying from COVID-19.
Among ages 40-64, there was one death from COVID-19 in 1,418 treated patients, compared with 16 in the 65,015 untreated patients. The risk of death wasn’t significantly lower for this age group.
For both age groups, a lack of previous COVID-19 immunity and a previous hospitalization were most strongly linked to high rates of hospitalization during the Omicron wave.
The researchers noted that they didn’t break down the data on ages 40-64 who had cancer and other severe conditions that weaken the immune system. These patients may be more likely to benefit from Paxlovid, they said, though future studies will need to analyze the data.
The study didn’t receive any financial or in-kind support, the authors said.
A version of this article first appeared on WebMD.com.
The antiviral drug Paxlovid appears to reduce the risk of dying from COVID-19 by 79% and decrease hospitalizations by 73% in at-risk patients who are ages 65 and older, according to a new study published in The New England Journal of Medicine.
The pill, which is a combination of the drugs nirmatrelvir and ritonavir, received FDA emergency use authorization in December 2021 to treat mild to moderate disease in ages 12 and older who face high risks for having severe COVID-19, hospitalization, and death.
“The results of the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from COVID-19,” Doron Netzer, MD, the senior study author and a researcher with Clalit Health Services, Tel Aviv, told The Jerusalem Post.
“We are the country’s leader in the provision of giving Paxlovid to relevant patients,” he said. “It was given to patients all over the country, with medical teams monitoring the patients who took the pills.”
, the news outlet reported. The research team analyzed information from Clalit’s electronic medical records. The health care organization covers about 52% of the Israeli population and almost two-thirds of older adults. More than 30,000 COVID-19 patients in Israel have been treated with the drug so far.
Dr. Netzer and colleagues looked at hospitalization and death data for at-risk COVID-19 patients ages 40 and older between Jan. 9 and March 31, when the original Omicron variant was the dominant strain in Israel. During that time, more than 1.1 million Clalit patients were infected with COVID-19, 109,000 patients were considered at-risk, and 3,900 patients received the drug.
The average age of the patients was 60, and 39% of the patients were 65 and older. Overall, 78% of the patients had previous COVID-19 immunity due to vaccination, prior infection, or both.
Among ages 65 and older, the rate of COVID-19 hospitalization was 14.7 cases per 100,000 person-days among treated patients, compared with 58.9 cases per 100,000 person-days among untreated patients. This represented a 73% lower chance of being hospitalized.
Among ages 40-64, the rate of hospitalization due to COVID-19 was 15.2 cases per 100,000 person-days among treated patients, compared with 15.8 cases per 100,000 person-days among untreated patients. The risk of hospitalization wasn’t significantly lower for this age group.
Among ages 65 and older, there were two deaths from COVID-19 in 2,484 treated patients, compared with 158 in the 40,337 untreated patients. This represented a 79% lower chance of dying from COVID-19.
Among ages 40-64, there was one death from COVID-19 in 1,418 treated patients, compared with 16 in the 65,015 untreated patients. The risk of death wasn’t significantly lower for this age group.
For both age groups, a lack of previous COVID-19 immunity and a previous hospitalization were most strongly linked to high rates of hospitalization during the Omicron wave.
The researchers noted that they didn’t break down the data on ages 40-64 who had cancer and other severe conditions that weaken the immune system. These patients may be more likely to benefit from Paxlovid, they said, though future studies will need to analyze the data.
The study didn’t receive any financial or in-kind support, the authors said.
A version of this article first appeared on WebMD.com.
The antiviral drug Paxlovid appears to reduce the risk of dying from COVID-19 by 79% and decrease hospitalizations by 73% in at-risk patients who are ages 65 and older, according to a new study published in The New England Journal of Medicine.
The pill, which is a combination of the drugs nirmatrelvir and ritonavir, received FDA emergency use authorization in December 2021 to treat mild to moderate disease in ages 12 and older who face high risks for having severe COVID-19, hospitalization, and death.
“The results of the study show unequivocally that treatment with Paxlovid significantly reduces the risk of hospitalization and death from COVID-19,” Doron Netzer, MD, the senior study author and a researcher with Clalit Health Services, Tel Aviv, told The Jerusalem Post.
“We are the country’s leader in the provision of giving Paxlovid to relevant patients,” he said. “It was given to patients all over the country, with medical teams monitoring the patients who took the pills.”
, the news outlet reported. The research team analyzed information from Clalit’s electronic medical records. The health care organization covers about 52% of the Israeli population and almost two-thirds of older adults. More than 30,000 COVID-19 patients in Israel have been treated with the drug so far.
Dr. Netzer and colleagues looked at hospitalization and death data for at-risk COVID-19 patients ages 40 and older between Jan. 9 and March 31, when the original Omicron variant was the dominant strain in Israel. During that time, more than 1.1 million Clalit patients were infected with COVID-19, 109,000 patients were considered at-risk, and 3,900 patients received the drug.
The average age of the patients was 60, and 39% of the patients were 65 and older. Overall, 78% of the patients had previous COVID-19 immunity due to vaccination, prior infection, or both.
Among ages 65 and older, the rate of COVID-19 hospitalization was 14.7 cases per 100,000 person-days among treated patients, compared with 58.9 cases per 100,000 person-days among untreated patients. This represented a 73% lower chance of being hospitalized.
Among ages 40-64, the rate of hospitalization due to COVID-19 was 15.2 cases per 100,000 person-days among treated patients, compared with 15.8 cases per 100,000 person-days among untreated patients. The risk of hospitalization wasn’t significantly lower for this age group.
Among ages 65 and older, there were two deaths from COVID-19 in 2,484 treated patients, compared with 158 in the 40,337 untreated patients. This represented a 79% lower chance of dying from COVID-19.
Among ages 40-64, there was one death from COVID-19 in 1,418 treated patients, compared with 16 in the 65,015 untreated patients. The risk of death wasn’t significantly lower for this age group.
For both age groups, a lack of previous COVID-19 immunity and a previous hospitalization were most strongly linked to high rates of hospitalization during the Omicron wave.
The researchers noted that they didn’t break down the data on ages 40-64 who had cancer and other severe conditions that weaken the immune system. These patients may be more likely to benefit from Paxlovid, they said, though future studies will need to analyze the data.
The study didn’t receive any financial or in-kind support, the authors said.
A version of this article first appeared on WebMD.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
COVID-19 vaccine safe in patients with heart failure
Patients with heart failure (HF) who received two doses of COVID mRNA vaccines were not more likely to have worsening disease, venous thromboembolism, or myocarditis within 90 days than similar unvaccinated patients, in a case-control study in Denmark.
Moreover, in the 90 days after receiving the second shot, vaccinated patients were less likely to die of any cause, compared with unvaccinated patients during a similar 90-day period.
Caroline Sindet-Pedersen, PhD, Herlev and Gentofte Hospital, Hellerup, Denmark, and colleagues presented these findings at the annual congress of the European Society of Cardiology.
Major risk is not receiving vaccine
These results “confirm that the major risk for patients with HF is not receiving vaccination for COVID-19,” Marco Metra, MD, who was not involved with this research, said in an interview.
Dr. Metra was coauthor of an ESC guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic, published online ahead of print November 2021 in the European Heart Journal.
The guidance explains that patients with HF are at increased risk for hospitalization, need for mechanical ventilation, and death because of COVID-19, and that vaccination reduces the risk for serious illness from COVID-19, Dr. Sindet-Pedersen and colleagues explained in a press release from the ESC.
However, “concerns remain,” they added, “about the safety of the SARS-CoV-2 mRNA vaccines in heart failure patients, due to a perceived increased risk of cardiovascular side effects.”
The study findings suggest that “there should be no concern about cardiovascular side effects from mRNA vaccines in heart failure patients,” Dr. Sindet-Pedersen and colleagues summarized.
The results also “point to a beneficial effect of vaccination on mortality” and “indicate that patients with HF should be prioritized for COVID-19 vaccinations and boosters,” they added.
“There are ongoing concerns about the safety of COVID-19 vaccination in fragile patients and patients with heart failure,” said Dr. Metra, professor of cardiology and director of the Institute of Cardiology of the Civil Hospital and University of Brescia (Italy).
“These concerns are not based on evidence but just on reports of rare side effects (namely, myocarditis and pericarditis) in vaccinated people,” he added.
Dr. Metra also coauthored a position paper on COVID-19 vaccination in patients with HF from the Heart Failure Association of the ESC, which was published online October 2021 in the European Journal of Heart Failure.
“The current study,” he summarized, “shows a lower risk of mortality among patients vaccinated, compared with those not vaccinated.
“It has limitations,” he cautioned, “as it is not a prospective randomized study, but [rather] an observational one with comparison between vaccinated and not vaccinated patients with similar characteristics.
“However, it was done in a large population,” he noted, “and its results confirm that the major risk for patients with HF is not receiving vaccination for COVID-19.”
95% of patients with HF in Denmark double vaccinated
The group did not analyze the types of all-cause death in their study, Dr. Sindet-Pedersen clarified in an interview.
Other studies have shown that vaccines are associated with improved survival, she noted. For example, bacillus Calmette-Guérin vaccines and the measles vaccines have been linked with a decreased risk for nonspecific mortality in children, and influenza vaccines are associated with decreased all-cause mortality in patients with HF.
The rates of vaccination in this study were much higher than those for patients with HF in the United States.
In a study of 7,094 patients with HF seen at the Mount Sinai Health System between January 2021 and January 2022, 31% of patients were fully vaccinated with two doses and 14.8% had also received a booster, as per Centers for Disease Control and Prevention guidance. However, another 9.1% of patients were only partially vaccinated with one dose, and 45% remained unvaccinated by January 2022,
In the current study, “the uptake was very high,” Dr. Sindet-Pedersen noted, that is, “95% of the prevalent heart failure patients in 2021 received a vaccine.”
“It might be that the last 5% of the patients that did not receive a vaccine were too ill [terminal] to receive the vaccine,” she speculated, “or that was due to personal reasons.”
The researchers identified 50,893 patients with HF who were double vaccinated in 2021 and they matched them with 50,893 unvaccinated patients with HF in 2019 (prepandemic), with the same age, sex, HF duration, use of HF medications, ischemic heart disease, cancer, diabetes, atrial fibrillation, and admission with HF within 90 days.
Almost all patients in the vaccinated group received the Pfizer/BioNTech mRNA vaccine (92%) and the rest received the Moderna mRNA vaccine (8%), in 2021.
The patients had a mean age of 74, and 64% were men. They had HF for a median of 4.1 years.
During the 90-day follow-up, 1,311 patients in the unvaccinated cohort (2.56%) and 1,113 patients in the vaccinated cohort (2.23%) died; there was a significantly lower risk for all-cause death in the vaccinated cohort versus the unvaccinated cohort (–0.33 percentage points; 95% CI, –0.52 to –0.15 percentage points).
The risk for worsening heart failure was 1.1% in each group; myocarditis and venous thromboembolism were extremely rare, and risks for these conditions were not significantly different in the two groups.
The researchers and Dr. Metra declared they have no relevant financial disclosures. Dr. Metra is editor-in-chief of the European Journal of Heart Failure and senior consulting editor of the European Heart Journal.
A version of this article first appeared on Medscape.com.
Patients with heart failure (HF) who received two doses of COVID mRNA vaccines were not more likely to have worsening disease, venous thromboembolism, or myocarditis within 90 days than similar unvaccinated patients, in a case-control study in Denmark.
Moreover, in the 90 days after receiving the second shot, vaccinated patients were less likely to die of any cause, compared with unvaccinated patients during a similar 90-day period.
Caroline Sindet-Pedersen, PhD, Herlev and Gentofte Hospital, Hellerup, Denmark, and colleagues presented these findings at the annual congress of the European Society of Cardiology.
Major risk is not receiving vaccine
These results “confirm that the major risk for patients with HF is not receiving vaccination for COVID-19,” Marco Metra, MD, who was not involved with this research, said in an interview.
Dr. Metra was coauthor of an ESC guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic, published online ahead of print November 2021 in the European Heart Journal.
The guidance explains that patients with HF are at increased risk for hospitalization, need for mechanical ventilation, and death because of COVID-19, and that vaccination reduces the risk for serious illness from COVID-19, Dr. Sindet-Pedersen and colleagues explained in a press release from the ESC.
However, “concerns remain,” they added, “about the safety of the SARS-CoV-2 mRNA vaccines in heart failure patients, due to a perceived increased risk of cardiovascular side effects.”
The study findings suggest that “there should be no concern about cardiovascular side effects from mRNA vaccines in heart failure patients,” Dr. Sindet-Pedersen and colleagues summarized.
The results also “point to a beneficial effect of vaccination on mortality” and “indicate that patients with HF should be prioritized for COVID-19 vaccinations and boosters,” they added.
“There are ongoing concerns about the safety of COVID-19 vaccination in fragile patients and patients with heart failure,” said Dr. Metra, professor of cardiology and director of the Institute of Cardiology of the Civil Hospital and University of Brescia (Italy).
“These concerns are not based on evidence but just on reports of rare side effects (namely, myocarditis and pericarditis) in vaccinated people,” he added.
Dr. Metra also coauthored a position paper on COVID-19 vaccination in patients with HF from the Heart Failure Association of the ESC, which was published online October 2021 in the European Journal of Heart Failure.
“The current study,” he summarized, “shows a lower risk of mortality among patients vaccinated, compared with those not vaccinated.
“It has limitations,” he cautioned, “as it is not a prospective randomized study, but [rather] an observational one with comparison between vaccinated and not vaccinated patients with similar characteristics.
“However, it was done in a large population,” he noted, “and its results confirm that the major risk for patients with HF is not receiving vaccination for COVID-19.”
95% of patients with HF in Denmark double vaccinated
The group did not analyze the types of all-cause death in their study, Dr. Sindet-Pedersen clarified in an interview.
Other studies have shown that vaccines are associated with improved survival, she noted. For example, bacillus Calmette-Guérin vaccines and the measles vaccines have been linked with a decreased risk for nonspecific mortality in children, and influenza vaccines are associated with decreased all-cause mortality in patients with HF.
The rates of vaccination in this study were much higher than those for patients with HF in the United States.
In a study of 7,094 patients with HF seen at the Mount Sinai Health System between January 2021 and January 2022, 31% of patients were fully vaccinated with two doses and 14.8% had also received a booster, as per Centers for Disease Control and Prevention guidance. However, another 9.1% of patients were only partially vaccinated with one dose, and 45% remained unvaccinated by January 2022,
In the current study, “the uptake was very high,” Dr. Sindet-Pedersen noted, that is, “95% of the prevalent heart failure patients in 2021 received a vaccine.”
“It might be that the last 5% of the patients that did not receive a vaccine were too ill [terminal] to receive the vaccine,” she speculated, “or that was due to personal reasons.”
The researchers identified 50,893 patients with HF who were double vaccinated in 2021 and they matched them with 50,893 unvaccinated patients with HF in 2019 (prepandemic), with the same age, sex, HF duration, use of HF medications, ischemic heart disease, cancer, diabetes, atrial fibrillation, and admission with HF within 90 days.
Almost all patients in the vaccinated group received the Pfizer/BioNTech mRNA vaccine (92%) and the rest received the Moderna mRNA vaccine (8%), in 2021.
The patients had a mean age of 74, and 64% were men. They had HF for a median of 4.1 years.
During the 90-day follow-up, 1,311 patients in the unvaccinated cohort (2.56%) and 1,113 patients in the vaccinated cohort (2.23%) died; there was a significantly lower risk for all-cause death in the vaccinated cohort versus the unvaccinated cohort (–0.33 percentage points; 95% CI, –0.52 to –0.15 percentage points).
The risk for worsening heart failure was 1.1% in each group; myocarditis and venous thromboembolism were extremely rare, and risks for these conditions were not significantly different in the two groups.
The researchers and Dr. Metra declared they have no relevant financial disclosures. Dr. Metra is editor-in-chief of the European Journal of Heart Failure and senior consulting editor of the European Heart Journal.
A version of this article first appeared on Medscape.com.
Patients with heart failure (HF) who received two doses of COVID mRNA vaccines were not more likely to have worsening disease, venous thromboembolism, or myocarditis within 90 days than similar unvaccinated patients, in a case-control study in Denmark.
Moreover, in the 90 days after receiving the second shot, vaccinated patients were less likely to die of any cause, compared with unvaccinated patients during a similar 90-day period.
Caroline Sindet-Pedersen, PhD, Herlev and Gentofte Hospital, Hellerup, Denmark, and colleagues presented these findings at the annual congress of the European Society of Cardiology.
Major risk is not receiving vaccine
These results “confirm that the major risk for patients with HF is not receiving vaccination for COVID-19,” Marco Metra, MD, who was not involved with this research, said in an interview.
Dr. Metra was coauthor of an ESC guidance for the diagnosis and management of cardiovascular disease during the COVID-19 pandemic, published online ahead of print November 2021 in the European Heart Journal.
The guidance explains that patients with HF are at increased risk for hospitalization, need for mechanical ventilation, and death because of COVID-19, and that vaccination reduces the risk for serious illness from COVID-19, Dr. Sindet-Pedersen and colleagues explained in a press release from the ESC.
However, “concerns remain,” they added, “about the safety of the SARS-CoV-2 mRNA vaccines in heart failure patients, due to a perceived increased risk of cardiovascular side effects.”
The study findings suggest that “there should be no concern about cardiovascular side effects from mRNA vaccines in heart failure patients,” Dr. Sindet-Pedersen and colleagues summarized.
The results also “point to a beneficial effect of vaccination on mortality” and “indicate that patients with HF should be prioritized for COVID-19 vaccinations and boosters,” they added.
“There are ongoing concerns about the safety of COVID-19 vaccination in fragile patients and patients with heart failure,” said Dr. Metra, professor of cardiology and director of the Institute of Cardiology of the Civil Hospital and University of Brescia (Italy).
“These concerns are not based on evidence but just on reports of rare side effects (namely, myocarditis and pericarditis) in vaccinated people,” he added.
Dr. Metra also coauthored a position paper on COVID-19 vaccination in patients with HF from the Heart Failure Association of the ESC, which was published online October 2021 in the European Journal of Heart Failure.
“The current study,” he summarized, “shows a lower risk of mortality among patients vaccinated, compared with those not vaccinated.
“It has limitations,” he cautioned, “as it is not a prospective randomized study, but [rather] an observational one with comparison between vaccinated and not vaccinated patients with similar characteristics.
“However, it was done in a large population,” he noted, “and its results confirm that the major risk for patients with HF is not receiving vaccination for COVID-19.”
95% of patients with HF in Denmark double vaccinated
The group did not analyze the types of all-cause death in their study, Dr. Sindet-Pedersen clarified in an interview.
Other studies have shown that vaccines are associated with improved survival, she noted. For example, bacillus Calmette-Guérin vaccines and the measles vaccines have been linked with a decreased risk for nonspecific mortality in children, and influenza vaccines are associated with decreased all-cause mortality in patients with HF.
The rates of vaccination in this study were much higher than those for patients with HF in the United States.
In a study of 7,094 patients with HF seen at the Mount Sinai Health System between January 2021 and January 2022, 31% of patients were fully vaccinated with two doses and 14.8% had also received a booster, as per Centers for Disease Control and Prevention guidance. However, another 9.1% of patients were only partially vaccinated with one dose, and 45% remained unvaccinated by January 2022,
In the current study, “the uptake was very high,” Dr. Sindet-Pedersen noted, that is, “95% of the prevalent heart failure patients in 2021 received a vaccine.”
“It might be that the last 5% of the patients that did not receive a vaccine were too ill [terminal] to receive the vaccine,” she speculated, “or that was due to personal reasons.”
The researchers identified 50,893 patients with HF who were double vaccinated in 2021 and they matched them with 50,893 unvaccinated patients with HF in 2019 (prepandemic), with the same age, sex, HF duration, use of HF medications, ischemic heart disease, cancer, diabetes, atrial fibrillation, and admission with HF within 90 days.
Almost all patients in the vaccinated group received the Pfizer/BioNTech mRNA vaccine (92%) and the rest received the Moderna mRNA vaccine (8%), in 2021.
The patients had a mean age of 74, and 64% were men. They had HF for a median of 4.1 years.
During the 90-day follow-up, 1,311 patients in the unvaccinated cohort (2.56%) and 1,113 patients in the vaccinated cohort (2.23%) died; there was a significantly lower risk for all-cause death in the vaccinated cohort versus the unvaccinated cohort (–0.33 percentage points; 95% CI, –0.52 to –0.15 percentage points).
The risk for worsening heart failure was 1.1% in each group; myocarditis and venous thromboembolism were extremely rare, and risks for these conditions were not significantly different in the two groups.
The researchers and Dr. Metra declared they have no relevant financial disclosures. Dr. Metra is editor-in-chief of the European Journal of Heart Failure and senior consulting editor of the European Heart Journal.
A version of this article first appeared on Medscape.com.
FROM ESC CONGRESS 2022
Transverse Leukonychia and Beau Lines Following COVID-19 Vaccination
To the Editor:
Nail abnormalities associated with SARS-CoV-2 infection that have been reported in the medical literature include nail psoriasis,1 Beau lines,2 onychomadesis,3 heterogeneous red-white discoloration of the nail bed,4 transverse orange nail lesions,3 and the red half‐moon nail sign.3,5 It has been hypothesized that these nail findings may be an indication of microvascular injury to the distal subungual arcade of the digit or may be indicative of a procoagulant state.5,6 Currently, there is limited knowledge of the effect of COVID-19 vaccines on nail changes. We report a patient who presented with transverse leukonychia (Mees lines) and Beau lines shortly after each dose of the Pfizer-BioNTech COVID-19 messenger RNA vaccine was administered (with a total of 2 doses administered on presentation).
A 64-year-old woman with a history of rheumatoid arthritis presented with peeling of the fingernails and proximal white discoloration of several fingernails of 2 months’ duration. The patient first noticed whitening of the nails 3 weeks after she recevied the first dose of the COVID-19 vaccine. Five days after receiving the second, she presented to the dermatology clinic and exhibited transverse leukonychia in most fingernails (Figure 1).
Six weeks following the second dose of the COVID-19 vaccine, the patient returned to the dermatology clinic with Beau lines on the second and third fingernails on the right hand (Figure 2A). Subtle erythema of the proximal nail folds and distal fingers was observed in both hands. The patient also exhibited mild onychorrhexis of the left thumbnail and mottled red-brown discoloration of the third finger on the left hand (Figure 2B). Splinter hemorrhages and melanonychia of several fingernails also were observed. Our patient denied any known history of infection with SARS-CoV-2, which was confirmed by a negative COVID-19 polymerase chain reaction test result. She also denied fevers, chills, nausea, and vomiting, she and reported feeling generally well in the context of these postvaccination nail changes.
She reported no trauma or worsening of rheumatoid arthritis before or after COVID-19 vaccination. She was seronegative for rheumatoid arthritis and was being treated with hydroxychloroquine for the last year and methotrexate for the last 2 years. After each dose of the vaccine, methotrexate was withheld for 1 week and then resumed.
Subsequent follow-up examinations revealed the migration and resolution of transverse leukonychia and Beau lines. There also was interval improvement of the splinter hemorrhages. At 17 weeks following the second vaccine dose, all transverse leukonychia and Beau lines had resolved (Figure 3). The patient’s melanonychia remained unchanged.
Laboratory evaluations drawn 1 month following the first dose of the COVID-19 vaccine, including comprehensive metabolic panel; erythrocyte sedimentation rate; C-reactive protein; and vitamin B12, ferritin, and iron levels were within reference range. The complete blood cell count only showed a mildly decreased white blood cell count (3.55×103/µL [reference range, 4.16–9.95×103/µL]) and mildly elevated mean corpuscular volume (101.9 fL [reference range, 79.3–98.6 fL), both near the patient’s baseline values prior to vaccination.
Documented cutaneous manifestations of SARS‐CoV‐2 infection have included perniolike lesions (known as COVID toes) and vesicular, urticarial, petechial, livedoid, or retiform purpura eruptions. Less frequently, nail findings in patients infected with COVID-19 have been reported, including Beau lines,2 onychomadesis,3 transverse leukonychia,3,7 and the red half‐moon nail sign.3,5 Single or multiple nails may be affected. Although the pathogenesis of nail manifestations related to COVID-19 remains unclear, complement-mediated microvascular injury and thrombosis as well as the procoagulant state, which have been associated with COVID-19, may offer possible explanations.5,6 The presence of microvascular abnormalities was observed in a nail fold video capillaroscopy study of the nails of 82 patients with COVID-19, revealing pericapillary edema, capillary ectasia, sludge flow, meandering capillaries and microvascular derangement, and low capillary density.8
Our patient exhibited transverse leukonychia of the fingernails, which is thought to result from abnormal keratinization of the nail plate due to systemic disorders that induce a temporary dysfunction of nail growth.9 Fernandez-Nieto et al7 reported transverse leukonychia in a patient with COVID-19 that was hypothesized to be due to a transitory nail matrix injury.
Beau lines and onychomadesis, which represent nail matrix arrest, commonly are seen with systemic drug treatments such as chemotherapy and in infectious diseases that precipitate systemic illness, such as hand, foot, and mouth disease. Although histologic examination was not performed in our patient due to cosmetic concerns, we believe that inflammation induced by the vaccine response also can trigger nail abnormalities such as transverse leukonychia and Beau lines. Both SARS-CoV-2 infections and the COVID-19 messenger RNA vaccines can induce systemic inflammation largely due a TH1-dominant response, and they also can trigger other inflammatory conditions. Reports of lichen planus and psoriasis triggered by vaccination—the hepatitis B vaccine,10 influenza vaccine,11 and even COVID-19 vaccines1,12—have been reported. Beau lines have been observed to spontaneously resolve in a self-limiting manner in asymptomatic patients with COVID-19.
Interestingly, our patient only showed 2 nails with Beau lines. We hypothesize that the immune response triggered by vaccination was more subdued than that caused by SARS-CoV-2 infection. Additionally, our patient was already being treated with immunosuppressants, which may have been associated with a reduced immune response despite being withheld right before vaccination. One may debate whether the nail abnormalities observed in our patient constituted an isolated finding from COVID-19 vaccination or were caused by reactivation of rheumatoid arthritis. We favor the former, as the rheumatoid arthritis remained stable before and after COVID-19 vaccination. Laboratory evaluations and physical examination revealed no evidence of flares, and our patient was otherwise healthy. Although the splinter hemorrhages also improved, it is difficult to comment as to whether they were caused by the vaccine or had existed prior to vaccination. However, we believe the melanonychia observed in the nails was unrelated to the vaccine and was likely a chronic manifestation due to long-term hydroxychloroquine and/or methotrexate use.
Given accelerated global vaccination efforts to control the COVID-19 pandemic, more cases of adverse nail manifestations associated with COVID-19 vaccines are expected. Dermatologists should be aware of and use the reported nail findings to educate patients and reassure them that ungual abnormalities are potential adverse effects of COVID-19 vaccines, but they should not discourage vaccination because they usually are temporary and self-resolving.
- Ricardo JW, Lipner SR. Case of de novo nail psoriasis triggered by the second dose of Pfizer-BioNTech BNT162b2 COVID-19 messenger RNA vaccine. JAAD Case Rep. 2021;17:18-20.
- Deng J, Ngo T, Zhu TH, et al. Telogen effluvium, Beau lines, and acral peeling associated with COVID-19 infection. JAAD Case Rep. 2021;13:138-140.
- Hadeler E, Morrison BW, Tosti A. A review of nail findings associated with COVID-19 infection. J Eur Acad Dermatol Venereol. 2021;35:E699-E709.
- Demir B, Yuksel EI, Cicek D, et al. Heterogeneous red-white discoloration of the nail bed and distal onycholysis in a patient with COVID-19. J Eur Acad Dermatol Venereol. 2021;35:E551-E553.
- Neri I, Guglielmo A, Virdi A, et al. The red half-moon nail sign: a novel manifestation of coronavirus infection. J Eur Acad Dermatol Venereol. 2020;34:E663-E665.
- Magro C, Mulvey JJ, Berlin D, et al. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: a report of five cases. Transl Res. 2020;220:1-13.
- Fernandez-Nieto D, Jimenez-Cauhe J, Ortega-Quijano D, et al. Transverse leukonychia (Mees’ lines) nail alterations in a COVID-19 patient. Dermatol Ther. 2020;33:E13863.
- Natalello G, De Luca G, Gigante L, et al. Nailfold capillaroscopy findings in patients with coronavirus disease 2019: broadening the spectrum of COVID-19 microvascular involvement [published online September 17, 2020]. Microvasc Res. doi:10.1016/j.mvr.2020.104071
- Piccolo V, Corneli P, Zalaudek I, et al. Mees’ lines because of chemotherapy for Hodgkin’s lymphoma. Int J Dermatol. 2020;59:E38.
- Miteva L. Bullous lichen planus with nail involvement induced by hepatitis B vaccine in a child. Int J Dermatol. 2005;44:142-144.
- Gunes AT, Fetil E, Akarsu S, et al. Possible triggering effect of influenza vaccination on psoriasis [published online August 25, 2015]. J Immunol Res. doi:10.1155/2015/258430
- Hiltun I, Sarriugarte J, Martínez-de-Espronceda I, et al. Lichen planus arising after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:e414-e415.
To the Editor:
Nail abnormalities associated with SARS-CoV-2 infection that have been reported in the medical literature include nail psoriasis,1 Beau lines,2 onychomadesis,3 heterogeneous red-white discoloration of the nail bed,4 transverse orange nail lesions,3 and the red half‐moon nail sign.3,5 It has been hypothesized that these nail findings may be an indication of microvascular injury to the distal subungual arcade of the digit or may be indicative of a procoagulant state.5,6 Currently, there is limited knowledge of the effect of COVID-19 vaccines on nail changes. We report a patient who presented with transverse leukonychia (Mees lines) and Beau lines shortly after each dose of the Pfizer-BioNTech COVID-19 messenger RNA vaccine was administered (with a total of 2 doses administered on presentation).
A 64-year-old woman with a history of rheumatoid arthritis presented with peeling of the fingernails and proximal white discoloration of several fingernails of 2 months’ duration. The patient first noticed whitening of the nails 3 weeks after she recevied the first dose of the COVID-19 vaccine. Five days after receiving the second, she presented to the dermatology clinic and exhibited transverse leukonychia in most fingernails (Figure 1).
Six weeks following the second dose of the COVID-19 vaccine, the patient returned to the dermatology clinic with Beau lines on the second and third fingernails on the right hand (Figure 2A). Subtle erythema of the proximal nail folds and distal fingers was observed in both hands. The patient also exhibited mild onychorrhexis of the left thumbnail and mottled red-brown discoloration of the third finger on the left hand (Figure 2B). Splinter hemorrhages and melanonychia of several fingernails also were observed. Our patient denied any known history of infection with SARS-CoV-2, which was confirmed by a negative COVID-19 polymerase chain reaction test result. She also denied fevers, chills, nausea, and vomiting, she and reported feeling generally well in the context of these postvaccination nail changes.
She reported no trauma or worsening of rheumatoid arthritis before or after COVID-19 vaccination. She was seronegative for rheumatoid arthritis and was being treated with hydroxychloroquine for the last year and methotrexate for the last 2 years. After each dose of the vaccine, methotrexate was withheld for 1 week and then resumed.
Subsequent follow-up examinations revealed the migration and resolution of transverse leukonychia and Beau lines. There also was interval improvement of the splinter hemorrhages. At 17 weeks following the second vaccine dose, all transverse leukonychia and Beau lines had resolved (Figure 3). The patient’s melanonychia remained unchanged.
Laboratory evaluations drawn 1 month following the first dose of the COVID-19 vaccine, including comprehensive metabolic panel; erythrocyte sedimentation rate; C-reactive protein; and vitamin B12, ferritin, and iron levels were within reference range. The complete blood cell count only showed a mildly decreased white blood cell count (3.55×103/µL [reference range, 4.16–9.95×103/µL]) and mildly elevated mean corpuscular volume (101.9 fL [reference range, 79.3–98.6 fL), both near the patient’s baseline values prior to vaccination.
Documented cutaneous manifestations of SARS‐CoV‐2 infection have included perniolike lesions (known as COVID toes) and vesicular, urticarial, petechial, livedoid, or retiform purpura eruptions. Less frequently, nail findings in patients infected with COVID-19 have been reported, including Beau lines,2 onychomadesis,3 transverse leukonychia,3,7 and the red half‐moon nail sign.3,5 Single or multiple nails may be affected. Although the pathogenesis of nail manifestations related to COVID-19 remains unclear, complement-mediated microvascular injury and thrombosis as well as the procoagulant state, which have been associated with COVID-19, may offer possible explanations.5,6 The presence of microvascular abnormalities was observed in a nail fold video capillaroscopy study of the nails of 82 patients with COVID-19, revealing pericapillary edema, capillary ectasia, sludge flow, meandering capillaries and microvascular derangement, and low capillary density.8
Our patient exhibited transverse leukonychia of the fingernails, which is thought to result from abnormal keratinization of the nail plate due to systemic disorders that induce a temporary dysfunction of nail growth.9 Fernandez-Nieto et al7 reported transverse leukonychia in a patient with COVID-19 that was hypothesized to be due to a transitory nail matrix injury.
Beau lines and onychomadesis, which represent nail matrix arrest, commonly are seen with systemic drug treatments such as chemotherapy and in infectious diseases that precipitate systemic illness, such as hand, foot, and mouth disease. Although histologic examination was not performed in our patient due to cosmetic concerns, we believe that inflammation induced by the vaccine response also can trigger nail abnormalities such as transverse leukonychia and Beau lines. Both SARS-CoV-2 infections and the COVID-19 messenger RNA vaccines can induce systemic inflammation largely due a TH1-dominant response, and they also can trigger other inflammatory conditions. Reports of lichen planus and psoriasis triggered by vaccination—the hepatitis B vaccine,10 influenza vaccine,11 and even COVID-19 vaccines1,12—have been reported. Beau lines have been observed to spontaneously resolve in a self-limiting manner in asymptomatic patients with COVID-19.
Interestingly, our patient only showed 2 nails with Beau lines. We hypothesize that the immune response triggered by vaccination was more subdued than that caused by SARS-CoV-2 infection. Additionally, our patient was already being treated with immunosuppressants, which may have been associated with a reduced immune response despite being withheld right before vaccination. One may debate whether the nail abnormalities observed in our patient constituted an isolated finding from COVID-19 vaccination or were caused by reactivation of rheumatoid arthritis. We favor the former, as the rheumatoid arthritis remained stable before and after COVID-19 vaccination. Laboratory evaluations and physical examination revealed no evidence of flares, and our patient was otherwise healthy. Although the splinter hemorrhages also improved, it is difficult to comment as to whether they were caused by the vaccine or had existed prior to vaccination. However, we believe the melanonychia observed in the nails was unrelated to the vaccine and was likely a chronic manifestation due to long-term hydroxychloroquine and/or methotrexate use.
Given accelerated global vaccination efforts to control the COVID-19 pandemic, more cases of adverse nail manifestations associated with COVID-19 vaccines are expected. Dermatologists should be aware of and use the reported nail findings to educate patients and reassure them that ungual abnormalities are potential adverse effects of COVID-19 vaccines, but they should not discourage vaccination because they usually are temporary and self-resolving.
To the Editor:
Nail abnormalities associated with SARS-CoV-2 infection that have been reported in the medical literature include nail psoriasis,1 Beau lines,2 onychomadesis,3 heterogeneous red-white discoloration of the nail bed,4 transverse orange nail lesions,3 and the red half‐moon nail sign.3,5 It has been hypothesized that these nail findings may be an indication of microvascular injury to the distal subungual arcade of the digit or may be indicative of a procoagulant state.5,6 Currently, there is limited knowledge of the effect of COVID-19 vaccines on nail changes. We report a patient who presented with transverse leukonychia (Mees lines) and Beau lines shortly after each dose of the Pfizer-BioNTech COVID-19 messenger RNA vaccine was administered (with a total of 2 doses administered on presentation).
A 64-year-old woman with a history of rheumatoid arthritis presented with peeling of the fingernails and proximal white discoloration of several fingernails of 2 months’ duration. The patient first noticed whitening of the nails 3 weeks after she recevied the first dose of the COVID-19 vaccine. Five days after receiving the second, she presented to the dermatology clinic and exhibited transverse leukonychia in most fingernails (Figure 1).
Six weeks following the second dose of the COVID-19 vaccine, the patient returned to the dermatology clinic with Beau lines on the second and third fingernails on the right hand (Figure 2A). Subtle erythema of the proximal nail folds and distal fingers was observed in both hands. The patient also exhibited mild onychorrhexis of the left thumbnail and mottled red-brown discoloration of the third finger on the left hand (Figure 2B). Splinter hemorrhages and melanonychia of several fingernails also were observed. Our patient denied any known history of infection with SARS-CoV-2, which was confirmed by a negative COVID-19 polymerase chain reaction test result. She also denied fevers, chills, nausea, and vomiting, she and reported feeling generally well in the context of these postvaccination nail changes.
She reported no trauma or worsening of rheumatoid arthritis before or after COVID-19 vaccination. She was seronegative for rheumatoid arthritis and was being treated with hydroxychloroquine for the last year and methotrexate for the last 2 years. After each dose of the vaccine, methotrexate was withheld for 1 week and then resumed.
Subsequent follow-up examinations revealed the migration and resolution of transverse leukonychia and Beau lines. There also was interval improvement of the splinter hemorrhages. At 17 weeks following the second vaccine dose, all transverse leukonychia and Beau lines had resolved (Figure 3). The patient’s melanonychia remained unchanged.
Laboratory evaluations drawn 1 month following the first dose of the COVID-19 vaccine, including comprehensive metabolic panel; erythrocyte sedimentation rate; C-reactive protein; and vitamin B12, ferritin, and iron levels were within reference range. The complete blood cell count only showed a mildly decreased white blood cell count (3.55×103/µL [reference range, 4.16–9.95×103/µL]) and mildly elevated mean corpuscular volume (101.9 fL [reference range, 79.3–98.6 fL), both near the patient’s baseline values prior to vaccination.
Documented cutaneous manifestations of SARS‐CoV‐2 infection have included perniolike lesions (known as COVID toes) and vesicular, urticarial, petechial, livedoid, or retiform purpura eruptions. Less frequently, nail findings in patients infected with COVID-19 have been reported, including Beau lines,2 onychomadesis,3 transverse leukonychia,3,7 and the red half‐moon nail sign.3,5 Single or multiple nails may be affected. Although the pathogenesis of nail manifestations related to COVID-19 remains unclear, complement-mediated microvascular injury and thrombosis as well as the procoagulant state, which have been associated with COVID-19, may offer possible explanations.5,6 The presence of microvascular abnormalities was observed in a nail fold video capillaroscopy study of the nails of 82 patients with COVID-19, revealing pericapillary edema, capillary ectasia, sludge flow, meandering capillaries and microvascular derangement, and low capillary density.8
Our patient exhibited transverse leukonychia of the fingernails, which is thought to result from abnormal keratinization of the nail plate due to systemic disorders that induce a temporary dysfunction of nail growth.9 Fernandez-Nieto et al7 reported transverse leukonychia in a patient with COVID-19 that was hypothesized to be due to a transitory nail matrix injury.
Beau lines and onychomadesis, which represent nail matrix arrest, commonly are seen with systemic drug treatments such as chemotherapy and in infectious diseases that precipitate systemic illness, such as hand, foot, and mouth disease. Although histologic examination was not performed in our patient due to cosmetic concerns, we believe that inflammation induced by the vaccine response also can trigger nail abnormalities such as transverse leukonychia and Beau lines. Both SARS-CoV-2 infections and the COVID-19 messenger RNA vaccines can induce systemic inflammation largely due a TH1-dominant response, and they also can trigger other inflammatory conditions. Reports of lichen planus and psoriasis triggered by vaccination—the hepatitis B vaccine,10 influenza vaccine,11 and even COVID-19 vaccines1,12—have been reported. Beau lines have been observed to spontaneously resolve in a self-limiting manner in asymptomatic patients with COVID-19.
Interestingly, our patient only showed 2 nails with Beau lines. We hypothesize that the immune response triggered by vaccination was more subdued than that caused by SARS-CoV-2 infection. Additionally, our patient was already being treated with immunosuppressants, which may have been associated with a reduced immune response despite being withheld right before vaccination. One may debate whether the nail abnormalities observed in our patient constituted an isolated finding from COVID-19 vaccination or were caused by reactivation of rheumatoid arthritis. We favor the former, as the rheumatoid arthritis remained stable before and after COVID-19 vaccination. Laboratory evaluations and physical examination revealed no evidence of flares, and our patient was otherwise healthy. Although the splinter hemorrhages also improved, it is difficult to comment as to whether they were caused by the vaccine or had existed prior to vaccination. However, we believe the melanonychia observed in the nails was unrelated to the vaccine and was likely a chronic manifestation due to long-term hydroxychloroquine and/or methotrexate use.
Given accelerated global vaccination efforts to control the COVID-19 pandemic, more cases of adverse nail manifestations associated with COVID-19 vaccines are expected. Dermatologists should be aware of and use the reported nail findings to educate patients and reassure them that ungual abnormalities are potential adverse effects of COVID-19 vaccines, but they should not discourage vaccination because they usually are temporary and self-resolving.
- Ricardo JW, Lipner SR. Case of de novo nail psoriasis triggered by the second dose of Pfizer-BioNTech BNT162b2 COVID-19 messenger RNA vaccine. JAAD Case Rep. 2021;17:18-20.
- Deng J, Ngo T, Zhu TH, et al. Telogen effluvium, Beau lines, and acral peeling associated with COVID-19 infection. JAAD Case Rep. 2021;13:138-140.
- Hadeler E, Morrison BW, Tosti A. A review of nail findings associated with COVID-19 infection. J Eur Acad Dermatol Venereol. 2021;35:E699-E709.
- Demir B, Yuksel EI, Cicek D, et al. Heterogeneous red-white discoloration of the nail bed and distal onycholysis in a patient with COVID-19. J Eur Acad Dermatol Venereol. 2021;35:E551-E553.
- Neri I, Guglielmo A, Virdi A, et al. The red half-moon nail sign: a novel manifestation of coronavirus infection. J Eur Acad Dermatol Venereol. 2020;34:E663-E665.
- Magro C, Mulvey JJ, Berlin D, et al. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: a report of five cases. Transl Res. 2020;220:1-13.
- Fernandez-Nieto D, Jimenez-Cauhe J, Ortega-Quijano D, et al. Transverse leukonychia (Mees’ lines) nail alterations in a COVID-19 patient. Dermatol Ther. 2020;33:E13863.
- Natalello G, De Luca G, Gigante L, et al. Nailfold capillaroscopy findings in patients with coronavirus disease 2019: broadening the spectrum of COVID-19 microvascular involvement [published online September 17, 2020]. Microvasc Res. doi:10.1016/j.mvr.2020.104071
- Piccolo V, Corneli P, Zalaudek I, et al. Mees’ lines because of chemotherapy for Hodgkin’s lymphoma. Int J Dermatol. 2020;59:E38.
- Miteva L. Bullous lichen planus with nail involvement induced by hepatitis B vaccine in a child. Int J Dermatol. 2005;44:142-144.
- Gunes AT, Fetil E, Akarsu S, et al. Possible triggering effect of influenza vaccination on psoriasis [published online August 25, 2015]. J Immunol Res. doi:10.1155/2015/258430
- Hiltun I, Sarriugarte J, Martínez-de-Espronceda I, et al. Lichen planus arising after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:e414-e415.
- Ricardo JW, Lipner SR. Case of de novo nail psoriasis triggered by the second dose of Pfizer-BioNTech BNT162b2 COVID-19 messenger RNA vaccine. JAAD Case Rep. 2021;17:18-20.
- Deng J, Ngo T, Zhu TH, et al. Telogen effluvium, Beau lines, and acral peeling associated with COVID-19 infection. JAAD Case Rep. 2021;13:138-140.
- Hadeler E, Morrison BW, Tosti A. A review of nail findings associated with COVID-19 infection. J Eur Acad Dermatol Venereol. 2021;35:E699-E709.
- Demir B, Yuksel EI, Cicek D, et al. Heterogeneous red-white discoloration of the nail bed and distal onycholysis in a patient with COVID-19. J Eur Acad Dermatol Venereol. 2021;35:E551-E553.
- Neri I, Guglielmo A, Virdi A, et al. The red half-moon nail sign: a novel manifestation of coronavirus infection. J Eur Acad Dermatol Venereol. 2020;34:E663-E665.
- Magro C, Mulvey JJ, Berlin D, et al. Complement associated microvascular injury and thrombosis in the pathogenesis of severe COVID-19 infection: a report of five cases. Transl Res. 2020;220:1-13.
- Fernandez-Nieto D, Jimenez-Cauhe J, Ortega-Quijano D, et al. Transverse leukonychia (Mees’ lines) nail alterations in a COVID-19 patient. Dermatol Ther. 2020;33:E13863.
- Natalello G, De Luca G, Gigante L, et al. Nailfold capillaroscopy findings in patients with coronavirus disease 2019: broadening the spectrum of COVID-19 microvascular involvement [published online September 17, 2020]. Microvasc Res. doi:10.1016/j.mvr.2020.104071
- Piccolo V, Corneli P, Zalaudek I, et al. Mees’ lines because of chemotherapy for Hodgkin’s lymphoma. Int J Dermatol. 2020;59:E38.
- Miteva L. Bullous lichen planus with nail involvement induced by hepatitis B vaccine in a child. Int J Dermatol. 2005;44:142-144.
- Gunes AT, Fetil E, Akarsu S, et al. Possible triggering effect of influenza vaccination on psoriasis [published online August 25, 2015]. J Immunol Res. doi:10.1155/2015/258430
- Hiltun I, Sarriugarte J, Martínez-de-Espronceda I, et al. Lichen planus arising after COVID-19 vaccination. J Eur Acad Dermatol Venereol. 2021;35:e414-e415.
Practice Points
- Given accelerated global vaccination efforts to control the COVID-19 pandemic, cases of nail changes associated with COVID-19 vaccines are expected.
- Nail abnormalities are a potential general, temporary, and self-limiting adverse effect of COVID-19 vaccines that should not discourage patients from getting vaccinated.
Hospitalized COVID-19 patients with GI symptoms have worse outcomes
Patients with COVID-19 who experience gastrointestinal symptoms have overall worse in-hospital complications but less cardiomyopathy and mortality, according to a new study.
About 20% of COVID-19 patients experience gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea, and vomiting, which clinicians should consider when treating their hospitalized patients, wrote researchers led by Nikita Patil, MD, a hospitalist at Nash General Hospital–UNC Nash Healthcare in Rocky Mount, N.C., in Gastro Hep Advances.
“It’s important to know that certain complications are higher in people with GI symptoms,” she said in an interview. “Even without an increased risk of death, there are many problems that affect quality of life and lead to people not being able to do the things they were able to do before.”
Dr. Patil and colleagues analyzed the association of GI symptoms with adverse outcomes in 100,902 patients from the Cerner Real-World Data COVID-19 Database, which included hospital encounters and ED visits for COVID-19 between December 2019 to November 2020; the data were taken from EMRs at centers with which Cerner has a data use agreement. They also looked at factors associated with poor outcomes such as acute respiratory distress syndrome, sepsis, and ventilator requirement or oxygen dependence.
The average age of the patients was 52, and a higher proportion of patients with GI symptoms were 50 and older. Of those with GI symptoms, 54.5% were women. Overall, patients with GI symptoms were more likely to have higher Charlson Comorbidity Index scores and have comorbidities such as acute liver failure, gastroesophageal reflux disease, GI malignancy, and inflammatory bowel disease.
The research team found that COVID-19 patients with GI symptoms were more likely to have acute respiratory distress syndrome (odds ratio, 1.20; 95% confidence interval, 1.11-1.29), sepsis (OR, 1.19; 95% CI, 1.14-1.24), acute kidney injury (OR, 1.30; 95% CI, 1.24-1.36), venous thromboembolism (OR, 1.36; 95% CI, 1.22-1.52), and GI bleeding (OR 1.62; 95% CI, 1.47-1.79), as compared with COVID-19 patients without GI symptoms (P < .0001 for all comparisons). At the same time, those with GI symptoms were less likely to experience cardiomyopathy (OR, 0.87; 95% CI, 0.77-0.99; P = .027), respiratory failure (OR, 0.92; 95% CI, 0.88-0.95; P < .0001), or death (OR, 0.71; 95% CI, 0.67-0.75; P < .0001).
GI bleed was the most common GI complication, found among 2% of all patients, and was more likely in patients with GI symptoms than in those without (3.5% vs. 1.6%). Intestinal ischemia, pancreatitis, acute liver injury, and intestinal pseudo-obstruction weren’t associated with GI symptoms.
Among the 19,915 patients with GI symptoms, older age, higher Charlson Comorbidity Index scores, use of proton pump inhibitors, and use of H2 receptor antagonists were associated with higher mortality, acute respiratory distress syndrome, sepsis, and ventilator or oxygen requirement. Men with GI symptoms also had a higher risk of mortality, acute respiratory distress syndrome, and sepsis.
In particular, proton pump inhibitor use was associated with more than twice the risk of acute respiratory distress syndrome (OR, 2.19; 95% CI, 1.32-1.66; P < .0001). Similarly, H2 receptor antagonist use was associated with higher likelihood of death (OR, 1.78; 95% CI, 1.57-2.02), as well as more than three times the risk of acute respiratory distress syndrome (OR, 3.75; 95% CI, 3.29-4.28), more than twice the risk of sepsis (OR, 2.50; 95% CI, 2.28-2.73), and nearly twice the risk of ventilator or oxygen dependence (OR, 1.97; 95% CI, 1.68-2.30) (P < .0001 for all).
The findings could guide risk stratification, prognosis, and treatment decisions in COVID-19 patients with GI symptoms, as well as inform future research focused on risk mitigation and improvement of COVID-19 outcomes, Dr. Patil said.
“The protocols for COVID-19 treatment have changed over the past 2 years with blood thinners and steroids,” she said. “Although we likely can’t avoid anti-reflux medicines entirely, it’s something we need to be cognizant of and look out for in our hospitalized patients.”
One study limitation was its inclusion of only inpatient or ED encounters and, therefore, omission of those treated at home; this confers bias toward those with more aggressive disease, according to the authors.
The authors reported no grant support or funding sources for this study. One author declared grant support and consultant fees from several companies, including some medical and pharmaceutical companies, which were unrelated to this research. Dr. Patil reported no disclosures.
This article was updated Aug. 26, 2022.
Patients with COVID-19 who experience gastrointestinal symptoms have overall worse in-hospital complications but less cardiomyopathy and mortality, according to a new study.
About 20% of COVID-19 patients experience gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea, and vomiting, which clinicians should consider when treating their hospitalized patients, wrote researchers led by Nikita Patil, MD, a hospitalist at Nash General Hospital–UNC Nash Healthcare in Rocky Mount, N.C., in Gastro Hep Advances.
“It’s important to know that certain complications are higher in people with GI symptoms,” she said in an interview. “Even without an increased risk of death, there are many problems that affect quality of life and lead to people not being able to do the things they were able to do before.”
Dr. Patil and colleagues analyzed the association of GI symptoms with adverse outcomes in 100,902 patients from the Cerner Real-World Data COVID-19 Database, which included hospital encounters and ED visits for COVID-19 between December 2019 to November 2020; the data were taken from EMRs at centers with which Cerner has a data use agreement. They also looked at factors associated with poor outcomes such as acute respiratory distress syndrome, sepsis, and ventilator requirement or oxygen dependence.
The average age of the patients was 52, and a higher proportion of patients with GI symptoms were 50 and older. Of those with GI symptoms, 54.5% were women. Overall, patients with GI symptoms were more likely to have higher Charlson Comorbidity Index scores and have comorbidities such as acute liver failure, gastroesophageal reflux disease, GI malignancy, and inflammatory bowel disease.
The research team found that COVID-19 patients with GI symptoms were more likely to have acute respiratory distress syndrome (odds ratio, 1.20; 95% confidence interval, 1.11-1.29), sepsis (OR, 1.19; 95% CI, 1.14-1.24), acute kidney injury (OR, 1.30; 95% CI, 1.24-1.36), venous thromboembolism (OR, 1.36; 95% CI, 1.22-1.52), and GI bleeding (OR 1.62; 95% CI, 1.47-1.79), as compared with COVID-19 patients without GI symptoms (P < .0001 for all comparisons). At the same time, those with GI symptoms were less likely to experience cardiomyopathy (OR, 0.87; 95% CI, 0.77-0.99; P = .027), respiratory failure (OR, 0.92; 95% CI, 0.88-0.95; P < .0001), or death (OR, 0.71; 95% CI, 0.67-0.75; P < .0001).
GI bleed was the most common GI complication, found among 2% of all patients, and was more likely in patients with GI symptoms than in those without (3.5% vs. 1.6%). Intestinal ischemia, pancreatitis, acute liver injury, and intestinal pseudo-obstruction weren’t associated with GI symptoms.
Among the 19,915 patients with GI symptoms, older age, higher Charlson Comorbidity Index scores, use of proton pump inhibitors, and use of H2 receptor antagonists were associated with higher mortality, acute respiratory distress syndrome, sepsis, and ventilator or oxygen requirement. Men with GI symptoms also had a higher risk of mortality, acute respiratory distress syndrome, and sepsis.
In particular, proton pump inhibitor use was associated with more than twice the risk of acute respiratory distress syndrome (OR, 2.19; 95% CI, 1.32-1.66; P < .0001). Similarly, H2 receptor antagonist use was associated with higher likelihood of death (OR, 1.78; 95% CI, 1.57-2.02), as well as more than three times the risk of acute respiratory distress syndrome (OR, 3.75; 95% CI, 3.29-4.28), more than twice the risk of sepsis (OR, 2.50; 95% CI, 2.28-2.73), and nearly twice the risk of ventilator or oxygen dependence (OR, 1.97; 95% CI, 1.68-2.30) (P < .0001 for all).
The findings could guide risk stratification, prognosis, and treatment decisions in COVID-19 patients with GI symptoms, as well as inform future research focused on risk mitigation and improvement of COVID-19 outcomes, Dr. Patil said.
“The protocols for COVID-19 treatment have changed over the past 2 years with blood thinners and steroids,” she said. “Although we likely can’t avoid anti-reflux medicines entirely, it’s something we need to be cognizant of and look out for in our hospitalized patients.”
One study limitation was its inclusion of only inpatient or ED encounters and, therefore, omission of those treated at home; this confers bias toward those with more aggressive disease, according to the authors.
The authors reported no grant support or funding sources for this study. One author declared grant support and consultant fees from several companies, including some medical and pharmaceutical companies, which were unrelated to this research. Dr. Patil reported no disclosures.
This article was updated Aug. 26, 2022.
Patients with COVID-19 who experience gastrointestinal symptoms have overall worse in-hospital complications but less cardiomyopathy and mortality, according to a new study.
About 20% of COVID-19 patients experience gastrointestinal symptoms, such as abdominal pain, diarrhea, nausea, and vomiting, which clinicians should consider when treating their hospitalized patients, wrote researchers led by Nikita Patil, MD, a hospitalist at Nash General Hospital–UNC Nash Healthcare in Rocky Mount, N.C., in Gastro Hep Advances.
“It’s important to know that certain complications are higher in people with GI symptoms,” she said in an interview. “Even without an increased risk of death, there are many problems that affect quality of life and lead to people not being able to do the things they were able to do before.”
Dr. Patil and colleagues analyzed the association of GI symptoms with adverse outcomes in 100,902 patients from the Cerner Real-World Data COVID-19 Database, which included hospital encounters and ED visits for COVID-19 between December 2019 to November 2020; the data were taken from EMRs at centers with which Cerner has a data use agreement. They also looked at factors associated with poor outcomes such as acute respiratory distress syndrome, sepsis, and ventilator requirement or oxygen dependence.
The average age of the patients was 52, and a higher proportion of patients with GI symptoms were 50 and older. Of those with GI symptoms, 54.5% were women. Overall, patients with GI symptoms were more likely to have higher Charlson Comorbidity Index scores and have comorbidities such as acute liver failure, gastroesophageal reflux disease, GI malignancy, and inflammatory bowel disease.
The research team found that COVID-19 patients with GI symptoms were more likely to have acute respiratory distress syndrome (odds ratio, 1.20; 95% confidence interval, 1.11-1.29), sepsis (OR, 1.19; 95% CI, 1.14-1.24), acute kidney injury (OR, 1.30; 95% CI, 1.24-1.36), venous thromboembolism (OR, 1.36; 95% CI, 1.22-1.52), and GI bleeding (OR 1.62; 95% CI, 1.47-1.79), as compared with COVID-19 patients without GI symptoms (P < .0001 for all comparisons). At the same time, those with GI symptoms were less likely to experience cardiomyopathy (OR, 0.87; 95% CI, 0.77-0.99; P = .027), respiratory failure (OR, 0.92; 95% CI, 0.88-0.95; P < .0001), or death (OR, 0.71; 95% CI, 0.67-0.75; P < .0001).
GI bleed was the most common GI complication, found among 2% of all patients, and was more likely in patients with GI symptoms than in those without (3.5% vs. 1.6%). Intestinal ischemia, pancreatitis, acute liver injury, and intestinal pseudo-obstruction weren’t associated with GI symptoms.
Among the 19,915 patients with GI symptoms, older age, higher Charlson Comorbidity Index scores, use of proton pump inhibitors, and use of H2 receptor antagonists were associated with higher mortality, acute respiratory distress syndrome, sepsis, and ventilator or oxygen requirement. Men with GI symptoms also had a higher risk of mortality, acute respiratory distress syndrome, and sepsis.
In particular, proton pump inhibitor use was associated with more than twice the risk of acute respiratory distress syndrome (OR, 2.19; 95% CI, 1.32-1.66; P < .0001). Similarly, H2 receptor antagonist use was associated with higher likelihood of death (OR, 1.78; 95% CI, 1.57-2.02), as well as more than three times the risk of acute respiratory distress syndrome (OR, 3.75; 95% CI, 3.29-4.28), more than twice the risk of sepsis (OR, 2.50; 95% CI, 2.28-2.73), and nearly twice the risk of ventilator or oxygen dependence (OR, 1.97; 95% CI, 1.68-2.30) (P < .0001 for all).
The findings could guide risk stratification, prognosis, and treatment decisions in COVID-19 patients with GI symptoms, as well as inform future research focused on risk mitigation and improvement of COVID-19 outcomes, Dr. Patil said.
“The protocols for COVID-19 treatment have changed over the past 2 years with blood thinners and steroids,” she said. “Although we likely can’t avoid anti-reflux medicines entirely, it’s something we need to be cognizant of and look out for in our hospitalized patients.”
One study limitation was its inclusion of only inpatient or ED encounters and, therefore, omission of those treated at home; this confers bias toward those with more aggressive disease, according to the authors.
The authors reported no grant support or funding sources for this study. One author declared grant support and consultant fees from several companies, including some medical and pharmaceutical companies, which were unrelated to this research. Dr. Patil reported no disclosures.
This article was updated Aug. 26, 2022.
FROM GASTRO HEP ADVANCES
Preparing for back to school amid monkeypox outbreak and ever-changing COVID landscape
Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.
The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.
The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.
As older children may be heading to college, it is important
to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.
Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
Monkeypox
We now have a new health concern for this school year.
Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.
Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:
- sexual activity with those with lesions consistent with monkeypox;
- sharing eating and drinking utensils; and
- sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.
Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.
Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.
At the time of this article, CDC guidance recommends the vaccine against monkeypox for:
- those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
- those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
- those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
- those whose jobs may expose them to monkeypox.
Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.
Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.
Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.
As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.
Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.
The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.
The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.
As older children may be heading to college, it is important
to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.
Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
Monkeypox
We now have a new health concern for this school year.
Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.
Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:
- sexual activity with those with lesions consistent with monkeypox;
- sharing eating and drinking utensils; and
- sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.
Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.
Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.
At the time of this article, CDC guidance recommends the vaccine against monkeypox for:
- those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
- those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
- those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
- those whose jobs may expose them to monkeypox.
Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.
Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.
Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.
As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.
Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
Unlike last school year, there are now vaccines available for all over the age of 6 months, and home rapid antigen tests are more readily available. Additionally, many have now been exposed either by infection or vaccination to the virus.
The CDC has removed the recommendations for maintaining cohorts in the K-12 population. This changing landscape along with differing levels of personal risk make it challenging to counsel families about what to expect in terms of COVID this year.
The best defense that we currently have against COVID is the vaccine. Although it seems that many are susceptible to the virus despite the vaccine, those who have been vaccinated are less susceptible to serious disease, including young children.
As older children may be heading to college, it is important
to encourage them to isolate when they have symptoms, even when they test negative for COVID as we would all like to avoid being sick in general.
Additionally, they should pay attention to the COVID risk level in their area and wear masks, particularly when indoors, as the levels increase. College students should have a plan for where they can isolate when not feeling well. If anyone does test positive for COVID, they should follow the most recent quarantine guidelines, including wearing a well fitted mask when they do begin returning to activities.
Monkeypox
We now have a new health concern for this school year.
Monkeypox has come onto the scene with information changing as rapidly as information previously did for COVID. With this virus, we must particularly counsel those heading away to college to be careful to limit their exposure to this disease.
Dormitories and other congregate settings are high-risk locations for the spread of monkeypox. Particularly, students headed to stay in dormitories should be counseled about avoiding:
- sexual activity with those with lesions consistent with monkeypox;
- sharing eating and drinking utensils; and
- sleeping in the same bed as or sharing bedding or towels with anyone with a diagnosis of or lesions consistent with monkeypox.
Additionally, as with prevention of all infections, it is important to frequently wash hands or use alcohol-based sanitizer before eating, and avoid touching the face after using the restroom.
Guidance for those eligible for vaccines against monkeypox seems to be quickly changing as well.
At the time of this article, CDC guidance recommends the vaccine against monkeypox for:
- those considered to be at high risk for it, including those identified by public health officials as a contact of someone with monkeypox;
- those who are aware that a sexual partner had a diagnosis of monkeypox within the past 2 weeks;
- those with multiple sex partners in the past 2 weeks in an area with known monkeypox; and
- those whose jobs may expose them to monkeypox.
Currently, the CDC recommends the vaccine JYNNEOS, a two-dose vaccine that reaches maximum protection after fourteen days. Ultimately, guidance is likely to continue to quickly change for both COVID-19 and Monkeypox throughout the fall. It is possible that new vaccinations will become available, and families and physicians alike will have many questions.
Primary care offices should ensure that someone is keeping up to date with the latest guidance to share with the office so that physicians may share accurate information with their patients.
Families should be counseled that we anticipate information about monkeypox, particularly related to vaccinations, to continue to change, as it has during all stages of the COVID pandemic.
As always, patients should be reminded to continue regular routine vaccinations, including the annual influenza vaccine.
Dr. Wheat is a family physician at Erie Family Health Center and program director of Northwestern University’s McGaw Family Medicine residency program, both in Chicago. Dr. Wheat serves on the editorial advisory board of Family Practice News. You can contact her at [email protected].
Implementation of a Virtual Huddle to Support Patient Care During the COVID-19 Pandemic
The COVID-19 pandemic challenged hospital medicine teams to care for patients with complex respiratory needs, comply with evolving protocols, and remain abreast of new therapies.1,2 Pulmonary and critical care medicine (PCCM) faculty grappled with similar issues, acknowledging that their critical care expertise could be beneficial outside of the intensive care unit (ICU). Clinical pharmacists managed the procurement, allocation, and monitoring of complex (and sometimes limited) pharmacologic therapies. Although strategies used by health care systems to prepare and restructure for COVID-19 are reported, processes to enhance multidisciplinary care are limited.3,4 Therefore, we developed the COVID-19 Tele-Huddle Program using video conference to support hospital medicine teams caring for patients with COVID-19 and high disease severity.
Program Description
The Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, is a 349-bed, level 1A federal health care facility serving more than 113,000 veterans in southeast Texas.5 The COVID-19 Tele-Huddle Program took place over a 4-week period from July 6 to August 2, 2020. By the end of the 4-week period, there was a decline in the number of COVID patient admissions and thus the need for the huddle. Participation in the huddle also declined, likely reflecting the end of the surge and an increase in knowledge about COVID management acquired by the teams. Each COVID-19 Tele-Huddle Program consultation session consisted of at least 1 member from each hospital medicine team, 1 to 2 PCCM faculty members, and 1 to 2 clinical pharmacy specialists (Figure). The consultation team members included 4 PCCM faculty members and 2 clinical pharmacy specialists. The internal medicine (IM) participants included 10 ward teams with a total of 20 interns (PGY1), 12 upper-level residents (PGY2 and PGY 3), and 10 attending physicians.
The COVID-19 Tele-Huddle Program was a daily (including weekends) video conference. The hospital medicine team members joined the huddle from team workrooms, using webcams supplied by the MEDVAMC information technology department. The COVID-19 Tele-Huddle Program consultation team members joined remotely. Each hospital medicine team joined the huddle at a pre-assigned 15- to 30-minute time allotment, which varied based on patient volume. Participation in the huddle was mandatory for the first week and became optional thereafter. This was in recognition of the steep learning curve and provided the teams both basic knowledge of COVID management and a shared understanding of when a multidisciplinary consultation would be critical. Mandatory daily participation was challenging due to the pressures of patient volume during the surge.
COVID-19 patients with high disease severity were discussed during huddles based on specific criteria: all newly admitted COVID-19 patients, patients requiring step-down level of care, those with increasing oxygen requirements, and/or patients requiring authorization of remdesivir therapy, which required clinical pharmacy authorization at MEDVAMC. The hospital medicine teams reported the patients’ oxygen requirements, comorbid medical conditions, current and prior therapies, fluid status, and relevant laboratory values. A dashboard using the Premier Inc. TheraDoc clinical decision support system was developed to display patient vital signs, laboratory values, and medications. The PCCM faculty and clinical pharmacists listened to inpatient medicine teams presentations and used the dashboard and radiographic images to formulate clinical decisions. Discussion of a patient at the huddle did not preclude in-person consultation at any time.
Tele-Huddles were not recorded, and all protected health information discussed was accessed through the electronic health record using a secure network. Data on length of the meeting, number of patients discussed, and management decisions were recorded daily in a spreadsheet. At the end of the 4-week surge, participants in the program completed a survey, which assessed participant demographics, prior experience with COVID-19, and satisfaction with the program based on a series of agree/disagree questions.
Program Metrics
During the COVID-19 Tele-Huddle Program 4-week evaluation period, 323 encounters were discussed with 117 unique patients with COVID-19. A median (IQR) of 5 (4-8) hospital medicine teams discussed 15 (9-18) patients. The COVID-19 Tele-Huddle Program lasted a median (IQR) 74 (53-94) minutes. A mean (SD) 27% (13) of patients with COVID-19 admitted to the acute care services were discussed.
The multidisciplinary team provided 247 chest X-ray interpretations, 82 diagnostic recommendations, 206 therapeutic recommendations, and 32 transition of care recommendations (Table 1). A total of 55 (47%) patients were given remdesivir with first dose authorized by clinical pharmacy and given within a median (IQR) 6 (3-10) hours after the order was placed. Oxygen therapy, including titration and de-escalation of high-flow nasal cannula and noninvasive positive pressure ventilation (NIPPV), was used for 26 (22.2%) patients. Additional interventions included the review of imaging, the assessment of volume status to guide diuretic recommendations, and the discussion of goals of care.
Of the participating IM trainees and attendings, 16 of 37 (43%) completed the user survey (Table 2). Prior experience with COVID-19 patients varied, with 7 of 16 respondents indicating experience with ≥ 5 patients with COVID-19 prior to the intervention period. Respondents believed that the huddle was helpful in management of respiratory issues (13 of 16), management of medications (13 of 16), escalation of care to ICU (10 of 16), and management of nonrespiratory issues (8 of 16) and goals of care (12 of 16). Fifteen of 16 participants strongly agreed or agreed that the COVID-19 Tele-Huddle Program improved their knowledge and confidence in managing patients. One participant commented, “Getting interdisciplinary help on COVID patients has really helped our team feel confident in our decisions about some of these very complex patients.” Another respondent commented, “Reliability was very helpful for planning how to discuss updates with our patients rather than the formal consultative process.”
Discussion
During the unprecedented COVID-19 pandemic, health care systems have been challenged to manage a large volume of patients, often with high disease severity, in non-ICU settings. This surge in cases has placed strain on hospital medicine teams. There is a subset of patients with COVID-19 with high disease severity that may be managed safely by hospital medicine teams, provided the accessibility and support of consultants, such as PCCM faculty and clinical pharmacists.
Huddles are defined as functional groups of people focused on enhancing communication and care coordination to benefit patient safety. While often brief in nature, huddles can encompass a variety of structures, agendas, and outcome measures.6,7 We implemented a modified huddle using video conferencing to provide important aspects of critical care for patients with COVID-19. Face-to-face evaluation of about 15 patients each day would have strained an already burdened PCCM faculty who were providing additional critical care services as part of the surge response. Conversion of in-person consultations to the COVID-19 Tele-Huddle Program allowed for mitigation of COVID-19 transmission risk for additional clinicians, conservation of personal protective equipment, and more effective communication between acute inpatient practitioners and clinical services. The huddle model expedited the authorization and delivery of therapeutics, including remdesivir, which was prescribed for many patients discussed. Clinical pharmacists provided a review of all medications with input on escalation, de-escalation, dosing, drug-drug interactions, and emergency use authorization therapies.
Our experience resonates with previously described advantages of a huddle model, including the reliability of the consultation, empowerment for all members with a de-emphasis on hierarchy and accountability expected by all.8 The huddle provided situational awareness about patients that may require escalation of care to the ICU and/or further goals of care conversations. Assistance with these transitions of care was highly appreciated by the hospital medicine teams who voiced that these decisions were quite challenging. COVID-19 patients at risk for decompensation were referred for in-person consultation and follow-up if required.
addition, the COVID-19 Tele-Huddle Program allowed for a safe and dependable venue for IM trainees and attending physicians to voice questions and concerns about their patients. We observed the development of a shared mental model among all huddle participants, in the face of a steep learning curve on the management of patients with complex respiratory needs. This was reflected in the survey: Most respondents reported improved knowledge and confidence in managing these patients. Situational awareness that arose from the huddle provided the PCCM faculty the opportunity to guide the inpatient ward teams on next steps whether it be escalation to the ICU and/or further goals of care conversations. Facilitation of transitions of care were voiced as challenging decisions faced by the inpatient ward teams, and there was appreciation for additional support from the PCCM faculty in making these difficult decisions.
Challenges and Opportunities
This was a single-center experience caring for veterans. Challenges with having virtual huddles during the COVID-19 surge involved both time for the health care practitioners and technology. This was recognized early by the educational leaders at our facility, and headsets and cameras were purchased for the team rooms and made available as quickly as possible. Another limitation was the unpredictability and variability of patient volume for specific teams that sometimes would affect the efficiency of the huddle. The number of teams who attended the COVID-19 huddle was highest for the first 2 weeks (maximum of 9 teams) but declined to a nadir of 3 at the end of the month. This reflected the increase in knowledge about COVID-19 and respiratory disease that the teams acquired initially as well as a decline in COVID-19 patient admissions over those weeks.
The COVID-19 Tele-Huddle Program model also can be expanded to include other frontline clinicians, including nurses and respiratory therapists. For example, case management huddles were performed in a similar way during the COVID-19 surge to allow for efficient and effective multidisciplinary conversations about patients
Conclusions
Given the rise of telemedicine and availability of video conferencing services, virtual huddles can be implemented in institutions with appropriate staff and remote access to health records. Multidisciplinary consultation services using video conferencing can serve as an adjunct to the traditional, in-person consultation service model for patients with complex needs.
Acknowledgments
The authors acknowledge all of the Baylor Internal Medicine house staff and internal medicine attendings who participated in our huddle and more importantly, cared for our veterans during this COVID-19 surge.
1. Heymann DL, Shindo N; WHO Scientific and Technical Advisory Group for Infectious Hazards. COVID-19: what is next for public health?. Lancet. 2020;395(10224):542-545. doi:10.1016/S0140-6736(20)30374-3
2. Dichter JR, Kanter RK, Dries D, et al; Task Force for Mass Critical Care. System-level planning, coordination, and communication: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement. Chest. 2014;146(suppl 4):e87S-e102S. doi:10.1378/chest.14-0738
3. Chowdhury JM, Patel M, Zheng M, Abramian O, Criner GJ. Mobilization and preparation of a large urban academic center during the COVID-19 pandemic. Ann Am Thorac Soc. 2020;17(8):922-925. doi:10.1513/AnnalsATS.202003-259PS
4. Uppal A, Silvestri DM, Siegler M, et al. Critical care and emergency department response at the epicenter of the COVID-19 pandemic. Health Aff (Millwood). 2020;39(8):1443-1449. doi:10.1377/hlthaff.2020.00901
5. US Department of Veterans Affairs. Michael E. DeBakey VA Medical Center- Houston, Texas. Accessed December 10, 2020. https://www.houston.va.gov/about
6. Provost SM, Lanham HJ, Leykum LK, McDaniel RR Jr, Pugh J. Health care huddles: managing complexity to achieve high reliability. Health Care Manage Rev. 2015;40(1):2-12. doi:10.1097/HMR.0000000000000009
7. Franklin BJ, Gandhi TK, Bates DW, et al. Impact of multidisciplinary team huddles on patient safety: a systematic review and proposed taxonomy. BMJ Qual Saf. 2020;29(10):1-2. doi:10.1136/bmjqs-2019-009911
8. Goldenhar LM, Brady PW, Sutcliffe KM, Muething SE. Huddling for high reliability and situation awareness. BMJ Qual Saf. 2013;22(11):899-906. doi:10.1136/bmjqs-2012-001467
The COVID-19 pandemic challenged hospital medicine teams to care for patients with complex respiratory needs, comply with evolving protocols, and remain abreast of new therapies.1,2 Pulmonary and critical care medicine (PCCM) faculty grappled with similar issues, acknowledging that their critical care expertise could be beneficial outside of the intensive care unit (ICU). Clinical pharmacists managed the procurement, allocation, and monitoring of complex (and sometimes limited) pharmacologic therapies. Although strategies used by health care systems to prepare and restructure for COVID-19 are reported, processes to enhance multidisciplinary care are limited.3,4 Therefore, we developed the COVID-19 Tele-Huddle Program using video conference to support hospital medicine teams caring for patients with COVID-19 and high disease severity.
Program Description
The Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, is a 349-bed, level 1A federal health care facility serving more than 113,000 veterans in southeast Texas.5 The COVID-19 Tele-Huddle Program took place over a 4-week period from July 6 to August 2, 2020. By the end of the 4-week period, there was a decline in the number of COVID patient admissions and thus the need for the huddle. Participation in the huddle also declined, likely reflecting the end of the surge and an increase in knowledge about COVID management acquired by the teams. Each COVID-19 Tele-Huddle Program consultation session consisted of at least 1 member from each hospital medicine team, 1 to 2 PCCM faculty members, and 1 to 2 clinical pharmacy specialists (Figure). The consultation team members included 4 PCCM faculty members and 2 clinical pharmacy specialists. The internal medicine (IM) participants included 10 ward teams with a total of 20 interns (PGY1), 12 upper-level residents (PGY2 and PGY 3), and 10 attending physicians.
The COVID-19 Tele-Huddle Program was a daily (including weekends) video conference. The hospital medicine team members joined the huddle from team workrooms, using webcams supplied by the MEDVAMC information technology department. The COVID-19 Tele-Huddle Program consultation team members joined remotely. Each hospital medicine team joined the huddle at a pre-assigned 15- to 30-minute time allotment, which varied based on patient volume. Participation in the huddle was mandatory for the first week and became optional thereafter. This was in recognition of the steep learning curve and provided the teams both basic knowledge of COVID management and a shared understanding of when a multidisciplinary consultation would be critical. Mandatory daily participation was challenging due to the pressures of patient volume during the surge.
COVID-19 patients with high disease severity were discussed during huddles based on specific criteria: all newly admitted COVID-19 patients, patients requiring step-down level of care, those with increasing oxygen requirements, and/or patients requiring authorization of remdesivir therapy, which required clinical pharmacy authorization at MEDVAMC. The hospital medicine teams reported the patients’ oxygen requirements, comorbid medical conditions, current and prior therapies, fluid status, and relevant laboratory values. A dashboard using the Premier Inc. TheraDoc clinical decision support system was developed to display patient vital signs, laboratory values, and medications. The PCCM faculty and clinical pharmacists listened to inpatient medicine teams presentations and used the dashboard and radiographic images to formulate clinical decisions. Discussion of a patient at the huddle did not preclude in-person consultation at any time.
Tele-Huddles were not recorded, and all protected health information discussed was accessed through the electronic health record using a secure network. Data on length of the meeting, number of patients discussed, and management decisions were recorded daily in a spreadsheet. At the end of the 4-week surge, participants in the program completed a survey, which assessed participant demographics, prior experience with COVID-19, and satisfaction with the program based on a series of agree/disagree questions.
Program Metrics
During the COVID-19 Tele-Huddle Program 4-week evaluation period, 323 encounters were discussed with 117 unique patients with COVID-19. A median (IQR) of 5 (4-8) hospital medicine teams discussed 15 (9-18) patients. The COVID-19 Tele-Huddle Program lasted a median (IQR) 74 (53-94) minutes. A mean (SD) 27% (13) of patients with COVID-19 admitted to the acute care services were discussed.
The multidisciplinary team provided 247 chest X-ray interpretations, 82 diagnostic recommendations, 206 therapeutic recommendations, and 32 transition of care recommendations (Table 1). A total of 55 (47%) patients were given remdesivir with first dose authorized by clinical pharmacy and given within a median (IQR) 6 (3-10) hours after the order was placed. Oxygen therapy, including titration and de-escalation of high-flow nasal cannula and noninvasive positive pressure ventilation (NIPPV), was used for 26 (22.2%) patients. Additional interventions included the review of imaging, the assessment of volume status to guide diuretic recommendations, and the discussion of goals of care.
Of the participating IM trainees and attendings, 16 of 37 (43%) completed the user survey (Table 2). Prior experience with COVID-19 patients varied, with 7 of 16 respondents indicating experience with ≥ 5 patients with COVID-19 prior to the intervention period. Respondents believed that the huddle was helpful in management of respiratory issues (13 of 16), management of medications (13 of 16), escalation of care to ICU (10 of 16), and management of nonrespiratory issues (8 of 16) and goals of care (12 of 16). Fifteen of 16 participants strongly agreed or agreed that the COVID-19 Tele-Huddle Program improved their knowledge and confidence in managing patients. One participant commented, “Getting interdisciplinary help on COVID patients has really helped our team feel confident in our decisions about some of these very complex patients.” Another respondent commented, “Reliability was very helpful for planning how to discuss updates with our patients rather than the formal consultative process.”
Discussion
During the unprecedented COVID-19 pandemic, health care systems have been challenged to manage a large volume of patients, often with high disease severity, in non-ICU settings. This surge in cases has placed strain on hospital medicine teams. There is a subset of patients with COVID-19 with high disease severity that may be managed safely by hospital medicine teams, provided the accessibility and support of consultants, such as PCCM faculty and clinical pharmacists.
Huddles are defined as functional groups of people focused on enhancing communication and care coordination to benefit patient safety. While often brief in nature, huddles can encompass a variety of structures, agendas, and outcome measures.6,7 We implemented a modified huddle using video conferencing to provide important aspects of critical care for patients with COVID-19. Face-to-face evaluation of about 15 patients each day would have strained an already burdened PCCM faculty who were providing additional critical care services as part of the surge response. Conversion of in-person consultations to the COVID-19 Tele-Huddle Program allowed for mitigation of COVID-19 transmission risk for additional clinicians, conservation of personal protective equipment, and more effective communication between acute inpatient practitioners and clinical services. The huddle model expedited the authorization and delivery of therapeutics, including remdesivir, which was prescribed for many patients discussed. Clinical pharmacists provided a review of all medications with input on escalation, de-escalation, dosing, drug-drug interactions, and emergency use authorization therapies.
Our experience resonates with previously described advantages of a huddle model, including the reliability of the consultation, empowerment for all members with a de-emphasis on hierarchy and accountability expected by all.8 The huddle provided situational awareness about patients that may require escalation of care to the ICU and/or further goals of care conversations. Assistance with these transitions of care was highly appreciated by the hospital medicine teams who voiced that these decisions were quite challenging. COVID-19 patients at risk for decompensation were referred for in-person consultation and follow-up if required.
addition, the COVID-19 Tele-Huddle Program allowed for a safe and dependable venue for IM trainees and attending physicians to voice questions and concerns about their patients. We observed the development of a shared mental model among all huddle participants, in the face of a steep learning curve on the management of patients with complex respiratory needs. This was reflected in the survey: Most respondents reported improved knowledge and confidence in managing these patients. Situational awareness that arose from the huddle provided the PCCM faculty the opportunity to guide the inpatient ward teams on next steps whether it be escalation to the ICU and/or further goals of care conversations. Facilitation of transitions of care were voiced as challenging decisions faced by the inpatient ward teams, and there was appreciation for additional support from the PCCM faculty in making these difficult decisions.
Challenges and Opportunities
This was a single-center experience caring for veterans. Challenges with having virtual huddles during the COVID-19 surge involved both time for the health care practitioners and technology. This was recognized early by the educational leaders at our facility, and headsets and cameras were purchased for the team rooms and made available as quickly as possible. Another limitation was the unpredictability and variability of patient volume for specific teams that sometimes would affect the efficiency of the huddle. The number of teams who attended the COVID-19 huddle was highest for the first 2 weeks (maximum of 9 teams) but declined to a nadir of 3 at the end of the month. This reflected the increase in knowledge about COVID-19 and respiratory disease that the teams acquired initially as well as a decline in COVID-19 patient admissions over those weeks.
The COVID-19 Tele-Huddle Program model also can be expanded to include other frontline clinicians, including nurses and respiratory therapists. For example, case management huddles were performed in a similar way during the COVID-19 surge to allow for efficient and effective multidisciplinary conversations about patients
Conclusions
Given the rise of telemedicine and availability of video conferencing services, virtual huddles can be implemented in institutions with appropriate staff and remote access to health records. Multidisciplinary consultation services using video conferencing can serve as an adjunct to the traditional, in-person consultation service model for patients with complex needs.
Acknowledgments
The authors acknowledge all of the Baylor Internal Medicine house staff and internal medicine attendings who participated in our huddle and more importantly, cared for our veterans during this COVID-19 surge.
The COVID-19 pandemic challenged hospital medicine teams to care for patients with complex respiratory needs, comply with evolving protocols, and remain abreast of new therapies.1,2 Pulmonary and critical care medicine (PCCM) faculty grappled with similar issues, acknowledging that their critical care expertise could be beneficial outside of the intensive care unit (ICU). Clinical pharmacists managed the procurement, allocation, and monitoring of complex (and sometimes limited) pharmacologic therapies. Although strategies used by health care systems to prepare and restructure for COVID-19 are reported, processes to enhance multidisciplinary care are limited.3,4 Therefore, we developed the COVID-19 Tele-Huddle Program using video conference to support hospital medicine teams caring for patients with COVID-19 and high disease severity.
Program Description
The Michael E. DeBakey Veterans Affairs Medical Center (MEDVAMC) in Houston, Texas, is a 349-bed, level 1A federal health care facility serving more than 113,000 veterans in southeast Texas.5 The COVID-19 Tele-Huddle Program took place over a 4-week period from July 6 to August 2, 2020. By the end of the 4-week period, there was a decline in the number of COVID patient admissions and thus the need for the huddle. Participation in the huddle also declined, likely reflecting the end of the surge and an increase in knowledge about COVID management acquired by the teams. Each COVID-19 Tele-Huddle Program consultation session consisted of at least 1 member from each hospital medicine team, 1 to 2 PCCM faculty members, and 1 to 2 clinical pharmacy specialists (Figure). The consultation team members included 4 PCCM faculty members and 2 clinical pharmacy specialists. The internal medicine (IM) participants included 10 ward teams with a total of 20 interns (PGY1), 12 upper-level residents (PGY2 and PGY 3), and 10 attending physicians.
The COVID-19 Tele-Huddle Program was a daily (including weekends) video conference. The hospital medicine team members joined the huddle from team workrooms, using webcams supplied by the MEDVAMC information technology department. The COVID-19 Tele-Huddle Program consultation team members joined remotely. Each hospital medicine team joined the huddle at a pre-assigned 15- to 30-minute time allotment, which varied based on patient volume. Participation in the huddle was mandatory for the first week and became optional thereafter. This was in recognition of the steep learning curve and provided the teams both basic knowledge of COVID management and a shared understanding of when a multidisciplinary consultation would be critical. Mandatory daily participation was challenging due to the pressures of patient volume during the surge.
COVID-19 patients with high disease severity were discussed during huddles based on specific criteria: all newly admitted COVID-19 patients, patients requiring step-down level of care, those with increasing oxygen requirements, and/or patients requiring authorization of remdesivir therapy, which required clinical pharmacy authorization at MEDVAMC. The hospital medicine teams reported the patients’ oxygen requirements, comorbid medical conditions, current and prior therapies, fluid status, and relevant laboratory values. A dashboard using the Premier Inc. TheraDoc clinical decision support system was developed to display patient vital signs, laboratory values, and medications. The PCCM faculty and clinical pharmacists listened to inpatient medicine teams presentations and used the dashboard and radiographic images to formulate clinical decisions. Discussion of a patient at the huddle did not preclude in-person consultation at any time.
Tele-Huddles were not recorded, and all protected health information discussed was accessed through the electronic health record using a secure network. Data on length of the meeting, number of patients discussed, and management decisions were recorded daily in a spreadsheet. At the end of the 4-week surge, participants in the program completed a survey, which assessed participant demographics, prior experience with COVID-19, and satisfaction with the program based on a series of agree/disagree questions.
Program Metrics
During the COVID-19 Tele-Huddle Program 4-week evaluation period, 323 encounters were discussed with 117 unique patients with COVID-19. A median (IQR) of 5 (4-8) hospital medicine teams discussed 15 (9-18) patients. The COVID-19 Tele-Huddle Program lasted a median (IQR) 74 (53-94) minutes. A mean (SD) 27% (13) of patients with COVID-19 admitted to the acute care services were discussed.
The multidisciplinary team provided 247 chest X-ray interpretations, 82 diagnostic recommendations, 206 therapeutic recommendations, and 32 transition of care recommendations (Table 1). A total of 55 (47%) patients were given remdesivir with first dose authorized by clinical pharmacy and given within a median (IQR) 6 (3-10) hours after the order was placed. Oxygen therapy, including titration and de-escalation of high-flow nasal cannula and noninvasive positive pressure ventilation (NIPPV), was used for 26 (22.2%) patients. Additional interventions included the review of imaging, the assessment of volume status to guide diuretic recommendations, and the discussion of goals of care.
Of the participating IM trainees and attendings, 16 of 37 (43%) completed the user survey (Table 2). Prior experience with COVID-19 patients varied, with 7 of 16 respondents indicating experience with ≥ 5 patients with COVID-19 prior to the intervention period. Respondents believed that the huddle was helpful in management of respiratory issues (13 of 16), management of medications (13 of 16), escalation of care to ICU (10 of 16), and management of nonrespiratory issues (8 of 16) and goals of care (12 of 16). Fifteen of 16 participants strongly agreed or agreed that the COVID-19 Tele-Huddle Program improved their knowledge and confidence in managing patients. One participant commented, “Getting interdisciplinary help on COVID patients has really helped our team feel confident in our decisions about some of these very complex patients.” Another respondent commented, “Reliability was very helpful for planning how to discuss updates with our patients rather than the formal consultative process.”
Discussion
During the unprecedented COVID-19 pandemic, health care systems have been challenged to manage a large volume of patients, often with high disease severity, in non-ICU settings. This surge in cases has placed strain on hospital medicine teams. There is a subset of patients with COVID-19 with high disease severity that may be managed safely by hospital medicine teams, provided the accessibility and support of consultants, such as PCCM faculty and clinical pharmacists.
Huddles are defined as functional groups of people focused on enhancing communication and care coordination to benefit patient safety. While often brief in nature, huddles can encompass a variety of structures, agendas, and outcome measures.6,7 We implemented a modified huddle using video conferencing to provide important aspects of critical care for patients with COVID-19. Face-to-face evaluation of about 15 patients each day would have strained an already burdened PCCM faculty who were providing additional critical care services as part of the surge response. Conversion of in-person consultations to the COVID-19 Tele-Huddle Program allowed for mitigation of COVID-19 transmission risk for additional clinicians, conservation of personal protective equipment, and more effective communication between acute inpatient practitioners and clinical services. The huddle model expedited the authorization and delivery of therapeutics, including remdesivir, which was prescribed for many patients discussed. Clinical pharmacists provided a review of all medications with input on escalation, de-escalation, dosing, drug-drug interactions, and emergency use authorization therapies.
Our experience resonates with previously described advantages of a huddle model, including the reliability of the consultation, empowerment for all members with a de-emphasis on hierarchy and accountability expected by all.8 The huddle provided situational awareness about patients that may require escalation of care to the ICU and/or further goals of care conversations. Assistance with these transitions of care was highly appreciated by the hospital medicine teams who voiced that these decisions were quite challenging. COVID-19 patients at risk for decompensation were referred for in-person consultation and follow-up if required.
addition, the COVID-19 Tele-Huddle Program allowed for a safe and dependable venue for IM trainees and attending physicians to voice questions and concerns about their patients. We observed the development of a shared mental model among all huddle participants, in the face of a steep learning curve on the management of patients with complex respiratory needs. This was reflected in the survey: Most respondents reported improved knowledge and confidence in managing these patients. Situational awareness that arose from the huddle provided the PCCM faculty the opportunity to guide the inpatient ward teams on next steps whether it be escalation to the ICU and/or further goals of care conversations. Facilitation of transitions of care were voiced as challenging decisions faced by the inpatient ward teams, and there was appreciation for additional support from the PCCM faculty in making these difficult decisions.
Challenges and Opportunities
This was a single-center experience caring for veterans. Challenges with having virtual huddles during the COVID-19 surge involved both time for the health care practitioners and technology. This was recognized early by the educational leaders at our facility, and headsets and cameras were purchased for the team rooms and made available as quickly as possible. Another limitation was the unpredictability and variability of patient volume for specific teams that sometimes would affect the efficiency of the huddle. The number of teams who attended the COVID-19 huddle was highest for the first 2 weeks (maximum of 9 teams) but declined to a nadir of 3 at the end of the month. This reflected the increase in knowledge about COVID-19 and respiratory disease that the teams acquired initially as well as a decline in COVID-19 patient admissions over those weeks.
The COVID-19 Tele-Huddle Program model also can be expanded to include other frontline clinicians, including nurses and respiratory therapists. For example, case management huddles were performed in a similar way during the COVID-19 surge to allow for efficient and effective multidisciplinary conversations about patients
Conclusions
Given the rise of telemedicine and availability of video conferencing services, virtual huddles can be implemented in institutions with appropriate staff and remote access to health records. Multidisciplinary consultation services using video conferencing can serve as an adjunct to the traditional, in-person consultation service model for patients with complex needs.
Acknowledgments
The authors acknowledge all of the Baylor Internal Medicine house staff and internal medicine attendings who participated in our huddle and more importantly, cared for our veterans during this COVID-19 surge.
1. Heymann DL, Shindo N; WHO Scientific and Technical Advisory Group for Infectious Hazards. COVID-19: what is next for public health?. Lancet. 2020;395(10224):542-545. doi:10.1016/S0140-6736(20)30374-3
2. Dichter JR, Kanter RK, Dries D, et al; Task Force for Mass Critical Care. System-level planning, coordination, and communication: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement. Chest. 2014;146(suppl 4):e87S-e102S. doi:10.1378/chest.14-0738
3. Chowdhury JM, Patel M, Zheng M, Abramian O, Criner GJ. Mobilization and preparation of a large urban academic center during the COVID-19 pandemic. Ann Am Thorac Soc. 2020;17(8):922-925. doi:10.1513/AnnalsATS.202003-259PS
4. Uppal A, Silvestri DM, Siegler M, et al. Critical care and emergency department response at the epicenter of the COVID-19 pandemic. Health Aff (Millwood). 2020;39(8):1443-1449. doi:10.1377/hlthaff.2020.00901
5. US Department of Veterans Affairs. Michael E. DeBakey VA Medical Center- Houston, Texas. Accessed December 10, 2020. https://www.houston.va.gov/about
6. Provost SM, Lanham HJ, Leykum LK, McDaniel RR Jr, Pugh J. Health care huddles: managing complexity to achieve high reliability. Health Care Manage Rev. 2015;40(1):2-12. doi:10.1097/HMR.0000000000000009
7. Franklin BJ, Gandhi TK, Bates DW, et al. Impact of multidisciplinary team huddles on patient safety: a systematic review and proposed taxonomy. BMJ Qual Saf. 2020;29(10):1-2. doi:10.1136/bmjqs-2019-009911
8. Goldenhar LM, Brady PW, Sutcliffe KM, Muething SE. Huddling for high reliability and situation awareness. BMJ Qual Saf. 2013;22(11):899-906. doi:10.1136/bmjqs-2012-001467
1. Heymann DL, Shindo N; WHO Scientific and Technical Advisory Group for Infectious Hazards. COVID-19: what is next for public health?. Lancet. 2020;395(10224):542-545. doi:10.1016/S0140-6736(20)30374-3
2. Dichter JR, Kanter RK, Dries D, et al; Task Force for Mass Critical Care. System-level planning, coordination, and communication: care of the critically ill and injured during pandemics and disasters: CHEST consensus statement. Chest. 2014;146(suppl 4):e87S-e102S. doi:10.1378/chest.14-0738
3. Chowdhury JM, Patel M, Zheng M, Abramian O, Criner GJ. Mobilization and preparation of a large urban academic center during the COVID-19 pandemic. Ann Am Thorac Soc. 2020;17(8):922-925. doi:10.1513/AnnalsATS.202003-259PS
4. Uppal A, Silvestri DM, Siegler M, et al. Critical care and emergency department response at the epicenter of the COVID-19 pandemic. Health Aff (Millwood). 2020;39(8):1443-1449. doi:10.1377/hlthaff.2020.00901
5. US Department of Veterans Affairs. Michael E. DeBakey VA Medical Center- Houston, Texas. Accessed December 10, 2020. https://www.houston.va.gov/about
6. Provost SM, Lanham HJ, Leykum LK, McDaniel RR Jr, Pugh J. Health care huddles: managing complexity to achieve high reliability. Health Care Manage Rev. 2015;40(1):2-12. doi:10.1097/HMR.0000000000000009
7. Franklin BJ, Gandhi TK, Bates DW, et al. Impact of multidisciplinary team huddles on patient safety: a systematic review and proposed taxonomy. BMJ Qual Saf. 2020;29(10):1-2. doi:10.1136/bmjqs-2019-009911
8. Goldenhar LM, Brady PW, Sutcliffe KM, Muething SE. Huddling for high reliability and situation awareness. BMJ Qual Saf. 2013;22(11):899-906. doi:10.1136/bmjqs-2012-001467