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In Case You Missed It: COVID
MIS-C follow-up proves challenging across pediatric hospitals
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
Dining restrictions, mask mandates tied to less illness, death, CDC reaffirms
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care clinicians neglect hearing loss, survey finds
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
Routine vaccinations missed by older adults during pandemic
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
FROM MMWR
BMI, age, and sex affect COVID-19 vaccine antibody response
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The Physician Support Line: One psychiatrist strives to make a difference
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
ACIP recommendations for COVID-19 vaccines—and more
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
AT PRESS TIME
The US Food and Drug Administration issued an Emergency Use Authorization for a third COVID-19 vaccine. The single-dose vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. For more information, go to www.mdedge.com/familymedicine
Study clarifies who gets post–COVID-19 interstitial lung disease
A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.
In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.
Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.
Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.
The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.
“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.
Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”
The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.
The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.
The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.
Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.
The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.
The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”
The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.
The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”
Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.
Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.
A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.
In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.
Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.
Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.
The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.
“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.
Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”
The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.
The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.
The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.
Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.
The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.
The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”
The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.
The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”
Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.
Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.
A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.
In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.
Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.
Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.
The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.
“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.
Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”
The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.
The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.
The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.
Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.
The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.
The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”
The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.
The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”
Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.
Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.
FROM ANNALS OF THE AMERICAN THORACIC SOCIETY
Decline in children’s COVID-19 cases slows
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.
The number of new COVID-19 cases in children declined for the sixth consecutive week, but the drop was the smallest yet, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That drop of almost 6,400 cases, or 9.0%, falls short of the declines recorded in any the previous 5 weeks, which ranged from 18,000 to 46,000 cases and 15.3% to 28.7%, based on data from the heath departments of 49 states (excluding New York), as well as the District of Columbia, New York City, Puerto Rico, and Guam.
The total number of children infected with SARS-CoV-2 is up to almost 3.17 million, which represents 13.1% of cases among all age groups. That cumulative proportion was unchanged from the previous week, which has occurred only three other times over the course of the pandemic, the AAP and CHA said in their weekly COVID-19 report.
Despite the 6-week decline in new cases, however, the cumulative rate continued to climb, rising from 4,124 cases per 100,000 children to 4,209 for the week of Feb. 19-25. The states, not surprisingly, fall on both sides of that national tally. The lowest rates can be found in Hawaii (1,040 per 100,000 children), Vermont (2,111 per 100,000), and Maine (2,394), while the highest rates were recorded in North Dakota (8,580), Tennessee (7,851), and Rhode Island (7,223), the AAP and CHA said.
The number of new child deaths, nine, stayed in single digits for a second consecutive week, although it was up from six deaths reported a week earlier. Total COVID-19–related deaths in children now number 256, which represents just 0.06% of coronavirus deaths for all ages among the 43 states (along with New York City and Guam) reporting such data.
Among those jurisdictions, Texas (40), Arizona (27), and New York City (23) have reported the most deaths in children, while nine states and the District of Columbia have reported no deaths yet, the AAP and CHA noted.
Armpit swelling after COVID-19 vaccine may mimic breast cancer
Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.
“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.
“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.
In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”
They hope they will decrease unnecessary biopsies and help reassure patients.
Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.
“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.
“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”
Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.
“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
New recommendations from SBI
The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.
“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.
“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.
In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.
“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”
If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
Differences between the vaccines?
The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.
For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.
For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.
The average duration of adenopathy was approximately 10 days.
Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.
However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.
In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.
In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.
The authors and Dr. Leung have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.
“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.
“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.
In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”
They hope they will decrease unnecessary biopsies and help reassure patients.
Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.
“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.
“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”
Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.
“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
New recommendations from SBI
The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.
“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.
“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.
In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.
“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”
If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
Differences between the vaccines?
The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.
For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.
For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.
The average duration of adenopathy was approximately 10 days.
Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.
However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.
In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.
In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.
The authors and Dr. Leung have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Clinicians should therefore consider recent COVID-19 vaccination history in the differential diagnosis of patients who present with unilateral axillary adenopathy, according to a new article.
“We noticed an increasing number of patients with swollen lymph nodes on just one side/one underarm who presented for routine screening mammography or ultrasound, and some women who actually felt these swollen nodes,” said author Katerina Dodelzon, MD, assistant professor of clinical radiology at Weill Cornell Medicine, New York.
“Historically, swollen lymph nodes on just one side are relatively rare and are an uncommon occurrence on screening mammography – seen only 0.02%-0.04% of the time – and is a sign that alerts a radiologist to exclude the presence of breast malignancy on that side,” she added.
In an article published in Clinical Imaging, Dr. Dodelzon and colleagues described four cases involving women who received a COVID-19 vaccine and then sought breast screening. In describing these cases, the authors sought “to inform the medical community to consider this benign and self-resolving diagnosis in the setting of what can be alarming presentation of unilateral axillary adenopathy.”
They hope they will decrease unnecessary biopsies and help reassure patients.
Adenopathy has been reported in association with other vaccines, such as the bacille Calmette-Guérin vaccine, influenza vaccines, and the human papillomavirus vaccine, commented Jessica W. T. Leung, MD, president of the Society of Breast Imaging.
“It’s too early to say if there is something different about the COVID-19 vaccines,” said Dr. Leung, who is also professor of diagnostic radiology and deputy chair of breast imaging at the University of Texas MD Anderson Cancer Center, Houston.
“The two vaccines that are currently in use – Pfizer and Moderna – are both mRNA vaccines, and it is unknown if those will give a stronger immune response,” she said. “If the Johnson & Johnson and AstraZeneca vaccines do become available, it will be interesting to see if they elicit as strong a response, since they are not mRNA vaccines. At this time, we have no data to say one way or the other.”
Dr. Leung also noted that these latest vaccine reactions may be getting more attention because “it is COVID-19 related, and everything related to COVID-19 gets more attention.
“It may also be more noticeable because of the large number of people getting vaccinated within a short period of time in an effort to contain the pandemic, and this is not the case with the other vaccines,” she said.
New recommendations from SBI
The SBI recently issued recommendations to clinicians that women who experience axillary adenopathy and who have recently been vaccinated on the same side on which the adenopathy occurs be followed for a few weeks to see whether the lymph nodes return to normal, rather than undergo biopsy.
“Many practices are now routinely inquiring about history of recent vaccination and on which side it was given,” Dr. Dodelzon said. She emphasized that women should feel empowered to share that history if they are not asked.
“Letting your mammography technologist or breast imager know that you have recently been vaccinated, and on which side, will provide the breast imager more accurate context within which to interpret the results,” she said.
In addition, the SBI recommends that, if feasible, women schedule routine screening mammography either before the first dose of the COVID-19 vaccine or 4-6 weeks after the second dose to avoid a false-positive finding.
“We want to emphasize that screening mammography is very important, and if possible, to schedule it around the vaccine,” commented Dr. Leung. “But that may not be possible, as most of us don’t have a choice when to get the vaccine.”
If it is not possible to reschedule either the mammogram or the vaccine, Dr. Leung recommends that women inform the facility that they have recently received a COVID-19 vaccine. “Currently, we recommend a follow-up in 4-12 weeks,” she said. “The swelling could subside sooner, perhaps even within 1-2 weeks, but we generally recommend waiting at least 4 weeks to capture the majority of women.”
Differences between the vaccines?
The frequency with which axillary adenopathy occurs as a side effect differs with the two COVID-19 vaccines, according to reports from the Centers for Disease Control and Prevention.
For the Moderna vaccine, axillary adenopathy ipsilateral to the vaccination arm was the second most frequently reported local reaction, with 11.6% of recipients aged 18-64 years reporting it after the first dose, and 16.0% reporting it after the second. The average duration of this adenopathy was 1-2 days.
For the Pfizer-BioNTech COVID-19 vaccine, the CDC notes that reports of adenopathy were imbalanced between the vaccine and placebo groups and concluded that adenopathy was plausibly related to the vaccine.
The average duration of adenopathy was approximately 10 days.
Adenopathy was reported within 2-4 days after vaccination for both vaccine groups, the CDC noted.
However, details from the cases reported by Dr. Dodelzon and colleagues paint a somewhat different picture. For example, in case 1, the patient self-detected unilateral axillary adenopathy 9 days after receiving the first dose of the Pfizer-BioNTech vaccine. In case 3, the time between receiving the Moderna vaccine and detection of adenopathy was 13 days.
In both of these cases, the time was much longer than the average duration of 1-2 days noted by the CDC. The authors suggest that in taking the patient’s vaccination history, radiologists understand that the side effect may occur up to several weeks following the COVID-19 vaccination.
In cases 2 and 4, the axillary adenopathy was incidentally noted during mammography, so it is unclear when the onset of this reaction occurred after receiving the COVID-19 vaccine.
The authors and Dr. Leung have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.