I arrived on the 6th floor nursing unit one day last fall to find halls abuzz with people. Something didn’t feel right, and then I a saw a nursing colleague with tears streaming down her face. My heart dropped. She looked up at me and said, “Dr Hass, K died last night.” She started to sob. I stood dumbfounded for a moment. We had lost a beloved coworker to COVID.

There has been a collective sense of grief in our country since the beginning of the COVID-19 pandemic as we have all been suffering losses: smiles, touch, in-person relationships, a “normal life.” But it went to another level for us at Alta Bates Summit Medical Center in Oakland, Calif., with the passing of a couple of our beloved teammates in the fall. Strong emotions triggered by these events caused me to pause and think: “What is grief? Is it another word for sadness? How do we work through it?”

What is the difference between sadness and grief? While related, they are temporally and functionally quite different. Sadness is an emotion, and like all emotions, we feel it in brief episodes. Those moments of profound sadness only last minutes at a time. Sadness leads to decreased physiological arousal, especially after crying. When less intense, the physiological slowing is thought to allow for some mental clarity that lets the loss sink in and moves us toward a recalibration process. These episodes of sadness occur more frequently and with greater intensity the closer we are to the triggering event.

While emotions last minutes, mood, another affective state, lasts hours to days and is less intense and specific in content. A sad mood can be present much of the time after a significant loss. Emotions predispose to moods and vice versa.

Grief, on the other hand, is a complex and lengthy process that moves us from a place of loss to a new place with a new equilibrium without the lost object. While sadness is about fully acknowledging the loss, the grieving process is about getting beyond it. The bigger the loss, the bigger the hole in your life and the longer the grieving process. Grief is a multi-emotional process with people often experiencing a range of emotions, such as shock, anger, and fear in addition to sadness.

As I grappled with my sense of loss, I realized that understanding the grieving process was going to help me as I navigate this world now full of loss. Here are a few things we should all keep in mind.
 

A sense of mindful self-awareness

As we work through our grief, a mindful self-awareness can help us identify our emotions and see them as part of the grieving process. Simply anticipating emotions can lessen the impact of them when they come. As they come on, try to name the emotion, e.g., “I am so sad,” and feel the experience in the body. The sadness can be cathartic, and by focusing on the body and not the head, we can also drop the sometimes healthy, sometimes unhealthy rants and ruminations that can accompany these events. If we experience the emotions with mindful self-awareness, we can see our emotions as part of a healing, grieving process, and we will likely be able to handle them more gracefully.

In the days after the death of my nursing colleague, my sad mood would be interrupted with flares of anger triggered by thoughts of those not wearing masks or spreading misinformation. Moving my thoughts to the emotions, I would say to myself, “I am really angry, and I am angry because of these deaths.” I felt the recognition of the emotions helped me better ride the big waves on the grieving journey.

Counter to the thinking of the 20th century, research by George Bonanno at Columbia University found that the majority of bereavement is met with resilience. We will be sad, we might have moments of anger or denial or fear, but for most of us, despite the gravity of the loss, our innate resilience will lead about 50-80% of us to recover to near our baseline in months. It is nice to know we are not repressing things if we don’t pass through all the stages postulated by Elizabeth Kubler-Ross, the dominate paradigm in the field.¹

For those grieving, this idea of resilience being the norm can provide reassurance during tough moments. While our degree of resilience will depend on our loss and our circumstance, the work of Lucy Hone, PhD, suggests that resilience can be fostered. Many of the negative feelings we experience have a flip side we can seek out. We can be grateful for what remains and what the departed has left us with. We can aid in our grieving journey by using many of the resources available from UC Berkeley’s Greater Good in Action (https://ggia.berkeley.edu/).

While most grief is met with resilience, complicated grieving with persistent negative moods and emotions is common. We should consider seeking professional help if our emotions and pattern of thought continue to feel unhealthy.
 

Meaning and wisdom, not acceptance

Another change in our understanding of grief is this: Instead of “acceptance” being seen as the end result of grieving, meaning and wisdom are now recognized as the outcomes. Research has found that efforts to find meaning in loss facilitates the grieving process. As time passes and our sadness lessens, the loved one doesn’t leave us but stays with us as a better understanding of the beauty and complexity of life. The loss, through grieving, is transformed to wisdom that will guide us through future challenges and help us make sense of the world.

Last week, masked and robed and with an iPad in hand so the family could join the conversation, I was talking to Ms. B who is hospitalized with COVID-19. She said, “I just keep thinking, ‘Why is this happening to me? To all of us?’ And then I realized that it is a message from God that we need to do a better job of taking care of each other, and I suddenly felt a little better. What do you think, Dr. Hass?”

“Wow,” I said. “Thank you for sharing that. There is definitely some truth there. There is a lot to learn from the pandemic about how we care for each other. I need to keep that in mind when I start feeling down.”

So much is going on now: climate change, racial violence, frightening political dysfunction, and a global pandemic that has upended our daily routines and the economy. It is hard to keep track of all the loss and uncertainty. We might not know why feelings of sadness, anger and anxiety come on, but if we can meet these emotions with mindful equanimity, see them as part of our intrinsic healing process and keep in mind that our path will likely be towards one of wisdom and sense-making, we can better navigate these profoundly unsettling times.

Just as sadness is not grief, joy alone does not lead to happiness. A happy life comes as much from meaning as joy. While unbridled joy might be in short supply, our grief, our work as hospitalists with the suffering, and confronting the many problems our world faces gives us the opportunity to lead a meaningful life. If we couple this search for meaning with healthy habits that promote wellbeing, such as hugs, investing in relationships, and moving our body in the natural world, we can survive these crazy times and be wiser beings as a result of our experiences.
 

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley-UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Reference

1. Bonanno GA, and Boerner K. The stage theory of grief. JAMA. 2007;297(24):2692-2694. doi:10.1001/jama.297.24.2693-a.

I arrived on the 6th floor nursing unit one day last fall to find halls abuzz with people. Something didn’t feel right, and then I a saw a nursing colleague with tears streaming down her face. My heart dropped. She looked up at me and said, “Dr Hass, K died last night.” She started to sob. I stood dumbfounded for a moment. We had lost a beloved coworker to COVID.

There has been a collective sense of grief in our country since the beginning of the COVID-19 pandemic as we have all been suffering losses: smiles, touch, in-person relationships, a “normal life.” But it went to another level for us at Alta Bates Summit Medical Center in Oakland, Calif., with the passing of a couple of our beloved teammates in the fall. Strong emotions triggered by these events caused me to pause and think: “What is grief? Is it another word for sadness? How do we work through it?”

What is the difference between sadness and grief? While related, they are temporally and functionally quite different. Sadness is an emotion, and like all emotions, we feel it in brief episodes. Those moments of profound sadness only last minutes at a time. Sadness leads to decreased physiological arousal, especially after crying. When less intense, the physiological slowing is thought to allow for some mental clarity that lets the loss sink in and moves us toward a recalibration process. These episodes of sadness occur more frequently and with greater intensity the closer we are to the triggering event.

While emotions last minutes, mood, another affective state, lasts hours to days and is less intense and specific in content. A sad mood can be present much of the time after a significant loss. Emotions predispose to moods and vice versa.

Grief, on the other hand, is a complex and lengthy process that moves us from a place of loss to a new place with a new equilibrium without the lost object. While sadness is about fully acknowledging the loss, the grieving process is about getting beyond it. The bigger the loss, the bigger the hole in your life and the longer the grieving process. Grief is a multi-emotional process with people often experiencing a range of emotions, such as shock, anger, and fear in addition to sadness.

As I grappled with my sense of loss, I realized that understanding the grieving process was going to help me as I navigate this world now full of loss. Here are a few things we should all keep in mind.
 

A sense of mindful self-awareness

As we work through our grief, a mindful self-awareness can help us identify our emotions and see them as part of the grieving process. Simply anticipating emotions can lessen the impact of them when they come. As they come on, try to name the emotion, e.g., “I am so sad,” and feel the experience in the body. The sadness can be cathartic, and by focusing on the body and not the head, we can also drop the sometimes healthy, sometimes unhealthy rants and ruminations that can accompany these events. If we experience the emotions with mindful self-awareness, we can see our emotions as part of a healing, grieving process, and we will likely be able to handle them more gracefully.

In the days after the death of my nursing colleague, my sad mood would be interrupted with flares of anger triggered by thoughts of those not wearing masks or spreading misinformation. Moving my thoughts to the emotions, I would say to myself, “I am really angry, and I am angry because of these deaths.” I felt the recognition of the emotions helped me better ride the big waves on the grieving journey.

Counter to the thinking of the 20th century, research by George Bonanno at Columbia University found that the majority of bereavement is met with resilience. We will be sad, we might have moments of anger or denial or fear, but for most of us, despite the gravity of the loss, our innate resilience will lead about 50-80% of us to recover to near our baseline in months. It is nice to know we are not repressing things if we don’t pass through all the stages postulated by Elizabeth Kubler-Ross, the dominate paradigm in the field.¹

For those grieving, this idea of resilience being the norm can provide reassurance during tough moments. While our degree of resilience will depend on our loss and our circumstance, the work of Lucy Hone, PhD, suggests that resilience can be fostered. Many of the negative feelings we experience have a flip side we can seek out. We can be grateful for what remains and what the departed has left us with. We can aid in our grieving journey by using many of the resources available from UC Berkeley’s Greater Good in Action (https://ggia.berkeley.edu/).

While most grief is met with resilience, complicated grieving with persistent negative moods and emotions is common. We should consider seeking professional help if our emotions and pattern of thought continue to feel unhealthy.
 

Meaning and wisdom, not acceptance

Another change in our understanding of grief is this: Instead of “acceptance” being seen as the end result of grieving, meaning and wisdom are now recognized as the outcomes. Research has found that efforts to find meaning in loss facilitates the grieving process. As time passes and our sadness lessens, the loved one doesn’t leave us but stays with us as a better understanding of the beauty and complexity of life. The loss, through grieving, is transformed to wisdom that will guide us through future challenges and help us make sense of the world.

Last week, masked and robed and with an iPad in hand so the family could join the conversation, I was talking to Ms. B who is hospitalized with COVID-19. She said, “I just keep thinking, ‘Why is this happening to me? To all of us?’ And then I realized that it is a message from God that we need to do a better job of taking care of each other, and I suddenly felt a little better. What do you think, Dr. Hass?”

“Wow,” I said. “Thank you for sharing that. There is definitely some truth there. There is a lot to learn from the pandemic about how we care for each other. I need to keep that in mind when I start feeling down.”

So much is going on now: climate change, racial violence, frightening political dysfunction, and a global pandemic that has upended our daily routines and the economy. It is hard to keep track of all the loss and uncertainty. We might not know why feelings of sadness, anger and anxiety come on, but if we can meet these emotions with mindful equanimity, see them as part of our intrinsic healing process and keep in mind that our path will likely be towards one of wisdom and sense-making, we can better navigate these profoundly unsettling times.

Just as sadness is not grief, joy alone does not lead to happiness. A happy life comes as much from meaning as joy. While unbridled joy might be in short supply, our grief, our work as hospitalists with the suffering, and confronting the many problems our world faces gives us the opportunity to lead a meaningful life. If we couple this search for meaning with healthy habits that promote wellbeing, such as hugs, investing in relationships, and moving our body in the natural world, we can survive these crazy times and be wiser beings as a result of our experiences.
 

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley-UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Reference

1. Bonanno GA, and Boerner K. The stage theory of grief. JAMA. 2007;297(24):2692-2694. doi:10.1001/jama.297.24.2693-a.

I arrived on the 6th floor nursing unit one day last fall to find halls abuzz with people. Something didn’t feel right, and then I a saw a nursing colleague with tears streaming down her face. My heart dropped. She looked up at me and said, “Dr Hass, K died last night.” She started to sob. I stood dumbfounded for a moment. We had lost a beloved coworker to COVID.

There has been a collective sense of grief in our country since the beginning of the COVID-19 pandemic as we have all been suffering losses: smiles, touch, in-person relationships, a “normal life.” But it went to another level for us at Alta Bates Summit Medical Center in Oakland, Calif., with the passing of a couple of our beloved teammates in the fall. Strong emotions triggered by these events caused me to pause and think: “What is grief? Is it another word for sadness? How do we work through it?”

What is the difference between sadness and grief? While related, they are temporally and functionally quite different. Sadness is an emotion, and like all emotions, we feel it in brief episodes. Those moments of profound sadness only last minutes at a time. Sadness leads to decreased physiological arousal, especially after crying. When less intense, the physiological slowing is thought to allow for some mental clarity that lets the loss sink in and moves us toward a recalibration process. These episodes of sadness occur more frequently and with greater intensity the closer we are to the triggering event.

While emotions last minutes, mood, another affective state, lasts hours to days and is less intense and specific in content. A sad mood can be present much of the time after a significant loss. Emotions predispose to moods and vice versa.

Grief, on the other hand, is a complex and lengthy process that moves us from a place of loss to a new place with a new equilibrium without the lost object. While sadness is about fully acknowledging the loss, the grieving process is about getting beyond it. The bigger the loss, the bigger the hole in your life and the longer the grieving process. Grief is a multi-emotional process with people often experiencing a range of emotions, such as shock, anger, and fear in addition to sadness.

As I grappled with my sense of loss, I realized that understanding the grieving process was going to help me as I navigate this world now full of loss. Here are a few things we should all keep in mind.
 

A sense of mindful self-awareness

As we work through our grief, a mindful self-awareness can help us identify our emotions and see them as part of the grieving process. Simply anticipating emotions can lessen the impact of them when they come. As they come on, try to name the emotion, e.g., “I am so sad,” and feel the experience in the body. The sadness can be cathartic, and by focusing on the body and not the head, we can also drop the sometimes healthy, sometimes unhealthy rants and ruminations that can accompany these events. If we experience the emotions with mindful self-awareness, we can see our emotions as part of a healing, grieving process, and we will likely be able to handle them more gracefully.

In the days after the death of my nursing colleague, my sad mood would be interrupted with flares of anger triggered by thoughts of those not wearing masks or spreading misinformation. Moving my thoughts to the emotions, I would say to myself, “I am really angry, and I am angry because of these deaths.” I felt the recognition of the emotions helped me better ride the big waves on the grieving journey.

Counter to the thinking of the 20th century, research by George Bonanno at Columbia University found that the majority of bereavement is met with resilience. We will be sad, we might have moments of anger or denial or fear, but for most of us, despite the gravity of the loss, our innate resilience will lead about 50-80% of us to recover to near our baseline in months. It is nice to know we are not repressing things if we don’t pass through all the stages postulated by Elizabeth Kubler-Ross, the dominate paradigm in the field.¹

For those grieving, this idea of resilience being the norm can provide reassurance during tough moments. While our degree of resilience will depend on our loss and our circumstance, the work of Lucy Hone, PhD, suggests that resilience can be fostered. Many of the negative feelings we experience have a flip side we can seek out. We can be grateful for what remains and what the departed has left us with. We can aid in our grieving journey by using many of the resources available from UC Berkeley’s Greater Good in Action (https://ggia.berkeley.edu/).

While most grief is met with resilience, complicated grieving with persistent negative moods and emotions is common. We should consider seeking professional help if our emotions and pattern of thought continue to feel unhealthy.
 

Meaning and wisdom, not acceptance

Another change in our understanding of grief is this: Instead of “acceptance” being seen as the end result of grieving, meaning and wisdom are now recognized as the outcomes. Research has found that efforts to find meaning in loss facilitates the grieving process. As time passes and our sadness lessens, the loved one doesn’t leave us but stays with us as a better understanding of the beauty and complexity of life. The loss, through grieving, is transformed to wisdom that will guide us through future challenges and help us make sense of the world.

Last week, masked and robed and with an iPad in hand so the family could join the conversation, I was talking to Ms. B who is hospitalized with COVID-19. She said, “I just keep thinking, ‘Why is this happening to me? To all of us?’ And then I realized that it is a message from God that we need to do a better job of taking care of each other, and I suddenly felt a little better. What do you think, Dr. Hass?”

“Wow,” I said. “Thank you for sharing that. There is definitely some truth there. There is a lot to learn from the pandemic about how we care for each other. I need to keep that in mind when I start feeling down.”

So much is going on now: climate change, racial violence, frightening political dysfunction, and a global pandemic that has upended our daily routines and the economy. It is hard to keep track of all the loss and uncertainty. We might not know why feelings of sadness, anger and anxiety come on, but if we can meet these emotions with mindful equanimity, see them as part of our intrinsic healing process and keep in mind that our path will likely be towards one of wisdom and sense-making, we can better navigate these profoundly unsettling times.

Just as sadness is not grief, joy alone does not lead to happiness. A happy life comes as much from meaning as joy. While unbridled joy might be in short supply, our grief, our work as hospitalists with the suffering, and confronting the many problems our world faces gives us the opportunity to lead a meaningful life. If we couple this search for meaning with healthy habits that promote wellbeing, such as hugs, investing in relationships, and moving our body in the natural world, we can survive these crazy times and be wiser beings as a result of our experiences.
 

Dr. Hass is a hospitalist at Sutter East Bay Medical Group in Oakland, Calif. He is a member of the clinical faculty at the University of California, Berkeley-UC San Francisco joint medical program, and an adviser on health and health care at the Greater Good Science Center at UC Berkeley.

Reference

1. Bonanno GA, and Boerner K. The stage theory of grief. JAMA. 2007;297(24):2692-2694. doi:10.1001/jama.297.24.2693-a.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Giving a COVID-19 vaccine at the same time as a seasonal flu vaccine appears safe and effective in the first study to test how people react to getting both shots at the same time.

Overall, the NVX-CoV2373 vaccine (Novavax) is showing 89.8% efficacy in an ongoing, placebo-controlled phase 3 study. When the researchers gave a smaller group of 431 volunteers from the same study an influenza shot at the same time, efficacy dropped slightly to 87.5%.

“These results demonstrate the promising opportunity for concomitant vaccination, which may lead to higher vaccination rates and further protection against both viruses,” said study coauthor Raja Rajaram, MD, medical affairs lead, Europe, Middle East, and Africa at Seqirus, the company that supplied the influenza vaccines for the research.

The research was published online June 13 as a medRxiv preprint.

“With these COVID-19 vaccines, there are essentially no concurrent use studies,” Paul A. Offit, MD, told this news organization when asked to comment.

Traditionally, how a new vaccine might interact with existing vaccines is studied before the product is cleared for use. That was not the case, however, with the COVID-19 vaccines made available through expedited emergency use authorization.

The researchers found no major safety concerns associated with concomitant vaccination, Dr. Rajaram said. In addition to safety, the aim of the current study was to determine whether either vaccine changes the immunogenicity or effectiveness of the other.

“It’s a small study, but it’s certainly encouraging to know that there didn’t seem to be a big decrease in immunogenicity either way and the safety profile was similar. Not identical, but similar,” added Dr. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Some adverse events were more common in the co-administration group. For example, injection-site tenderness was reported by 70%, versus 58% for those who got the COVID-19 shot alone. The same was true for pain at the injection site, 40% versus 29%; fatigue, 28% versus 19%; and muscle pain, 28% versus 21%.

Rates of unsolicited adverse events, adverse events that required medical attention, and serious adverse events were low and well balanced between groups.
 

Fewer antibodies important?

Although co-administering the two vaccines did not change the immune response for the influenza vaccine, the spike protein antibody response to the COVID-19 vaccine was less robust.

Antibody titer levels at day 35 were 46,678 among people in the Novavax vaccine alone group, compared with 31,236 titers in the participants who received both vaccines.

“This impact did not seem to be clinically meaningful as vaccine efficacy appeared to be preserved,” the researchers noted.

Gregory A. Poland, MD, an internist and part of the Vaccine Research Group at Mayo Clinic in Rochester, Minn., agreed. “I highly doubt that is significant,” he said in an interview.

Dr. Rajaram said the antibody findings are “slightly surprising but not completely unexpected” because the same observation has been made in other combination vaccine studies. He added that the antibody levels “remain very high, although we do not yet know what antibody levels are required to achieve protection against COVID-19.”

The decrease could become more concerning if people start with fewer antibodies and they drop over time with normal waning of protection, Dr. Poland said. This group could include people over age 65 or people who are immunocompromised. More data would be needed to confirm this, he added.
 

A boost for booster vaccines?

The research could carry implications for future COVID-19 booster shots, Dr. Poland said.

“Overall, the study results are reassuring and of potential practical importance if we have to give booster doses. It will make it easier to give them both in one visit,” said Dr. Poland, who was not affiliated with the research.

Although Novavax could be positioning itself as a logical choice for a COVID-19 booster based on the findings, Dr. Offit believes it is more important to focus on having more COVID-19 vaccine options available.

“There may be, as we say at the track, ‘courses for horses,’ ” he said, meaning that different vaccines may be better suited for different situations.

“It’s likely we’re going to find these vaccines have different safety profiles, they may have different populations for whom they work best, and they may have differences in terms of their long-term durability,” he added. Also, some may prove more effective against certain variants of concern.

The Novavax vaccine would add a new class of COVID-19 vaccine to the mRNA and adenovirus vaccines. NVX-CoV2373 is a recombinant spike protein vaccine.

“I think the more vaccines that are available here, the better,” Dr. Offit said.
 

Study limitations

Dr. Poland shared some caveats. The study was primarily conducted in adults aged 18-64 years, so there is less certainty on what could happen in people over 65. Furthermore, co-administration was evaluated after the first dose of the Novavax vaccine. “The reason I bring that up is most of the COVID-19 vaccine reactogenicity occurs with dose two, not dose one.

“All in all, it’s an important first step – but it’s only a first step,” Dr. Poland said. “We need more data, including in elderly people who are primarily at risk for morbidity and mortality from the flu.”

He suggested expanding the research to study co-administration of COVID-19 vaccines with different formulations of influenza vaccines.

The study was supported by Novavax. Dr. Offit had no relevant financial disclosures. Dr. Poland serves as a consultant to all of the COVID-19 vaccine companies.

A version of this article first appeared on Medscape.com.

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

A version of this article first appeared on Medscape.com.

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

A version of this article first appeared on Medscape.com.

Agents that reverse the effect of direct oral anticoagulants (DOACs) are highly effective in patients with severe bleeding, but mortality rates remain high despite their use, a meta-analysis shows.

Effective hemostasis was achieved in 78.5% of patients treated with a reversal agent, whereas failure to achieve hemostasis was associated with more than a threefold higher relative risk for death (relative risk, 3.63; 95% confidence interval, 2.56-5.16).

“This has implications in practice because it emphasizes the need for achieving effective hemostasis, if not with only one agent, trying other agents or treatment modalities, because it is a strong predictor of survival,” lead author Antonio Gómez-Outes, MD, PhD, said in an interview.

The bad news, he said, is that the mortality rate was still significant, at 17.7%, and approximately half of patients with DOAC-related severe intracranial bleeding survived with long-term moderate/severe disability.

“The lesson is to prevent these bleeding events because once they appear, even if you give an antidote, the outcome is poor, particularly for intracranial bleeding,” said Dr. Gómez-Outes, division of pharmacology and clinical drug evaluation, Spanish Agency for Medicines and Medical Devices, Madrid.

To put this in context, mortality rates were close to 50% after intracranial bleeding a decade ago when there were no antidotes or reversal agents, he observed. “So to some extent, patient care has improved, and the outcome has improved, but there is a long road to improve regarding disability.”

More than 100,000 DOAC-related major bleeding cases occur each year in the United States and European Union, Dr. Gómez-Outes said, and about half are severe enough to require hospitalization and potentially the use of a reversal agent. These include idarucizumab (Praxbind) for dabigatran reversal and prothombin complex concentrates (4CCC) or andexanet alpha (Andexxa) for reversal of direct factor Xa inhibitors like rivaroxaban, apixaban, and edoxaban.

As reported in the June 22 issue of the Journal of the American College of Cardiology, the meta-analysis comprised 4,735 patients (mean age, 77 years; 57% male) with severe DOAC-related bleeding who received 4PCC (n = 2,688), idarucizumab (n = 1,111), or andexanet (n = 936) in 60 studies between January 2010 and December 2020.

Atrial fibrillation (AFib) was the most common reason for use of a DOAC (82%), followed by venous thromboembolism (14%). Rivaroxaban was used in 36%, apixaban in 32%, dabigatran in 31%, and edoxaban in 1%.

The index bleeding event was intracranial hemorrhage (ICH) in 55%. Anticoagulation was restarted in 57% of patients an average of 11 days after admission.

Mortality rates were 20.2% in patients with ICH and 15.4% in those with extracranial bleeding. There were no differences in death rates by reversal agent used, type of study, risk for bias, or study sponsorship in meta-regression analysis.

Rebleeding occurred in 13.2% of patients; 82.0% of these events were described as an ICH, and 78.0% occurred after anticoagulation was restarted.

The overall rate of thromboembolism was 4.6%. The risk was particularly high with andexanet, at 10.7%, and relatively low with idarucizumab (3.8%) and 4PCC (4.3%), the authors note.

“Our meta-analysis suggests specific reversal with andexanet is not superior to unspecific reversal with 4PCC, and that’s good news because many centers, in many countries, have no access to specific antidotes that are more costly,” Dr. Gómez-Outes said. “4PCC is an effective and relatively safe drug, so it’s still a good option for these patients.”

Labeling for andexanet includes a warning for thromboembolic events, but in the absence of direct comparisons, the findings should be interpreted with caution, he added. Further insights are expected from an ongoing randomized trial of andexanet and standard of care in 900 patients who present with acute ICH less than 15 hours after taking an oral factor Xa inhibitor. The preliminary completion date is set for 2023.

“The meta-analysis raises awareness about the rates of mortality and thromboembolism after reversal agent administration, although understanding the implications of these data is challenging,” Christopher Granger, MD, and Sean P. Pokomey, MD, MBA, Duke University Medical Center, Durham, N.C., say in an accompanying editorial.

The fact that failure to achieve hemostasis was associated with death is expected and might be related to the way hemostasis was defined, rather than the actual failure of the hemostatic treatments, they suggest. “The prothrombotic effects of each agent, including andexanet, need to be better understood, as clinicians work toward including reversal agents into algorithms for bleeding management.”

Effective hemostasis was defined in the studies through various methods as: “Excellent/good” using the Sarode and ANNEXA-4 scales; “yes” in the International Society on Thrombosis and Hemostasis Scale; and with other scales and through clinical judgment.

Although the size of the meta-analysis dwarfs previous reviews, the editorialists and authors point out that 47 of the 60 studies were retrospective, only two had control groups, and 45 had a high risk for bias.

In general, there was also poor reporting of key clinical data, such as postbleeding anticoagulation management, and a limitation of the mortality analysis is that it was based in selected patients with effective hemostasis assessed within 48 hours, which may not capture early deaths, the authors note.

“The morbidity and mortality from ischemic strokes as a result of undertreatment of stroke prevention in patients with AFib continue to dwarf the bleeding related mortality among patients with AFib and on DOACs, and thus the number one priority is to treat nearly all patients with AFib with a DOAC,” Dr. Granger and Dr. Pokomey conclude. “The availability of reversal agents for DOACs should provide reassurance, with another tool in our armamentarium, to providers to prescribe OACs for stroke prevention.”

No funding/grant support was received to conduct the study. Coauthor Ramón Lecumberri has received personal fees from Boehringer Ingelheim and Bristol Myers Squibb outside the submitted work. All other authors report no relevant financial relationships. Dr. Granger has received research and consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer, Janssen, Boston Scientific, Apple, AstraZeneca, Novartis, AbbVie, Biomed, CeleCor, GSK, Novartis, Medtronic, Merck, Novo Nordisk, Philips, Rho, and the U.S. Food and Drug Administration. Dr. Pokomey has received modest consulting support from Bristol Myers Squibb, Pfizer, Boston Scientific, Medtronic, Janssen, and Zoll; modest research support from Gilead, Boston Scientific, Bristol Myers Squibb, Pfizer, and Janssen; and significant research support from the FDA.

A version of this article first appeared on Medscape.com.

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

Gerald E. Harmon, MD, a family physician in South Carolina whose patients sometimes leave produce in the back of his pickup truck, has practiced medicine during military deployments and during 15-hour shifts in the COVID-19 pandemic.

He has encountered “all manner of unexpected situations” and feels “more than prepared” to serve as president of the American Medical Association, he said.

At the same time, “I still find myself a little nervous about it,” Dr. Harmon said in an interview the day after he was sworn in as president. “I would be less than candid if I didn’t tell you that. I don’t mean intimidated. ... It’s almost like before an athletic event.”

Dr. Harmon was sworn in June 15 as the 176th president of the AMA during the virtual Special Meeting of the AMA House of Delegates. He follows Susan R. Bailey, MD, an allergist from Fort Worth, Tex., in leading the organization, which has more than 270,000 members.
 

Advancing health equity

During his inaugural address, Dr. Harmon discussed the pandemic and the AMA’s plan to advance health equity.

COVID-19 “has revealed enormous gaps in how we care for people and communities in America, demonstrated in the disproportionate impact of this pandemic on communities of color and in the weaknesses of our underfunded and underresourced public health infrastructure,” Dr. Harmon said.

He described medical professionals as being “at war against seemingly formidable adversaries,” including the pandemic, the effects of prolonged isolation on emotional and behavioral health, and political and racial tension. There is an “immense battle to rid our health system – and society – of health disparities and racism,” he said. “As we face these battles, we must remember that our actions as physicians and as leaders will have far-reaching consequences.”

Other challenges before the AMA include vaccinating patients, recovering from the ongoing pandemic, removing unnecessary obstacles to care, ending an epidemic of drug overdoses, improving outcomes for patients with chronic disease, incorporating technology in ways that benefit doctors and patients, and preparing future physicians, Dr. Harmon noted.

“We are going to embed the principles of equity and racial justice within the AMA and throughout our health system,” added Dr. Harmon, who has been an AMA board member since 2013 and served as board chair from 2017 to 2018. He highlighted the AMA’s strategic plan, released in May 2021, to advance health equity and justice and improve the quality of care for people who have been marginalized.

“Meaningful progress won’t happen until we, as doctors, recognize how profoundly systemic racism influences the health of our patients, and until we commit to taking action within our own spheres of influence,” Dr. Harmon said. “As a family doctor in a very diverse state, I have treated people from all backgrounds, and have seen inequities up close, inequities that understandably lead to distrust.”

Commenting in an interview on JAMA’s controversial tweet and podcast related to structural racism from earlier this year that have been deleted and removed from JAMA’s website, Dr. Harmon said, JAMA maintains editorial independence from the AMA, but that direction from a journal oversight committee could lead to changes at the journal that could help prevent similar incidents.

“We’ll support whatever the journal oversight committee suggests,” Dr. Harmon said.

“We had public statements about [the podcast]. I do think that we’ll be able to move very quickly in a stronger direction to address the issue of systemic racism,” Dr. Harmon said. “The AMA has acknowledged that it is a public health threat. We have acknowledged that it is ... a political description versus a biologic construct. So, I would anticipate that you’ll find changes.”

The AMA began developing its strategic plan to advance equity several years ago, Dr. Harmon noted. “I think we are very well poised to move forward and attack this enemy of health disparity.”
 

AAFP president supporting Dr. Harmon’s inauguration

Among those congratulating Dr. Harmon on his inauguration was Ada Stewart, MD, a fellow family physician and South Carolina resident who is the president of the American Academy of Family Physicians.

“We are very excited that family physician Dr. Gerald Harmon will serve as president of the AMA this coming year,” Dr. Stewart said. “Family medicine encompasses the very essence of medicine – treating the whole person, in the context of family, community, and each individual’s unique circumstances. As a family physician, Dr. Harmon brings important perspectives from the front lines of primary care. His commitment to health equity and evidence-based care, as well as his concern for practice sustainability and physician well-being, will serve him well as he leads the house of medicine into the future.”

Dr. Harmon has practiced as a family medicine specialist in Georgetown, S.C., for more than 30 years. He is a member of the clinical faculty for the Tidelands Health Medical University of South Carolina family medicine residency program, advises a community health system, and is vice president of a multispecialty physician practice. In addition, Dr. Harmon is the medical director of a nonprofit hospice and volunteers as medical supervisor for his local school district.

Dr. Harmon received his undergraduate degree in physics and mathematics from the University of South Carolina, Columbia, and received his medical degree from the Medical University of South Carolina, Charleston. He completed a residency training program in family medicine with the U.S. Air Force at Eglin (Fla.) AFB, Florida.

During a 35-year military career, Dr. Harmon served as chief surgeon for the National Guard Bureau and assistant surgeon general for the U.S. Air Force. He retired from the military as a major general.

Dr. Harmon and his wife, Linda, have three married children and eight grandchildren.

Every now and then, a bucket of tomatoes or even a half bushel of corn shows up in the back of Dr. Harmon’s pickup truck, with a note on the window thanking him. “That really touches you deeply,” Dr. Harmon said. “I practice that type of medicine and I’m honored to be able to do that every day.”

[email protected]

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

A version of this article first appeared on WebMD.com.

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

A version of this article first appeared on WebMD.com.

The U.S. Supreme Court upheld the Affordable Care Act June 17 in a 7 to 2 vote, rejecting claims by the challengers that the requirement for all Americans to obtain health insurance is unconstitutional.

ETIENJones/thinkstockphotos

The challengers were comprised of 18 GOP-dominated states, led by Texas, that took issue with the ACA’s individual mandate – which required most Americans to have health insurance or pay a tax penalty.

But Congress reduced the penalty to zero in 2017. Challengers argued that without the mandate,  the rest of the law should be scrapped, too. The court ruled that eliminated the harm the states were claiming.

“To have standing, a plaintiff must ‘allege personal injury fairly traceable to the defendant’s allegedly unlawful conduct and likely to be redressed by the requested relief,’” the majority wrote. “No plaintiff has shown such an injury ‘fairly traceable’ to the ‘allegedly unlawful conduct’ challenged here.”

Justice Stephen Breyer authored the opinion. Justices Samuel Alito and Neil Gorsuch dissented.

The decision said that the mandate in question did not require the 18 states that brought the complaint to pay anything, and therefore they had no standing.

President Joe Biden has said he plans to build on the ACA – which was enacted while he was vice president – to offer coverage to more Americans.

This marks the third time the Supreme Court spared the Obama-era law from GOP attacks. The mandate was also upheld in 2012 in a 5 to 4 ruling.

American Medical Association president Gerald Harmon, MD, also called for building on the ruling to expand the law.

“With yet another court decision upholding the ACA now behind us, we remain committed to strengthening the current law and look forward to policymakers advancing solutions to improve the ACA,” Dr. Harmon said in a statement. “The AMA will continue working to expand access to health care and ensure that all Americans have meaningful, comprehensive, and affordable health coverage to improve the health of the nation.”

House Speaker Nancy Pelosi (D-Calif.), a longtime advocate for the ACA, called the decision a “landmark victory for Democrats.”

“Thanks to the tireless advocacy of Americans across the country and Democrats in Congress, the Affordable Care Act endures as a pillar of American health and economic security alongside Medicare, Medicaid and Social Security,” she said in a statement.

Senate Majority Leader Chuck Schumer (D-N.Y.) also celebrated the ruling.

“The Affordable Care Act has won. The Supreme Court has just ruled: the ACA is here to stay and now we’re going to try to make it bigger and better,” he said, according to CNN. “For more than a decade, the assault on our health care law was relentless from Republicans in Congress, from the executive branch itself and from Republican attorneys general in the courts. Each time in each arena, the ACA has prevailed.”

This article was updated June 17, 2021.

A version of this article first appeared on WebMD.com.

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

A version of this article first appeared on Medscape.com.

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

A version of this article first appeared on Medscape.com.

While the investigation into cases of myocarditis possibly associated with COVID vaccines proceeds, the American Heart Association/American Stroke Association (ASA) continue to urge everyone who is eligible for the vaccine to get it without delay.

“We remain confident that the benefits of vaccination far exceed the very unusual risks,” the leadership of the AHA/ASA said in a statement issued June 12.

“The risks of COVID-19 infection include its potentially fatal consequences and the potential long-term health effects that are still revealing themselves, including lingering consequences affecting the heart, brain, vascular system, and other organs after infection,” they point out.

Late last week, the Centers for Disease Control and Prevention alerted health care providers that the COVID-19 Vaccine Safety Technical Work Group (VaST) of the Advisory Committee on Immunization Practices (ACIP) will meet June 18 to review cases of myocarditis reported in adolescents and young adults after they received a COVID-19 vaccine manufactured by Pfizer-BioNTech or Moderna.

The CDC is monitoring the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD) for cases of myocarditis that have been associated with the mRNA vaccines against SARS-CoV-2 from Pfizer and Moderna.

These cases may occur more often in males than females and more frequently after the second dose than the first dose of either mRNA vaccine. Symptoms typically occur in the 3 days after administration.

“The CDC’s ongoing investigation into cases of suspected myocarditis reflects a strong and steadfast commitment to transparency and the importance of scientific rigor on all fronts. We applaud the CDC’s unwavering efforts to lead our nation’s scientific and public health efforts, including ensuring the continued safety of the COVID-19 vaccines,” the AHA/ASA states.

They emphasize that vaccinations should continue, and say it’s important to consider the details of the suspected myocarditis cases being investigated by the CDC.

As of June 11, more than 306 million doses of COVID-19 vaccines have been administered in the United States (since Dec. 14, 2020) and nearly 43% of Americans – more than 142 million people – are now fully vaccinated.

According to the June 10 CDC VAERS report detailing adverse events through May 31:

• 789 cases of suspected myocarditis have been reported, with 475 involving people younger than 30 years; 79 cases reported were in patients 16 or 17 years old.
• The vast majority (81%) of the 270 patients younger than 30 years who were discharged from care after suspected myocarditis related to COVID-19 vaccination have recovered fully; the remaining 19% of patients report ongoing symptoms or complete data are missing.
• 196 cases of suspected myocarditis after a COVID-19 vaccine were reported in young adults 18 to 24 years of age, which is higher than expected for this age group.

As of May 31, only about 9% of the COVID-19 vaccine doses administered were to people 16 to 24 years of age, which is why this “higher-than-normal rate of possible myocarditis cases” warrants investigation, the AHA/ASA says.

They note that these suspected myocarditis cases were reported to VAERS because of their proximity to COVID-19 vaccine administration.

It remains to be determined which cases meet the clinical criteria for a diagnosis of myocarditis and whether they have any direct connection to the COVID-19 vaccine, the AHA/ASA says.

They urge all health care professionals to be aware of “very rare” adverse events that could be related to a COVID-19 vaccine, including myocarditis, blood clots, low platelets, and symptoms of severe inflammation.

They advise asking patients who present with symptoms related to these conditions about the timing of recent COVID vaccinations, as needed, to confirm the diagnosis and provide appropriate treatment quickly.

The AHA will be at the CDC’s June 18 meeting to review the latest evidence on cases of suspected myocarditis after the COVID-19 vaccine, the statement adds.

The statement notes that it reflects the views of the AHA/ASA and its scientific leadership, including current president Mitchel S.V. Elkind, MD, PhD; immediate past-president Robert A. Harrington, MD; president-elect Donald M. Lloyd-Jones, MD; AHA/ASA chief science and medical officer Mariell Jessup, MD; and chief medical officer for prevention Eduardo Sanchez, MD, MPH.

A version of this article first appeared on Medscape.com.

A 19-month-old boy comes to the office with a large firm erythematous swelling of his anterior left thigh that reaches from just below the inguinal crease to the patella. He got his routine immunizations 2 days prior to this visit including the fourth DTaP dose in his left thigh. Clinicians who care for children and who give routine immunizations occasionally see such an adverse effect following immunization (AEFI). These large local reactions have been described for many decades and occur after many vaccines.

What is extensive limb swelling (ELS)? ELS is defined as erythema/swelling crossing a joint or extending mostly joint to joint. It is a subset of large local AEFIs. ELS is generally firm and often erythematous with varying degrees of pain. ELS is now most frequent after pneumococcal conjugate vaccines (PCV) and DTaP, with a 1%-4% rate after DTaP boosters.^1-3 ELS and other large local swelling reactions occur at nearly any age.¹ And yet there is still much that is not known about their true pathogenesis. Likewise, there are no accurate predictors of which vaccinees will develop large inflammatory processes at or near the site of immunization.
 

ELS after standard vaccines

The largest report to date on AEFI of all ages, including ELS, covered 1990-2003.¹ Two upfront caveats are: This study evaluated ELS before PCVs were available, and in adults, repeat 23-valent pneumococcal polysaccharide vaccine was the most common cause of ELS in this study, comprising 45% of all adult ELS.

Considering all ages, ELS onset was nearly always greater than 1 hour and was less than 24 hours post vaccine in almost 75% of patients. However, for those aged under 2 years, onset in less than 24 hours was even more frequent (84%). Interestingly, concomitant fever occurred in less than 25% regardless of age. In adults, ELS after tetanus- and diphtheria-containing vaccines occurred mostly in women (75%); whereas for ELS under 8 years of age, males predominated (about 60%). Of note, tetanus- and diphtheria-containing vaccines were the most frequent ELS-inducing vaccines in children, that is, 75% aged under 8 years and 55% for those aged 8-17 years. Focusing on pediatric ELS after DTaP by dose, 33% were after the fourth, 31% after the fifth, 12% after the second, 10% after the first, and 3% after the third dose. In the case above, ELS was after the fourth dose.

Clinicians caring for children know how to manage ELS after DTaP or PCVs. They understand that ELS looks scary and is uncomfortable but is not dangerous and requires no specific treatment. Supportive management, that is, pain reliever, cool compresses, and TLC, are warranted. ELS is not a contraindication to subsequent immunization with the same vaccine. That said, large local reactions or ELS do occur with subsequent doses of that same vaccine at varying rates up to 66% of the time. Management is the same with repeat episodes, and no sequelae are expected. Supportive management only is standard unless one suspects a very rare Arthus reaction. If central necrosis occurs or swelling evolution/resolution is not per expectations, referral to a vaccine expert can sort out if it is an Arthus reaction, in which case, subsequent use of the same vaccine in not recommended.
 

ELS and SARS-CoV-2 vaccines

With SARS-CoV-2 vaccines now authorized for adolescents and expected in a few months for younger children, large local AEFI reactions related to pediatric SARS-CoV-2 vaccines are expected, given that “COVID arm” is now well described in adults.⁴ Overall, ELS/large local reactions have been reported more frequently with the Moderna than Pfizer mRNA vaccine.⁴ In the almost 42% of adults having ELS post first dose, repeat ELS post second dose often appears sooner but also resolves more quickly, with no known sequelae.⁵

Some biopsies have shown delayed-type hypersensitivity reactions (DTH) (superficial perivascular and perifollicular lymphocytic infiltrates with rare eosinophils and scattered mast cells),^6,7 while others show no DTH but these patients have findings of immediate hypersensitivity findings and negative skin testing to the vaccine.⁸ With regard to sex, Dutch ELS data in White adults reveal 90% occur in females – higher than the 75% female rate after standard vaccines.⁷ Onset of ELS data show that Pfizer mRNA vaccinees had onset on average at 38 hours (range, <1 hr to 12 days). Boston data mostly in White adults reveal later onset (median, 6 days; range, 2-12 days).⁴ In contrast, adults of color appear to have later onset (mean, 8 days; range, 4-14 days).⁹

In addition to the local swelling, patients had concurrent injection-site AEFIs of pain (65%), warmth (63%), and pruritus (26%), plus myalgia (51%), headache (48%), malaise (45%), fatigue (43%), chills (33%), arthralgia (30%), and fever (28%).⁷

What should we tell families about pediatric ELS before we give SARS-CoV-2 vaccines to children? Clinical pediatric SARS-CoV-2 vaccine trials are smaller “immunologic bridging” studies, not requiring proof of efficacy. So, the precise incidence of pediatric ELS (adult rate is estimated under 1/100,000) may not be known until months after general use. Nevertheless, part of our counseling of families will need to include ELS/large local reactions. Unless new data show otherwise, the spiel that clinicians have developed to counsel about the rare chance of ELS after routine vaccines should also be useful to inform families of the rare chance of ELS post SARS-CoV-2 vaccine.

The bottom line is that the management of pediatric ELS after SARS-CoV-2 vaccines should be the same as after standard vaccines. And remember, whether the reactions are DTH or not, neither immediate local injection-site reactions nor DTH reactions are contraindications to subsequent vaccination unless anaphylaxis or Arthus reaction is suspected.^10,11

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at [email protected].

References

1. Woo EJ and the Vaccine Adverse Event Reporting System Working Group. Clin Infect Dis 2003;37:351-8.

2. Rennels MB et al. Pediatrics 2000;105:e12.

3. Huber BM, Goetschel P. J Pediatr. 2011;158:1033.

4. Blumenthal KG et al. N Engl J Med. 2021;384:1273-7.

5. McMahon DE et al. J Amer Acad Dermatol. 2021;85(1):46-55. 6. Johnston MS et al. JAMA Dermatol. 2021;157(6):716-20 .

7. ELS associated with the administration of Comirnaty®. WHO database Vigilyze (cited 2021 Feb 22). Available from https://vigilyze.who-umc.org/.

8. Baeck M et al. N Engl J Med. 2021 Jun. doi: 10.1056/NEJMc2104751.

9. Samarakoon U et al. N Eng J Med. 2021 Jun 9. doi: 10.1056/NEJMc2108620.

10. Kelso JM et al. J Allergy Clin Immunol. 2012;130:25-43.

11. Zafack JG et al. Pediatrics. 2017;140(3):e20163707.

A 19-month-old boy comes to the office with a large firm erythematous swelling of his anterior left thigh that reaches from just below the inguinal crease to the patella. He got his routine immunizations 2 days prior to this visit including the fourth DTaP dose in his left thigh. Clinicians who care for children and who give routine immunizations occasionally see such an adverse effect following immunization (AEFI). These large local reactions have been described for many decades and occur after many vaccines.

What is extensive limb swelling (ELS)? ELS is defined as erythema/swelling crossing a joint or extending mostly joint to joint. It is a subset of large local AEFIs. ELS is generally firm and often erythematous with varying degrees of pain. ELS is now most frequent after pneumococcal conjugate vaccines (PCV) and DTaP, with a 1%-4% rate after DTaP boosters.^1-3 ELS and other large local swelling reactions occur at nearly any age.¹ And yet there is still much that is not known about their true pathogenesis. Likewise, there are no accurate predictors of which vaccinees will develop large inflammatory processes at or near the site of immunization.
 

ELS after standard vaccines

The largest report to date on AEFI of all ages, including ELS, covered 1990-2003.¹ Two upfront caveats are: This study evaluated ELS before PCVs were available, and in adults, repeat 23-valent pneumococcal polysaccharide vaccine was the most common cause of ELS in this study, comprising 45% of all adult ELS.

Considering all ages, ELS onset was nearly always greater than 1 hour and was less than 24 hours post vaccine in almost 75% of patients. However, for those aged under 2 years, onset in less than 24 hours was even more frequent (84%). Interestingly, concomitant fever occurred in less than 25% regardless of age. In adults, ELS after tetanus- and diphtheria-containing vaccines occurred mostly in women (75%); whereas for ELS under 8 years of age, males predominated (about 60%). Of note, tetanus- and diphtheria-containing vaccines were the most frequent ELS-inducing vaccines in children, that is, 75% aged under 8 years and 55% for those aged 8-17 years. Focusing on pediatric ELS after DTaP by dose, 33% were after the fourth, 31% after the fifth, 12% after the second, 10% after the first, and 3% after the third dose. In the case above, ELS was after the fourth dose.

Clinicians caring for children know how to manage ELS after DTaP or PCVs. They understand that ELS looks scary and is uncomfortable but is not dangerous and requires no specific treatment. Supportive management, that is, pain reliever, cool compresses, and TLC, are warranted. ELS is not a contraindication to subsequent immunization with the same vaccine. That said, large local reactions or ELS do occur with subsequent doses of that same vaccine at varying rates up to 66% of the time. Management is the same with repeat episodes, and no sequelae are expected. Supportive management only is standard unless one suspects a very rare Arthus reaction. If central necrosis occurs or swelling evolution/resolution is not per expectations, referral to a vaccine expert can sort out if it is an Arthus reaction, in which case, subsequent use of the same vaccine in not recommended.
 

ELS and SARS-CoV-2 vaccines

With SARS-CoV-2 vaccines now authorized for adolescents and expected in a few months for younger children, large local AEFI reactions related to pediatric SARS-CoV-2 vaccines are expected, given that “COVID arm” is now well described in adults.⁴ Overall, ELS/large local reactions have been reported more frequently with the Moderna than Pfizer mRNA vaccine.⁴ In the almost 42% of adults having ELS post first dose, repeat ELS post second dose often appears sooner but also resolves more quickly, with no known sequelae.⁵

Some biopsies have shown delayed-type hypersensitivity reactions (DTH) (superficial perivascular and perifollicular lymphocytic infiltrates with rare eosinophils and scattered mast cells),^6,7 while others show no DTH but these patients have findings of immediate hypersensitivity findings and negative skin testing to the vaccine.⁸ With regard to sex, Dutch ELS data in White adults reveal 90% occur in females – higher than the 75% female rate after standard vaccines.⁷ Onset of ELS data show that Pfizer mRNA vaccinees had onset on average at 38 hours (range, <1 hr to 12 days). Boston data mostly in White adults reveal later onset (median, 6 days; range, 2-12 days).⁴ In contrast, adults of color appear to have later onset (mean, 8 days; range, 4-14 days).⁹

In addition to the local swelling, patients had concurrent injection-site AEFIs of pain (65%), warmth (63%), and pruritus (26%), plus myalgia (51%), headache (48%), malaise (45%), fatigue (43%), chills (33%), arthralgia (30%), and fever (28%).⁷

What should we tell families about pediatric ELS before we give SARS-CoV-2 vaccines to children? Clinical pediatric SARS-CoV-2 vaccine trials are smaller “immunologic bridging” studies, not requiring proof of efficacy. So, the precise incidence of pediatric ELS (adult rate is estimated under 1/100,000) may not be known until months after general use. Nevertheless, part of our counseling of families will need to include ELS/large local reactions. Unless new data show otherwise, the spiel that clinicians have developed to counsel about the rare chance of ELS after routine vaccines should also be useful to inform families of the rare chance of ELS post SARS-CoV-2 vaccine.

The bottom line is that the management of pediatric ELS after SARS-CoV-2 vaccines should be the same as after standard vaccines. And remember, whether the reactions are DTH or not, neither immediate local injection-site reactions nor DTH reactions are contraindications to subsequent vaccination unless anaphylaxis or Arthus reaction is suspected.^10,11

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at [email protected].

References

1. Woo EJ and the Vaccine Adverse Event Reporting System Working Group. Clin Infect Dis 2003;37:351-8.

2. Rennels MB et al. Pediatrics 2000;105:e12.

3. Huber BM, Goetschel P. J Pediatr. 2011;158:1033.

4. Blumenthal KG et al. N Engl J Med. 2021;384:1273-7.

5. McMahon DE et al. J Amer Acad Dermatol. 2021;85(1):46-55. 6. Johnston MS et al. JAMA Dermatol. 2021;157(6):716-20 .

7. ELS associated with the administration of Comirnaty®. WHO database Vigilyze (cited 2021 Feb 22). Available from https://vigilyze.who-umc.org/.

8. Baeck M et al. N Engl J Med. 2021 Jun. doi: 10.1056/NEJMc2104751.

9. Samarakoon U et al. N Eng J Med. 2021 Jun 9. doi: 10.1056/NEJMc2108620.

10. Kelso JM et al. J Allergy Clin Immunol. 2012;130:25-43.

11. Zafack JG et al. Pediatrics. 2017;140(3):e20163707.

A 19-month-old boy comes to the office with a large firm erythematous swelling of his anterior left thigh that reaches from just below the inguinal crease to the patella. He got his routine immunizations 2 days prior to this visit including the fourth DTaP dose in his left thigh. Clinicians who care for children and who give routine immunizations occasionally see such an adverse effect following immunization (AEFI). These large local reactions have been described for many decades and occur after many vaccines.

What is extensive limb swelling (ELS)? ELS is defined as erythema/swelling crossing a joint or extending mostly joint to joint. It is a subset of large local AEFIs. ELS is generally firm and often erythematous with varying degrees of pain. ELS is now most frequent after pneumococcal conjugate vaccines (PCV) and DTaP, with a 1%-4% rate after DTaP boosters.^1-3 ELS and other large local swelling reactions occur at nearly any age.¹ And yet there is still much that is not known about their true pathogenesis. Likewise, there are no accurate predictors of which vaccinees will develop large inflammatory processes at or near the site of immunization.
 

ELS after standard vaccines

The largest report to date on AEFI of all ages, including ELS, covered 1990-2003.¹ Two upfront caveats are: This study evaluated ELS before PCVs were available, and in adults, repeat 23-valent pneumococcal polysaccharide vaccine was the most common cause of ELS in this study, comprising 45% of all adult ELS.

Considering all ages, ELS onset was nearly always greater than 1 hour and was less than 24 hours post vaccine in almost 75% of patients. However, for those aged under 2 years, onset in less than 24 hours was even more frequent (84%). Interestingly, concomitant fever occurred in less than 25% regardless of age. In adults, ELS after tetanus- and diphtheria-containing vaccines occurred mostly in women (75%); whereas for ELS under 8 years of age, males predominated (about 60%). Of note, tetanus- and diphtheria-containing vaccines were the most frequent ELS-inducing vaccines in children, that is, 75% aged under 8 years and 55% for those aged 8-17 years. Focusing on pediatric ELS after DTaP by dose, 33% were after the fourth, 31% after the fifth, 12% after the second, 10% after the first, and 3% after the third dose. In the case above, ELS was after the fourth dose.

Clinicians caring for children know how to manage ELS after DTaP or PCVs. They understand that ELS looks scary and is uncomfortable but is not dangerous and requires no specific treatment. Supportive management, that is, pain reliever, cool compresses, and TLC, are warranted. ELS is not a contraindication to subsequent immunization with the same vaccine. That said, large local reactions or ELS do occur with subsequent doses of that same vaccine at varying rates up to 66% of the time. Management is the same with repeat episodes, and no sequelae are expected. Supportive management only is standard unless one suspects a very rare Arthus reaction. If central necrosis occurs or swelling evolution/resolution is not per expectations, referral to a vaccine expert can sort out if it is an Arthus reaction, in which case, subsequent use of the same vaccine in not recommended.
 

ELS and SARS-CoV-2 vaccines

With SARS-CoV-2 vaccines now authorized for adolescents and expected in a few months for younger children, large local AEFI reactions related to pediatric SARS-CoV-2 vaccines are expected, given that “COVID arm” is now well described in adults.⁴ Overall, ELS/large local reactions have been reported more frequently with the Moderna than Pfizer mRNA vaccine.⁴ In the almost 42% of adults having ELS post first dose, repeat ELS post second dose often appears sooner but also resolves more quickly, with no known sequelae.⁵

Some biopsies have shown delayed-type hypersensitivity reactions (DTH) (superficial perivascular and perifollicular lymphocytic infiltrates with rare eosinophils and scattered mast cells),^6,7 while others show no DTH but these patients have findings of immediate hypersensitivity findings and negative skin testing to the vaccine.⁸ With regard to sex, Dutch ELS data in White adults reveal 90% occur in females – higher than the 75% female rate after standard vaccines.⁷ Onset of ELS data show that Pfizer mRNA vaccinees had onset on average at 38 hours (range, <1 hr to 12 days). Boston data mostly in White adults reveal later onset (median, 6 days; range, 2-12 days).⁴ In contrast, adults of color appear to have later onset (mean, 8 days; range, 4-14 days).⁹

In addition to the local swelling, patients had concurrent injection-site AEFIs of pain (65%), warmth (63%), and pruritus (26%), plus myalgia (51%), headache (48%), malaise (45%), fatigue (43%), chills (33%), arthralgia (30%), and fever (28%).⁷

What should we tell families about pediatric ELS before we give SARS-CoV-2 vaccines to children? Clinical pediatric SARS-CoV-2 vaccine trials are smaller “immunologic bridging” studies, not requiring proof of efficacy. So, the precise incidence of pediatric ELS (adult rate is estimated under 1/100,000) may not be known until months after general use. Nevertheless, part of our counseling of families will need to include ELS/large local reactions. Unless new data show otherwise, the spiel that clinicians have developed to counsel about the rare chance of ELS after routine vaccines should also be useful to inform families of the rare chance of ELS post SARS-CoV-2 vaccine.

The bottom line is that the management of pediatric ELS after SARS-CoV-2 vaccines should be the same as after standard vaccines. And remember, whether the reactions are DTH or not, neither immediate local injection-site reactions nor DTH reactions are contraindications to subsequent vaccination unless anaphylaxis or Arthus reaction is suspected.^10,11

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Hospitals and Clinics, Kansas City, Mo. He said he had no relevant financial disclosures. Email him at [email protected].

References

1. Woo EJ and the Vaccine Adverse Event Reporting System Working Group. Clin Infect Dis 2003;37:351-8.

2. Rennels MB et al. Pediatrics 2000;105:e12.

3. Huber BM, Goetschel P. J Pediatr. 2011;158:1033.

4. Blumenthal KG et al. N Engl J Med. 2021;384:1273-7.

5. McMahon DE et al. J Amer Acad Dermatol. 2021;85(1):46-55. 6. Johnston MS et al. JAMA Dermatol. 2021;157(6):716-20 .

7. ELS associated with the administration of Comirnaty®. WHO database Vigilyze (cited 2021 Feb 22). Available from https://vigilyze.who-umc.org/.

8. Baeck M et al. N Engl J Med. 2021 Jun. doi: 10.1056/NEJMc2104751.

9. Samarakoon U et al. N Eng J Med. 2021 Jun 9. doi: 10.1056/NEJMc2108620.

10. Kelso JM et al. J Allergy Clin Immunol. 2012;130:25-43.

11. Zafack JG et al. Pediatrics. 2017;140(3):e20163707.

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Busting the myth of skipping breakfast

Your mother told you that breakfast was the most important meal of the day. Cereal marketing teams banked on that, selling breakfast to millions of people based on a common turn of phrase like “an apple a day keeps the doctor away.” Well, what if the notion of breakfast’s importance isn’t just marketing BS?

NorthStar203/iStock/Getty Images Plus

A new study suggests that adults who don’t eat breakfast are setting themselves up for a nutritional gap. Common breakfast foods pack a ton of calcium, fiber, and vitamin C from milk, cereals, and fruit. Christopher Taylor, PhD, senior author of the study and professor of dietetics at the Ohio State University, Columbus, said that if you’re not getting those nutrients from foods at breakfast, there’s a tendency to skip them throughout the rest of your day.

Data from a sample of the National Health and Nutrition Examination Survey – 30,889 adults aged 19 and older who participated between 2005 and 2016 – showed that 15.2% of participants reported skipping breakfast.

The research team then estimated nutrient consumption using federal dietary studies and guidelines and compared it to Food and Nutrition Board of National Academies nutrient recommendations. The breakfast skippers, they determined, were missing out on pronounced levels of fiber, magnesium, iron, calcium, and vitamins A, B₁, B₂, B₃, C, and D and were more likely to fall prey to lower-quality snacking. Cue those Oreos at 3 pm.

You may get more total calories within the day by eating breakfast, but your lunch, dinner, and snacks are much larger when you skip it. So the case of breakfast being the most important meal of the day checks out. Who knew that Tony the Tiger – and Mom – were actually on to something?
 

The bitter taste of a healthy liver

Alcohol and liver disease. They go together like, well, alcohol and liver disease. But alcohol isn’t the only reason people get liver disease, and now there’s a potential new treatment for people with hepatic steatosis on the way to becoming nonalcoholic fatty liver disease: beer.

Okay, not literally beer, but a pair of compounds derived from hops, the plant that gives beer its color and bitter flavor. In a study published in eLife, researchers from Oregon State University fed mice either a low-fat diet or a high-fat diet to induce hepatic steatosis, with some on the high-fat diet receiving either xanthohumol, a prenylated flavonoid from the hop plant, or tetrahydroxanthohumol, a hydrogenated derivative of xanthohumol.

Courtesy Oregon State University

Life’s great mysteries, from A to zinc

Thanks to science, we now have answers to what were once unanswerable questions: Is Jello a solid or a liquid? If someone leads but no one follows, are they just out for a walk? Does zinc inhibit or promote the growth of kidney stones? How many licks does it take to get to the center of a Tootsie Pop? (Turns out science really did answer this one.)

If you’re anything like us, then you’ve been following the big debate on the two competing theories involving the role of zinc in kidney stone formation for years. One theory says that zinc stops the growth of calcium oxalate crystals that make up stones. The other says that zinc alters the surfaces of crystals, which encourages growth.

We can’t stand the suspense any longer, so here goes: The answer to “does zinc inhibit or promote the growth of kidney stones?” is … yes.

decade3d/Thinkstock

Babies’ ‘gut instinct’ to cry

At some point or another, you’ve probably been told not to “be such a baby” when you were scared of something. If you’ve been called a crybaby, it may be an indicator that you had a different gut microbiome as an infant.

Investigators from Michigan State University and the University of North Carolina say that babies who react more strongly to scary situations have different gut microbiomes compared with babies who don’t have such a strong reaction. The way babies react to scary situations can say a lot about their future, and there is even some evidence that gut microbiomes may have something to do with mental health.

©a-fitz/iStockphoto.com

Lupus images in medical resource materials underrepresent patients with skin of color, based on data from a review of more than 1,400 images published between 2014 and 2019 in materials from a university’s online medical library.

Courtesy Dr. Catalina Matiz

Patients with skin of color who develop lupus tend to present earlier and with more severe cases, and often experience worse outcomes, compared with other populations, wrote Amaad Rana, MD, of Washington University, St. Louis, and colleagues. Medical resources in general have historically underrepresented patients of color, and the researchers reviewed lupus materials for a similar publication bias.

In a study published in Arthritis Care & Research, the investigators identified 1,417 images in rheumatology, dermatology, and internal medicine resources, including 119 medical textbooks, 15 medical journals, 2 online image libraries, and the online image collections of Google and UpToDate. An additional 24 images came from skin of color atlases.

Excluding the skin of color atlases, 56.4% of the images represented light skin, 35.1% showed medium skin, and 8.5% showed dark skin. Overall, publishers were more than twice as likely to portray light skin tones and were significantly less likely to portray dark skin tones (odds ratios, 2.59 and 0.19, respectively), compared with an equal representation of skin tones; however, the difference was not significant for portrayal of medium skin tones (OR, 1.08).

By specialty, dermatology was more inclusive of skin of color images than rheumatology or internal medicine, although the internal medicine sample size was too small for comparable analysis, the researchers noted. Dermatology textbooks were 2.42 times more likely and rheumatology textbooks were 4.87 times more likely to depict light skin tones than an equal representation of light, medium, and dark skin tones.

The researchers rated the skin color in the images using the New Immigrant Survey Skin Color Scale and categorized the images as representing light (NISSCS scores, 1-2), medium (NISSCS scores, 3-5), or dark skin (NISSCS scores, 6-10). Medical journals had the most images of dark skin, excluding skin of color atlases. In a comparison of specialties, dermatology materials included the most images of medium and darker skin tones.

The underrepresentation of skin of color patients can contribute to a limited knowledge of lupus presentation that could lead to disparate health outcomes, the researchers noted.

The study findings were limited by several factors, including the review of only the online textbooks and journals available through the medical library of a single university, the researchers noted. In addition, definitions of light, medium, and dark skin tones were variable among studies, and the researchers did not distinguish among lupus pathologies.

“Further research is needed to quantitatively assess the influence these materials have on healthcare providers’ ability to care for patients with lupus and SOC, and new material and strategies will be required to correct this disparity and promote equitable representation,” the researchers emphasized. “Ultimately, this will arm practitioners with the resources to competently treat patients with any skin color and work towards reducing disparities in health outcomes.”

The study received no outside funding. The researchers had no financial conflicts to disclose.

Lupus images in medical resource materials underrepresent patients with skin of color, based on data from a review of more than 1,400 images published between 2014 and 2019 in materials from a university’s online medical library.

Courtesy Dr. Catalina Matiz

Patients with skin of color who develop lupus tend to present earlier and with more severe cases, and often experience worse outcomes, compared with other populations, wrote Amaad Rana, MD, of Washington University, St. Louis, and colleagues. Medical resources in general have historically underrepresented patients of color, and the researchers reviewed lupus materials for a similar publication bias.

In a study published in Arthritis Care & Research, the investigators identified 1,417 images in rheumatology, dermatology, and internal medicine resources, including 119 medical textbooks, 15 medical journals, 2 online image libraries, and the online image collections of Google and UpToDate. An additional 24 images came from skin of color atlases.

Excluding the skin of color atlases, 56.4% of the images represented light skin, 35.1% showed medium skin, and 8.5% showed dark skin. Overall, publishers were more than twice as likely to portray light skin tones and were significantly less likely to portray dark skin tones (odds ratios, 2.59 and 0.19, respectively), compared with an equal representation of skin tones; however, the difference was not significant for portrayal of medium skin tones (OR, 1.08).

By specialty, dermatology was more inclusive of skin of color images than rheumatology or internal medicine, although the internal medicine sample size was too small for comparable analysis, the researchers noted. Dermatology textbooks were 2.42 times more likely and rheumatology textbooks were 4.87 times more likely to depict light skin tones than an equal representation of light, medium, and dark skin tones.

The researchers rated the skin color in the images using the New Immigrant Survey Skin Color Scale and categorized the images as representing light (NISSCS scores, 1-2), medium (NISSCS scores, 3-5), or dark skin (NISSCS scores, 6-10). Medical journals had the most images of dark skin, excluding skin of color atlases. In a comparison of specialties, dermatology materials included the most images of medium and darker skin tones.

The underrepresentation of skin of color patients can contribute to a limited knowledge of lupus presentation that could lead to disparate health outcomes, the researchers noted.

The study findings were limited by several factors, including the review of only the online textbooks and journals available through the medical library of a single university, the researchers noted. In addition, definitions of light, medium, and dark skin tones were variable among studies, and the researchers did not distinguish among lupus pathologies.

“Further research is needed to quantitatively assess the influence these materials have on healthcare providers’ ability to care for patients with lupus and SOC, and new material and strategies will be required to correct this disparity and promote equitable representation,” the researchers emphasized. “Ultimately, this will arm practitioners with the resources to competently treat patients with any skin color and work towards reducing disparities in health outcomes.”

The study received no outside funding. The researchers had no financial conflicts to disclose.

Lupus images in medical resource materials underrepresent patients with skin of color, based on data from a review of more than 1,400 images published between 2014 and 2019 in materials from a university’s online medical library.

Courtesy Dr. Catalina Matiz

Patients with skin of color who develop lupus tend to present earlier and with more severe cases, and often experience worse outcomes, compared with other populations, wrote Amaad Rana, MD, of Washington University, St. Louis, and colleagues. Medical resources in general have historically underrepresented patients of color, and the researchers reviewed lupus materials for a similar publication bias.

In a study published in Arthritis Care & Research, the investigators identified 1,417 images in rheumatology, dermatology, and internal medicine resources, including 119 medical textbooks, 15 medical journals, 2 online image libraries, and the online image collections of Google and UpToDate. An additional 24 images came from skin of color atlases.

Excluding the skin of color atlases, 56.4% of the images represented light skin, 35.1% showed medium skin, and 8.5% showed dark skin. Overall, publishers were more than twice as likely to portray light skin tones and were significantly less likely to portray dark skin tones (odds ratios, 2.59 and 0.19, respectively), compared with an equal representation of skin tones; however, the difference was not significant for portrayal of medium skin tones (OR, 1.08).

By specialty, dermatology was more inclusive of skin of color images than rheumatology or internal medicine, although the internal medicine sample size was too small for comparable analysis, the researchers noted. Dermatology textbooks were 2.42 times more likely and rheumatology textbooks were 4.87 times more likely to depict light skin tones than an equal representation of light, medium, and dark skin tones.

The researchers rated the skin color in the images using the New Immigrant Survey Skin Color Scale and categorized the images as representing light (NISSCS scores, 1-2), medium (NISSCS scores, 3-5), or dark skin (NISSCS scores, 6-10). Medical journals had the most images of dark skin, excluding skin of color atlases. In a comparison of specialties, dermatology materials included the most images of medium and darker skin tones.

The underrepresentation of skin of color patients can contribute to a limited knowledge of lupus presentation that could lead to disparate health outcomes, the researchers noted.

The study findings were limited by several factors, including the review of only the online textbooks and journals available through the medical library of a single university, the researchers noted. In addition, definitions of light, medium, and dark skin tones were variable among studies, and the researchers did not distinguish among lupus pathologies.

“Further research is needed to quantitatively assess the influence these materials have on healthcare providers’ ability to care for patients with lupus and SOC, and new material and strategies will be required to correct this disparity and promote equitable representation,” the researchers emphasized. “Ultimately, this will arm practitioners with the resources to competently treat patients with any skin color and work towards reducing disparities in health outcomes.”

The study received no outside funding. The researchers had no financial conflicts to disclose.

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”

Medicare has made two changes that are expected to improve access to continuous glucose monitoring (CGM) devices for beneficiaries with diabetes.

Courtesy Medtronic

Beginning July 18, 2021, the Centers for Medicare & Medicaid Services will no longer require that beneficiaries test their blood sugar four times a day in order to qualify for CGM. In addition, the term “multiple daily injections” of insulin has been changed to multiple daily “administrations” in order to allow coverage for people who use inhaled insulin.

The changes are among those lobbied for by several organizations, including the American Diabetes Association and the Association of Diabetes Care and Education Specialists, which represents the professionals formerly known as “diabetes educators.”

The ADA tweeted on July 11 that “the removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management and better health outcomes. A big win for the diabetes community!”

“After years of advocacy from the diabetes community and ADCES, Medicare has taken an important step to make [CGM] more accessible for Medicare beneficiaries with diabetes,” Kate Thomas, ADCES chief advocacy and external affairs officer, wrote in a blog post. “This updated [Local Coverage Determination] was a direct result of coordinated advocacy efforts among patient and provider groups, as well as industry partners, coalitions and other entities.”
 

It’s tough to test four times a day with only three strips

In a Jan. 29, 2021, letter to the Medicare Administrative Contractors, who oversee the policies for durable medical equipment, ADCES explained why the organization strongly supported removal of the four-daily fingerstick requirement, noting that “There is no evidence to suggest that requiring four or more fingerstick tests per day significantly impacts the outcomes of CGM therapy.”

Moreover, they pointed out that the requirement was particularly burdensome, considering the fact that Medicare only covers three test strips per day for insulin-using beneficiaries. “Removing this coverage requirement would allow for increased access to CGM systems and improved health outcomes for beneficiaries with diabetes by improving glycemic control. This also represents a step toward addressing the disparities that exist around diabetes technology under the Medicare program.”

As for the terminology change from “injection” to “administration,” ADCES said that, in addition to allowing CGM coverage for individuals who use rapid-acting inhaled insulin, “we also hope that updating this terminology will help to expedite coverage as future innovations in insulin delivery methods come to market.”
 

More changes needed, ADCES says

In that January 2021 letter, ADCES recommended several other changes, including covering CGM for anyone diagnosed with type 1 diabetes at any age and without having to meet other requirements except for twice-yearly clinician visits, and for anyone with type 2 diabetes who uses any type of insulin or who has had documented hypoglycemia regardless of therapy.

They also recommended that CGM coverage be considered for patients with chronic kidney disease, and that the required 6-month clinician visits be allowed to take place via telehealth. “ADCES believes that allowing the initiation of CGM therapy through a virtual visit will reduce barriers associated with travel and difficulty accessing a trained provider that are experienced by Medicare beneficiaries.”

In addition, ADCES requested that CMS eliminate the requirement that beneficiaries use insulin three times a day to qualify for CGM, noting that this creates a barrier for patients who can’t afford insulin at all but are at risk for hypoglycemia because they take sulfonylureas or other insulin secretagogues, or for those who use cheaper synthetic human insulins that are only taken twice a day, such as NPH.

“The existing CGM coverage criteria creates an unbalanced and disparate system that excludes from coverage beneficiaries who could greatly benefit from a CGM system, but do not qualify due to issues with insulin affordability,” ADCES wrote in the January letter.

Ms. Thomas wrote in the June 14th blog: “Our work is not done. We know there are more changes that must be made.”