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Immune response detected in most IBD patients after COVID vaccines
Most patients with inflammatory bowel disease (IBD) develop a humoral immune response after completing an mRNA SARS-CoV-2 vaccine series, according to data from almost 800 patients.
Anti–receptor binding domain IgG antibodies specific to SARS-CoV-2 were detectable in 95% of patients, with “generally similar” results across vaccine type, age group, and medication class, apart from corticosteroid users, who had an 86% antibody detection rate, reported lead author Kimberly N. Weaver, MD, of the University of North Carolina at Chapel Hill, and colleagues.
“Patients with IBD on immunosuppressive medications have the potential for attenuated response to the SARS-CoV-2 vaccination,” Dr. Weaver said at the annual meeting of the American College of Gastroenterology.
In support of this possibility, Dr. Weaver cited two recent trials from earlier in 2021: one demonstrated blunted antibody responses in IBD patients taking infliximab, while the other showed that full vaccination was less effective at preventing SARS-CoV-2 infection among patients with IBD than nonimmunosuppressed individuals.
To better characterize antibody responses after receiving an mRNA vaccination series, Dr. Weaver and colleagues launched the PREVENT-COVID trial, including the present dataset of 787 patients with IBD older than 12 years, all of whom provided serum samples 8 weeks after completing an mRNA vaccine series. Patients with positive nucleocapsid antibody (indicating prior infection), and/or those who reported prior COVID-19 infection, were excluded. Most patients were White (95%) and female (73%), with an average age of 48 years. Slightly more patients received the BNT162b2 vaccine than the mRNA-1273 vaccine (58% vs. 42%).
At 8 weeks, 752 out of 787 patients had detectable antibodies (95%). Antibody rates were highest among patients receiving vedolizumab monotherapy (n = 83; 99%) or ustekinumab monotherapy (n = 102; 99%), followed by mercaptopurine, azathioprine, or methotrexate monotherapy (n = 67; 97%); anti–tumor necrosis factor monotherapy (n = 270; 96%); mesalamine, sulfasalazine, or budesonide monotherapy or no medication (n = 143; 95%); and finally anti-TNF/immunosuppressive combination therapy (n = 75; 86%). Median and mean antibody titers were lowest for anti-TNF combination therapy and highest for vedolizumab.
Thirty-five patients taking corticosteroids had an antibody detection rate of 85.7% (95% CI, 70.6-93.7), compared with 95.9% (95% CI, 94.2-97.1) among nonsteroid users. In contrast, antibody detection rates were not significantly affected by age or vaccine type.
“Reassuringly, most IBD medications do not prevent an initial antibody response after SARS-CoV-2 vaccination, and this is unlike other classes of immune suppression such as B-cell depletion therapy,” Dr. Weaver concluded. “Additional data are forthcoming on a larger subset of participants in the PREVENT-COVID study which will allow for analysis of factors associated with humoral immune response and potential optimization of immunization strategies.” She described a dataset of about 500 IBD patients in which booster vaccines overcame poor antibody responses to the initial vaccine series.
‘The data we need’
Serre-yu Wong, MD, PhD, of Icahn School of Medicine at Mount Sinai, New York, agreed that the findings should offer some reassurance to patients with IBD and their care providers.
“At the end of the day we have really nice seroconversion rates for the IBD population,” Dr. Wong said.
In April 2021, Dr. Wong and the ICARUS-IBD Working Group published a similar report of 48 patients with IBD receiving biologic therapies, among whom the seroconversion rate was 100%.
“A lot of the early data, including ours, are on infusion medications, and that’s sort of a practical thing because those were the only patients we could get samples from, but [Dr. Weaver and colleagues] were able to get samples from patients not on medications, on oral medications, and on other injection medications that people can take at home, and these are really the data we need for all of our other IBD patients,” Dr. Wong said.
Dr. Wong highlighted that both trials showed some IBD patients generating “very, very high” titers, many of them above the threshold needed for donating convalescent plasma for COVID-19 treatment; still, exact titer levels needed to protect against SARS-CoV-2 infection remain unclear.
“This is going to require longitudinal studies,” Dr. Wong said. “We can’t answer that perfectly right now. We don’t know the magic level of antibodies. I don’t know if you need a titer of 1:100 or 1:1,000.”
Although postvaccination antibody testing is not recommended by the Centers for Disease Control and Prevention, Dr. Wong said that “many patients” check their titers anyway, leading to anxiety if antibodies are low or undetectable.
“I know that it’s very disconcerting sometimes when you don’t see an antibody response, and this is one of the hardest things to try to explain to patients,” Dr. Wong said. “[It’s necessary] to have a frank discussion about the fact that we don’t know the magic level of antibodies, and that there are also other parts of the immune system that we haven’t tested with antibodies. We haven’t tested the T-cell response, and we do know you can have a T-cell response even if you don’t have a B-cell response.”
Dr. Wong suggested that more work is needed to determine the impact of the IBD disease process on susceptibility to SARS-CoV-2 infection, and the rates of antibody responses for the various other vaccines being used around the world.
The PREVENT-COVID study was supported by the Leona M. and Harry B. Helmsley Charitable Trust. The investigators disclosed additional relationships with AbbVie, Johnson & Johnson, Genentech, and others. Dr. Wong reported no relevant conflicts of interest.
This article was updated Oct. 28, 2021.
Most patients with inflammatory bowel disease (IBD) develop a humoral immune response after completing an mRNA SARS-CoV-2 vaccine series, according to data from almost 800 patients.
Anti–receptor binding domain IgG antibodies specific to SARS-CoV-2 were detectable in 95% of patients, with “generally similar” results across vaccine type, age group, and medication class, apart from corticosteroid users, who had an 86% antibody detection rate, reported lead author Kimberly N. Weaver, MD, of the University of North Carolina at Chapel Hill, and colleagues.
“Patients with IBD on immunosuppressive medications have the potential for attenuated response to the SARS-CoV-2 vaccination,” Dr. Weaver said at the annual meeting of the American College of Gastroenterology.
In support of this possibility, Dr. Weaver cited two recent trials from earlier in 2021: one demonstrated blunted antibody responses in IBD patients taking infliximab, while the other showed that full vaccination was less effective at preventing SARS-CoV-2 infection among patients with IBD than nonimmunosuppressed individuals.
To better characterize antibody responses after receiving an mRNA vaccination series, Dr. Weaver and colleagues launched the PREVENT-COVID trial, including the present dataset of 787 patients with IBD older than 12 years, all of whom provided serum samples 8 weeks after completing an mRNA vaccine series. Patients with positive nucleocapsid antibody (indicating prior infection), and/or those who reported prior COVID-19 infection, were excluded. Most patients were White (95%) and female (73%), with an average age of 48 years. Slightly more patients received the BNT162b2 vaccine than the mRNA-1273 vaccine (58% vs. 42%).
At 8 weeks, 752 out of 787 patients had detectable antibodies (95%). Antibody rates were highest among patients receiving vedolizumab monotherapy (n = 83; 99%) or ustekinumab monotherapy (n = 102; 99%), followed by mercaptopurine, azathioprine, or methotrexate monotherapy (n = 67; 97%); anti–tumor necrosis factor monotherapy (n = 270; 96%); mesalamine, sulfasalazine, or budesonide monotherapy or no medication (n = 143; 95%); and finally anti-TNF/immunosuppressive combination therapy (n = 75; 86%). Median and mean antibody titers were lowest for anti-TNF combination therapy and highest for vedolizumab.
Thirty-five patients taking corticosteroids had an antibody detection rate of 85.7% (95% CI, 70.6-93.7), compared with 95.9% (95% CI, 94.2-97.1) among nonsteroid users. In contrast, antibody detection rates were not significantly affected by age or vaccine type.
“Reassuringly, most IBD medications do not prevent an initial antibody response after SARS-CoV-2 vaccination, and this is unlike other classes of immune suppression such as B-cell depletion therapy,” Dr. Weaver concluded. “Additional data are forthcoming on a larger subset of participants in the PREVENT-COVID study which will allow for analysis of factors associated with humoral immune response and potential optimization of immunization strategies.” She described a dataset of about 500 IBD patients in which booster vaccines overcame poor antibody responses to the initial vaccine series.
‘The data we need’
Serre-yu Wong, MD, PhD, of Icahn School of Medicine at Mount Sinai, New York, agreed that the findings should offer some reassurance to patients with IBD and their care providers.
“At the end of the day we have really nice seroconversion rates for the IBD population,” Dr. Wong said.
In April 2021, Dr. Wong and the ICARUS-IBD Working Group published a similar report of 48 patients with IBD receiving biologic therapies, among whom the seroconversion rate was 100%.
“A lot of the early data, including ours, are on infusion medications, and that’s sort of a practical thing because those were the only patients we could get samples from, but [Dr. Weaver and colleagues] were able to get samples from patients not on medications, on oral medications, and on other injection medications that people can take at home, and these are really the data we need for all of our other IBD patients,” Dr. Wong said.
Dr. Wong highlighted that both trials showed some IBD patients generating “very, very high” titers, many of them above the threshold needed for donating convalescent plasma for COVID-19 treatment; still, exact titer levels needed to protect against SARS-CoV-2 infection remain unclear.
“This is going to require longitudinal studies,” Dr. Wong said. “We can’t answer that perfectly right now. We don’t know the magic level of antibodies. I don’t know if you need a titer of 1:100 or 1:1,000.”
Although postvaccination antibody testing is not recommended by the Centers for Disease Control and Prevention, Dr. Wong said that “many patients” check their titers anyway, leading to anxiety if antibodies are low or undetectable.
“I know that it’s very disconcerting sometimes when you don’t see an antibody response, and this is one of the hardest things to try to explain to patients,” Dr. Wong said. “[It’s necessary] to have a frank discussion about the fact that we don’t know the magic level of antibodies, and that there are also other parts of the immune system that we haven’t tested with antibodies. We haven’t tested the T-cell response, and we do know you can have a T-cell response even if you don’t have a B-cell response.”
Dr. Wong suggested that more work is needed to determine the impact of the IBD disease process on susceptibility to SARS-CoV-2 infection, and the rates of antibody responses for the various other vaccines being used around the world.
The PREVENT-COVID study was supported by the Leona M. and Harry B. Helmsley Charitable Trust. The investigators disclosed additional relationships with AbbVie, Johnson & Johnson, Genentech, and others. Dr. Wong reported no relevant conflicts of interest.
This article was updated Oct. 28, 2021.
Most patients with inflammatory bowel disease (IBD) develop a humoral immune response after completing an mRNA SARS-CoV-2 vaccine series, according to data from almost 800 patients.
Anti–receptor binding domain IgG antibodies specific to SARS-CoV-2 were detectable in 95% of patients, with “generally similar” results across vaccine type, age group, and medication class, apart from corticosteroid users, who had an 86% antibody detection rate, reported lead author Kimberly N. Weaver, MD, of the University of North Carolina at Chapel Hill, and colleagues.
“Patients with IBD on immunosuppressive medications have the potential for attenuated response to the SARS-CoV-2 vaccination,” Dr. Weaver said at the annual meeting of the American College of Gastroenterology.
In support of this possibility, Dr. Weaver cited two recent trials from earlier in 2021: one demonstrated blunted antibody responses in IBD patients taking infliximab, while the other showed that full vaccination was less effective at preventing SARS-CoV-2 infection among patients with IBD than nonimmunosuppressed individuals.
To better characterize antibody responses after receiving an mRNA vaccination series, Dr. Weaver and colleagues launched the PREVENT-COVID trial, including the present dataset of 787 patients with IBD older than 12 years, all of whom provided serum samples 8 weeks after completing an mRNA vaccine series. Patients with positive nucleocapsid antibody (indicating prior infection), and/or those who reported prior COVID-19 infection, were excluded. Most patients were White (95%) and female (73%), with an average age of 48 years. Slightly more patients received the BNT162b2 vaccine than the mRNA-1273 vaccine (58% vs. 42%).
At 8 weeks, 752 out of 787 patients had detectable antibodies (95%). Antibody rates were highest among patients receiving vedolizumab monotherapy (n = 83; 99%) or ustekinumab monotherapy (n = 102; 99%), followed by mercaptopurine, azathioprine, or methotrexate monotherapy (n = 67; 97%); anti–tumor necrosis factor monotherapy (n = 270; 96%); mesalamine, sulfasalazine, or budesonide monotherapy or no medication (n = 143; 95%); and finally anti-TNF/immunosuppressive combination therapy (n = 75; 86%). Median and mean antibody titers were lowest for anti-TNF combination therapy and highest for vedolizumab.
Thirty-five patients taking corticosteroids had an antibody detection rate of 85.7% (95% CI, 70.6-93.7), compared with 95.9% (95% CI, 94.2-97.1) among nonsteroid users. In contrast, antibody detection rates were not significantly affected by age or vaccine type.
“Reassuringly, most IBD medications do not prevent an initial antibody response after SARS-CoV-2 vaccination, and this is unlike other classes of immune suppression such as B-cell depletion therapy,” Dr. Weaver concluded. “Additional data are forthcoming on a larger subset of participants in the PREVENT-COVID study which will allow for analysis of factors associated with humoral immune response and potential optimization of immunization strategies.” She described a dataset of about 500 IBD patients in which booster vaccines overcame poor antibody responses to the initial vaccine series.
‘The data we need’
Serre-yu Wong, MD, PhD, of Icahn School of Medicine at Mount Sinai, New York, agreed that the findings should offer some reassurance to patients with IBD and their care providers.
“At the end of the day we have really nice seroconversion rates for the IBD population,” Dr. Wong said.
In April 2021, Dr. Wong and the ICARUS-IBD Working Group published a similar report of 48 patients with IBD receiving biologic therapies, among whom the seroconversion rate was 100%.
“A lot of the early data, including ours, are on infusion medications, and that’s sort of a practical thing because those were the only patients we could get samples from, but [Dr. Weaver and colleagues] were able to get samples from patients not on medications, on oral medications, and on other injection medications that people can take at home, and these are really the data we need for all of our other IBD patients,” Dr. Wong said.
Dr. Wong highlighted that both trials showed some IBD patients generating “very, very high” titers, many of them above the threshold needed for donating convalescent plasma for COVID-19 treatment; still, exact titer levels needed to protect against SARS-CoV-2 infection remain unclear.
“This is going to require longitudinal studies,” Dr. Wong said. “We can’t answer that perfectly right now. We don’t know the magic level of antibodies. I don’t know if you need a titer of 1:100 or 1:1,000.”
Although postvaccination antibody testing is not recommended by the Centers for Disease Control and Prevention, Dr. Wong said that “many patients” check their titers anyway, leading to anxiety if antibodies are low or undetectable.
“I know that it’s very disconcerting sometimes when you don’t see an antibody response, and this is one of the hardest things to try to explain to patients,” Dr. Wong said. “[It’s necessary] to have a frank discussion about the fact that we don’t know the magic level of antibodies, and that there are also other parts of the immune system that we haven’t tested with antibodies. We haven’t tested the T-cell response, and we do know you can have a T-cell response even if you don’t have a B-cell response.”
Dr. Wong suggested that more work is needed to determine the impact of the IBD disease process on susceptibility to SARS-CoV-2 infection, and the rates of antibody responses for the various other vaccines being used around the world.
The PREVENT-COVID study was supported by the Leona M. and Harry B. Helmsley Charitable Trust. The investigators disclosed additional relationships with AbbVie, Johnson & Johnson, Genentech, and others. Dr. Wong reported no relevant conflicts of interest.
This article was updated Oct. 28, 2021.
AT ACG 2021
The devil in the (masking) details
The Devil’s own face covering?
It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?
Maybe not forever, but …
A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”
There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.
Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.
COVID, you never let us down.
You’re the (hurricane) wind beneath my wings
Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.
In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.
One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.
And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.
Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”
Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
Not-so-essential oils
Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.
According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.
The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.
If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
Welcome to the Ministry of Sleep-Deprived Walks
Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.
Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.
In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.
To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.
The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.
The Devil’s own face covering?
It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?
Maybe not forever, but …
A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”
There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.
Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.
COVID, you never let us down.
You’re the (hurricane) wind beneath my wings
Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.
In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.
One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.
And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.
Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”
Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
Not-so-essential oils
Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.
According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.
The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.
If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
Welcome to the Ministry of Sleep-Deprived Walks
Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.
Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.
In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.
To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.
The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.
The Devil’s own face covering?
It’s been over a year and a half since the COVID-19 emergency was declared in the United States, and we’ve been starting to wonder what our good friend SARS-CoV-2 has left to give. The collective cynic/optimist in us figures that the insanity can’t last forever, right?
Maybe not forever, but …
A group of parents is suing the Central Bucks (Pa.) School District over school mask mandates, suggesting that the district has no legal authority to enforce such measures. Most of their arguments, Philadelphia Magazine says, are pretty standard stuff: Masks are causing depression, anxiety, and discomfort in their children; masks are a violation of their constitutional rights; and “masks are being used as a control mechanism over the population.”
There are some unusual claims, though. One of the parents, Shannon Harris, said that “wearing masks interferes with their religious duty to spread the word of God and forces them to participate in a satanic ritual,” according to the Philadelphia Inquirer.
Philadelphia Magazine decided to check on that “satanic ritual” claim by asking an expert, in this case a spokesperson for the Church of Satan. The Reverend Raul Antony said that “simply ‘wearing a mask’ is not a Satanic ritual, and anyone that genuinely thinks otherwise is a blithering idiot,” adding that the group’s rituals were available on its website.
COVID, you never let us down.
You’re the (hurricane) wind beneath my wings
Marriage isn’t easy. From finances to everyday stressors like work and children, maintaining a solid relationship is tough. Then a natural disaster shows up on top of everything else, and marriages actually improve, researchers found.
In a study published by Psychological Science, researchers surveyed 231 newlywed couples about the satisfaction of their marriage before and after Hurricane Harvey in 2017. They found after the hurricane couples had a “significant boost” in the satisfaction of their relationship.
One would think something like this would create what researchers call a “stress spillover,” creating a decrease in relationship satisfaction. Destruction to your home or even displacement after a natural disaster seems pretty stressful. But, “a natural disaster can really put things in perspective. People realize how important their partner is to them when they are jolted out of the day-to-day stress of life,” said Hannah Williamson, PhD, the lead author of the study.
And although everyone saw an increase, the biggest jumps in relationship satisfaction belonged to the people who were most unhappy before the hurricane. Unfortunately, the researchers also found that the effects were only temporary and the dissatisfaction came back within a year.
Dr. Williamson thinks there may be something to these findings that can be beneficial from a therapy standpoint where “couples can shift their perspective in a similar way without having to go through a natural disaster.”
Let’s hope she’s right, because the alternative is to seek out a rampaging hurricane every time your relationship is on the rocks, and that just seems impractical after the second or third year.
Not-so-essential oils
Many people use essential oils as a way to unwind and relax. Stressed? Can’t sleep? There’s probably an essential oil for that. However, it seems like these days a lot of things we love and/or think are good for us have a side that’s not so.
According to the Centers for Disease Control and Prevention, a woman from Georgia died from a rare bacteria called Burkholderia pseudomallei. There have been three previous infections in Kansas, Minnesota, and Texas throughout 2021; two of the four infections were in children. Melioidosis, the disease caused by B. pseudomallei, is usually found in southeast Asia and isn’t obvious or easy to diagnose, especially in places like decidedly untropical Minnesota.
The Georgia case was the real break in this medical mystery, as the infection was traced back to a Walmart product called “Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones” (a very pithy name). The bacteria were in the lavender and chamomile scent. The CDC is investigating all other product scents, and Walmart has recalled all lots of the product.
If you’ve got that particular essential oil, it’s probably for the best that you stop using it. Don’t worry, we’re sure there’s plenty of other essential oil–infused aromatherapy room sprays with gemstones out there for your scent-based needs.
Welcome to the Ministry of Sleep-Deprived Walks
Walking is simple, right? You put one foot in front of the other, and soon you’re walking out the door. Little kids can do it. Even zombies can walk, and they don’t even have brains.
Research from MIT and the University of São Paulo has shown that walking is a little trickier than we might think. One researcher in particular noticed that student volunteers tended to perform worse toward the end of semesters, as project deadlines and multiple exams crashed over their heads and they were deprived of solid sleep schedules.
In a study published in Scientific Reports, our intrepid walking researchers had a collection of students monitor their sleep patterns for 2 weeks; on average, the students got 6 hours per night, though some were able to compensate on weekends. On the final day of a 14-day period, some students pulled all-nighters while the rest were allowed to sleep as usual. Then all students performed a walking test involving keeping time with a metronome.
To absolutely no one’s surprise, the students who performed all-nighters before being tested walked the worst, but between the other students, the ones who compensated for sleep deprivation on weekends did better than those who got 6 hours every night, despite getting a similar amount of sleep overall. This effect persisted even when the compensating students performed their walking tests late in the week, just before they got their weekend beauty sleep.
The moral of the story? Sleep is good, and you should get more of it. But if you can’t, sleep in on weekends. Science has given you permission. All those suburban dads looking to get their teenagers up at 8 in the morning must be sweating right now.
Ohio records more deaths than births for first time
In 2020, around 143,661 Ohioans died and 129,313 Ohioans were born, according to The Columbus Dispatch. The trend appears to have continued so far this year, with 107,462 deaths and 100,781 births reported to date.
Deaths haven’t surpassed births in the 112 years since the state began compiling data in 1909, the newspaper reported. The state’s birth rate has been declining for years while the number of deaths has risen, though data shows that the COVID-19 pandemic accelerated the shift.
“It doesn’t surprise me at all,” Joseph Gastaldo, MD, the medical director of infectious diseases for OhioHealth, told the newspaper.
Ohio’s birth rate fell by 4% in 2020, which defied public expectations about a pandemic birth boom. In addition, the state reported 13,927 COVID-19 deaths throughout the year.
“It’s COVID, clearly,” he noted.
Alabama also recorded more deaths than births for the first time last year, according to The New York Times. The state reported 64,714 deaths and 57,641 births in 2020.
“Our state literally shrunk in 2020,” Scott Harris, MD, the state health officer for Alabama, said at a news conference in September.
The state had never recorded a gap that large, even during World War I, World War II, and the 1918 flu pandemic, he said. Alabama has kept records on the numbers since 1900.
“We’ve never had a time when deaths exceeded births,” Dr. Harris said.
In fact, about half of U.S. states reported death rates higher than birth rates in 2020, according to a recent study from researchers at the University of New Hampshire. In 2019, only five states --Maine, New Hampshire, Rhode Island, Vermont, and West Virginia -- reported more deaths than births.
In 2020, the United States reported a record of nearly 3.4 million deaths, which was 18% more than in 2019, the researchers found. COVID-19 was the primary reason for the increase in deaths, accounting for about 11% of total deaths. Meanwhile, births dropped by 4% to about 3.6 million.
The surplus of births over deaths added 229,000 people to the U.S. population in 2020, as compared to 892,000 in 2019, which means the country’s population growth slowed last year. The decline, paired with lower immigration rates during the pandemic, led to the smallest annual percentage population gain in at least 100 years.
“Deaths will likely exceed births again in many states in 2021,” Kenneth Johnson, PhD, a senior demographer and study author, wrote in a statement.
“How large or protracted these fertility declines and mortality increases will be remains to be seen, but they have already dramatically reduced population growth in the United States,” he said.
A version of this article first appeared on WebMD.com.
In 2020, around 143,661 Ohioans died and 129,313 Ohioans were born, according to The Columbus Dispatch. The trend appears to have continued so far this year, with 107,462 deaths and 100,781 births reported to date.
Deaths haven’t surpassed births in the 112 years since the state began compiling data in 1909, the newspaper reported. The state’s birth rate has been declining for years while the number of deaths has risen, though data shows that the COVID-19 pandemic accelerated the shift.
“It doesn’t surprise me at all,” Joseph Gastaldo, MD, the medical director of infectious diseases for OhioHealth, told the newspaper.
Ohio’s birth rate fell by 4% in 2020, which defied public expectations about a pandemic birth boom. In addition, the state reported 13,927 COVID-19 deaths throughout the year.
“It’s COVID, clearly,” he noted.
Alabama also recorded more deaths than births for the first time last year, according to The New York Times. The state reported 64,714 deaths and 57,641 births in 2020.
“Our state literally shrunk in 2020,” Scott Harris, MD, the state health officer for Alabama, said at a news conference in September.
The state had never recorded a gap that large, even during World War I, World War II, and the 1918 flu pandemic, he said. Alabama has kept records on the numbers since 1900.
“We’ve never had a time when deaths exceeded births,” Dr. Harris said.
In fact, about half of U.S. states reported death rates higher than birth rates in 2020, according to a recent study from researchers at the University of New Hampshire. In 2019, only five states --Maine, New Hampshire, Rhode Island, Vermont, and West Virginia -- reported more deaths than births.
In 2020, the United States reported a record of nearly 3.4 million deaths, which was 18% more than in 2019, the researchers found. COVID-19 was the primary reason for the increase in deaths, accounting for about 11% of total deaths. Meanwhile, births dropped by 4% to about 3.6 million.
The surplus of births over deaths added 229,000 people to the U.S. population in 2020, as compared to 892,000 in 2019, which means the country’s population growth slowed last year. The decline, paired with lower immigration rates during the pandemic, led to the smallest annual percentage population gain in at least 100 years.
“Deaths will likely exceed births again in many states in 2021,” Kenneth Johnson, PhD, a senior demographer and study author, wrote in a statement.
“How large or protracted these fertility declines and mortality increases will be remains to be seen, but they have already dramatically reduced population growth in the United States,” he said.
A version of this article first appeared on WebMD.com.
In 2020, around 143,661 Ohioans died and 129,313 Ohioans were born, according to The Columbus Dispatch. The trend appears to have continued so far this year, with 107,462 deaths and 100,781 births reported to date.
Deaths haven’t surpassed births in the 112 years since the state began compiling data in 1909, the newspaper reported. The state’s birth rate has been declining for years while the number of deaths has risen, though data shows that the COVID-19 pandemic accelerated the shift.
“It doesn’t surprise me at all,” Joseph Gastaldo, MD, the medical director of infectious diseases for OhioHealth, told the newspaper.
Ohio’s birth rate fell by 4% in 2020, which defied public expectations about a pandemic birth boom. In addition, the state reported 13,927 COVID-19 deaths throughout the year.
“It’s COVID, clearly,” he noted.
Alabama also recorded more deaths than births for the first time last year, according to The New York Times. The state reported 64,714 deaths and 57,641 births in 2020.
“Our state literally shrunk in 2020,” Scott Harris, MD, the state health officer for Alabama, said at a news conference in September.
The state had never recorded a gap that large, even during World War I, World War II, and the 1918 flu pandemic, he said. Alabama has kept records on the numbers since 1900.
“We’ve never had a time when deaths exceeded births,” Dr. Harris said.
In fact, about half of U.S. states reported death rates higher than birth rates in 2020, according to a recent study from researchers at the University of New Hampshire. In 2019, only five states --Maine, New Hampshire, Rhode Island, Vermont, and West Virginia -- reported more deaths than births.
In 2020, the United States reported a record of nearly 3.4 million deaths, which was 18% more than in 2019, the researchers found. COVID-19 was the primary reason for the increase in deaths, accounting for about 11% of total deaths. Meanwhile, births dropped by 4% to about 3.6 million.
The surplus of births over deaths added 229,000 people to the U.S. population in 2020, as compared to 892,000 in 2019, which means the country’s population growth slowed last year. The decline, paired with lower immigration rates during the pandemic, led to the smallest annual percentage population gain in at least 100 years.
“Deaths will likely exceed births again in many states in 2021,” Kenneth Johnson, PhD, a senior demographer and study author, wrote in a statement.
“How large or protracted these fertility declines and mortality increases will be remains to be seen, but they have already dramatically reduced population growth in the United States,” he said.
A version of this article first appeared on WebMD.com.
Unvaccinated pregnant women have more severe COVID
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.
An increasing number of people who are unvaccinated and pregnant are being hospitalized for COVID-19, report investigators who saw hospital admissions double in a single year.
“With the surge, we had expected to begin treating patients who developed severe or critical illness again in pregnancy,” says Emily Adhikari, MD, from the University of Texas Southwestern Medical Center in Dallas. “But we did not expect the level of respiratory illness that we began to see in our patients. That was a surprise and an alarming finding that we felt was really important to get out there.”
The researchers followed more than 1,500 pregnant women diagnosed with COVID-19 who received care from Parkland Health and Hospital System in Dallas County, one of the nation’s busiest for deliveries. After the emergence of the Delta variant, the number of pregnant women hospitalized with COVID-19 more than doubled over the previous year.
And 82 pregnant women went on to develop severe or critical COVID, they report in their study, published online in the American Journal of Obstetrics and Gynecology. All but 1 of these patients were unvaccinated, 10 needed a ventilator, and two died.
The proportion of cases that were critical was about 5% in 2020. However, in April 2021, even though the number of total cases remained low, the number of severe illnesses started to rise. After the Delta variant became dominant, both the number and severity of cases increased, and after August 2021, more than 25% of pregnant people diagnosed with COVID-19 required hospitalization.
Hospitalizations Double
“We need to focus and really act urgently to recommend vaccination in pregnancy because that is the primary prevention tool that we have,” says Dr. Adhikari. “We do not have a proven cure for this illness, and that is important to know.”
These findings, which focus on a vulnerable population, are especially important given the elevated prevalence of COVID-19 in pregnant people of lower economic status, said Lissette Tanner, MD, MPH, from Emory University in Atlanta, who was not involved with the study.
“There are higher rates of hospitalization and death among Black, Hispanic, and Native American communities,” she reported. “It is essential to know how the virus is affecting those most affected and often most disadvantaged to deal with the pandemic.”
Vaccination rates are low in this population; just 19.2% of pregnant women receive at least one dose during pregnancy, according to the CDC. But pregnancy confers a higher risk for severe COVID-19 illness and for adverse outcomes, such as preterm birth and stillbirth.
Of the 665 people in the study cohort who were pregnant or had given birth when the vaccines were available, only 21.4% received at least one dose of a COVID-19 vaccine.
Given the increased risk for COVID-19 during pregnancy, the American College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, and the CDC recommend vaccination for people who are pregnant, breastfeeding, or trying to get pregnant.
According to ACOG, pregnant women who are fully vaccinated can follow the same guidelines as everyone else who is fully vaccinated; however, to prevent breakthrough infections, they might want to continue wearing a mask. ACOG also recommends that those not fully vaccinated follow physical-distancing guidelines and limit contact with people as much as possible to avoid infection.
A version of this article first appeared on WebMD.com.
FDA panel votes to approve Pfizer’s vaccine for children
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Pandemic exacerbates primary care practices’ financial struggles
according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).
Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.
Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.
PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.
Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.
“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”
COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.
Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.
In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”
The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.
Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”
End to paycheck protection hurt practices
Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.
“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.
Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.
His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.
“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.
The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.
“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”
Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.
Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.
Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
COVID-19 brought ‘accelerated change’
COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.
Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.
A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.
From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.
Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.
One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”
According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.
These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.
Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
Uncertainty around telemedicine
A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.
In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.
Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.
In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.
“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.
If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
Possible safety nets
Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.
The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.
“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”
Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.
according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).
Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.
Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.
PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.
Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.
“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”
COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.
Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.
In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”
The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.
Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”
End to paycheck protection hurt practices
Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.
“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.
Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.
His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.
“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.
The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.
“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”
Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.
Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.
Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
COVID-19 brought ‘accelerated change’
COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.
Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.
A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.
From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.
Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.
One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”
According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.
These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.
Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
Uncertainty around telemedicine
A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.
In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.
Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.
In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.
“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.
If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
Possible safety nets
Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.
The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.
“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”
Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.
according to experts and the results of recent surveys by the Primary Care Collaborative (PCC).
Fewer than 30% (26.4%) of primary care clinicians report that their practices are financially healthy, according to the latest results from a periodic survey by the PCC. An earlier survey by the PCC suggests clinicians’ confidence in the financial viability of their practices has significantly declined since last year, when compared with the new survey’s results. When the older survey was taken between Sept. 4 and Sept. 8 of 2020, only 35% of primary care clinicians said that revenue and pay were significantly lower than they were before the pandemic.
Submissions to the new PCC survey were collected between Aug. 13 and Aug. 17 of 2021 and included 1,263 respondents from 49 states, the District of Columbia, and two territories. The PCC and the Larry A. Green Center have been regularly surveying primary care clinicians to better understand the impact of COVID-19 throughout the pandemic.
PCC President and CEO Ann Greiner said in an interview that the drop over a year follows a trend.
Though primary care faced struggles before the pandemic, the COVID-19 effect has been striking and cumulative, she noted.
“[Primary care practices] were healthier prepandemic,” said Ms. Greiner. “The precipitous drop in revenue when stay-at-home orders went into effect had a very big effect though pay structure and lack of investment in primary care was a problem long before COVID-19.”
COVID-19 has exacerbated all that ails primary care, and has increased fears of viability of primary care offices, she said.
Ms. Greiner pointed to a report from Health Affairs, that projected in 2020 that primary care would lose $65,000 in revenue per full-time physician by the end of the year for a total shortfall of $15 billion, following steep drops in office visits and fees for services from March to May, 2020.
In July of this year, she said, PCC’s survey found that, “Four in 10 clinicians worry that primary care will be gone in 5 years and one-fifth of respondents expect to leave the profession within the next three.”
The July PCC survey also showed that 13% of primary care clinicians said they have discussed selling their practice and cite high-level burnout/exhaustion as a main challenge for the next 6 months.
Robert L. Phillips, MD, a Virginia-based physician who oversees research for the American Board of Family Medicine, said, “Practices in our national primary care practice registry (PRIME) saw visit volumes drop 40% in the 2-3 months around the start of the pandemic and had not seen them return to normal as of June of this year. This means most remain financially underwater.”
End to paycheck protection hurt practices
Conrad L. Flick, MD, managing partner of Family Medical Associates in Raleigh, N.C., said the end of the federal Paycheck Protection Program (PPP) at the end of 2020 caused further distress to primary care and could also help explain the drop in healthy practices that PCC’s survey from last year suggested.
“Many of us who struggled financially as the pandemic hit last year were really worried. PPP certainly shored that up for a lot of us. But now it’s no longer here,” he said.
Dr. Flick said his 10-clinician independent practice is financially sound and he credits that to having the PPP loan, shared savings from an accountable care organization, and holding some profit over from last year to this year.
His practice had to cut two nurse practitioners this year when volume did not return to prepandemic levels.
“The PPP loan let us keep [those NPs] employed through spring, but we were hoping the volume would come back. Come spring this year the volume hasn’t come back, and we couldn’t afford to keep the office at full staff,” he said.
The way primary care physicians are paid is what makes them so vulnerable in a pandemic, he explained.
“Our revenue is purely based on how many people I can get through my office at a given period of time. We don’t have ways to generate revenue and build a cushion.”
Family physician L. Allen Dobson, MD, said the survey results may have become even more grim in the last year, because primary care practices, especially small practices, have not recovered from the 2020 losses and effects have snowballed.
Even though primary care offices have largely reopened and many patients have returned to in-person visits, he said, physicians are dealing with uncertainties of COVID-19 surges and variants and are having trouble recruiting and maintaining staff.
Revenue that should have come to primary care practices in testing and distributing vaccines instead went elsewhere to larger vaccination sites and retail clinics, noted Dr. Dobson, who is chair of the board of managers of Community Care Physicians Network in Mount Pleasant, N.C., which provides assistance with administrative tasks to small and solo primary care practices.
COVID-19 brought ‘accelerated change’
COVID-19 brought “an accelerated change,” in decreasing revenue, Dr. Dobson said.
Small primary care practices have followed the rules of changing to electronic health records, getting patient-centered medical home certification, and documenting quality improvement measures, but they have not reaped the financial benefits from these changes, he explained.
A report commissioned by the Physician Advocacy Institute found that the pandemic accelerated a long national trend of hospitals and corporate entities acquiring physician practices and employing physicians.
From January 2019 to January 2021, these entities acquired 20,900 additional physician practices and 48,000 additional physicians left independent practice for employment by hospital systems or other corporate entities.
Further straining practices is a thinning workforce, with 21% or respondents to the most recent PCC survey having said they were unable to hire clinicians for open positions and 54% saying they are unable to hire staff for open positions.
One respondent to the PCC survey from Utah said, “We need more support. It’s a moral injury to have our pay cut and be severely understaffed. Most of the burden of educating patients and getting them vaccinated has fallen to primary care and we are already overwhelmed with taking care of patients with worsening mental and physical health.”
According to Bruce Landon, MD, MBA, professor of health care policy at the Harvard Medical School’s Center for Primary Care, Boston, another source of financial strain for primary care practices is that they are having difficulty attracting doctors, nurses, and administrators.
These practices often need to increase pay for those positions to recruit people, and they are leaving many positions unfilled, Dr. Landon explained.
Plus, COVID-19 introduced costs for personal protective equipment (PPE) and cleaning products, and those expenses generally have not been reimbursed, Dr. Landon said.
Uncertainty around telemedicine
A new risk for primary care is a decline in telemedicine payments at a time when practices are still relying on telemedicine for revenue.
In the most recent PCC report, 40% of clinicians said they use telemedicine for at least a fifth of all office visits.
Even though most practices have reopened there’s still a fair amount of telemedicine and that will continue, Dr. Landon said in an interview.
In March of 2020, the Centers for Medicare & Medicaid Services lifted restrictions and that helped physicians with getting reimbursed for the services as they would office visits. But some commercial payers are starting to back off full payment for telemedicine, Dr. Landon noted.
“At some point the feds will probably start to do that with Medicare. I think that’s a mistake. [Telemedicine] has been one of the silver linings of this cloud of the pandemic,” he said.
If prepandemic payment regulations are restored, 41% of clinicians said, in the most recent PCC survey, that they worry their practices will no longer be able to support telemedicine.
Possible safety nets
Dr. Landon said that one thing that’s also clear is that some form of primary care capitation payment is necessary, at least for some of the work in primary care.
The practices that had capitation as part of payment were the ones who were most easily able to handle the pandemic because they didn’t see the immediate drop in revenue that fee-for-service practices saw, he noted.
“If we have a next pandemic, having a steady revenue stream to support primary care is really important and having a different way to pay for primary care is probably the best way to do that,” he said. “These longer-term strategies are going to be really crucial if we want to have a primary care system 10 years from now.”
Ms. Greiner, Dr. Flick, Dr. Phillips, Dr. Dobson, and Dr. Landon report no relevant financial relationships.
Unvaccinated people likely to catch COVID repeatedly
according to a recent study published in The Lancet Microbe.
Since COVID-19 hasn’t existed for long enough to perform a long-term study, researchers at Yale University and the University of North Carolina at Charlotte looked at reinfection data for six other human-infecting coronaviruses, including SARS and MERS.
“Reinfection can reasonably happen in three months or less,” Jeffrey Townsend, PhD, lead study author and a biostatistics professor at the Yale School of Public Health, said in a statement.
“Therefore, those who have been naturally infected should get vaccinated,” he said. “Previous infection alone can offer very little long-term protection against subsequent infections.”
The research team looked at post-infection data for six coronaviruses between 1984-2020 and found reinfection ranged from 128 days to 28 years. They calculated that reinfection with COVID-19 would likely occur between 3 months to 5 years after peak antibody response, with an average of 16 months. This is less than half the duration seen for other coronaviruses that circulate among humans.
The risk of COVID-19 reinfection is about 5% at three months, which jumps to 50% after 17 months, the research team found. Reinfection could become increasingly common as immunity wanes and new variants develop, they said.
“We tend to think about immunity as being immune or not immune. Our study cautions that we instead should be more focused on the risk of reinfection through time,” Alex Dornburg, PhD, senior study author and assistant professor of bioinformatics and genomics at UNC, said in the statement.
“As new variants arise, previous immune responses become less effective at combating the virus,” he said. “Those who were naturally infected early in the pandemic are increasingly likely to become reinfected in the near future.”
Study estimates are based on average times of declining immunity across different coronaviruses, the researchers told the Yale Daily News. At the individual level, people have different levels of immunity, which can provide shorter or longer duration of protection based on immune status, immunity within a community, age, underlying health conditions, environmental exposure, and other factors.
The research team said that preventive health measures and global distribution of vaccines will be “critical” in minimizing reinfection and COVID-19 deaths. In areas with low vaccination rates, for instance, unvaccinated people should continue safety practices such as social distancing, wearing masks, and proper indoor ventilation to avoid reinfection.
“We need to be very aware of the fact that this disease is likely to be circulating over the long term and that we don’t have this long-term immunity that many people seem to be hoping to rely on in order to protect them from disease,” Dr. Townsend told the newspaper.
A version of this article first appeared on WebMD.com.
according to a recent study published in The Lancet Microbe.
Since COVID-19 hasn’t existed for long enough to perform a long-term study, researchers at Yale University and the University of North Carolina at Charlotte looked at reinfection data for six other human-infecting coronaviruses, including SARS and MERS.
“Reinfection can reasonably happen in three months or less,” Jeffrey Townsend, PhD, lead study author and a biostatistics professor at the Yale School of Public Health, said in a statement.
“Therefore, those who have been naturally infected should get vaccinated,” he said. “Previous infection alone can offer very little long-term protection against subsequent infections.”
The research team looked at post-infection data for six coronaviruses between 1984-2020 and found reinfection ranged from 128 days to 28 years. They calculated that reinfection with COVID-19 would likely occur between 3 months to 5 years after peak antibody response, with an average of 16 months. This is less than half the duration seen for other coronaviruses that circulate among humans.
The risk of COVID-19 reinfection is about 5% at three months, which jumps to 50% after 17 months, the research team found. Reinfection could become increasingly common as immunity wanes and new variants develop, they said.
“We tend to think about immunity as being immune or not immune. Our study cautions that we instead should be more focused on the risk of reinfection through time,” Alex Dornburg, PhD, senior study author and assistant professor of bioinformatics and genomics at UNC, said in the statement.
“As new variants arise, previous immune responses become less effective at combating the virus,” he said. “Those who were naturally infected early in the pandemic are increasingly likely to become reinfected in the near future.”
Study estimates are based on average times of declining immunity across different coronaviruses, the researchers told the Yale Daily News. At the individual level, people have different levels of immunity, which can provide shorter or longer duration of protection based on immune status, immunity within a community, age, underlying health conditions, environmental exposure, and other factors.
The research team said that preventive health measures and global distribution of vaccines will be “critical” in minimizing reinfection and COVID-19 deaths. In areas with low vaccination rates, for instance, unvaccinated people should continue safety practices such as social distancing, wearing masks, and proper indoor ventilation to avoid reinfection.
“We need to be very aware of the fact that this disease is likely to be circulating over the long term and that we don’t have this long-term immunity that many people seem to be hoping to rely on in order to protect them from disease,” Dr. Townsend told the newspaper.
A version of this article first appeared on WebMD.com.
according to a recent study published in The Lancet Microbe.
Since COVID-19 hasn’t existed for long enough to perform a long-term study, researchers at Yale University and the University of North Carolina at Charlotte looked at reinfection data for six other human-infecting coronaviruses, including SARS and MERS.
“Reinfection can reasonably happen in three months or less,” Jeffrey Townsend, PhD, lead study author and a biostatistics professor at the Yale School of Public Health, said in a statement.
“Therefore, those who have been naturally infected should get vaccinated,” he said. “Previous infection alone can offer very little long-term protection against subsequent infections.”
The research team looked at post-infection data for six coronaviruses between 1984-2020 and found reinfection ranged from 128 days to 28 years. They calculated that reinfection with COVID-19 would likely occur between 3 months to 5 years after peak antibody response, with an average of 16 months. This is less than half the duration seen for other coronaviruses that circulate among humans.
The risk of COVID-19 reinfection is about 5% at three months, which jumps to 50% after 17 months, the research team found. Reinfection could become increasingly common as immunity wanes and new variants develop, they said.
“We tend to think about immunity as being immune or not immune. Our study cautions that we instead should be more focused on the risk of reinfection through time,” Alex Dornburg, PhD, senior study author and assistant professor of bioinformatics and genomics at UNC, said in the statement.
“As new variants arise, previous immune responses become less effective at combating the virus,” he said. “Those who were naturally infected early in the pandemic are increasingly likely to become reinfected in the near future.”
Study estimates are based on average times of declining immunity across different coronaviruses, the researchers told the Yale Daily News. At the individual level, people have different levels of immunity, which can provide shorter or longer duration of protection based on immune status, immunity within a community, age, underlying health conditions, environmental exposure, and other factors.
The research team said that preventive health measures and global distribution of vaccines will be “critical” in minimizing reinfection and COVID-19 deaths. In areas with low vaccination rates, for instance, unvaccinated people should continue safety practices such as social distancing, wearing masks, and proper indoor ventilation to avoid reinfection.
“We need to be very aware of the fact that this disease is likely to be circulating over the long term and that we don’t have this long-term immunity that many people seem to be hoping to rely on in order to protect them from disease,” Dr. Townsend told the newspaper.
A version of this article first appeared on WebMD.com.
My experience as a family medicine resident in 2021
I did not get a medical school graduation; I was one of the many thousands of newly graduated students who simply left their 4th-year rotation sites one chilly day in March 2020 and just never went back. My medical school education didn’t end with me walking triumphantly across the stage – a first-generation college student finally achieving the greatest dream in her life. Instead, it ended with a Zoom “graduation” and a cross-country move from Georgia to Pennsylvania amidst the greatest pandemic in recent memory. To say my impostor syndrome was bad would be an understatement.
Residency in the COVID-19-era
The joy and the draw to family medicine for me has always been the broad scope of conditions that we see and treat. From day 1, however, much of my residency has been devoted to one very small subset of patients – those with COVID-19. At one point, our hospital was so strained that our family medicine program had to run a second inpatient service alongside our usual five-resident service team just to provide care to everybody. Patients were in the hallways. The ER was packed to the gills. We were sleepless, terrified, unvaccinated, and desperate to help our patients survive a disease that was incompletely understood, with very few tools in our toolbox to combat it.
I distinctly remember sitting in the workroom with a coresident of mine, our faces seemingly permanently lined from wearing N95s all shift, and saying to him, “I worry I will be a bad family medicine physician. I worry I haven’t seen enough, other than COVID.” It was midway through my intern year; the days were short, so I was driving to and from the hospital in chilly darkness. My patients, like many around the country, were doing poorly. Vaccines seemed like a promise too good to be true. Worst of all: Those of us who were interns, who had no triumphant podium moment to end our medical school education, were suffering with an intense sense of impostor syndrome which was strengthened by every “there is nothing else we can offer your loved one at this time,” conversation we had. My apprehension about not having seen a wider breadth of medicine during my training is a sentiment still widely shared by COVID-era residents.
Luckily, my coresident was supportive.
“We’re going to be great family medicine physicians,” he said. “We’re learning the hard stuff – the bread and butter of FM – up-front. You’ll see.”
In some ways, I think he was right. Clinical skills, empathy, humility, and forging strong relationships are at the center of every family medicine physician’s heart; my generation has had to learn these skills early and under pressure. Sometimes, there are no answers. Sometimes, the best thing a family doctor can do for a patient is to hear them, understand them, and hold their hand.
‘We watched Cinderella together’
Shortly after that conversation with my coresident, I had a particular case which moved me. This gentleman with intellectual disability and COVID had been declining steadily since his admission to the hospital. He was isolated from everybody he knew and loved, but it did not dampen his spirits. He was cheerful to every person who entered his room, clad in their shrouds of PPE, which more often than not felt more like mourning garb than protective wear. I remember very little about this patient’s clinical picture – the COVID, the superimposed pneumonia, the repeated intubations. What I do remember is he loved the Disney classic, Cinderella. I knew this because I developed a very close relationship with his family during the course of his hospitalization. Amidst the torrential onslaught of patients, I made sure to call families every day – not because I wanted to, but because my mentors and attendings and coresidents had all drilled into me from day 1 that we are family medicine, and a large part of our role is to advocate for our patients, and to communicate with their loved ones. So I called. I learned a lot about him; his likes, his dislikes, his close bond with his siblings, and of course his lifelong love for Cinderella. On the last week of my ICU rotation, my patient passed peacefully. His nurse and I were bedside. We held his hand. We told him his family loved him. We watched Cinderella together on an iPad encased in protective plastic.
My next rotation was an outpatient one and it looked more like the “bread and butter” of family medicine. But as I whisked in and out of patient rooms, attending to patients with diabetes, with depression, with pain, I could not stop thinking about my hospitalized patients who my coresidents had assumed care of. Each exam room I entered, I rather morbidly thought “this patient could be next on our hospital service.” Without realizing it, I made more of an effort to get to know each patient holistically. I learned who they were as people. I found myself writing small, medically low-yield details in the chart: “Margaret loves to sing in her church choir;” “Katherine is a self-published author.”
I learned from my attendings. As I sat at the precepting table with them, observing their conversations about patients, their collective decades of experience were apparent.
“I’ve been seeing this patient every few weeks since I was a resident,” said one of my attendings.
“I don’t even see my parents that often,” I thought.
The depth of her relationship with, understanding of, and compassion for this patient struck me deeply. This was why I went into family medicine. My attending knew her patients; they were not faceless unknowns in a hospital gown to her. She would have known to play Cinderella for them in the end.
This is a unique time for trainees. We have been challenged, terrified, overwhelmed, and heartbroken. But at no point have we been isolated. We’ve had the generations of doctors before us to lead the way, to teach us the “hard stuff.” We’ve had senior residents to lean on, who have taken us aside and told us, “I can do the goals-of-care talk today, you need a break.” While the plague seems to have passed over our hospital for now, it has left behind a class of family medicine residents who are proud to carry on our specialty’s long tradition of compassionate, empathetic, lifelong care. “We care for all life stages, from cradle to grave,” says every family medicine physician.
My class, for better or for worse, has cared more often for patients in the twilight of their lives, and while it has been hard, I believe it has made us all better doctors. Now, when I hold a newborn in my arms for a well-child check, I am exceptionally grateful – for the opportunities I have been given, for new beginnings amidst so much sadness, and for the great privilege of being a family medicine physician.
Dr. Persampiere is a 2nd-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
I did not get a medical school graduation; I was one of the many thousands of newly graduated students who simply left their 4th-year rotation sites one chilly day in March 2020 and just never went back. My medical school education didn’t end with me walking triumphantly across the stage – a first-generation college student finally achieving the greatest dream in her life. Instead, it ended with a Zoom “graduation” and a cross-country move from Georgia to Pennsylvania amidst the greatest pandemic in recent memory. To say my impostor syndrome was bad would be an understatement.
Residency in the COVID-19-era
The joy and the draw to family medicine for me has always been the broad scope of conditions that we see and treat. From day 1, however, much of my residency has been devoted to one very small subset of patients – those with COVID-19. At one point, our hospital was so strained that our family medicine program had to run a second inpatient service alongside our usual five-resident service team just to provide care to everybody. Patients were in the hallways. The ER was packed to the gills. We were sleepless, terrified, unvaccinated, and desperate to help our patients survive a disease that was incompletely understood, with very few tools in our toolbox to combat it.
I distinctly remember sitting in the workroom with a coresident of mine, our faces seemingly permanently lined from wearing N95s all shift, and saying to him, “I worry I will be a bad family medicine physician. I worry I haven’t seen enough, other than COVID.” It was midway through my intern year; the days were short, so I was driving to and from the hospital in chilly darkness. My patients, like many around the country, were doing poorly. Vaccines seemed like a promise too good to be true. Worst of all: Those of us who were interns, who had no triumphant podium moment to end our medical school education, were suffering with an intense sense of impostor syndrome which was strengthened by every “there is nothing else we can offer your loved one at this time,” conversation we had. My apprehension about not having seen a wider breadth of medicine during my training is a sentiment still widely shared by COVID-era residents.
Luckily, my coresident was supportive.
“We’re going to be great family medicine physicians,” he said. “We’re learning the hard stuff – the bread and butter of FM – up-front. You’ll see.”
In some ways, I think he was right. Clinical skills, empathy, humility, and forging strong relationships are at the center of every family medicine physician’s heart; my generation has had to learn these skills early and under pressure. Sometimes, there are no answers. Sometimes, the best thing a family doctor can do for a patient is to hear them, understand them, and hold their hand.
‘We watched Cinderella together’
Shortly after that conversation with my coresident, I had a particular case which moved me. This gentleman with intellectual disability and COVID had been declining steadily since his admission to the hospital. He was isolated from everybody he knew and loved, but it did not dampen his spirits. He was cheerful to every person who entered his room, clad in their shrouds of PPE, which more often than not felt more like mourning garb than protective wear. I remember very little about this patient’s clinical picture – the COVID, the superimposed pneumonia, the repeated intubations. What I do remember is he loved the Disney classic, Cinderella. I knew this because I developed a very close relationship with his family during the course of his hospitalization. Amidst the torrential onslaught of patients, I made sure to call families every day – not because I wanted to, but because my mentors and attendings and coresidents had all drilled into me from day 1 that we are family medicine, and a large part of our role is to advocate for our patients, and to communicate with their loved ones. So I called. I learned a lot about him; his likes, his dislikes, his close bond with his siblings, and of course his lifelong love for Cinderella. On the last week of my ICU rotation, my patient passed peacefully. His nurse and I were bedside. We held his hand. We told him his family loved him. We watched Cinderella together on an iPad encased in protective plastic.
My next rotation was an outpatient one and it looked more like the “bread and butter” of family medicine. But as I whisked in and out of patient rooms, attending to patients with diabetes, with depression, with pain, I could not stop thinking about my hospitalized patients who my coresidents had assumed care of. Each exam room I entered, I rather morbidly thought “this patient could be next on our hospital service.” Without realizing it, I made more of an effort to get to know each patient holistically. I learned who they were as people. I found myself writing small, medically low-yield details in the chart: “Margaret loves to sing in her church choir;” “Katherine is a self-published author.”
I learned from my attendings. As I sat at the precepting table with them, observing their conversations about patients, their collective decades of experience were apparent.
“I’ve been seeing this patient every few weeks since I was a resident,” said one of my attendings.
“I don’t even see my parents that often,” I thought.
The depth of her relationship with, understanding of, and compassion for this patient struck me deeply. This was why I went into family medicine. My attending knew her patients; they were not faceless unknowns in a hospital gown to her. She would have known to play Cinderella for them in the end.
This is a unique time for trainees. We have been challenged, terrified, overwhelmed, and heartbroken. But at no point have we been isolated. We’ve had the generations of doctors before us to lead the way, to teach us the “hard stuff.” We’ve had senior residents to lean on, who have taken us aside and told us, “I can do the goals-of-care talk today, you need a break.” While the plague seems to have passed over our hospital for now, it has left behind a class of family medicine residents who are proud to carry on our specialty’s long tradition of compassionate, empathetic, lifelong care. “We care for all life stages, from cradle to grave,” says every family medicine physician.
My class, for better or for worse, has cared more often for patients in the twilight of their lives, and while it has been hard, I believe it has made us all better doctors. Now, when I hold a newborn in my arms for a well-child check, I am exceptionally grateful – for the opportunities I have been given, for new beginnings amidst so much sadness, and for the great privilege of being a family medicine physician.
Dr. Persampiere is a 2nd-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
I did not get a medical school graduation; I was one of the many thousands of newly graduated students who simply left their 4th-year rotation sites one chilly day in March 2020 and just never went back. My medical school education didn’t end with me walking triumphantly across the stage – a first-generation college student finally achieving the greatest dream in her life. Instead, it ended with a Zoom “graduation” and a cross-country move from Georgia to Pennsylvania amidst the greatest pandemic in recent memory. To say my impostor syndrome was bad would be an understatement.
Residency in the COVID-19-era
The joy and the draw to family medicine for me has always been the broad scope of conditions that we see and treat. From day 1, however, much of my residency has been devoted to one very small subset of patients – those with COVID-19. At one point, our hospital was so strained that our family medicine program had to run a second inpatient service alongside our usual five-resident service team just to provide care to everybody. Patients were in the hallways. The ER was packed to the gills. We were sleepless, terrified, unvaccinated, and desperate to help our patients survive a disease that was incompletely understood, with very few tools in our toolbox to combat it.
I distinctly remember sitting in the workroom with a coresident of mine, our faces seemingly permanently lined from wearing N95s all shift, and saying to him, “I worry I will be a bad family medicine physician. I worry I haven’t seen enough, other than COVID.” It was midway through my intern year; the days were short, so I was driving to and from the hospital in chilly darkness. My patients, like many around the country, were doing poorly. Vaccines seemed like a promise too good to be true. Worst of all: Those of us who were interns, who had no triumphant podium moment to end our medical school education, were suffering with an intense sense of impostor syndrome which was strengthened by every “there is nothing else we can offer your loved one at this time,” conversation we had. My apprehension about not having seen a wider breadth of medicine during my training is a sentiment still widely shared by COVID-era residents.
Luckily, my coresident was supportive.
“We’re going to be great family medicine physicians,” he said. “We’re learning the hard stuff – the bread and butter of FM – up-front. You’ll see.”
In some ways, I think he was right. Clinical skills, empathy, humility, and forging strong relationships are at the center of every family medicine physician’s heart; my generation has had to learn these skills early and under pressure. Sometimes, there are no answers. Sometimes, the best thing a family doctor can do for a patient is to hear them, understand them, and hold their hand.
‘We watched Cinderella together’
Shortly after that conversation with my coresident, I had a particular case which moved me. This gentleman with intellectual disability and COVID had been declining steadily since his admission to the hospital. He was isolated from everybody he knew and loved, but it did not dampen his spirits. He was cheerful to every person who entered his room, clad in their shrouds of PPE, which more often than not felt more like mourning garb than protective wear. I remember very little about this patient’s clinical picture – the COVID, the superimposed pneumonia, the repeated intubations. What I do remember is he loved the Disney classic, Cinderella. I knew this because I developed a very close relationship with his family during the course of his hospitalization. Amidst the torrential onslaught of patients, I made sure to call families every day – not because I wanted to, but because my mentors and attendings and coresidents had all drilled into me from day 1 that we are family medicine, and a large part of our role is to advocate for our patients, and to communicate with their loved ones. So I called. I learned a lot about him; his likes, his dislikes, his close bond with his siblings, and of course his lifelong love for Cinderella. On the last week of my ICU rotation, my patient passed peacefully. His nurse and I were bedside. We held his hand. We told him his family loved him. We watched Cinderella together on an iPad encased in protective plastic.
My next rotation was an outpatient one and it looked more like the “bread and butter” of family medicine. But as I whisked in and out of patient rooms, attending to patients with diabetes, with depression, with pain, I could not stop thinking about my hospitalized patients who my coresidents had assumed care of. Each exam room I entered, I rather morbidly thought “this patient could be next on our hospital service.” Without realizing it, I made more of an effort to get to know each patient holistically. I learned who they were as people. I found myself writing small, medically low-yield details in the chart: “Margaret loves to sing in her church choir;” “Katherine is a self-published author.”
I learned from my attendings. As I sat at the precepting table with them, observing their conversations about patients, their collective decades of experience were apparent.
“I’ve been seeing this patient every few weeks since I was a resident,” said one of my attendings.
“I don’t even see my parents that often,” I thought.
The depth of her relationship with, understanding of, and compassion for this patient struck me deeply. This was why I went into family medicine. My attending knew her patients; they were not faceless unknowns in a hospital gown to her. She would have known to play Cinderella for them in the end.
This is a unique time for trainees. We have been challenged, terrified, overwhelmed, and heartbroken. But at no point have we been isolated. We’ve had the generations of doctors before us to lead the way, to teach us the “hard stuff.” We’ve had senior residents to lean on, who have taken us aside and told us, “I can do the goals-of-care talk today, you need a break.” While the plague seems to have passed over our hospital for now, it has left behind a class of family medicine residents who are proud to carry on our specialty’s long tradition of compassionate, empathetic, lifelong care. “We care for all life stages, from cradle to grave,” says every family medicine physician.
My class, for better or for worse, has cared more often for patients in the twilight of their lives, and while it has been hard, I believe it has made us all better doctors. Now, when I hold a newborn in my arms for a well-child check, I am exceptionally grateful – for the opportunities I have been given, for new beginnings amidst so much sadness, and for the great privilege of being a family medicine physician.
Dr. Persampiere is a 2nd-year resident in the family medicine residency program at Abington (Pa.) Jefferson Health. You can contact her directly at [email protected] or via [email protected].
Antithrombotic therapy not warranted in COVID-19 outpatients
Antithrombotic therapy in clinically stable, nonhospitalized COVID-19 patients does not offer protection against adverse cardiovascular or pulmonary events, new randomized clinical trial results suggest.
Antithrombotic therapy has proven useful in acutely ill inpatients with COVID-19, but in this study, treatment with aspirin or apixaban (Eliquis) did not reduce the rate of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary causes in patients ill with COVID-19 but who were not hospitalized.
“Among symptomatic, clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome,” the authors conclude. “However, the study was terminated after enrollment of 9% of participants because of a primary event rate lower than anticipated.”
The study, which was led by Jean M. Connors, MD, Brigham and Women’s Hospital, Boston, was published online October 11 in JAMA.
The ACTIV-4B Outpatient Thrombosis Prevention Trial was a randomized, adaptive, double-blind, placebo-controlled trial that sought to compare anticoagulant and antiplatelet therapy among 7,000 symptomatic but clinically stable outpatients with COVID-19.
The trial was conducted at 52 sites in the U.S. between Sept. 2020 and June 2021, with final follow-up this past August 5, and involved minimal face-to-face interactions with study participants.
Patients were randomized in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164 patients), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days.
The primary endpoint was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause.
The trial was terminated early this past June by the independent data monitoring committee because of lower than anticipated event rates. At the time, just 657 symptomatic outpatients with COVID-19 had been enrolled.
The median age of the study participants was 54 years (Interquartile Range [IQR] 46-59); 59% were women.
The median time from diagnosis to randomization was 7 days, and the median time from randomization to initiation of study medications was 3 days.
The trial’s primary efficacy and safety analyses were restricted to patients who received at least one dose of trial medication, for a final number of 558 patients.
Among these patients, the primary endpoint occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5 mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group.
The researchers found that the absolute risk reductions compared with placebo for the primary outcome were 0.0% (95% confidence interval not calculable) in the aspirin group, 0.7% (95% confidence interval, -2.1% to 4.1%) in the prophylactic-dose apixaban group, and 1.4% (95% CI, -1.5% to 5%) in the therapeutic-dose apixaban group.
No major bleeding events were reported.
The absolute risk differences compared with placebo for clinically relevant nonmajor bleeding events were 2% (95% CI, -2.7% to 6.8%) in the aspirin group, 4.5% (95% CI, -0.7% to 10.2%) in the prophylactic-dose apixaban group, and 6.9% (95% CI, 1.4% to 12.9%) in the therapeutic-dose apixaban group.
Safety and efficacy results were similar in all randomly assigned patients.
The researchers speculated that a combination of two demographic shifts over time may have led to the lower than anticipated rate of events in ACTIV-4B.
“First, the threshold for hospital admission has markedly declined since the beginning of the pandemic, such that hospitalization is no longer limited almost exclusively to those with severe pulmonary distress likely to require mechanical ventilation,” they write. “As a result, the severity of illness among individuals with COVID-19 and destined for outpatient care has declined.”
“Second, at least within the U.S., where the trial was conducted, individuals currently being infected with SARS-CoV-2 tend to be younger and have fewer comorbidities when compared with individuals with incident infection at the onset of the pandemic,” they add.
Further, COVID-19 testing was quite limited early in the pandemic, they note, “and it is possible that the anticipated event rates based on data from registries available at that time were overestimated because the denominator (that is, the number of infected individuals overall) was essentially unknown.”
Robust evidence
“The ACTIV-4B trial is the first randomized trial to generate robust evidence about the effects of antithrombotic therapy in outpatients with COVID-19,” Otavio Berwanger, MD, PhD, director of the Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo-SP, Brazil, told this news organization.
“It should be noted that this was a well-designed trial with low risk of bias. On the other hand, the main limitation is the low number of events and, consequently, the limited statistical power,” said Dr. Berwanger, who wrote an accompanying editorial.
The ACTIV-4B trial has immediate implications for clinical practice, he added.
“In this sense, considering the neutral results for major cardiopulmonary outcomes, the use of aspirin or apixaban for the management of outpatients with COVID-19 should not be recommended.”
ACTIV-4B also provides useful information for the steering committees of other ongoing trials of antithrombotic therapy for patients with COVID-19 who are not hospitalized, Dr. Berwanger added.
“In this sense, probably issues like statistical power, outcome choices, recruitment feasibility, and even futility would need to be revisited. And finally, lessons learned from the implementation of an innovative, pragmatic, and decentralized trial design represent an important legacy for future trials in cardiovascular diseases and other common conditions,” he said.
The study was funded by the National Institutes of Health, and the National Heart, Lung, and Blood Institute. Dr. Connors reports financial relationships with Bristol-Myers Squibb, Pfizer, Abbott, Alnylam, Takeda, Roche, and Sanofi. Dr. Berwanger reports financial relationships with AstraZeneca, Amgen, Servier, Bristol-Myers Squibb, Bayer, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
Antithrombotic therapy in clinically stable, nonhospitalized COVID-19 patients does not offer protection against adverse cardiovascular or pulmonary events, new randomized clinical trial results suggest.
Antithrombotic therapy has proven useful in acutely ill inpatients with COVID-19, but in this study, treatment with aspirin or apixaban (Eliquis) did not reduce the rate of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary causes in patients ill with COVID-19 but who were not hospitalized.
“Among symptomatic, clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome,” the authors conclude. “However, the study was terminated after enrollment of 9% of participants because of a primary event rate lower than anticipated.”
The study, which was led by Jean M. Connors, MD, Brigham and Women’s Hospital, Boston, was published online October 11 in JAMA.
The ACTIV-4B Outpatient Thrombosis Prevention Trial was a randomized, adaptive, double-blind, placebo-controlled trial that sought to compare anticoagulant and antiplatelet therapy among 7,000 symptomatic but clinically stable outpatients with COVID-19.
The trial was conducted at 52 sites in the U.S. between Sept. 2020 and June 2021, with final follow-up this past August 5, and involved minimal face-to-face interactions with study participants.
Patients were randomized in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164 patients), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days.
The primary endpoint was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause.
The trial was terminated early this past June by the independent data monitoring committee because of lower than anticipated event rates. At the time, just 657 symptomatic outpatients with COVID-19 had been enrolled.
The median age of the study participants was 54 years (Interquartile Range [IQR] 46-59); 59% were women.
The median time from diagnosis to randomization was 7 days, and the median time from randomization to initiation of study medications was 3 days.
The trial’s primary efficacy and safety analyses were restricted to patients who received at least one dose of trial medication, for a final number of 558 patients.
Among these patients, the primary endpoint occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5 mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group.
The researchers found that the absolute risk reductions compared with placebo for the primary outcome were 0.0% (95% confidence interval not calculable) in the aspirin group, 0.7% (95% confidence interval, -2.1% to 4.1%) in the prophylactic-dose apixaban group, and 1.4% (95% CI, -1.5% to 5%) in the therapeutic-dose apixaban group.
No major bleeding events were reported.
The absolute risk differences compared with placebo for clinically relevant nonmajor bleeding events were 2% (95% CI, -2.7% to 6.8%) in the aspirin group, 4.5% (95% CI, -0.7% to 10.2%) in the prophylactic-dose apixaban group, and 6.9% (95% CI, 1.4% to 12.9%) in the therapeutic-dose apixaban group.
Safety and efficacy results were similar in all randomly assigned patients.
The researchers speculated that a combination of two demographic shifts over time may have led to the lower than anticipated rate of events in ACTIV-4B.
“First, the threshold for hospital admission has markedly declined since the beginning of the pandemic, such that hospitalization is no longer limited almost exclusively to those with severe pulmonary distress likely to require mechanical ventilation,” they write. “As a result, the severity of illness among individuals with COVID-19 and destined for outpatient care has declined.”
“Second, at least within the U.S., where the trial was conducted, individuals currently being infected with SARS-CoV-2 tend to be younger and have fewer comorbidities when compared with individuals with incident infection at the onset of the pandemic,” they add.
Further, COVID-19 testing was quite limited early in the pandemic, they note, “and it is possible that the anticipated event rates based on data from registries available at that time were overestimated because the denominator (that is, the number of infected individuals overall) was essentially unknown.”
Robust evidence
“The ACTIV-4B trial is the first randomized trial to generate robust evidence about the effects of antithrombotic therapy in outpatients with COVID-19,” Otavio Berwanger, MD, PhD, director of the Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo-SP, Brazil, told this news organization.
“It should be noted that this was a well-designed trial with low risk of bias. On the other hand, the main limitation is the low number of events and, consequently, the limited statistical power,” said Dr. Berwanger, who wrote an accompanying editorial.
The ACTIV-4B trial has immediate implications for clinical practice, he added.
“In this sense, considering the neutral results for major cardiopulmonary outcomes, the use of aspirin or apixaban for the management of outpatients with COVID-19 should not be recommended.”
ACTIV-4B also provides useful information for the steering committees of other ongoing trials of antithrombotic therapy for patients with COVID-19 who are not hospitalized, Dr. Berwanger added.
“In this sense, probably issues like statistical power, outcome choices, recruitment feasibility, and even futility would need to be revisited. And finally, lessons learned from the implementation of an innovative, pragmatic, and decentralized trial design represent an important legacy for future trials in cardiovascular diseases and other common conditions,” he said.
The study was funded by the National Institutes of Health, and the National Heart, Lung, and Blood Institute. Dr. Connors reports financial relationships with Bristol-Myers Squibb, Pfizer, Abbott, Alnylam, Takeda, Roche, and Sanofi. Dr. Berwanger reports financial relationships with AstraZeneca, Amgen, Servier, Bristol-Myers Squibb, Bayer, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
Antithrombotic therapy in clinically stable, nonhospitalized COVID-19 patients does not offer protection against adverse cardiovascular or pulmonary events, new randomized clinical trial results suggest.
Antithrombotic therapy has proven useful in acutely ill inpatients with COVID-19, but in this study, treatment with aspirin or apixaban (Eliquis) did not reduce the rate of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary causes in patients ill with COVID-19 but who were not hospitalized.
“Among symptomatic, clinically stable outpatients with COVID-19, treatment with aspirin or apixaban compared with placebo did not reduce the rate of a composite clinical outcome,” the authors conclude. “However, the study was terminated after enrollment of 9% of participants because of a primary event rate lower than anticipated.”
The study, which was led by Jean M. Connors, MD, Brigham and Women’s Hospital, Boston, was published online October 11 in JAMA.
The ACTIV-4B Outpatient Thrombosis Prevention Trial was a randomized, adaptive, double-blind, placebo-controlled trial that sought to compare anticoagulant and antiplatelet therapy among 7,000 symptomatic but clinically stable outpatients with COVID-19.
The trial was conducted at 52 sites in the U.S. between Sept. 2020 and June 2021, with final follow-up this past August 5, and involved minimal face-to-face interactions with study participants.
Patients were randomized in a 1:1:1:1 ratio to aspirin (81 mg orally once daily; n = 164 patients), prophylactic-dose apixaban (2.5 mg orally twice daily; n = 165), therapeutic-dose apixaban (5 mg orally twice daily; n = 164), or placebo (n = 164) for 45 days.
The primary endpoint was a composite of all-cause mortality, symptomatic venous or arterial thromboembolism, myocardial infarction, stroke, or hospitalization for cardiovascular or pulmonary cause.
The trial was terminated early this past June by the independent data monitoring committee because of lower than anticipated event rates. At the time, just 657 symptomatic outpatients with COVID-19 had been enrolled.
The median age of the study participants was 54 years (Interquartile Range [IQR] 46-59); 59% were women.
The median time from diagnosis to randomization was 7 days, and the median time from randomization to initiation of study medications was 3 days.
The trial’s primary efficacy and safety analyses were restricted to patients who received at least one dose of trial medication, for a final number of 558 patients.
Among these patients, the primary endpoint occurred in 1 patient (0.7%) in the aspirin group, 1 patient (0.7%) in the 2.5 mg apixaban group, 2 patients (1.4%) in the 5-mg apixaban group, and 1 patient (0.7%) in the placebo group.
The researchers found that the absolute risk reductions compared with placebo for the primary outcome were 0.0% (95% confidence interval not calculable) in the aspirin group, 0.7% (95% confidence interval, -2.1% to 4.1%) in the prophylactic-dose apixaban group, and 1.4% (95% CI, -1.5% to 5%) in the therapeutic-dose apixaban group.
No major bleeding events were reported.
The absolute risk differences compared with placebo for clinically relevant nonmajor bleeding events were 2% (95% CI, -2.7% to 6.8%) in the aspirin group, 4.5% (95% CI, -0.7% to 10.2%) in the prophylactic-dose apixaban group, and 6.9% (95% CI, 1.4% to 12.9%) in the therapeutic-dose apixaban group.
Safety and efficacy results were similar in all randomly assigned patients.
The researchers speculated that a combination of two demographic shifts over time may have led to the lower than anticipated rate of events in ACTIV-4B.
“First, the threshold for hospital admission has markedly declined since the beginning of the pandemic, such that hospitalization is no longer limited almost exclusively to those with severe pulmonary distress likely to require mechanical ventilation,” they write. “As a result, the severity of illness among individuals with COVID-19 and destined for outpatient care has declined.”
“Second, at least within the U.S., where the trial was conducted, individuals currently being infected with SARS-CoV-2 tend to be younger and have fewer comorbidities when compared with individuals with incident infection at the onset of the pandemic,” they add.
Further, COVID-19 testing was quite limited early in the pandemic, they note, “and it is possible that the anticipated event rates based on data from registries available at that time were overestimated because the denominator (that is, the number of infected individuals overall) was essentially unknown.”
Robust evidence
“The ACTIV-4B trial is the first randomized trial to generate robust evidence about the effects of antithrombotic therapy in outpatients with COVID-19,” Otavio Berwanger, MD, PhD, director of the Academic Research Organization, Hospital Israelita Albert Einstein, Sao Paulo-SP, Brazil, told this news organization.
“It should be noted that this was a well-designed trial with low risk of bias. On the other hand, the main limitation is the low number of events and, consequently, the limited statistical power,” said Dr. Berwanger, who wrote an accompanying editorial.
The ACTIV-4B trial has immediate implications for clinical practice, he added.
“In this sense, considering the neutral results for major cardiopulmonary outcomes, the use of aspirin or apixaban for the management of outpatients with COVID-19 should not be recommended.”
ACTIV-4B also provides useful information for the steering committees of other ongoing trials of antithrombotic therapy for patients with COVID-19 who are not hospitalized, Dr. Berwanger added.
“In this sense, probably issues like statistical power, outcome choices, recruitment feasibility, and even futility would need to be revisited. And finally, lessons learned from the implementation of an innovative, pragmatic, and decentralized trial design represent an important legacy for future trials in cardiovascular diseases and other common conditions,” he said.
The study was funded by the National Institutes of Health, and the National Heart, Lung, and Blood Institute. Dr. Connors reports financial relationships with Bristol-Myers Squibb, Pfizer, Abbott, Alnylam, Takeda, Roche, and Sanofi. Dr. Berwanger reports financial relationships with AstraZeneca, Amgen, Servier, Bristol-Myers Squibb, Bayer, Novartis, Pfizer, and Boehringer Ingelheim.
A version of this article first appeared on Medscape.com.
COVID vaccination rates vary by zodiac sign
COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.
The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.
“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.
“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”
According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.
Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.
“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.
The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.
“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.
The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”
Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.
If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.
“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.
Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.
“We do have message fatigue around vaccines,” Mr. Rupp said.
A version of this article first appeared on WebMD.com.
COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.
The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.
“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.
“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”
According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.
Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.
“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.
The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.
“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.
The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”
Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.
If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.
“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.
Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.
“We do have message fatigue around vaccines,” Mr. Rupp said.
A version of this article first appeared on WebMD.com.
COVID-19 vaccination rates vary dramatically by astrological sign, with Leos at the top of the list and Scorpios at the bottom, according to The Salt Lake Tribune.
The Salt Lake County Health Department calculated the rates based on anonymous birth dates from the county’s vaccination data and then compared those figures to national estimates for the overall population represented by each sign.
“Now that Mercury is not in retrograde, we’re just going to leave this here … (and yes, this is based on data),” the Health Department wrote in a Twitter post on Tuesday.
“The COVID-19 vaccine is backed by science and is no way influenced by horoscopes,” the department continued. “But come on Scorpios!”
According to the graphic, 70% of those with the Leo sign are fully vaccinated, followed by Aquarius at 67%, and Aries and Sagittarius both at 59%. The other signs range from 58% to 50%, in descending order: Cancer, Taurus, Gemini, Libra, Pisces, Capricorn, and Virgo. Scorpio sits at the bottom of the list, with 46% fully vaccinated.
Notably, three of the top four signs are elemental fire signs, The Salt Lake Tribune noted.
“We are overachievers,” Jeff Eason, an Aries and the department’s bureau manager of population health and informatics, who did the analysis, told the newspaper.
The Health Department’s post sparked positive and negative feedback across social media, with some musing about their own sign’s inclinations and others scoffing at astrology altogether.
“What we’re really doing is finding new and different ways to keep our community talking about vaccination when there is significant message fatigue around this topic,” the department wrote in the comments.
The range of vaccination rates was startlingly wide, Mr. Eason told The Salt Lake Tribune. But he noted that the difference “could all come down to denominators.”
Each sign’s vaccination rate was ranked almost exactly inverse to its share of the overall population, the newspaper reported. Scorpios and Virgos make up 9.4% and 9.3% of the U.S. population, respectively, as compared with 7.1% for Leos and 6.3% for Aquarians.
If the 12 astrological signs were more evenly distributed in Salt Lake County than nationally, Mr. Eason said, the range of vaccinations rates wouldn’t be as wide as the analysis shows.
“Obviously, it’s not super scientific because we are talking astrology,” Nicholas Rupp, a spokesman for the health department and a vaccinated Scorpio, told the newspaper.
Still, health department officials wanted to do the analysis as a fun way to start conversations and promote vaccinations. About 59% of Salt Lake County residents are fully vaccinated, and about 54% of Utah residents are fully vaccinated.
“We do have message fatigue around vaccines,” Mr. Rupp said.
A version of this article first appeared on WebMD.com.