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In Case You Missed It: COVID
Vaccinating homebound patients is an uphill battle
There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.
Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.
“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”
Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
Many roadblocks to vaccination
Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.
“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.
Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.
“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.
“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.
Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.
“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
Expenses are greater
The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.
Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.
For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.
There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.
William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.
“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”
Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.
“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”
Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.
While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.
Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.
“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
Overcoming the challenges
With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24. 
Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program.
“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.
People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.
“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.
If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”
Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.
“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.
Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.
The experts interviewed in this article have no conflicts.
Katie Lennon contributed to this report.
This article was updated 4/29/21.
There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.
Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.
“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”
Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
Many roadblocks to vaccination
Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.
“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.
Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.
“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.
“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.
Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.
“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
Expenses are greater
The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.
Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.
For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.
There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.
William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.
“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”
Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.
“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”
Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.
While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.
Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.
“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
Overcoming the challenges
With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.
Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program.
“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.
People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.
“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.
If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”
Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.
“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.
Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.
The experts interviewed in this article have no conflicts.
Katie Lennon contributed to this report.
This article was updated 4/29/21.
There are about 2 million to 4 million homebound patients in the United States, according to a webinar from The Trust for America’s Health, which was broadcast in March. But many of these individuals have not been vaccinated yet because of logistical challenges.
Some homebound COVID-19 immunization programs are administering Moderna and Pfizer vaccines to their patients, but many state, city, and local programs administered the Johnson & Johnson vaccine after it was cleared for use by the Food and Drug Administration in February 2021. The efficacy of the one-shot vaccine, as well as it being easier to store and ship than the Moderna and Pfizer vaccines, makes getting it to homebound patients less challenging.
“With Pfizer and Moderna, transportation is a challenge because the temperature demands and the fragility of [messenger] RNA–based vaccines,” Brent Feorene, executive director of the American Academy of Home Care Medicine, said in an interview. That’s why [the Johnson & Johnson] vaccine held such promise – it’s less fragile, [can be stored in] higher temperatures, and was a one shot.”
Other hurdles to getting homebound patients vaccinated had already been in place prior to the 10-day-pause on using the J&J vaccine that occurred for federal agencies to consider possible serious side effects linked to it.
Many roadblocks to vaccination
Although many homebound patients can’t readily go out into the community and be exposed to the COVID-19 virus themselves, they are dependent on caregivers and family members who do go out into the community.
“Their friends, family, neighbors, home health aides, and other kinds of health care workers come into the home,” said Shawn Amer, clinical program director at Central Ohio Primary Care in Columbus.
Nurses from Ms. Amer’s practice vaccinated approximately ten homebound patients with the J&J vaccine through a pilot program in March. Then on April 24, nurses from Central Ohio Primary Care vaccinated just under 40 homebound patients and about a handful of their caregivers who were not able to get their vaccines elsewhere, according to Ms. Amer. This time they used the Pfizer vaccine and will be returning to these patients’ homes on May 15 to administer the second dose.
“Any time you are getting in the car and adding miles, it adds complexity,” Ms. Amer said.
“We called patients 24 to 36 hours before coming to their homes to make sure they were ready, but we learned that just because the healthcare power of attorney agrees to a patient getting vaccinated does not mean that patient will be willing to get the vaccine when the nurse shows up," she noted.
Ms. Amer elaborated that three patients with dementia refused the vaccine when nurses arrived at their home on April 24.
“We had to pivot and find other people,” Ms. Amer. Her practice ended up having to waste one shot.
Expenses are greater
The higher costs of getting homebound patients vaccinated is an additional hurdle to getting these vulnerable individuals protected by COVID-19 shots.
Vaccinating patients in their homes “doesn’t require a lot of technology, but it does require a lot of time” and the staffing expense becomes part of the challenge, Ms. Amer noted.
For each of the two days that Central Ohio Primary Care provides the Pfizer vaccine to homebound patients, the practice needs to pay seven nurses to administer the vaccine, Ms. Amer explained.
There have also been reports of organizations that administer the vaccines – which are free for patients because the federal government is paying for them – not being paid enough by Medicare to cover staff time and efforts to vaccinate patients in their homes, Kaiser Health News reported. According to the Centers for Medicare & Medicaid Services, they pay $40 for the administration of a single-dose COVID-19 vaccine and, for COVID-19 vaccines requiring multiple doses, Medicare pays approximately $40 for each dose in the series. These rates were implemented after March 15. Before that date, the rates were even lower, with the Medicare reimbursement rates for initial doses of COVID-19 vaccines being $16.94 and final doses being $28.39.
William Dombi, president of the National Association for Home Care & Hospice, told Kaiser Health News that the actual cost of these homebound visits are closer to $150 or $160.
“The reimbursement for the injection is pretty minimal,” Mr. Feorene said. “So unless you’re a larger organization and able to have staff to deploy some of your smaller practices, just couldn’t afford to do it.”
Many homebound patients have also been unable to get the lifesaving shots because of logistical roadblocks and many practices not being able to do home visits.
“I think that initially when the [Centers for Disease Control and Prevention] came out with vaccine guidance for medical providers, they offered no guidance for in-home medical providers and we had to go back and ask for that, which they did produce,” Mr. Feorene said. “And we’re grateful for that. But I think just this general understanding that there is a population of folks that are [limited to their home], that they do receive medical care and other care in the home, and that we have to remember that the medical providers who provide care in the home are also primary care providers.”
Furthermore, trying to navigate or find programs delivering vaccines to the homebound can be difficult depending on where a patient lives.
While some programs have been launched on the country or city level – the New York Fire Department launched a pilot program to bring the Johnson & Johnson vaccine to homebound seniors – other programs have been spearheaded by hospital networks like Northwell and Mount Sinai. However, many of these hospital networks only reach out to people who already have a relationship with the hospital.
Ms Amer said identifying homebound patients and reaching out to them can be tough and can contribute to the logistics and time involved in setting patients up for the vaccine.
“Reaching some of these patients is difficult,” Ms. Amer noted. “Sometimes the best way to reach them or get a hold of them is through their caregiver. And so do you have the right phone number? Do you have the right name?”
Overcoming the challenges
With the absence of a national plan targeting homebound patients, many local initiatives were launched to help these individuals get vaccinated. Local fire department paramedics have gone door to door to administer the COVID-19 vaccine in cities like Chicago, New York, and Miami. The suspension of the Johnson & Johnson vaccine resulted in the suspension of in-home vaccinations for some people in New York City. However, the program resumed after the FDA and CDC lifted the pause on April 24.
Health systems like Mount Sinai vaccinated approximately 530 people through the Mount Sinai Visiting Doctors Program, including patients and their caregivers, according to Peter Gliatto, MD, associate director of the Mount Sinai Visiting Doctors Program.
“In different cities, townships, and jurisdictions, different health departments and different provider groups are approaching [the distribution of the COVID-19 vaccine] slightly differently,” Ms. Amer said. So a lot of the decisions surrounding the distribution of shots are local or dependent on local resourcing.
People who live in rural areas present a unique challenge, but Mr. Feorene said reaching out to local emergency medical services or the local health departments can provide some insight on what their town is doing to vaccinate homebound patients.
“I think understanding what a [public health department] is doing would be the very first place to start,” Mr. Feorene said in an interview.
If a patient is bedridden and is mobile enough to sit in a car, Mr. Feorene also recommends finding out if there are vaccine fairs “within a reasonable driving distance.”
Ms. Amer said continuing this mission of getting homebound patients vaccinated is necessary for public health.
“Even if it’s going to take longer to vaccinate these homebound patients, we still have to make an effort. So much of the country’s vaccine efforts have been focused on getting as many shots in as many arms as quickly as possible. And that is definitely super important,” she said.
Ms. Amer is working with her practice’s primary care physicians to try to identify all of those patients who are functionally debilitated or unable to leave their home to get vaccinated and that Central Ohio Primary Care will vaccinate more homebound patients, she added.
The experts interviewed in this article have no conflicts.
Katie Lennon contributed to this report.
This article was updated 4/29/21.
COVID plus MI confers poor prognosis; 1 in 3 die in hospital
COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.
“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.
The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.
“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.
The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.
The initial findings from the registry were published online in the Journal of the American College of Cardiology.
Atypical symptoms may explain high death rate
The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls).
This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.
The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.
These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.
The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.
COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.
Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).
The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.
Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.
“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.
“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.
Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.
Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.
This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.
“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.
The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.
“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.
The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.
The initial findings from the registry were published online in the Journal of the American College of Cardiology.
Atypical symptoms may explain high death rate
The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls).
This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.
The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.
These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.
The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.
COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.
Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).
The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.
Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.
“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.
“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.
Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.
Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.
This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
COVID-19 patients with ST-segment elevation MI (STEMI) represent a population with unique demographic and clinical features resulting in a high risk for mortality, according to initial findings from the North American Cardiovascular COVID-19 Myocardial Infarction (NACMI) Registry.
“This is the largest registry of COVID-positive patients presenting with STEMI [and] the results clearly illustrate the challenges and uniqueness of this patient population that deserves prompt and special attention,” study cochair Timothy Henry, MD, president-elect of the Society for Cardiovascular Angiography & Interventions, said in a news release.
The NACMI registry is a collaborative effort between the SCAI, the American College of Cardiology Interventional Council, and the Canadian Association of Interventional Cardiology.
“The rapid development of this ongoing, critically important prospective registry reflects the strong and unique collaboration of all three societies. It was gratifying to be part of this process and hopefully the results will improve the care of our patients and stimulate further research,” Dr. Henry said in the news release.
The registry has enrolled 1,185 patients presenting with STEMI at 64 sites across the United States and Canada. Participants include 230 COVID-positive STEMI patients; 495 STEMI patients suspected but ultimately confirmed not to have COVID-19; and 460 age-and sex-matched control STEMI patients treated prior to the pandemic who are part of the Midwest STEMI Consortium.
The initial findings from the registry were published online in the Journal of the American College of Cardiology.
Atypical symptoms may explain high death rate
The primary outcome – a composite of in-hospital death, stroke, recurrent MI, or repeat unplanned revascularization – occurred in 36% of COVID-positive patients, compared with 13% of COVID-negative patients and 5% of control patients (P < .001 relative to controls).
This difference was driven largely by a “very high” in-hospital death rate in COVID-positive patients, lead author Santiago Garcia, MD, Minneapolis Heart Institute Foundation, said in an interview.
The in-hospital death rate was 33% in COVID-positive patients, compared with 11% in COVID-negative patients and 4% in controls. Stroke also occurred more often in COVID-positive patients at 3% versus 2% in COVID-negative and 0% in controls.
These initial findings suggest that the combination of STEMI and COVID-19 infection “confers a poor prognosis, with one in three patients succumbing to the disease, even among patients selected for invasive angiography (28% mortality),” the investigators wrote.
The data also show that STEMI in COVID-positive patients disproportionately affects ethnic minorities (23% Hispanic and 24% Black) with diabetes, which was present in 46% of COVID-positive patients.
COVID-positive patients with STEMI are more likely to present with atypical symptoms such as dyspnea (54%), pulmonary infiltrates on chest x-ray (46%), and high-risk conditions such as cardiogenic shock (18%), “which may explain the high fatality rate,” Dr. Garcia said.
Despite these high-risk features, COVID-positive patients are less apt to undergo invasive angiography when compared with COVID-negative and control STEMI patients (78% vs. 96% vs. 100%).
The majority of patients (71%) who did under angiography received primary percutaneous coronary intervention (PPCI) with very small treatment delays (at 15 minutes) during the pandemic.
Another notable finding is that “many patients (23%) have ‘no culprit’ vessel and may represent different etiologies of ST-segment elevation including microemboli, myocarditis, Takotsubo cardiomyopathy,” Dr. Garcia said in an interview.
“In line with current guidelines, patients with suspected STEMI should be managed with PPCI, without delay while the safety of health care providers is ensured,” Ran Kornowski, MD, and Katia Orvin, MD, both with Rabin Medical Center, Petah Tikva, Israel, and Tel Aviv University, wrote in a linked editorial.
“In this case, PPCI should be performed routinely, even if the patient is presumed to have COVID-19, because PPCI should not be postponed. Confirmation of SARS-CoV-2 infection should not delay urgent decision management concerning reperfusion strategy,” they advised.
Looking ahead, Garcia said plans for the registry include determining predictors of in-hospital mortality and studying demographic and treatment trends as the pandemic continues with more virulent strains of the virus.
Various subgroup analyses are also planned as well as an independent angiographic and electrocardiographic core lab analysis. A comparative analysis of data from the US and Canada is also planned.
This work was supported by an ACC Accreditation Grant, Saskatchewan Health Research Foundation, and grants from Medtronic and Abbott Vascular to SCAI. Dr. Garcia has received institutional research grants from Edwards Lifesciences, BSCI, Medtronic, and Abbott Vascular; has served as a consultant for Medtronic and BSCI; and has served as a proctor for Edwards Lifesciences. Dr. Kornowski and Dr. Orvin disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
More signs COVID shots are safe for pregnant women
As the U.S. races to vaccinate millions of people against the coronavirus, pregnant women face the extra challenge of not knowing whether the vaccines are safe for them or their unborn babies.
None of the recent COVID-19 vaccine trials, including those for Pfizer, Moderna, and Johnson & Johnson, enrolled pregnant or breastfeeding women because they consider them a high-risk group.
That was despite the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists asking that pregnant and breastfeeding women be included in trials. The Food and Drug Administration even included pregnant women in the COVID-19 vaccine emergency use authorization (EUA) because of their higher risk of having a more severe disease.
Despite that lack of clinical trial data, more and more smaller studies are suggesting that the vaccines are safe for both mother and child.
Pfizer is now studying its two-dose vaccine in 4,000 pregnant and breastfeeding women to see how safe, tolerated, and robust their immune response is. Researchers will also look at how safe the vaccine is for infants and whether mothers pass along antibodies to children. But the preliminary results won’t be available until the end of the year, a Pfizer spokesperson says.
Without that information, pregnant women are less likely to get vaccinated, according to a large international survey. Less than 45% of pregnant women in the United States said they intended to get vaccinated even when they were told the vaccine was safe and 90% effective. That figure rises to 52% of pregnant women in 16 countries, including the United States, compared with 74% of nonpregnant women willing to be vaccinated. The findings were published online March 1, 2021, in the European Journal of Epidemiology.
The vaccine-hesitant pregnant women in the international study were most concerned that the COVID-19 vaccine could harm their developing fetuses, a worry related to the lack of clinical evidence in pregnant women, said lead researcher Julia Wu, ScD, an epidemiologist at the Harvard School of Public Health’s Human Immunomics Initiative in Boston.
The information vacuum also increases the chances that “people will fall victim to misinformation campaigns like the one on social media that claims that the COVID-19 vaccine causes infertility,” Dr. Wu said. This unfounded claim has deterred some women of childbearing age from getting the vaccine.
Deciding to get vaccinated
Frontline health care professionals were in the first group eligible to receive the vaccine in December 2020. “All of us who were pregnant ... had to decide whether to wait for the data, because we don’t know what the risks are, or go ahead and get it [the vaccine]. We had been dealing with the pandemic for months and were afraid of being exposed to the virus and infecting family members,” said Jacqueline Parchem, MD, a maternal-fetal medicine specialist at the University of Texas Health Science Center, Houston.
Given the lack of safety data, the CDC guidance to pregnant women has been to consult with their doctors and that it’s a personal choice. The Center for Disease Control and Prevention’s latest vaccine guidance said that “there is no evidence that antibodies formed from COVID-19 vaccination cause any problem with pregnancy, including the development of the placenta.”
The CDC is monitoring vaccinated people through its v-safe program and reported on April 12 that more than 86,000 v-safe participants said they were pregnant when they were vaccinated.
Health care workers who were nursing their infants when they were eligible for the vaccine faced a similar dilemma as pregnant women – they lacked the data on them to make a truly informed decision.
“I was nervous about the vaccine side effects for myself and whether my son Bennett, who was about a year old, would experience any of these himself,” said Christa Carrig, a labor and delivery nurse at Massachusetts General Hospital in Boston, who was breastfeeding at the time.
She and Dr. Parchem know that pregnant women with COVID-19 are more likely to have severe illness and complications such as high blood pressure and preterm delivery. “Pregnancy takes a toll on the body. When a woman gets COVID-19 and that insult is added, women who were otherwise young and healthy get much sicker than you would expect,” said Ms. Carrig.
“As a high-risk pregnancy specialist, I know that, with COVID, that babies don’t do well when moms are sick,” said Dr. Parchem.
Pregnant women accounted for more than 84,629 cases of COVID-19 and 95 deaths in the United States between Jan. 22 last year and April 12 this year, according to the CDC COVID data tracker.
Dr. Parchem and Ms. Carrig decided to get vaccinated because of their high risk of exposure to COVID-19 at work. After the second dose, Ms. Carrig reported chills but Bennett had no side effects from breastfeeding. Dr. Parchem, who delivered a healthy baby boy in February, reported no side effects other than a sore arm.
“There’s also a psychological benefit to returning to some sense of normalcy,” said Dr. Parchem. “My mother was finally able to visit us to see the new baby after we were all vaccinated. This was the first visit in more than a year.”
New study results
Ms. Carrig was one of 131 vaccinated hospital workers in the Boston area who took part in the first study to profile the immune response in pregnant and breastfeeding women and compare it with both nonpregnant and pregnant women who had COVID-19.
The study was not designed to evaluate the safety of the vaccines or whether they prevent COVID-19 illness and hospitalizations. That is the role of the large vaccine trials, the authors said.
The participants were aged 18-45 years and received both doses of either Pfizer or Moderna vaccines during one of their trimesters. They provided blood and/or breast milk samples after each vaccine dose, 2-6 weeks after the last dose, and at delivery for the 10 who gave birth during the study.
The vaccines produced a similar strong antibody response among the pregnant/breastfeeding women and nonpregnant women. Their antibody levels were much higher than those found in the pregnant women who had COVID-19, the researchers reported on March 25, 2021, in the American Journal of Obstetrics and Gynecology.
“This is important because a lot of people tend to think once they’ve had COVID-19, they are protected from the virus. This finding suggests that the vaccines produce a stronger antibody response than the infection itself, and this might be important for long-lasting protection against COVID-19,” said Dr. Parchem.
The study also addressed whether newborns benefit from the antibodies produced by their mothers. “In the 10 women who delivered, we detected antibodies in their umbilical cords and breast milk,” says Andrea Edlow, MD, lead researcher and a maternal-fetal medicine specialist at Massachusetts General Hospital.
Newborns are particularly vulnerable to respiratory infections because they have small airways and their immune systems are underdeveloped. These infections can be lethal early in life.
“The public health strategy is to vaccinate mothers against respiratory viruses, bacteria, and parasites that neonates up to 6 months are exposed to. Influenza and pertussis (whooping cough) are two examples of vaccines that we give mothers that we know transfer [antibodies] across the umbilical cord,” said Dr. Edlow.
But this “passive transfer immunity” is different from active immunity, when the body produces its own antibody immune response, she explains.
A different study, also published in March, confirmed that antibodies were transferred from 27 vaccinated pregnant mothers to their infants when they delivered. A new finding was that the women who were vaccinated with both doses and earlier in their third semester passed on more antibodies than the women who were vaccinated later or with only one dose.
Impact of the studies
The Society for Maternal-Fetal Medicine updated its guidance on counseling pregnant and lactating patients about the COVID-19 vaccines to include Dr. Edlow’s study.
“We were struck by how much pregnant and breastfeeding women want to participate in research and to help others in the same situation make decisions. I hope this will be an example to drug companies doing research on new vaccines in the future – that they should not be left behind and can make decisions themselves whether to participate after weighing the risks and benefits,” said Dr. Edlow.
She continues to enroll more vaccinated women in her study in the Boston area, including non–health care workers who have asked to take part.
“It was worth getting vaccinated and participating in the study. I know that I have antibodies and it worked and that I passed them on to Bennett. Also, I know that all the information is available for other women who are questioning whether to get vaccinated or not,” said Ms. Carrig.
Dr. Parchem is also taking part in the CDC’s v-safe pregnancy registry, which is collecting health and safety data on vaccinated pregnant women.
Before she was vaccinated, Dr. Parchem said, “my advice was very measured because we lacked data either saying that it definitely works or showing that it was unsafe. Now that we have this data supporting the benefits, I feel more confident in recommending the vaccines.”
A version of this article first appeared on Medscape.com.
As the U.S. races to vaccinate millions of people against the coronavirus, pregnant women face the extra challenge of not knowing whether the vaccines are safe for them or their unborn babies.
None of the recent COVID-19 vaccine trials, including those for Pfizer, Moderna, and Johnson & Johnson, enrolled pregnant or breastfeeding women because they consider them a high-risk group.
That was despite the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists asking that pregnant and breastfeeding women be included in trials. The Food and Drug Administration even included pregnant women in the COVID-19 vaccine emergency use authorization (EUA) because of their higher risk of having a more severe disease.
Despite that lack of clinical trial data, more and more smaller studies are suggesting that the vaccines are safe for both mother and child.
Pfizer is now studying its two-dose vaccine in 4,000 pregnant and breastfeeding women to see how safe, tolerated, and robust their immune response is. Researchers will also look at how safe the vaccine is for infants and whether mothers pass along antibodies to children. But the preliminary results won’t be available until the end of the year, a Pfizer spokesperson says.
Without that information, pregnant women are less likely to get vaccinated, according to a large international survey. Less than 45% of pregnant women in the United States said they intended to get vaccinated even when they were told the vaccine was safe and 90% effective. That figure rises to 52% of pregnant women in 16 countries, including the United States, compared with 74% of nonpregnant women willing to be vaccinated. The findings were published online March 1, 2021, in the European Journal of Epidemiology.
The vaccine-hesitant pregnant women in the international study were most concerned that the COVID-19 vaccine could harm their developing fetuses, a worry related to the lack of clinical evidence in pregnant women, said lead researcher Julia Wu, ScD, an epidemiologist at the Harvard School of Public Health’s Human Immunomics Initiative in Boston.
The information vacuum also increases the chances that “people will fall victim to misinformation campaigns like the one on social media that claims that the COVID-19 vaccine causes infertility,” Dr. Wu said. This unfounded claim has deterred some women of childbearing age from getting the vaccine.
Deciding to get vaccinated
Frontline health care professionals were in the first group eligible to receive the vaccine in December 2020. “All of us who were pregnant ... had to decide whether to wait for the data, because we don’t know what the risks are, or go ahead and get it [the vaccine]. We had been dealing with the pandemic for months and were afraid of being exposed to the virus and infecting family members,” said Jacqueline Parchem, MD, a maternal-fetal medicine specialist at the University of Texas Health Science Center, Houston.
Given the lack of safety data, the CDC guidance to pregnant women has been to consult with their doctors and that it’s a personal choice. The Center for Disease Control and Prevention’s latest vaccine guidance said that “there is no evidence that antibodies formed from COVID-19 vaccination cause any problem with pregnancy, including the development of the placenta.”
The CDC is monitoring vaccinated people through its v-safe program and reported on April 12 that more than 86,000 v-safe participants said they were pregnant when they were vaccinated.
Health care workers who were nursing their infants when they were eligible for the vaccine faced a similar dilemma as pregnant women – they lacked the data on them to make a truly informed decision.
“I was nervous about the vaccine side effects for myself and whether my son Bennett, who was about a year old, would experience any of these himself,” said Christa Carrig, a labor and delivery nurse at Massachusetts General Hospital in Boston, who was breastfeeding at the time.
She and Dr. Parchem know that pregnant women with COVID-19 are more likely to have severe illness and complications such as high blood pressure and preterm delivery. “Pregnancy takes a toll on the body. When a woman gets COVID-19 and that insult is added, women who were otherwise young and healthy get much sicker than you would expect,” said Ms. Carrig.
“As a high-risk pregnancy specialist, I know that, with COVID, that babies don’t do well when moms are sick,” said Dr. Parchem.
Pregnant women accounted for more than 84,629 cases of COVID-19 and 95 deaths in the United States between Jan. 22 last year and April 12 this year, according to the CDC COVID data tracker.
Dr. Parchem and Ms. Carrig decided to get vaccinated because of their high risk of exposure to COVID-19 at work. After the second dose, Ms. Carrig reported chills but Bennett had no side effects from breastfeeding. Dr. Parchem, who delivered a healthy baby boy in February, reported no side effects other than a sore arm.
“There’s also a psychological benefit to returning to some sense of normalcy,” said Dr. Parchem. “My mother was finally able to visit us to see the new baby after we were all vaccinated. This was the first visit in more than a year.”
New study results
Ms. Carrig was one of 131 vaccinated hospital workers in the Boston area who took part in the first study to profile the immune response in pregnant and breastfeeding women and compare it with both nonpregnant and pregnant women who had COVID-19.
The study was not designed to evaluate the safety of the vaccines or whether they prevent COVID-19 illness and hospitalizations. That is the role of the large vaccine trials, the authors said.
The participants were aged 18-45 years and received both doses of either Pfizer or Moderna vaccines during one of their trimesters. They provided blood and/or breast milk samples after each vaccine dose, 2-6 weeks after the last dose, and at delivery for the 10 who gave birth during the study.
The vaccines produced a similar strong antibody response among the pregnant/breastfeeding women and nonpregnant women. Their antibody levels were much higher than those found in the pregnant women who had COVID-19, the researchers reported on March 25, 2021, in the American Journal of Obstetrics and Gynecology.
“This is important because a lot of people tend to think once they’ve had COVID-19, they are protected from the virus. This finding suggests that the vaccines produce a stronger antibody response than the infection itself, and this might be important for long-lasting protection against COVID-19,” said Dr. Parchem.
The study also addressed whether newborns benefit from the antibodies produced by their mothers. “In the 10 women who delivered, we detected antibodies in their umbilical cords and breast milk,” says Andrea Edlow, MD, lead researcher and a maternal-fetal medicine specialist at Massachusetts General Hospital.
Newborns are particularly vulnerable to respiratory infections because they have small airways and their immune systems are underdeveloped. These infections can be lethal early in life.
“The public health strategy is to vaccinate mothers against respiratory viruses, bacteria, and parasites that neonates up to 6 months are exposed to. Influenza and pertussis (whooping cough) are two examples of vaccines that we give mothers that we know transfer [antibodies] across the umbilical cord,” said Dr. Edlow.
But this “passive transfer immunity” is different from active immunity, when the body produces its own antibody immune response, she explains.
A different study, also published in March, confirmed that antibodies were transferred from 27 vaccinated pregnant mothers to their infants when they delivered. A new finding was that the women who were vaccinated with both doses and earlier in their third semester passed on more antibodies than the women who were vaccinated later or with only one dose.
Impact of the studies
The Society for Maternal-Fetal Medicine updated its guidance on counseling pregnant and lactating patients about the COVID-19 vaccines to include Dr. Edlow’s study.
“We were struck by how much pregnant and breastfeeding women want to participate in research and to help others in the same situation make decisions. I hope this will be an example to drug companies doing research on new vaccines in the future – that they should not be left behind and can make decisions themselves whether to participate after weighing the risks and benefits,” said Dr. Edlow.
She continues to enroll more vaccinated women in her study in the Boston area, including non–health care workers who have asked to take part.
“It was worth getting vaccinated and participating in the study. I know that I have antibodies and it worked and that I passed them on to Bennett. Also, I know that all the information is available for other women who are questioning whether to get vaccinated or not,” said Ms. Carrig.
Dr. Parchem is also taking part in the CDC’s v-safe pregnancy registry, which is collecting health and safety data on vaccinated pregnant women.
Before she was vaccinated, Dr. Parchem said, “my advice was very measured because we lacked data either saying that it definitely works or showing that it was unsafe. Now that we have this data supporting the benefits, I feel more confident in recommending the vaccines.”
A version of this article first appeared on Medscape.com.
As the U.S. races to vaccinate millions of people against the coronavirus, pregnant women face the extra challenge of not knowing whether the vaccines are safe for them or their unborn babies.
None of the recent COVID-19 vaccine trials, including those for Pfizer, Moderna, and Johnson & Johnson, enrolled pregnant or breastfeeding women because they consider them a high-risk group.
That was despite the Society for Maternal-Fetal Medicine and the American College of Obstetricians and Gynecologists asking that pregnant and breastfeeding women be included in trials. The Food and Drug Administration even included pregnant women in the COVID-19 vaccine emergency use authorization (EUA) because of their higher risk of having a more severe disease.
Despite that lack of clinical trial data, more and more smaller studies are suggesting that the vaccines are safe for both mother and child.
Pfizer is now studying its two-dose vaccine in 4,000 pregnant and breastfeeding women to see how safe, tolerated, and robust their immune response is. Researchers will also look at how safe the vaccine is for infants and whether mothers pass along antibodies to children. But the preliminary results won’t be available until the end of the year, a Pfizer spokesperson says.
Without that information, pregnant women are less likely to get vaccinated, according to a large international survey. Less than 45% of pregnant women in the United States said they intended to get vaccinated even when they were told the vaccine was safe and 90% effective. That figure rises to 52% of pregnant women in 16 countries, including the United States, compared with 74% of nonpregnant women willing to be vaccinated. The findings were published online March 1, 2021, in the European Journal of Epidemiology.
The vaccine-hesitant pregnant women in the international study were most concerned that the COVID-19 vaccine could harm their developing fetuses, a worry related to the lack of clinical evidence in pregnant women, said lead researcher Julia Wu, ScD, an epidemiologist at the Harvard School of Public Health’s Human Immunomics Initiative in Boston.
The information vacuum also increases the chances that “people will fall victim to misinformation campaigns like the one on social media that claims that the COVID-19 vaccine causes infertility,” Dr. Wu said. This unfounded claim has deterred some women of childbearing age from getting the vaccine.
Deciding to get vaccinated
Frontline health care professionals were in the first group eligible to receive the vaccine in December 2020. “All of us who were pregnant ... had to decide whether to wait for the data, because we don’t know what the risks are, or go ahead and get it [the vaccine]. We had been dealing with the pandemic for months and were afraid of being exposed to the virus and infecting family members,” said Jacqueline Parchem, MD, a maternal-fetal medicine specialist at the University of Texas Health Science Center, Houston.
Given the lack of safety data, the CDC guidance to pregnant women has been to consult with their doctors and that it’s a personal choice. The Center for Disease Control and Prevention’s latest vaccine guidance said that “there is no evidence that antibodies formed from COVID-19 vaccination cause any problem with pregnancy, including the development of the placenta.”
The CDC is monitoring vaccinated people through its v-safe program and reported on April 12 that more than 86,000 v-safe participants said they were pregnant when they were vaccinated.
Health care workers who were nursing their infants when they were eligible for the vaccine faced a similar dilemma as pregnant women – they lacked the data on them to make a truly informed decision.
“I was nervous about the vaccine side effects for myself and whether my son Bennett, who was about a year old, would experience any of these himself,” said Christa Carrig, a labor and delivery nurse at Massachusetts General Hospital in Boston, who was breastfeeding at the time.
She and Dr. Parchem know that pregnant women with COVID-19 are more likely to have severe illness and complications such as high blood pressure and preterm delivery. “Pregnancy takes a toll on the body. When a woman gets COVID-19 and that insult is added, women who were otherwise young and healthy get much sicker than you would expect,” said Ms. Carrig.
“As a high-risk pregnancy specialist, I know that, with COVID, that babies don’t do well when moms are sick,” said Dr. Parchem.
Pregnant women accounted for more than 84,629 cases of COVID-19 and 95 deaths in the United States between Jan. 22 last year and April 12 this year, according to the CDC COVID data tracker.
Dr. Parchem and Ms. Carrig decided to get vaccinated because of their high risk of exposure to COVID-19 at work. After the second dose, Ms. Carrig reported chills but Bennett had no side effects from breastfeeding. Dr. Parchem, who delivered a healthy baby boy in February, reported no side effects other than a sore arm.
“There’s also a psychological benefit to returning to some sense of normalcy,” said Dr. Parchem. “My mother was finally able to visit us to see the new baby after we were all vaccinated. This was the first visit in more than a year.”
New study results
Ms. Carrig was one of 131 vaccinated hospital workers in the Boston area who took part in the first study to profile the immune response in pregnant and breastfeeding women and compare it with both nonpregnant and pregnant women who had COVID-19.
The study was not designed to evaluate the safety of the vaccines or whether they prevent COVID-19 illness and hospitalizations. That is the role of the large vaccine trials, the authors said.
The participants were aged 18-45 years and received both doses of either Pfizer or Moderna vaccines during one of their trimesters. They provided blood and/or breast milk samples after each vaccine dose, 2-6 weeks after the last dose, and at delivery for the 10 who gave birth during the study.
The vaccines produced a similar strong antibody response among the pregnant/breastfeeding women and nonpregnant women. Their antibody levels were much higher than those found in the pregnant women who had COVID-19, the researchers reported on March 25, 2021, in the American Journal of Obstetrics and Gynecology.
“This is important because a lot of people tend to think once they’ve had COVID-19, they are protected from the virus. This finding suggests that the vaccines produce a stronger antibody response than the infection itself, and this might be important for long-lasting protection against COVID-19,” said Dr. Parchem.
The study also addressed whether newborns benefit from the antibodies produced by their mothers. “In the 10 women who delivered, we detected antibodies in their umbilical cords and breast milk,” says Andrea Edlow, MD, lead researcher and a maternal-fetal medicine specialist at Massachusetts General Hospital.
Newborns are particularly vulnerable to respiratory infections because they have small airways and their immune systems are underdeveloped. These infections can be lethal early in life.
“The public health strategy is to vaccinate mothers against respiratory viruses, bacteria, and parasites that neonates up to 6 months are exposed to. Influenza and pertussis (whooping cough) are two examples of vaccines that we give mothers that we know transfer [antibodies] across the umbilical cord,” said Dr. Edlow.
But this “passive transfer immunity” is different from active immunity, when the body produces its own antibody immune response, she explains.
A different study, also published in March, confirmed that antibodies were transferred from 27 vaccinated pregnant mothers to their infants when they delivered. A new finding was that the women who were vaccinated with both doses and earlier in their third semester passed on more antibodies than the women who were vaccinated later or with only one dose.
Impact of the studies
The Society for Maternal-Fetal Medicine updated its guidance on counseling pregnant and lactating patients about the COVID-19 vaccines to include Dr. Edlow’s study.
“We were struck by how much pregnant and breastfeeding women want to participate in research and to help others in the same situation make decisions. I hope this will be an example to drug companies doing research on new vaccines in the future – that they should not be left behind and can make decisions themselves whether to participate after weighing the risks and benefits,” said Dr. Edlow.
She continues to enroll more vaccinated women in her study in the Boston area, including non–health care workers who have asked to take part.
“It was worth getting vaccinated and participating in the study. I know that I have antibodies and it worked and that I passed them on to Bennett. Also, I know that all the information is available for other women who are questioning whether to get vaccinated or not,” said Ms. Carrig.
Dr. Parchem is also taking part in the CDC’s v-safe pregnancy registry, which is collecting health and safety data on vaccinated pregnant women.
Before she was vaccinated, Dr. Parchem said, “my advice was very measured because we lacked data either saying that it definitely works or showing that it was unsafe. Now that we have this data supporting the benefits, I feel more confident in recommending the vaccines.”
A version of this article first appeared on Medscape.com.
The neurology of long-haul COVID-19
Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.
Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
Examining the nervous system’s involvement in COVID-19
Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.
To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.
Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.
She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
A panoply of different syndromes
In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.
Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.
One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
Looking for biologic markers
An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.
A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.
Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
The research task ahead
The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.
Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”
Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.
Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.
Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
Examining the nervous system’s involvement in COVID-19
Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.
To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.
Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.
She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
A panoply of different syndromes
In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.
Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.
One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
Looking for biologic markers
An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.
A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.
Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
The research task ahead
The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.
Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”
Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.
Long-haul neurologic symptoms of COVID-19 seem to be distinct from neurologic conditions found in acute disease. Much work remains to be done to understand the biological mechanisms behind these problems, but inflammation and autoimmune responses may play a role in some cases.
Those were some of the takeaways from a talk by Serena Spudich, MD, who presented her research at the 2021 annual meeting of the American Academy of Neurology. Dr. Spudich is the division chief of neurologic infections and global neurology and codirector of the Center for Neuroepidemiology and Clinical Neurological Research at Yale University, New Haven, Conn.
Examining the nervous system’s involvement in COVID-19
Even early on in the pandemic, it became clear that there were lingering complaints of neuromuscular problems, cognitive dysfunction, and mood and psychiatric issues. Breathing and heart rate problems also can arise. “There seems to be a preponderance of syndromes that reflect involvement of the nervous system,” said Dr. Spudich.
To try to understand the etiology of these persistent problems, Dr. Spudich said it’s important to examine the nervous system’s involvement in acute COVID-19. She has been involved in these efforts since early in the pandemic, when she ran an inpatient consult service at Yale dedicated to neurologic effects of acute COVID-19. She witnessed complications including stroke, encephalopathy, and seizures, among others.
Stroke during acute COVID-19 seemed to be associated with inflammation and endothelial activation or endotheliopathy. SARS-CoV-2 has been undetectable in the cerebrospinal fluid (CSF) of patients with acute COVID-19 and neurologic symptoms, but inflammatory cytokines can be present along with increased frequency of B cells. Anti–SARS-CoV-2 antibodies have also been found in CSF, some of which were auto reactive to brain tissue. The immune response was altered, compared with healthy controls, and in the CNS, compared with in the blood, “raising the question of whether inflammation and autoimmunity may be underlying causes of these syndromes,” said Dr. Spudich.
She also pointed to an MRI study of autopsied brain tissue of patients with COVID-19 and neurologic complications, which showed indications of both hemorrhagic and ischemic microvascular injury. “It’s just a reminder that, during acute COVID-19, there may be inflammation in the brain, there may be autoimmune reactions, and there may be vascular changes that underlie some of the neurologic syndromes that are seen,” said Dr. Spudich.
A panoply of different syndromes
In October, Yale set up a post-COVID neurologic clinic that brought together pulmonary, cardiology, and psychiatric specialists, many of whom saw the same patients, about 60% of whom had cognitive impairment, more than 40% had neuromuscular problems, and over 30% headache. “There’s not a single entity of a post-COVID neurologic syndrome. There’s a panoply of different syndromes that may have similar or distinct etiologies,” said Dr. Spudich.
Most patients were in their 30s, 40s, or 50s. That doesn’t necessarily mean this is the most common age range for these issues, though. There could be some bias if these individuals are seeking specialty care because they expected to recover from COVID-19 quickly. But it could be that there is something biologically unique among this age group that predisposes them to complications. Regardless, two out of three patients were never hospitalized, “suggesting that even mild COVID-19 can lead to some long-term sequelae,” said Dr. Spudich.
One potential explanation for long-term neurologic syndromes is that they are an extension of the inflammation, autoimmunity, and immune perturbation occurring during acute disease. One study looked at 18 cancer patients who had neurologic complications with COVID-19. Two months after onset, they had elevated markers of neuroinflammation and neuronal injury in the cerebral spinal fluid compared to cancer patients with no history of COVID-19.
Looking for biologic markers
An Italian study looked at patients who were evaluated during acute hospitalization and again 3 months later, and found that some markers of inflation in the blood were associated with later cognitive impairment. The patients were more severely ill, so it’s not clear what the findings mean for patients who present with neurologic symptoms after milder illness.
A PET scan study of 35 patients with persistent neurologic symptoms found patterns of reduced fluorodeoxyglucose uptake in some regions of the brain that are believed to be associated with some symptoms. Lower values were associated with greater severity for symptoms like memory dysfunction, and anosmia. “Why there might be hypometabolism in these regions I think needs to be assessed and used as a biomarker to associate hypometabolism with other kinds of processes in blood and spinal fluid,” said Dr. Spudich.
Along with colleagues at Yale, Dr. Spudich is conducting the MIND study, which is using PET and MRI imaging along with blood and CSF biomarkers to track the progress of patients after COVID-19. There are few results to discuss since only 20 patients have been recruited so far, except that brain imaging and blood values are generally normal despite neurologic complaints. Most were not hospitalized for COVID-19. Dr. Spudich highlighted one man in his 30s who developed new-onset psychosis, despite no previous history. Although clinical tests were all negative, a novel autoantibody detection method revealed a previously unknown autoreactive antibody in his spinal fluid. “This may suggest that there is autoantibody production in some individuals with post–COVID-19 psychosis, and potentially other syndromes,” said Dr. Spudich.
The research task ahead
The case illustrates the task ahead for neurology. “There’s a real research mandate to understand the biological substrates of these diverse disorders, not only to address the emergent public health concern and reduce the stigma in our patients, but to develop targeted therapeutic interventions,” said Dr. Spudich.
Anna Cervantes-Arslanian, MD, an associate professor of neurology at Boston University who also treats and studies patients with post-COVID neurologic symptoms, agreed with that assessment. “It’s not like every patient that has muscle aches and fatigue also has brain fog. It’s really hard to parse them out into specific phenotypes that are pretty classic. Some people will have all of those things, some will have very few of them,” said Dr. Cervantes-Arslanian. “We need to be able to identify them sand see if there is clustering of symptoms so we can better look into what the biological underpinnings are. That’s the first step to thinking about a therapeutic target.”
Dr. Spudich and Dr. Cervantes-Arslanian had no relevant financial disclosures.
FROM AAN 2021
Study shows how COVID-19 disrupted RA meds
During the first 3 months of the COVID-19 pandemic last year, about one-third of people with rheumatoid arthritis in the United States made changes in their RA medications, and, before the American College of Rheumatology tweaked its guidelines midway through that period, they were about twice as likely to make medication changes on their own than before the pandemic, according to an analysis of data in FORWARD, the National Databank for Rheumatic Diseases.
The study, published in Arthritis Care & Research, also found that about 10% of RA patients on hydroxychloroquine lost access to the drug at a time it was drawing interest as a treatment for COVID-19. Another finding was that a high percentage of patients on non–tumor necrosis factor biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors canceled or postponed appointments.
“Our results show that persons with RA who had medication changes in the first 3 months of the COVID-19 pandemic in the U.S. were more likely to have worse disease activity and higher exposure to prior DMARDs, but no statistical difference was found in terms of comorbidities,” first author Kaleb Michaud, PhD, and coauthors wrote. Dr. Michaud is with the National Databank for Rheumatic Diseases, Wichita, Kan., and the University of Nebraska Medical Center, Omaha.
The study evaluated responses from 734 adults who participated in FORWARD, an observational, multidisease registry. They answered online surveys about COVID-19 in May 2020 and had provided data on their medication use before the pandemic. A total of 30% (n = 221) reported medication changes in that period.
Details on medication changes
Medication changers were more likely to use glucocorticoids (GCs) (32.6% vs. 18.1%) and less likely to use nonhydroxychloroquine conventional DMARDs (49.3% vs. 62%) pre-COVID. Changers also reported higher rates of economic hardship during the pandemic (22.6% vs. 14.6%).
In the midst of the study period, the ACR issued a clinical guideline for treatment of rheumatic and musculoskeletal diseases (RMDs), emphasizing the need to maintain DMARD therapy, control disease activity, and reduce prednisone/GC use. The guideline advised continuing hydroxychloroquine and interleukin-6 inhibitor biologics in people with suspected or confirmed COVID-19.
Dr. Michaud and coauthors acknowledged the ongoing lack of knowledge about real-world treatment patterns for RA during the pandemic. They set out with this study to fill those knowledge gaps.
They noted that patients on bDMARDs (17.6%) and JAK inhibitors (17.1%) were more than twice as likely to discontinue medications than were those on conventional DMARDs (8.2%).
Switching to telehealth was the most common pandemic-related behavior change among patients in all DMARD groups, with rates ranging from 31% to 47.1%, followed by canceling or postponing appointments, with rates ranging from 27.9% to 36.4% depending on the DMARD group.
The study also found that RA patients widely adopted the behavior changes that the Centers for Disease Control and Prevention recommended during the pandemic, although the rates of restricting social contacts were significantly lower than the 90% reported in an early Italian study.
Dr. Michaud and coauthors also provided some explanation of why people on GCs and DMARDs were more likely than others to change medication patterns. “This may reflect efforts to reduce the perceived risk of infections due to GCs as well as the likely less-controlled disease activity associated with GC use,” they wrote. While the ACR’s early pandemic guidance followed the 2015 guidelines – that patients should continue on GCs at the “lowest possible dose” and not stop them “abruptly” – most U.S. rheumatologists reported cutting back on GC use during the pandemic.
The researchers acknowledged that evidence linking GC use with hospitalization for COVID-19, which emerged after they had surveyed study participants, was consistent their findings, but that the overall risk of COVID-19 in RA patients still isn’t known.
Pfizer funded the analysis, and a coauthor is an employee of Pfizer.
During the first 3 months of the COVID-19 pandemic last year, about one-third of people with rheumatoid arthritis in the United States made changes in their RA medications, and, before the American College of Rheumatology tweaked its guidelines midway through that period, they were about twice as likely to make medication changes on their own than before the pandemic, according to an analysis of data in FORWARD, the National Databank for Rheumatic Diseases.
The study, published in Arthritis Care & Research, also found that about 10% of RA patients on hydroxychloroquine lost access to the drug at a time it was drawing interest as a treatment for COVID-19. Another finding was that a high percentage of patients on non–tumor necrosis factor biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors canceled or postponed appointments.
“Our results show that persons with RA who had medication changes in the first 3 months of the COVID-19 pandemic in the U.S. were more likely to have worse disease activity and higher exposure to prior DMARDs, but no statistical difference was found in terms of comorbidities,” first author Kaleb Michaud, PhD, and coauthors wrote. Dr. Michaud is with the National Databank for Rheumatic Diseases, Wichita, Kan., and the University of Nebraska Medical Center, Omaha.
The study evaluated responses from 734 adults who participated in FORWARD, an observational, multidisease registry. They answered online surveys about COVID-19 in May 2020 and had provided data on their medication use before the pandemic. A total of 30% (n = 221) reported medication changes in that period.
Details on medication changes
Medication changers were more likely to use glucocorticoids (GCs) (32.6% vs. 18.1%) and less likely to use nonhydroxychloroquine conventional DMARDs (49.3% vs. 62%) pre-COVID. Changers also reported higher rates of economic hardship during the pandemic (22.6% vs. 14.6%).
In the midst of the study period, the ACR issued a clinical guideline for treatment of rheumatic and musculoskeletal diseases (RMDs), emphasizing the need to maintain DMARD therapy, control disease activity, and reduce prednisone/GC use. The guideline advised continuing hydroxychloroquine and interleukin-6 inhibitor biologics in people with suspected or confirmed COVID-19.
Dr. Michaud and coauthors acknowledged the ongoing lack of knowledge about real-world treatment patterns for RA during the pandemic. They set out with this study to fill those knowledge gaps.
They noted that patients on bDMARDs (17.6%) and JAK inhibitors (17.1%) were more than twice as likely to discontinue medications than were those on conventional DMARDs (8.2%).
Switching to telehealth was the most common pandemic-related behavior change among patients in all DMARD groups, with rates ranging from 31% to 47.1%, followed by canceling or postponing appointments, with rates ranging from 27.9% to 36.4% depending on the DMARD group.
The study also found that RA patients widely adopted the behavior changes that the Centers for Disease Control and Prevention recommended during the pandemic, although the rates of restricting social contacts were significantly lower than the 90% reported in an early Italian study.
Dr. Michaud and coauthors also provided some explanation of why people on GCs and DMARDs were more likely than others to change medication patterns. “This may reflect efforts to reduce the perceived risk of infections due to GCs as well as the likely less-controlled disease activity associated with GC use,” they wrote. While the ACR’s early pandemic guidance followed the 2015 guidelines – that patients should continue on GCs at the “lowest possible dose” and not stop them “abruptly” – most U.S. rheumatologists reported cutting back on GC use during the pandemic.
The researchers acknowledged that evidence linking GC use with hospitalization for COVID-19, which emerged after they had surveyed study participants, was consistent their findings, but that the overall risk of COVID-19 in RA patients still isn’t known.
Pfizer funded the analysis, and a coauthor is an employee of Pfizer.
During the first 3 months of the COVID-19 pandemic last year, about one-third of people with rheumatoid arthritis in the United States made changes in their RA medications, and, before the American College of Rheumatology tweaked its guidelines midway through that period, they were about twice as likely to make medication changes on their own than before the pandemic, according to an analysis of data in FORWARD, the National Databank for Rheumatic Diseases.
The study, published in Arthritis Care & Research, also found that about 10% of RA patients on hydroxychloroquine lost access to the drug at a time it was drawing interest as a treatment for COVID-19. Another finding was that a high percentage of patients on non–tumor necrosis factor biologic disease-modifying antirheumatic drugs (bDMARDs) and Janus kinase (JAK) inhibitors canceled or postponed appointments.
“Our results show that persons with RA who had medication changes in the first 3 months of the COVID-19 pandemic in the U.S. were more likely to have worse disease activity and higher exposure to prior DMARDs, but no statistical difference was found in terms of comorbidities,” first author Kaleb Michaud, PhD, and coauthors wrote. Dr. Michaud is with the National Databank for Rheumatic Diseases, Wichita, Kan., and the University of Nebraska Medical Center, Omaha.
The study evaluated responses from 734 adults who participated in FORWARD, an observational, multidisease registry. They answered online surveys about COVID-19 in May 2020 and had provided data on their medication use before the pandemic. A total of 30% (n = 221) reported medication changes in that period.
Details on medication changes
Medication changers were more likely to use glucocorticoids (GCs) (32.6% vs. 18.1%) and less likely to use nonhydroxychloroquine conventional DMARDs (49.3% vs. 62%) pre-COVID. Changers also reported higher rates of economic hardship during the pandemic (22.6% vs. 14.6%).
In the midst of the study period, the ACR issued a clinical guideline for treatment of rheumatic and musculoskeletal diseases (RMDs), emphasizing the need to maintain DMARD therapy, control disease activity, and reduce prednisone/GC use. The guideline advised continuing hydroxychloroquine and interleukin-6 inhibitor biologics in people with suspected or confirmed COVID-19.
Dr. Michaud and coauthors acknowledged the ongoing lack of knowledge about real-world treatment patterns for RA during the pandemic. They set out with this study to fill those knowledge gaps.
They noted that patients on bDMARDs (17.6%) and JAK inhibitors (17.1%) were more than twice as likely to discontinue medications than were those on conventional DMARDs (8.2%).
Switching to telehealth was the most common pandemic-related behavior change among patients in all DMARD groups, with rates ranging from 31% to 47.1%, followed by canceling or postponing appointments, with rates ranging from 27.9% to 36.4% depending on the DMARD group.
The study also found that RA patients widely adopted the behavior changes that the Centers for Disease Control and Prevention recommended during the pandemic, although the rates of restricting social contacts were significantly lower than the 90% reported in an early Italian study.
Dr. Michaud and coauthors also provided some explanation of why people on GCs and DMARDs were more likely than others to change medication patterns. “This may reflect efforts to reduce the perceived risk of infections due to GCs as well as the likely less-controlled disease activity associated with GC use,” they wrote. While the ACR’s early pandemic guidance followed the 2015 guidelines – that patients should continue on GCs at the “lowest possible dose” and not stop them “abruptly” – most U.S. rheumatologists reported cutting back on GC use during the pandemic.
The researchers acknowledged that evidence linking GC use with hospitalization for COVID-19, which emerged after they had surveyed study participants, was consistent their findings, but that the overall risk of COVID-19 in RA patients still isn’t known.
Pfizer funded the analysis, and a coauthor is an employee of Pfizer.
FROM ARTHRITIS CARE & RESEARCH
Most patients with chronic inflammatory diseases have sufficient response to COVID-19 vaccination
Glucocorticoids and B-cell–depleting therapies are trouble spots
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
Glucocorticoids and B-cell–depleting therapies are trouble spots
Glucocorticoids and B-cell–depleting therapies are trouble spots
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
Although most patients with chronic inflammatory diseases mounted immune responses after two doses of mRNA-based COVID-19 vaccines, glucocorticoids and B-cell–depleting therapies markedly reduced the response, according to a recently published preprint of a new study.
The study, published on MedRxiv and not yet peer reviewed, involved a prospective look at 133 patients with chronic inflammatory disease (CID) and 53 patients with healthy immune systems at Washington University, St. Louis, and the University of California, San Francisco. It is regarded as the largest and most detailed study yet in how vaccines perform in people with immune-mediated inflammatory disease. The patients were enrolled between December 2020 and March 2021, and the most common diseases were inflammatory bowel disease (32%), rheumatoid arthritis (29%), spondyloarthritis (15%), and systemic lupus erythematosus (11%).
A ‘modest’ reduction in antibody response
Senior author Alfred Kim, MD, PhD, of the department of medicine at Washington University, said the overall results so far are encouraging.
“Most patients with an autoimmune disease that are on immunosuppression can mount antibody responses,” he said. “We’re seeing the majority of our subjects respond.”
The immune-healthy controls and most of the patients with CID had a robust immune response against the spike protein, although the CID group had a mean reduction in antibody titers that was three times lower than the controls (P = .0092). The CID group similarly had a 2.7-fold reduction in preventing neutralization, or halting the virus’ ability to infect (P < .0001), researchers reported.
This reduction in response is “modest,” he said.
“Is the level of reduction going to be detrimental for protection? Time will tell,” he said, adding that researchers anticipate that it won’t have a critical effect on protection because responses tended to be within the range of the immunocompetent controls, who themselves had wildly varied antibody titers across a 20-fold range. “ ‘Optimal’ isn’t necessarily the same as ‘sufficient.’ ”
Type of medication has big impact on antibody titers
But there was a wide variety of effects on the immune response depending on the medication. Glucorticoids resulted in a response that was 10 times lower than the immune-healthy controls, as well as fewer circulating plasmablasts after vaccination. Researchers found that 98% of controls were seropositive for antibody, compared with 92% of those with CID who were not taking prednisone, and 65% of CID patients on prednisone (P = .0006 and .0115, respectively). Prevention of neutralization of the virus was similarly reduced in those groups, compared with the controls. Dr. Kim noted this was a small sample size, with about 15 patients. These effects were seen regardless of the dose.
“We would’ve anticipated this would have been dose dependent, so this was a little bit surprising,” Dr. Kim said.
B-cell–depleting therapies, such as rituximab (Rituxan) and ocrelizumab (Ocrevus), reduced antibody titers by 36 times, compared with controls (P < .0001), with a similar reduction in preventing infection (P = .0066), the researchers found. The reduction in antibody titers was the most pronounced among those who had received B-cell–depleting therapies within the previous 6 months. Dr. Kim noted this was a small sample size, with about 10 patients.
CID study subjects taking an antimetabolite, including methotrexate, had an average of a two- to threefold reduction in antibody titers and in neutralization (P = .0006). This reduction was greatest with methotrexate, researchers found (P = .0027).
JAK inhibitors also significantly reduced antibody titers (P = .0066), but the reduction in neutralization of the virus was not significant. In addition, researchers found a reduction in antibody titers, the prevention of viral infection, and circulating plasmablasts among those on tumor necrosis factor (TNF) inhibitors, compared with controls, but these were insignificant statistically except for virus neutralization.
Dr. Kim said he hopes the glucocorticoid data spur physicians to try harder to wean patients off the drugs, when possible, in keeping with recommendations already in place.
“The general culture in rheumatology has been very lax about the need to reduce glucocorticoids,” he said. “This reinvigorates that call.” Questions about possible drug holidays from glucocorticoids remain, regarding how long a holiday would be needed, he said. He noted that many patients on glucocorticoids nonetheless mounted responses.
Those on B-cell–depleting therapies present a “much more difficult” question, he said. Some patients possibly could wait a bit longer than their normal, every-6-month schedule, but it’s an individual decision, he said. Since a booster of influenza vaccine has been found to enhance the response even within the 6-month window among ocrelizumab patients, a booster of COVID-19 vaccine might also help, although this remains to be studied.
The study group has already increased its sample size and is looking at adverse reactions and long-term immune responses, Dr. Kim said.
Encouraging, rather than discouraging, results
Leonard Calabrese, DO, professor of medicine at the Cleveland Clinic in Ohio, said the findings shouldn’t discourage clinicians from encouraging vaccination.
“There’s still a preponderance of people who will develop a robust antibody vaccine response,” he said.
He cautioned that the findings look only at antibodies to the spike protein and at plasmablasts. The reduction in these titers is “of concern,” he said, but “we don’t really know with certainty what are the effects of these drugs, and these data are on the overall biologic protective effect of the vaccine. There’s much more to a vaccine response than anti–spike protein and plasmablasts,” including cell-mediated immune response.
For an individual patient, the findings “mean a lot,” he said.
“I think that people who are on significant prednisone and B-cell–depleting agents, I think you have to share with them that there’s a reasonable chance that you’re not going to be making a response similar to healthy people,” he said. “Thus, even with your vaccine, we’re not going to cut you loose to do things that are violating social distancing and group settings. … Should you be hugging your grandchildren if you’re a rituximab vaccine recipient? I think I would wait until we have a little bit more data.”
Kevin Winthrop, MD, MPH, professor of ophthalmology at Oregon Health & Science University, Portland, where he studies vaccinations in the immunocompromised, said that glucocorticoids tend to have little effect on vaccinations generally at low doses.
When effects are seen they can be difficult to interpret, he said.
“It’s hard to extricate that from the effect of the underlying disease,” he said. The drug can be a proxy for worse disease control.
Although it’s a small study, it’s reassuring that overall the responses were similar to healthy controls.
For B-cell–depleting therapies, his usual guidance is to not give vaccine until a patient is at least 3 months out from their last dose, and not to restart until at least 2 weeks after vaccination.
“It’s not surprising that some of these DMARDs [disease-modifying antirheumatic drugs] do negatively affect vaccine response, particularly B-cell–depletion therapy. We need to do some studies to find a way to overcome that, or optimize delivery of the vaccine.”
Dr. Kim reported participating in consulting, advisory board, or speaker’s bureau for Alexion, Aurinia, Annexon Biosciences, Exagen Diagnostics, and GlaxoSmithKline, and receiving funding under a sponsored research agreement unrelated to the data in the paper from GlaxoSmithKline. Dr. Winthrop reported receiving consulting fees from Pfizer, AbbVie, UCB, Eli Lilly, Galapagos, GlaxoSmithKline, Roche, Gilead, Bristol-Myers Squibb, Regeneron, Sanofi, AstraZeneca, Novartis, and research grants from Bristol-Myers Squibb and Pfizer. Dr. Calabrese reported no relevant disclosures.
FROM MEDRXIV
Stroke is ‘not a common complication’ in COVID-19
One study showed a stroke rate of 2.2% among patients with COVID-19 admitted to intensive care in 52 different countries. Another found a stroke rate of 1.48% in patients hospitalized with COVID-19 from 70 different countries. These researchers also found a reduction in stroke presentations and stroke care during the pandemic.
Both studies will be presented at the American Academy of Neurology’s 2021 annual meeting.
“Stroke has been a known serious complication of COVID-19, with some studies reporting a higher-than-expected occurrence, especially in young people,” said coauthor of the intensive care study, Jonathon Fanning, MBBS, PhD, University of Queensland, Brisbane, Australia.
“However, among the sickest of COVID patients – those admitted to an ICU – our research found that stroke was not a common complication and that ischemic stroke did not increase the risk of death,” he added.
Hemorrhagic stroke more common?
In this study, researchers analyzed a database of 2,699 patients who were admitted to the intensive care unit with COVID-19 in 52 countries and found that 59 of these patients (2.2%) subsequently sustained a stroke.
Most of the strokes identified in this cohort were hemorrhagic (46%), with 32% being ischemic and 22% unspecified. Hemorrhagic stroke was associated with a fivefold increased risk for death compared with patients who did not have a stroke. Of those with a hemorrhagic stroke, 72% died, but only 15% died of the stroke. Rather, multiorgan failure was the leading cause of death.
There was no association between ischemic stroke and mortality.
“There is scarce research on new-onset stroke complicating ICU admissions, and many of the limitations of assessing stroke in ICU populations confound the true values and result in variability in reported incidence anywhere from a 1%-4% incidence,” Dr. Fanning said.
He noted that a large Korean study had shown a 1.2% rate of stroke in patients without COVID admitted to non-neurologic ICUs. “In light of this, I think this 2% is higher than we would expect in a general ICU population, but in the context of earlier reports of COVID-19–associated risk for stroke, this figure is actually somewhat reassuring,” Dr. Fanning said.
Asked how this study compared with the large American Heart Association study recently reported that showed an overall rate of ischemic stroke of 0.75%, Dr. Fanning said the two studies reported on different populations, which makes them difficult to compare.
“Our study specifically reports on new-onset stroke complicating ICU admission,” he noted. “The AHA study is a large study of all patients admitted to hospital, but both studies identified less than previous estimates of COVID-related stroke.”
Largest sample to date
The other study, which includes 119,967 COVID-19 hospitalizations and represents the largest sample reporting the concomitant diagnoses of stroke and SARS-CoV-2 infection to date, was presented at the AAN meeting by Thanh N. Nguyen, MD, a professor at Boston University.
This study has also been published online in Neurology, with first author Raul G. Nogueira, MD, Emory University, Atlanta.
In this international observational, retrospective study across 6 continents, 70 countries, and 457 stroke centers, there was a 1.48% stroke rate across 119,967 COVID-19 hospitalizations. SARS-CoV-2 infection was noted in 3.3% (1,722) of all stroke admissions, which numbered 52,026.
The researchers identified stroke diagnoses by the International Classification of Diseases, 10th revision, codes and/or classifications in stroke center databases, and rates of stroke hospitalizations and numbers of patients receiving thrombolysis were compared between the first 4 months of the pandemic (March to June 2020) compared with two control 4-month periods.
Global decline in stroke care during pandemic
Results showed a global decline in the number of stroke patients admitted to the hospital as well as acute stroke treatments, such as thrombolysis, during the first wave of the COVID-19 pandemic. The researchers found that there were 91,373 stroke admissions in the 4 months immediately before the pandemic, compared with 80,894 admissions during the first 4 pandemic months, representing an 11.5% decline.
They also report that 13,334 stroke patients received intravenous thrombolysis in the 4 months preceding the pandemic, compared with 11,570 during the first 4 pandemic months, representing a 13.2% drop.
Interhospital transfers after thrombolysis for a higher level of stroke care decreased from 1,337 before the pandemic to 1,178 during the pandemic, a reduction of 11.9%.
There were greater declines in primary compared with comprehensive stroke centers for stroke hospitalizations (change, –17.3% vs. –10.3%) and for the number of patients receiving thrombolysis (change, –15.5% vs. –12.6%).
The volume of stroke hospitalizations increased by 9.5% in the two later pandemic months (May, June) versus the two earlier months (March, April), with greater recovery in hospitals with lower COVID-19 hospitalization volume, high-volume stroke centers, and comprehensive stroke centers.
Dr. Nguyen suggested that reasons for the reductions in these stroke numbers at the beginning of the pandemic could include a reduction in stroke risk due to a reduction of exposure to other viral infections or patients not presenting to the hospital for fear of contracting the coronavirus.
The higher recovery of stroke volume in high-volume stroke centers and comprehensive stroke centers may represent patients with higher needs – those having more severe strokes – seeking care more frequently than those with milder symptoms, she noted.
“Preserving access to stroke care and emergency stroke care amidst a pandemic is as important as educating patients on the importance of presenting to the hospital in the event of stroke-like symptoms,” Dr. Nguyen concluded.
“We continue to advocate that if a patient has stroke-like symptoms, such as loss of speech, strength, vision, or balance, it is important for the patient to seek medical care as an emergency, as there are treatments that can improve a patient’s ability to recover from disabling stroke in earlier rather than later time windows,” she added.
In the publication, the authors wrote, “Our results concur with other recent reports on the collateral effects of the COVID-19 pandemic on stroke systems of care,” but added that “this is among the first descriptions of the change at a global level, including primary and comprehensive stroke centers.”
They said that hospital access related to high COVID-19 burden was unlikely a factor because the decline was seen in centers with a few or no patients with COVID-19. They suggested that patient fear of contracting coronavirus may have played a role, along with a decrease in presentation of transient ischemic attacks, mild strokes, or moderate strokes, and physical distancing measures may have prevented the timely witnessing of a stroke.
A version of this article first appeared on Medscape.com.
One study showed a stroke rate of 2.2% among patients with COVID-19 admitted to intensive care in 52 different countries. Another found a stroke rate of 1.48% in patients hospitalized with COVID-19 from 70 different countries. These researchers also found a reduction in stroke presentations and stroke care during the pandemic.
Both studies will be presented at the American Academy of Neurology’s 2021 annual meeting.
“Stroke has been a known serious complication of COVID-19, with some studies reporting a higher-than-expected occurrence, especially in young people,” said coauthor of the intensive care study, Jonathon Fanning, MBBS, PhD, University of Queensland, Brisbane, Australia.
“However, among the sickest of COVID patients – those admitted to an ICU – our research found that stroke was not a common complication and that ischemic stroke did not increase the risk of death,” he added.
Hemorrhagic stroke more common?
In this study, researchers analyzed a database of 2,699 patients who were admitted to the intensive care unit with COVID-19 in 52 countries and found that 59 of these patients (2.2%) subsequently sustained a stroke.
Most of the strokes identified in this cohort were hemorrhagic (46%), with 32% being ischemic and 22% unspecified. Hemorrhagic stroke was associated with a fivefold increased risk for death compared with patients who did not have a stroke. Of those with a hemorrhagic stroke, 72% died, but only 15% died of the stroke. Rather, multiorgan failure was the leading cause of death.
There was no association between ischemic stroke and mortality.
“There is scarce research on new-onset stroke complicating ICU admissions, and many of the limitations of assessing stroke in ICU populations confound the true values and result in variability in reported incidence anywhere from a 1%-4% incidence,” Dr. Fanning said.
He noted that a large Korean study had shown a 1.2% rate of stroke in patients without COVID admitted to non-neurologic ICUs. “In light of this, I think this 2% is higher than we would expect in a general ICU population, but in the context of earlier reports of COVID-19–associated risk for stroke, this figure is actually somewhat reassuring,” Dr. Fanning said.
Asked how this study compared with the large American Heart Association study recently reported that showed an overall rate of ischemic stroke of 0.75%, Dr. Fanning said the two studies reported on different populations, which makes them difficult to compare.
“Our study specifically reports on new-onset stroke complicating ICU admission,” he noted. “The AHA study is a large study of all patients admitted to hospital, but both studies identified less than previous estimates of COVID-related stroke.”
Largest sample to date
The other study, which includes 119,967 COVID-19 hospitalizations and represents the largest sample reporting the concomitant diagnoses of stroke and SARS-CoV-2 infection to date, was presented at the AAN meeting by Thanh N. Nguyen, MD, a professor at Boston University.
This study has also been published online in Neurology, with first author Raul G. Nogueira, MD, Emory University, Atlanta.
In this international observational, retrospective study across 6 continents, 70 countries, and 457 stroke centers, there was a 1.48% stroke rate across 119,967 COVID-19 hospitalizations. SARS-CoV-2 infection was noted in 3.3% (1,722) of all stroke admissions, which numbered 52,026.
The researchers identified stroke diagnoses by the International Classification of Diseases, 10th revision, codes and/or classifications in stroke center databases, and rates of stroke hospitalizations and numbers of patients receiving thrombolysis were compared between the first 4 months of the pandemic (March to June 2020) compared with two control 4-month periods.
Global decline in stroke care during pandemic
Results showed a global decline in the number of stroke patients admitted to the hospital as well as acute stroke treatments, such as thrombolysis, during the first wave of the COVID-19 pandemic. The researchers found that there were 91,373 stroke admissions in the 4 months immediately before the pandemic, compared with 80,894 admissions during the first 4 pandemic months, representing an 11.5% decline.
They also report that 13,334 stroke patients received intravenous thrombolysis in the 4 months preceding the pandemic, compared with 11,570 during the first 4 pandemic months, representing a 13.2% drop.
Interhospital transfers after thrombolysis for a higher level of stroke care decreased from 1,337 before the pandemic to 1,178 during the pandemic, a reduction of 11.9%.
There were greater declines in primary compared with comprehensive stroke centers for stroke hospitalizations (change, –17.3% vs. –10.3%) and for the number of patients receiving thrombolysis (change, –15.5% vs. –12.6%).
The volume of stroke hospitalizations increased by 9.5% in the two later pandemic months (May, June) versus the two earlier months (March, April), with greater recovery in hospitals with lower COVID-19 hospitalization volume, high-volume stroke centers, and comprehensive stroke centers.
Dr. Nguyen suggested that reasons for the reductions in these stroke numbers at the beginning of the pandemic could include a reduction in stroke risk due to a reduction of exposure to other viral infections or patients not presenting to the hospital for fear of contracting the coronavirus.
The higher recovery of stroke volume in high-volume stroke centers and comprehensive stroke centers may represent patients with higher needs – those having more severe strokes – seeking care more frequently than those with milder symptoms, she noted.
“Preserving access to stroke care and emergency stroke care amidst a pandemic is as important as educating patients on the importance of presenting to the hospital in the event of stroke-like symptoms,” Dr. Nguyen concluded.
“We continue to advocate that if a patient has stroke-like symptoms, such as loss of speech, strength, vision, or balance, it is important for the patient to seek medical care as an emergency, as there are treatments that can improve a patient’s ability to recover from disabling stroke in earlier rather than later time windows,” she added.
In the publication, the authors wrote, “Our results concur with other recent reports on the collateral effects of the COVID-19 pandemic on stroke systems of care,” but added that “this is among the first descriptions of the change at a global level, including primary and comprehensive stroke centers.”
They said that hospital access related to high COVID-19 burden was unlikely a factor because the decline was seen in centers with a few or no patients with COVID-19. They suggested that patient fear of contracting coronavirus may have played a role, along with a decrease in presentation of transient ischemic attacks, mild strokes, or moderate strokes, and physical distancing measures may have prevented the timely witnessing of a stroke.
A version of this article first appeared on Medscape.com.
One study showed a stroke rate of 2.2% among patients with COVID-19 admitted to intensive care in 52 different countries. Another found a stroke rate of 1.48% in patients hospitalized with COVID-19 from 70 different countries. These researchers also found a reduction in stroke presentations and stroke care during the pandemic.
Both studies will be presented at the American Academy of Neurology’s 2021 annual meeting.
“Stroke has been a known serious complication of COVID-19, with some studies reporting a higher-than-expected occurrence, especially in young people,” said coauthor of the intensive care study, Jonathon Fanning, MBBS, PhD, University of Queensland, Brisbane, Australia.
“However, among the sickest of COVID patients – those admitted to an ICU – our research found that stroke was not a common complication and that ischemic stroke did not increase the risk of death,” he added.
Hemorrhagic stroke more common?
In this study, researchers analyzed a database of 2,699 patients who were admitted to the intensive care unit with COVID-19 in 52 countries and found that 59 of these patients (2.2%) subsequently sustained a stroke.
Most of the strokes identified in this cohort were hemorrhagic (46%), with 32% being ischemic and 22% unspecified. Hemorrhagic stroke was associated with a fivefold increased risk for death compared with patients who did not have a stroke. Of those with a hemorrhagic stroke, 72% died, but only 15% died of the stroke. Rather, multiorgan failure was the leading cause of death.
There was no association between ischemic stroke and mortality.
“There is scarce research on new-onset stroke complicating ICU admissions, and many of the limitations of assessing stroke in ICU populations confound the true values and result in variability in reported incidence anywhere from a 1%-4% incidence,” Dr. Fanning said.
He noted that a large Korean study had shown a 1.2% rate of stroke in patients without COVID admitted to non-neurologic ICUs. “In light of this, I think this 2% is higher than we would expect in a general ICU population, but in the context of earlier reports of COVID-19–associated risk for stroke, this figure is actually somewhat reassuring,” Dr. Fanning said.
Asked how this study compared with the large American Heart Association study recently reported that showed an overall rate of ischemic stroke of 0.75%, Dr. Fanning said the two studies reported on different populations, which makes them difficult to compare.
“Our study specifically reports on new-onset stroke complicating ICU admission,” he noted. “The AHA study is a large study of all patients admitted to hospital, but both studies identified less than previous estimates of COVID-related stroke.”
Largest sample to date
The other study, which includes 119,967 COVID-19 hospitalizations and represents the largest sample reporting the concomitant diagnoses of stroke and SARS-CoV-2 infection to date, was presented at the AAN meeting by Thanh N. Nguyen, MD, a professor at Boston University.
This study has also been published online in Neurology, with first author Raul G. Nogueira, MD, Emory University, Atlanta.
In this international observational, retrospective study across 6 continents, 70 countries, and 457 stroke centers, there was a 1.48% stroke rate across 119,967 COVID-19 hospitalizations. SARS-CoV-2 infection was noted in 3.3% (1,722) of all stroke admissions, which numbered 52,026.
The researchers identified stroke diagnoses by the International Classification of Diseases, 10th revision, codes and/or classifications in stroke center databases, and rates of stroke hospitalizations and numbers of patients receiving thrombolysis were compared between the first 4 months of the pandemic (March to June 2020) compared with two control 4-month periods.
Global decline in stroke care during pandemic
Results showed a global decline in the number of stroke patients admitted to the hospital as well as acute stroke treatments, such as thrombolysis, during the first wave of the COVID-19 pandemic. The researchers found that there were 91,373 stroke admissions in the 4 months immediately before the pandemic, compared with 80,894 admissions during the first 4 pandemic months, representing an 11.5% decline.
They also report that 13,334 stroke patients received intravenous thrombolysis in the 4 months preceding the pandemic, compared with 11,570 during the first 4 pandemic months, representing a 13.2% drop.
Interhospital transfers after thrombolysis for a higher level of stroke care decreased from 1,337 before the pandemic to 1,178 during the pandemic, a reduction of 11.9%.
There were greater declines in primary compared with comprehensive stroke centers for stroke hospitalizations (change, –17.3% vs. –10.3%) and for the number of patients receiving thrombolysis (change, –15.5% vs. –12.6%).
The volume of stroke hospitalizations increased by 9.5% in the two later pandemic months (May, June) versus the two earlier months (March, April), with greater recovery in hospitals with lower COVID-19 hospitalization volume, high-volume stroke centers, and comprehensive stroke centers.
Dr. Nguyen suggested that reasons for the reductions in these stroke numbers at the beginning of the pandemic could include a reduction in stroke risk due to a reduction of exposure to other viral infections or patients not presenting to the hospital for fear of contracting the coronavirus.
The higher recovery of stroke volume in high-volume stroke centers and comprehensive stroke centers may represent patients with higher needs – those having more severe strokes – seeking care more frequently than those with milder symptoms, she noted.
“Preserving access to stroke care and emergency stroke care amidst a pandemic is as important as educating patients on the importance of presenting to the hospital in the event of stroke-like symptoms,” Dr. Nguyen concluded.
“We continue to advocate that if a patient has stroke-like symptoms, such as loss of speech, strength, vision, or balance, it is important for the patient to seek medical care as an emergency, as there are treatments that can improve a patient’s ability to recover from disabling stroke in earlier rather than later time windows,” she added.
In the publication, the authors wrote, “Our results concur with other recent reports on the collateral effects of the COVID-19 pandemic on stroke systems of care,” but added that “this is among the first descriptions of the change at a global level, including primary and comprehensive stroke centers.”
They said that hospital access related to high COVID-19 burden was unlikely a factor because the decline was seen in centers with a few or no patients with COVID-19. They suggested that patient fear of contracting coronavirus may have played a role, along with a decrease in presentation of transient ischemic attacks, mild strokes, or moderate strokes, and physical distancing measures may have prevented the timely witnessing of a stroke.
A version of this article first appeared on Medscape.com.
From AAN 2021
Ten reasons airborne transmission of SARS-CoV-2 appears airtight
The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.
Not that it’s without controversy.
The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.
“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).
“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.
“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.
“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.
Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
Top 10 reasons
They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:
- The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
- Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
- Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
- Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
- Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
- Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
- Investigators found SARS-CoV-2 in hospital air filters and building ducts.
- It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
- No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
- Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.
“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.
“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.
The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
Response to a review
The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”
However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”
The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”
Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.
“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”
As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”
The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.
Not that it’s without controversy.
The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.
“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).
“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.
“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.
“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.
Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
Top 10 reasons
They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:
- The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
- Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
- Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
- Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
- Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
- Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
- Investigators found SARS-CoV-2 in hospital air filters and building ducts.
- It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
- No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
- Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.
“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.
“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.
The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
Response to a review
The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”
However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”
The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”
Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.
“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”
As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”
The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
The scientific evidence for airborne transmission of the SARS-CoV-2 virus from different researchers all point in the same direction – that infectious aerosols are the principal means of person-to-person transmission, according to experts.
Not that it’s without controversy.
The science backing aerosol transmission “is clear-cut, but it is not accepted in many circles,” Trisha Greenhalgh, PhD, said in an interview.
“In particular, some in the evidence-based medicine movement and some infectious diseases clinicians are remarkably resistant to the evidence,” added Dr. Greenhalgh, professor of primary care health sciences at the University of Oxford (England).
“It’s very hard to see why, since the evidence all stacks up,” Dr. Greenhalgh said.
“The scientific evidence on spread from both near-field and far-field aerosols has been clear since early on in the pandemic, but there was resistance to acknowledging this in some circles, including the medical journals,” Joseph G. Allen, DSc, MPH, told this news organization when asked to comment.
“This is the week the dam broke. Three new commentaries came out … in top medical journals – BMJ, The Lancet, JAMA – all making the same point that aerosols are the dominant mode of transmission,” added Dr. Allen, associate professor of exposure assessment science at the Harvard T.H. Chan School of Public Health in Boston.
Dr. Greenhalgh and colleagues point to an increase in COVID-19 cases in the aftermath of so-called “super-spreader” events, spread of SARS-CoV-2 to people across different hotel rooms, and the relatively lower transmission detected after outdoor events.
Top 10 reasons
They outlined 10 scientific reasons backing airborne transmission in a commentary published online April 15 in The Lancet:
- The dominance of airborne transmission is supported by long-range transmission observed at super-spreader events.
- Long-range transmission has been reported among rooms at COVID-19 quarantine hotels, settings where infected people never spent time in the same room.
- Asymptomatic individuals account for an estimated 33%-59% of SARS-CoV-2 transmission, and could be spreading the virus through speaking, which produces thousands of aerosol particles and few large droplets.
- Transmission outdoors and in well-ventilated indoor spaces is lower than in enclosed spaces.
- Nosocomial infections are reported in health care settings where protective measures address large droplets but not aerosols.
- Viable SARS-CoV-2 has been detected in the air of hospital rooms and in the car of an infected person.
- Investigators found SARS-CoV-2 in hospital air filters and building ducts.
- It’s not just humans – infected animals can infect animals in other cages connected only through an air duct.
- No strong evidence refutes airborne transmission, and contact tracing supports secondary transmission in crowded, poorly ventilated indoor spaces.
- Only limited evidence supports other means of SARS-CoV-2 transmission, including through fomites or large droplets.
“We thought we’d summarize [the evidence] to clarify the arguments for and against. We looked hard for evidence against but found none,” Dr. Greenhalgh said.
“Although other routes can contribute, we believe that the airborne route is likely to be dominant,” the authors note.
The evidence on airborne transmission was there very early on but the Centers for Disease Control and Prevention, World Health Organization, and others repeated the message that the primary concern was droplets and fomites.
Response to a review
The top 10 list is also part rebuttal of a systematic review funded by the WHO and published last month that points to inconclusive evidence for airborne transmission. The researchers involved with that review state that “the lack of recoverable viral culture samples of SARS-CoV-2 prevents firm conclusions to be drawn about airborne transmission.”
However, Dr. Greenhalgh and colleagues note that “this conclusion, and the wide circulation of the review’s findings, is concerning because of the public health implications.”
The current authors also argue that enough evidence already exists on airborne transmission. “Policy should change. We don’t need more research on this topic; we need different policy,” Dr. Greenhalgh said. “We need ventilation front and center, air filtration when necessary, and better-fitting masks worn whenever indoors.”
Dr. Allen agreed that guidance hasn’t always kept pace with the science. “With all of the new evidence accumulated on airborne transmission since last winter, there is still widespread confusion in the public about modes of transmission,” he said. Dr. Allen also serves as commissioner of The Lancet COVID-19 Commission and is chair of the commission’s Task Force on Safe Work, Safe Schools, and Safe Travel.
“It was only just last week that CDC pulled back on guidance on ‘deep cleaning’ and in its place correctly said that the risk from touching surfaces is low,” he added. “The science has been clear on this for over a year, but official guidance was only recently updated.”
As a result, many companies and organizations continued to focus on “hygiene theatre,” Dr. Allen said, “wasting resources on overcleaning surfaces. Unbelievably, many schools still close for an entire day each week for deep cleaning and some still quarantine library books. The message that shared air is the problem, not shared surfaces, is a message that still needs to be reinforced.”
The National Institute for Health Research, Economic and Social Research Council, and Wellcome support Dr. Greenhalgh’s research. Dr. Greenhalgh and Dr. Allen had no relevant financial relationships to disclose.
A version of this article first appeared on Medscape.com.
Children’s share of COVID-19 burden has never been higher
For the first time since the pandemic began, children’s share of weekly COVID-19 cases topped 20% in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That represented 20.6% of all new cases for the week, eclipsing the previous high of 19.1% recorded just 3 weeks ago, based on data collected by the AAP and CHA from 49 states, the District of Columbia, New York City, Puerto Rico, and Guam.
Cumulative cases of COVID-19 in children exceed 3.6 million in those jurisdictions, which is 13.6% of the total reported among all ages, and the overall rate of coronavirus infection is 4,824 cases per 100,000 children in the population, the AAP and CHA said in their weekly COVID-19 report.
Among the 53 reporting jurisdictions, North Dakota has the highest cumulative rate, 9,167 per 100,000 children, followed by Tennessee (8,580), South Carolina (7,948), South Dakota (7,938), and Connecticut (7,707). Children’s share of cumulative cases is highest in Vermont, at 21.9%, with Alaska next at 20.0% and Wyoming at 19.2%, the AAP and CHA said.
Since the beginning of April, the largest local increases in cases reported came in Michigan (21.6%), Vermont (15.9%), and Maine (15.6%). Nationally, the increase over those same 2 weeks is just under 5%, the two organizations noted.
There were 5 deaths among children during the week of April 9-15, bringing the total to 297, but the recent increases in cases have not affected the long-term trends for serious illness. The death rate for children with COVID-19 has been 0.01% since early November – 43 states, New York City, Puerto Rico, and Guam are reporting such data – and the hospitalization rate has been 0.8% since mid-January in 24 states and New York City, the AAP/CHA data show.
For the first time since the pandemic began, children’s share of weekly COVID-19 cases topped 20% in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That represented 20.6% of all new cases for the week, eclipsing the previous high of 19.1% recorded just 3 weeks ago, based on data collected by the AAP and CHA from 49 states, the District of Columbia, New York City, Puerto Rico, and Guam.
Cumulative cases of COVID-19 in children exceed 3.6 million in those jurisdictions, which is 13.6% of the total reported among all ages, and the overall rate of coronavirus infection is 4,824 cases per 100,000 children in the population, the AAP and CHA said in their weekly COVID-19 report.
Among the 53 reporting jurisdictions, North Dakota has the highest cumulative rate, 9,167 per 100,000 children, followed by Tennessee (8,580), South Carolina (7,948), South Dakota (7,938), and Connecticut (7,707). Children’s share of cumulative cases is highest in Vermont, at 21.9%, with Alaska next at 20.0% and Wyoming at 19.2%, the AAP and CHA said.
Since the beginning of April, the largest local increases in cases reported came in Michigan (21.6%), Vermont (15.9%), and Maine (15.6%). Nationally, the increase over those same 2 weeks is just under 5%, the two organizations noted.
There were 5 deaths among children during the week of April 9-15, bringing the total to 297, but the recent increases in cases have not affected the long-term trends for serious illness. The death rate for children with COVID-19 has been 0.01% since early November – 43 states, New York City, Puerto Rico, and Guam are reporting such data – and the hospitalization rate has been 0.8% since mid-January in 24 states and New York City, the AAP/CHA data show.
For the first time since the pandemic began, children’s share of weekly COVID-19 cases topped 20% in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That represented 20.6% of all new cases for the week, eclipsing the previous high of 19.1% recorded just 3 weeks ago, based on data collected by the AAP and CHA from 49 states, the District of Columbia, New York City, Puerto Rico, and Guam.
Cumulative cases of COVID-19 in children exceed 3.6 million in those jurisdictions, which is 13.6% of the total reported among all ages, and the overall rate of coronavirus infection is 4,824 cases per 100,000 children in the population, the AAP and CHA said in their weekly COVID-19 report.
Among the 53 reporting jurisdictions, North Dakota has the highest cumulative rate, 9,167 per 100,000 children, followed by Tennessee (8,580), South Carolina (7,948), South Dakota (7,938), and Connecticut (7,707). Children’s share of cumulative cases is highest in Vermont, at 21.9%, with Alaska next at 20.0% and Wyoming at 19.2%, the AAP and CHA said.
Since the beginning of April, the largest local increases in cases reported came in Michigan (21.6%), Vermont (15.9%), and Maine (15.6%). Nationally, the increase over those same 2 weeks is just under 5%, the two organizations noted.
There were 5 deaths among children during the week of April 9-15, bringing the total to 297, but the recent increases in cases have not affected the long-term trends for serious illness. The death rate for children with COVID-19 has been 0.01% since early November – 43 states, New York City, Puerto Rico, and Guam are reporting such data – and the hospitalization rate has been 0.8% since mid-January in 24 states and New York City, the AAP/CHA data show.
Watch for abnormal movements in hospitalized COVID-19 patients
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
Myoclonus was diagnosed in about half of hospitalized COVID-19 patients who were evaluated for movement disorders, data from 50 cases show.
Abnormal movements often occur as complications from critical illness, and neurologic consultation can determine whether patients have experienced a seizure or stroke. However, restriction of bedside assessment in the wake of the COVID-19 pandemic increases the risk that abnormal movements will be missed, Jeffrey R. Clark and Eric M. Liotta, MD, of Northwestern University, Chicago, and colleagues wrote.
“Given the limited reports of abnormal movements in hospitalized COVID-19 patients and increased recognition of neurologic manifestations of COVID-19, we sought to examine the frequency and etiology of this finding as an indication of neurologic consultation,” they said.
In a study published in the Journal of the Neurological Sciences, the researchers reviewed data from the first 50 consecutive patients with COVID-19 symptoms who were hospitalized at a single center and underwent neurologic consultation between March 17, 2020, and May 18, 2020.
Overall, 11 patients (22.0%) of patients experienced abnormal movement, and all were admitted to the ICU within 7 days of meeting criteria for severe COVID-19. These patients included nine men and two women with an age range of 36-78 years. The most common comorbidities were obesity, hypertension, diabetes, chronic kidney disease, and coronary artery disease.
Myoclonus (generalized and focal) was the most common abnormal movement, and present in 6 of the 11 patients. Three cases were attributed to high-intensity sedation, and three to toxic-metabolic disturbances. In two patients, abnormal movements were attributed to focal seizures in the setting of encephalopathy, with focal facial twitching. An additional two patients experienced tremors; one showed an acute subdural hemorrhage on CT imaging. The second patient showed no sign of stroke or other abnormality on MRI and the tremor improved during the hospital stay. One patient who experienced abnormal high-amplitude nonrhythmic movements of the lower extremities was diagnosed with serotonin syndrome that resolved after discontinuing high-dose fentanyl.
The study findings were limited by several factors, including the small study population and limited availability of MRI, the researchers noted. Assessing severe COVID-19 cases in the ICU setting presents a challenge because of limited patient participation and the potentially confounding effects of sedation and mechanical ventilation.
However, the researchers said.
“A heightened awareness of abnormal eye movements, or subtle facial tremoring, may be the first steps in recognizing potentially dangerous neurologic manifestations,” and clinicians caring for patients with severe COVID-19 should be able to recognize abnormal movements and seek neurologic consultation when indicated, they emphasized.
The study was supported in part by grants to coauthors Nicholas J. Reish, MD, and Dr. Liotta from the National Institutes of Health. The researchers had no financial conflicts to disclose.
FROM THE JOURNAL OF THE NEUROLOGICAL SCIENCES