In Case You Missed It: COVID

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AHA guidance on blood clots linked to COVID-19 vaccine

Article Type
Changed
Thu, 08/26/2021 - 15:47

 

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

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A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

 

A newly released report is offering guidance concerning rare conditions associated with COVID-19 as well as vaccines against the virus.

The report was released April 29, 2021, by the American Heart Association/American Stroke Association Stroke Council Leadership in answer to the decision April 23 by the Centers for Disease Control and Prevention and the Food and Drug Administration to lift an earlier “pause” in administration of the Johnson & Johnson (Janssen) vaccine.

That pause had been put in place after reports were received of a possible association between the J&J vaccine and cerebral venous sinus thrombosis (CVST) and thrombosis-thrombocytopenia syndrome (TTS, blood clots plus low blood platelets). CVST and TTS were also linked to patients in Europe and Canada who received the AstraZeneca COVID-19 vaccine.

However, the new report noted that these conditions are very rare.

“The risk of CVST due to infection with COVID-19 is 8-10 times higher than the risk of CVST after receiving a COVID-19 vaccine,” lead author Karen L. Furie, MD, chair of the department of neurology at Brown University, Providence, R.I., said in a press release.

“The public can be reassured by the CDC’s and FDA’s investigation and these statistics – the likelihood of developing CVST after a COVID-19 vaccine is extremely low,” said Dr. Furie, adding that the authors “urge all adults to receive any of the approved COVID-19 vaccines.”

The new guidance, which was published online April 29, 2021, in Stroke, discusses signs and symptoms of CVST and TTS, as well as vaccine-induced immune thrombotic thrombocytopenia (VITT). It also recommends best options for treating these conditions.
 

Assessing 81 million patients

In their analysis, the investigators assessed a database of 59 health care organizations and 81 million patients, 98% of whom were in the United States.

Of almost 514,000 patients diagnosed with COVID-19 between January 2020 and March 2021, 20 also received a diagnosis of CVST.

Among about 490,000 adults who received either the Pfizer or Moderna vaccines, there were no diagnosed cases of thrombocytopenia.

Dr. Furie reiterated that CVST blood clots “are very rare adverse events,” but recommended that any patient in the ED with a suspected clot should be screened immediately to determine if they received a COVID vaccine during the previous few weeks.

For those who have recently received the COVID-19 vaccine, a suspected clot should be treated with nonheparin anticoagulants, Dr. Furie said.

“No heparin products in any dose should be given for suspected CVST, TTS, or VITT. With the right treatment, most patients can have a full recovery,” she added. The report includes additional, detailed treatment recommendations if one of these conditions are suspected. 
 

Rare events

The authors noted that cases of TTS/VITT occurred up to 2.5 weeks after receiving the J&J vaccine in the United States and up to 3.5 weeks after receiving the AstraZeneca vaccine in Europe.

An April 23 report from the CDC and FDA noted that, out of almost 7 million adults who received the J&J vaccine, the agencies investigated only 15 reported cases of TTS.

An April 7 report from the European Medicines Agency noted that, out of more than 25 million people who received the AstraZeneca vaccine in the European Union, it found 62 cases of CVST.

A statement put out by the American Heart Association/American Stroke Association urges “everyone to receive a COVID-19 vaccine” as soon as possible.

“We are confident the benefits of vaccination far exceed the very small, rare risks,” the organizations said. “The risks of vaccination are also far smaller than the risk of COVID-19 and its potentially fatal consequences.”

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

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Doctors more likely to prescribe opioids to COVID ‘long-haulers,’ raising addiction fears

Article Type
Changed
Thu, 08/26/2021 - 15:47

COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

opioid pills in pill bottles
sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

Dr. Ziyad Al-Aly

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

Dr. Andrw Kolodny

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

opioid pills in pill bottles
sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

Dr. Ziyad Al-Aly

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

Dr. Andrw Kolodny

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

COVID-19 survivors are at risk from a possible second pandemic, this time of opioid addiction, given the high rate of painkillers being prescribed to these patients, health experts say.

opioid pills in pill bottles
sdominick/Getty Images

A new study in Nature found alarmingly high rates of opioid use among COVID survivors with lingering symptoms at Veterans Affairs facilities. About 10% of COVID survivors develop “long COVID,” struggling with often disabling health problems even 6 months or longer after a diagnosis.

For every 1,000 long-COVID patients, known as “long-haulers,” who were treated at a VA facility, doctors wrote nine more prescriptions for opioids than they otherwise would have, along with 22 additional prescriptions for benzodiazepines, which include Xanax and other addictive pills used to treat anxiety.

Although previous studies have found many COVID survivors experience persistent health problems, the new article is the first to show they’re using more addictive medications, said Ziyad Al-Aly, MD, the paper’s lead author.

Dr. Ziyad Al-Aly

He’s concerned that even an apparently small increase in the inappropriate use of addictive pain pills will lead to a resurgence of the prescription opioid crisis, given the large number of COVID survivors. More than 3 million of the 31 million Americans infected with COVID develop long-term symptoms, which can include fatigue, shortness of breath, depression, anxiety, and memory problems known as “brain fog.”

The new study also found many patients have significant muscle and bone pain.

The frequent use of opioids was surprising, given concerns about their potential for addiction, said Dr. Al-Aly, chief of research and education service at the VA St. Louis Health Care System.

“Physicians now are supposed to shy away from prescribing opioids,” said Dr. Al-Aly, who studied more than 73,000 patients in the VA system. When Dr. Al-Aly saw the number of opioids prescriptions, he said, he thought to himself: “Is this really happening all over again?”

Doctors need to act now, before “it’s too late to do something,” Dr. Al-Aly said. “We must act now and ensure that people are getting the care they need. We do not want this to balloon into a suicide crisis or another opioid epidemic.”

As more doctors became aware of their addictive potential, new opioid prescriptions fell, by more than half since 2012. But U.S. doctors still prescribe far more of the drugs – which include OxyContin, Vicodin, and codeine – than physicians in other countries, said Andrew Kolodny, MD, medical director of opioid policy research at Brandeis University, Waltham, Mass.

Some patients who became addicted to prescription painkillers switched to heroin, either because it was cheaper or because they could no longer obtain opioids from their doctors. Overdose deaths surged in recent years as drug dealers began spiking heroin with a powerful synthetic opioid called fentanyl.

More than 88,000 Americans died from overdoses during the 12 months ending in August 2020, according to the Centers for Disease Control and Prevention. Health experts now advise doctors to avoid prescribing opioids for long periods.

Dr. Andrw Kolodny

The new study “suggests to me that many clinicians still don’t get it,” Dr. Kolodny said. “Many clinicians are under the false impression that opioids are appropriate for chronic pain patients.”

Hospitalized COVID patients often receive a lot of medication to control pain and anxiety, especially in ICUs, said Greg Martin, MD, president of the Society of Critical Care Medicine. Patients placed on ventilators, for example, are often sedated to make them more comfortable.

Martin said he’s concerned by the study’s findings, which suggest patients are unnecessarily continuing medications after leaving the hospital.

“I worry that COVID-19 patients, especially those who are severely and critically ill, receive a lot of medications during the hospitalization, and because they have persistent symptoms, the medications are continued after hospital discharge,” Dr. Martin said.

While some COVID patients are experiencing muscle and bone pain for the first time, others say the illness has intensified their preexisting pain.

Rachael Sunshine Burnett has suffered from chronic pain in her back and feet for 20 years, ever since an accident at a warehouse where she once worked. But Ms. Burnett, who first was diagnosed with COVID in April 2020, said the pain soon became 10 times worse and spread to the area between her shoulders and spine. Although she was already taking long-acting OxyContin twice a day, her doctor prescribed an additional opioid called oxycodone, which relieves pain immediately. She was reinfected with COVID in December.

“It’s been a horrible, horrible year,” said Ms. Burnett, 43, of Coxsackie, N.Y.

Doctors should recognize that pain can be a part of long COVID, Dr. Martin said. “We need to find the proper nonnarcotic treatment for it, just like we do with other forms of chronic pain,” he said.

The CDC recommends a number of alternatives to opioids – from physical therapy to biofeedback, over-the-counter anti-inflammatories, antidepressants, and antiseizure drugs that also relieve nerve pain.

The country also needs an overall strategy to cope with the wave of post-COVID complications, Dr. Al-Aly said.

“It’s better to be prepared than to be caught off guard years from now, when doctors realize: ‘Oh, we have a resurgence in opioids,’ ” Dr. Al-Aly said.

Dr. Al-Aly noted that his study may not capture the full complexity of post-COVID patient needs. Although women make up the majority of long-COVID patients in most studies, most patients in the VA system are men.

The study of VA patients makes it “abundantly clear that we are not prepared to meet the needs of 3 million Americans with long COVID,” said Eric Topol, MD, founder and director of the Scripps Research Translational Institute in San Diego. “We desperately need an intervention that will effectively treat these individuals.”

Dr. Al-Aly said COVID survivors may need care for years.

“That’s going to be a huge, significant burden on the health care system,” Dr. Al-Aly said. “Long COVID will reverberate in the health system for years or even decades to come.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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CDC guidelines coming on long COVID

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Changed
Thu, 08/26/2021 - 15:47

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

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The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

The Centers for Disease Control and Prevention is finalizing new guidelines to help clinicians diagnose and manage long COVID, or postacute sequelae of SARS-CoV-2 infection.

In a day-long congressional hearing on April 28, John Brooks, MD, a medical epidemiologist at the CDC’s division of HIV/AIDS prevention, testified that the guidelines were going through the clearance process at the agency, but would be forthcoming.

“They should be coming out very shortly,” Dr. Brooks said.

The guidelines, which were developed in collaboration with newly established long-COVID clinics and patient advocacy groups, will “illustrate how to diagnose and begin to pull together what we know about management,” of the complex condition, he said.

For many doctors and patients who are struggling to understand symptoms that persist for months after the initial viral infection, the guidelines can’t come soon enough.

National Institutes of Health Director Francis Collins, MD, PhD, who also testified at the hearing, estimated that as many as 3 million people could be left with chronic health problems after even mild COVID infections.

“I can’t overstate how serious this issue is for the health of our nation,” he said.

Dr. Collins said his estimate was based on studies showing that roughly 10% of people who get COVID could be affected by this and whose “long-term course is uncertain,” he said. So far, more than 32 million Americans are known to have been infected with the new coronavirus.

“We need to make sure we put our arms around them and bring answers and care to them,” said Rep. Anna Eshoo (D-Calif.), chairwoman of the Subcommittee on Health.

Jennifer Possick, MD, who directs the post-COVID recovery program at Yale New Haven (Conn.) Hospital, testified that the tidal wave of patients she and her colleagues were seeing was overwhelming.

“We are a well-resourced program at an academic medical center, but we are swamped by the need in our community. This year, we have seen more patients with post COVID-19 conditions in our clinic alone than we have new cases of asthma and COPD combined,” she said. “The magnitude of the challenge is daunting.”

Dr. Possick estimated that there are “over 60” clinics in the United States that have started to treat long-COVID patients, but said they are grassroots efforts and all very different from each other.

“Whoever had the resources, had the time, [and] was able to take the initiative and forge to the relationships because most of them are multidisciplinary, did so,” she said.
 

Patients testify

Several representatives shared moving personal stories of loved ones or staffers who remained ill months after a COVID diagnosis.

Rep. Ann Kuster, from New Hampshire, talked about her 34-year-old niece, a member of the U.S. Ski Team, who had COVID just over a year ago and “continues to struggle with everything, even the simplest activities of daily living” she said. “She has to choose between taking a shower or making dinner. I’m so proud of her for hanging in there.”

Long-COVID patients invited to testify by the subcommittee described months of disability that left them with soaring medical bills and no ability to work to pay them.

“I am now a poor, Black, disabled woman, living with long COVID,” said Chimere Smith, who said she had been a school teacher in Baltimore. “Saying it aloud makes it no more easy to accept.”

She said COVID had affected her ability to think clearly and caused debilitating fatigue, which prevented her from working. She said she lost her vision for almost 5 months because doctors misdiagnosed a cataract caused by long COVID as dry eye.

“If I did not have a loving family, I [would] be speaking to you today [from] my car, the only property I now own.”

Ms. Smith said that long-COVID clinics, which are mostly housed within academic medical centers, were not going to be accessible for all long-haulers, who are disproportionately women of color. She has started a clinic, based out of her church, to help other patients from her community.

“No one wants to hear that long COVID has decimated my life or the lives of other black women in less than a year,” Ms. Smith said. “We’ve just been waiting and hoping for compassionate doctors and politicians who would acknowledge us.”

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

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Being overweight ups risk of severe COVID-19 in hospital

Article Type
Changed
Thu, 08/26/2021 - 15:47

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenzadengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News
Dr. David P. Burgner


“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
 

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

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In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenzadengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News
Dr. David P. Burgner


“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
 

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

In a global meta-analysis of more than 7,000 patients who were hospitalized with COVID-19, individuals with overweight or obesity were more likely to need respiratory support but were not more likely to die in the hospital, compared to individuals of normal weight.
 

Compared to patients without diabetes, those with diabetes had higher odds of needing invasive respiratory support (with intubation) but not for needing noninvasive respiratory support or of dying in the hospital.

“Surprisingly,” among patients with diabetes, being overweight or having obesity did not further increase the odds of any of these outcomes, the researchers wrote. The finding needs to be confirmed in larger studies, they said, because the sample sizes in these subanalyses were small and the confidence intervals were large.

The study by Danielle K. Longmore, PhD, of Murdoch Children’s Research Institute (MCRI), Melbourne, and colleagues from the International BMI-COVID consortium, was published online April 15 in Diabetes Care.

This new research “adds to the known data on the associations between obesity and severe COVID-19 disease and extends these findings” to patients who are overweight and/or have diabetes, Dr. Longmore, a pediatric endocrinologist with a clinical and research interest in childhood and youth obesity, said in an interview.

Immunologist Siroon Bekkering, PhD, of Radboud University Medical Center, Nijmegen, the Netherlands, explained that never before have so much data of different types regarding obesity been combined in one large study. Dr. Bekkering is a coauthor of the article and was a principal investigator.

“Several national and international observations already showed the important role of overweight and obesity in a more severe COVID-19 course. This study adds to those observations by combining data from several countries with the possibility to look at the risk factors separately,” she said in a statement from her institution.

“Regardless of other risk factors (such as heart disease or diabetes), we now see that too high a BMI [body mass index] can actually lead to a more severe course in [coronavirus] infection,” she said.
 

Study implications: Data show that overweight, obesity add to risk

These latest findings highlight the urgent need to develop public health policies to address socioeconomic and psychological drivers of obesity, Dr. Longmore said.

“Although taking steps to address obesity in the short term is unlikely to have an immediate impact in the COVID-19 pandemic, it will likely reduce the disease burden in future viral pandemics and reduce risks of complications like heart disease and stroke,” she observed in a statement issued by MCRI.

Coauthor Kirsty R. Short, PhD, a research fellow at the University of Queensland, Brisbane, Australia, noted that “obesity is associated with numerous poor health outcomes, including increased risk of cardiometabolic and respiratory disease and more severe viral disease including influenzadengue, and SARS-CoV-1.

“Given the large scale of this study,” she said, “we have conclusively shown that being overweight or obese are independent risk factors for worse outcomes in adults hospitalized with COVID-19.”

“At the moment, the World Health Organization has not had enough high-quality data to include being overweight or obese as a risk factor for severe COVID-19 disease,” added another author, David P. Burgner, PhD, a pediatric infectious diseases clinician scientist from MCRI.

Bruce Jancin/MDedge News
Dr. David P. Burgner


“Our study should help inform decisions about which higher-risk groups should be vaccinated as a priority,” he observed.
 

Does being overweight up risk of worse COVID-19 outcomes?

About 13% of the world’s population are overweight, and 40% have obesity. There are wide between-country variations in these data, and about 90% of patients with type 2 diabetes are overweight or obese, the researchers noted.

The Organisation for Economic Co-operation and Development reported that the prevalence of obesity in 2016-2017 was 5.7% to 8.9% in Asia, 9.8% to 16.8% in Europe, 26.5% in South Africa, and 40.0% in the United States, they added.

Obesity is common and has emerged as an important risk factor for severe COVID-19. However, most previous studies of COVID-19 and elevated BMI were conducted in single centers and did not focus on patients with overweight.

To investigate, the researchers identified 7,244 patients (two-thirds were overweight or obese) who were hospitalized with COVID-19 in 69 hospitals (18 sites) in 11 countries from Jan. 17, 2020, to June 2, 2020.

Most patients were hospitalized with COVID-19 in the Netherlands (2,260), followed by New York City (1,682), Switzerland (920), St. Louis (805), Norway, Italy, China, South Africa, Indonesia, Denmark, Los Angeles, Austria, and Singapore.

Just over half (60%) of the individuals were male, and 52% were older than 65.

Overall, 34.8% were overweight, and 30.8% had obesity, but the average weight varied considerably between countries and sites.
 

Increased need for respiratory support, same mortality risk

Compared with patients with normal weight, patients who were overweight had a 44% increased risk of needing supplemental oxygen/noninvasive ventilation, and those with obesity had a 75% increased risk of this, after adjustment for age (< 65, ≥ 65), sex, hypertension, diabetes, or preexisting cardiovascular disease or respiratory conditions.

Patients who were overweight had a 22% increased risk of needing invasive (mechanical) ventilation, and those with obesity had a 73% increased risk of this, after multivariable adjustment.

Being overweight or having obesity was not associated with a significantly increased risk of dying in the hospital, however.

“In other viral respiratory infections, such as influenza, there is a similar pattern of increased requirement for ventilatory support but lower in-hospital mortality among individuals with obesity, when compared to those with normal range BMI,” Dr. Longmore noted. She said that larger studies are needed to further explore this finding regarding COVID-19.

Compared to patients without diabetes, those with diabetes had a 21% increased risk of requiring invasive ventilation, but they did not have an increased risk of needing noninvasive ventilation or of dying in the hospital.

As in previous studies, individuals who had cardiovascular and preexisting respiratory diseases were not at greater risk of needing oxygen or mechanical ventilation but were at increased risk for in-hospital death. Men had a greater risk of needing invasive mechanical ventilation, and individuals who were older than 65 had an increased risk of requiring oxygen or of dying in the hospital.
 

A living meta-analysis, call for more collaborators

“We consider this a ‘living meta-analysis’ and invite other centers to join us,” Dr. Longmore said. “We hope to update the analyses as more data are contributed.”

No specific project funded the study. The authors have disclosed no relevant financial relationships.

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

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Suicide in the early months of the pandemic: Unexpected trends

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Changed
Thu, 08/26/2021 - 15:47

Every psychiatrist knows that this past year has been a challenge. The COVID-19 pandemic altered our lives, practically overnight, in ways that most of us had never anticipated.

Dr. Dinah Miller

There were months of lockdown. A new work-from-home transition. Recommendations to distance and mask. The destruction and recreation of our social lives. And the end of some industries as we have known them.

Over a year later, many children are still in virtual school. This lifestyle and economic toll do not even begin to include the horror experienced by exhausted and distressed health care workers or by the many who have lost a loved one or survived a hospitalization. National and international anxiety are running high. More people are seeking mental health care, and many of the patients we were caring for prior to the pandemic have been distressed.

Rates of both depression and anxiety are up, and the fear has been that the isolation of lockdowns, with their emotional and economic toll, would also increase suicide rates. Despite the increase in psychiatric symptoms and general distress, initial studies in the United States have shown that overall suicide rates in the early months of the pandemic were lower than in prior years.

A study published in The Lancet looked at suicide data from around the world and compared expected suicides, based on data from past years, with observed suicides. The researchers restricted their analysis to the countries, and regions of countries, where real-time suicide data were available through internet searches. Their paper is based on findings from 21 countries, including 16 high-income countries and five upper-middle–income countries (from regions where data were available). The overall analysis showed a drop in suicides by 5% when looking at the first 4 months of the pandemic, defined as April 1, 2020, to July 31, 2020. There were statistically significant increases in suicide only in Vienna, Puerto Rico, and Japan.

Igor Galynker, MD, PhD, directs the Suicide Research and Prevention Lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai. He was not surprised by these findings.

“This is an important study,” Dr. Galynker said. “When it was discovered that U.S. rates went down, it was ‘U.S. specific’ and it was confounded by the fact that there was a dramatic increase in opiate overdose deaths in the U.S., which are not reported as suicides. This study shows that the decrease is international and that the finding in the United States is not related to the spike in overdose deaths.”

The study authors postulated that the drop in suicide may be due to proactive protective measures that societies have put in place, such as improved mental health services and fiscal support to mitigate financial consequences of the pandemic. They explained that “communities might have actively tried to support at-risk individuals, people might have connected in new ways, and some relationships might have been strengthened by households spending more time with each other. For some people, everyday stresses might have been reduced during stay-at-home periods, and for others the collective feeling of ‘we’re all in this together’ might have been beneficial”.

Dr. Galynker noted that, in times of calamity, suicide rates historically go down. “Short-term disasters invoke a fight-or-flight response that mobilizes us and improves our functioning under stress. Those acute responses last 2-3 months and then chronic stress sets in.” He is concerned that there will be increases in suicide rates down the road.

It is possible that individuals who consider social gatherings to be stressful, or who are bullied at school, may have found some relief from social interactions and expectations during the lockdown. “Some people have discovered that they like their families!” Dr. Galynker said.

While suicide rates have gone down, that is not true for all population subsets, and the authors of the Lancet paper noted that they were unable to give breakdowns of rates for different demographics.

Paul Nestadt, MD, is codirector of the Johns Hopkins Anxiety Disorders Clinic and studies suicide, firearms, and opiates. He looked at suicides in Maryland during the first 2 months of the lockdown (March 5, 2020 to May 7, 2020) and found that, while rates were down among White Maryland residents, compared with prior years, they were increased among Black Maryland residents. Studies in Connecticut and Chicago yielded similar findings. These findings indicate that the overall trends may not reflect the impact on a specific subpopulation.

Dr. Nestadt talked about the disparities of suicide trends. “Communities hit harder by this pandemic in terms of sickness and death may experience more distress in ways that may come out as suicide in the context of other comorbid mood disorders. Also, in line with the idea of suicide as a marker of community- or population-level distress, there’s a general idea that having less of an economic cushion makes the pandemic more of a problem for some than for others. We know that suicide has been correlated to economic distress in general, and it makes sense that it would be community-specific where there is more economic duress.”

It has been a difficult year – not just for the United States, but for the entire world. One thing that may come of it is a unique opportunity to look at how stress and loss affect suicide rates, with the hope that preventive measures will follow.

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

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Every psychiatrist knows that this past year has been a challenge. The COVID-19 pandemic altered our lives, practically overnight, in ways that most of us had never anticipated.

Dr. Dinah Miller

There were months of lockdown. A new work-from-home transition. Recommendations to distance and mask. The destruction and recreation of our social lives. And the end of some industries as we have known them.

Over a year later, many children are still in virtual school. This lifestyle and economic toll do not even begin to include the horror experienced by exhausted and distressed health care workers or by the many who have lost a loved one or survived a hospitalization. National and international anxiety are running high. More people are seeking mental health care, and many of the patients we were caring for prior to the pandemic have been distressed.

Rates of both depression and anxiety are up, and the fear has been that the isolation of lockdowns, with their emotional and economic toll, would also increase suicide rates. Despite the increase in psychiatric symptoms and general distress, initial studies in the United States have shown that overall suicide rates in the early months of the pandemic were lower than in prior years.

A study published in The Lancet looked at suicide data from around the world and compared expected suicides, based on data from past years, with observed suicides. The researchers restricted their analysis to the countries, and regions of countries, where real-time suicide data were available through internet searches. Their paper is based on findings from 21 countries, including 16 high-income countries and five upper-middle–income countries (from regions where data were available). The overall analysis showed a drop in suicides by 5% when looking at the first 4 months of the pandemic, defined as April 1, 2020, to July 31, 2020. There were statistically significant increases in suicide only in Vienna, Puerto Rico, and Japan.

Igor Galynker, MD, PhD, directs the Suicide Research and Prevention Lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai. He was not surprised by these findings.

“This is an important study,” Dr. Galynker said. “When it was discovered that U.S. rates went down, it was ‘U.S. specific’ and it was confounded by the fact that there was a dramatic increase in opiate overdose deaths in the U.S., which are not reported as suicides. This study shows that the decrease is international and that the finding in the United States is not related to the spike in overdose deaths.”

The study authors postulated that the drop in suicide may be due to proactive protective measures that societies have put in place, such as improved mental health services and fiscal support to mitigate financial consequences of the pandemic. They explained that “communities might have actively tried to support at-risk individuals, people might have connected in new ways, and some relationships might have been strengthened by households spending more time with each other. For some people, everyday stresses might have been reduced during stay-at-home periods, and for others the collective feeling of ‘we’re all in this together’ might have been beneficial”.

Dr. Galynker noted that, in times of calamity, suicide rates historically go down. “Short-term disasters invoke a fight-or-flight response that mobilizes us and improves our functioning under stress. Those acute responses last 2-3 months and then chronic stress sets in.” He is concerned that there will be increases in suicide rates down the road.

It is possible that individuals who consider social gatherings to be stressful, or who are bullied at school, may have found some relief from social interactions and expectations during the lockdown. “Some people have discovered that they like their families!” Dr. Galynker said.

While suicide rates have gone down, that is not true for all population subsets, and the authors of the Lancet paper noted that they were unable to give breakdowns of rates for different demographics.

Paul Nestadt, MD, is codirector of the Johns Hopkins Anxiety Disorders Clinic and studies suicide, firearms, and opiates. He looked at suicides in Maryland during the first 2 months of the lockdown (March 5, 2020 to May 7, 2020) and found that, while rates were down among White Maryland residents, compared with prior years, they were increased among Black Maryland residents. Studies in Connecticut and Chicago yielded similar findings. These findings indicate that the overall trends may not reflect the impact on a specific subpopulation.

Dr. Nestadt talked about the disparities of suicide trends. “Communities hit harder by this pandemic in terms of sickness and death may experience more distress in ways that may come out as suicide in the context of other comorbid mood disorders. Also, in line with the idea of suicide as a marker of community- or population-level distress, there’s a general idea that having less of an economic cushion makes the pandemic more of a problem for some than for others. We know that suicide has been correlated to economic distress in general, and it makes sense that it would be community-specific where there is more economic duress.”

It has been a difficult year – not just for the United States, but for the entire world. One thing that may come of it is a unique opportunity to look at how stress and loss affect suicide rates, with the hope that preventive measures will follow.

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

Every psychiatrist knows that this past year has been a challenge. The COVID-19 pandemic altered our lives, practically overnight, in ways that most of us had never anticipated.

Dr. Dinah Miller

There were months of lockdown. A new work-from-home transition. Recommendations to distance and mask. The destruction and recreation of our social lives. And the end of some industries as we have known them.

Over a year later, many children are still in virtual school. This lifestyle and economic toll do not even begin to include the horror experienced by exhausted and distressed health care workers or by the many who have lost a loved one or survived a hospitalization. National and international anxiety are running high. More people are seeking mental health care, and many of the patients we were caring for prior to the pandemic have been distressed.

Rates of both depression and anxiety are up, and the fear has been that the isolation of lockdowns, with their emotional and economic toll, would also increase suicide rates. Despite the increase in psychiatric symptoms and general distress, initial studies in the United States have shown that overall suicide rates in the early months of the pandemic were lower than in prior years.

A study published in The Lancet looked at suicide data from around the world and compared expected suicides, based on data from past years, with observed suicides. The researchers restricted their analysis to the countries, and regions of countries, where real-time suicide data were available through internet searches. Their paper is based on findings from 21 countries, including 16 high-income countries and five upper-middle–income countries (from regions where data were available). The overall analysis showed a drop in suicides by 5% when looking at the first 4 months of the pandemic, defined as April 1, 2020, to July 31, 2020. There were statistically significant increases in suicide only in Vienna, Puerto Rico, and Japan.

Igor Galynker, MD, PhD, directs the Suicide Research and Prevention Lab and the Zirinsky Center for Bipolar Disorder at the Icahn School of Medicine at Mount Sinai. He was not surprised by these findings.

“This is an important study,” Dr. Galynker said. “When it was discovered that U.S. rates went down, it was ‘U.S. specific’ and it was confounded by the fact that there was a dramatic increase in opiate overdose deaths in the U.S., which are not reported as suicides. This study shows that the decrease is international and that the finding in the United States is not related to the spike in overdose deaths.”

The study authors postulated that the drop in suicide may be due to proactive protective measures that societies have put in place, such as improved mental health services and fiscal support to mitigate financial consequences of the pandemic. They explained that “communities might have actively tried to support at-risk individuals, people might have connected in new ways, and some relationships might have been strengthened by households spending more time with each other. For some people, everyday stresses might have been reduced during stay-at-home periods, and for others the collective feeling of ‘we’re all in this together’ might have been beneficial”.

Dr. Galynker noted that, in times of calamity, suicide rates historically go down. “Short-term disasters invoke a fight-or-flight response that mobilizes us and improves our functioning under stress. Those acute responses last 2-3 months and then chronic stress sets in.” He is concerned that there will be increases in suicide rates down the road.

It is possible that individuals who consider social gatherings to be stressful, or who are bullied at school, may have found some relief from social interactions and expectations during the lockdown. “Some people have discovered that they like their families!” Dr. Galynker said.

While suicide rates have gone down, that is not true for all population subsets, and the authors of the Lancet paper noted that they were unable to give breakdowns of rates for different demographics.

Paul Nestadt, MD, is codirector of the Johns Hopkins Anxiety Disorders Clinic and studies suicide, firearms, and opiates. He looked at suicides in Maryland during the first 2 months of the lockdown (March 5, 2020 to May 7, 2020) and found that, while rates were down among White Maryland residents, compared with prior years, they were increased among Black Maryland residents. Studies in Connecticut and Chicago yielded similar findings. These findings indicate that the overall trends may not reflect the impact on a specific subpopulation.

Dr. Nestadt talked about the disparities of suicide trends. “Communities hit harder by this pandemic in terms of sickness and death may experience more distress in ways that may come out as suicide in the context of other comorbid mood disorders. Also, in line with the idea of suicide as a marker of community- or population-level distress, there’s a general idea that having less of an economic cushion makes the pandemic more of a problem for some than for others. We know that suicide has been correlated to economic distress in general, and it makes sense that it would be community-specific where there is more economic duress.”

It has been a difficult year – not just for the United States, but for the entire world. One thing that may come of it is a unique opportunity to look at how stress and loss affect suicide rates, with the hope that preventive measures will follow.

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

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Pfizer developing pill to treat COVID-19 symptoms

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Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

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Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

Pfizer CEO Albert Bourla, DVM, PhD, says an oral drug the company is developing to treat COVID-19 symptoms could be available to the public by the end of the year.

“If all goes well, and we implement the same speed that we are, and if regulators do the same, and they are, I hope that (it will be available) by the end of the year,” Dr. Bourla said on CNBC’s Squawk Box.

So far, the only antiviral drug authorized for use with COVID-19 is remdesivir, which is produced by Gilead Sciences and must be administered by injection in a health care setting.

An oral drug like the one Pfizer is developing could be taken at home and might keep people out of the hospital.

“Particular attention is on the oral because it provides several advantages,” Dr. Bourla said. “One of them is that you don’t need to go to the hospital to get the treatment, which is the case with all the injectables so far. You could get it at home, and that could be a game-changer.”

The drug might be effective against the emerging variants, he said. Pfizer is also working on an injectable antiviral drug.

Pfizer, with its European partner BioNTech, developed the first coronavirus vaccine authorized for use in the United States and Europe. The Pfizer pill under development would not be a vaccine to protect people from the virus but a drug to treat people who catch the virus.

The company announced in late March that it was starting clinical trials on the oral drug.

In a news release, the company said the oral drug would work by blocking protease, a critical enzyme that the virus needs to replicate. Protease inhibitors are used in medicines to treat HIV and hepatitis C.

A coronavirus vaccine that could be taken as a pill may enter clinical trials in the second quarter of 2021. The oral vaccine is being developed by Oravax Medical, a new joint venture of the Israeli-American company Oramed and the Indian company Premas Biotech. So far, all coronavirus vaccines are injectable.

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

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Head to Toe: Recommendations for Physician Head and Shoe Coverings to Limit COVID-19 Transmission

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Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.

Pathogens on Shoes and Hair

Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2

Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4

Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3

Recommendations for Hair and Shoe Coverings

We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).

Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10

Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.

References
  1. Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
  2. Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
  3. Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001 
  4. Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
  5. Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
  6. Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
  7. Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
  8. Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
  9. American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
  10. Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
  11. World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
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Author and Disclosure Information

Ms. Conway is from New York Medical College, New York. Dr. Lipner is from the Department of Dermatology, Weill Cornell Medicine, New York, New York.

The authors report no conflict of interest.

Correspondence: Shari R. Lipner, MD, PhD, 1305 York Ave, 9th Floor, New York, NY 10021 ([email protected]).

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Ms. Conway is from New York Medical College, New York. Dr. Lipner is from the Department of Dermatology, Weill Cornell Medicine, New York, New York.

The authors report no conflict of interest.

Correspondence: Shari R. Lipner, MD, PhD, 1305 York Ave, 9th Floor, New York, NY 10021 ([email protected]).

Author and Disclosure Information

Ms. Conway is from New York Medical College, New York. Dr. Lipner is from the Department of Dermatology, Weill Cornell Medicine, New York, New York.

The authors report no conflict of interest.

Correspondence: Shari R. Lipner, MD, PhD, 1305 York Ave, 9th Floor, New York, NY 10021 ([email protected]).

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Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.

Pathogens on Shoes and Hair

Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2

Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4

Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3

Recommendations for Hair and Shoe Coverings

We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).

Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10

Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.

 

Personal protective equipment (PPE) is an important component in limiting transmission of SARS-CoV-2. The World Health Organization and Centers for Disease Control and Prevention issued guidelines for appropriate PPE use, but recommendations for head and shoe coverings are lacking. In this article, we analyze the literature on pathogen transmission via hair and shoes and make evidence-based recommendations for PPE selection during the COVID-19 pandemic.

Pathogens on Shoes and Hair

Hair and shoes may act as vehicles for pathogen transmission. In a study that simulated contamination of uncovered skin in health care workers after intubating manikins in respiratory distress, 8 (100%) had fluorescent markers on the hair, 6 (75%) on the neck, and 4 (50%) on the shoes.1 In another study of postsurgical operating room (OR) surfaces (517 cultures), uncovered shoe tops and reusable hair coverings had 10-times more bacterial colony–forming units compared to other surfaces. On average, disposable shoe covers/head coverings had less than one-third bacterial colony–forming units compared with uncovered shoes/reusable hair coverings.2

Hair characteristics and coverings may affect pathogen transmission. Exposed hair may collect bacteria, as Staphylococcus aureus and Staphylococcus epidermidis attach to both scalp and facial hair. In one case, β-hemolytic streptococci cultured from the scalp of a perioperative nurse was linked to postsurgical infections in 20 patients.3 Hair coverings include bouffant caps and skullcaps. The bouffant cap is similar to a shower cap; it is relatively loose and secured around the head with elastic. The skullcap, or scrub cap, is tighter but leaves the neck nape and sideburns exposed. In a study comparing disposable bouffant caps, disposable skullcaps, and home-laundered cloth skullcaps worn by 2 teams of 5 surgeons, the disposable bouffant caps had the highest permeability, penetration, and microbial shed of airborne particles.4

Physicians’ shoes may act as fomites for transmission of pathogens to patients. In a study of 41 physicians and nurses in an acute care hospital, shoe soles were positive for at least one pathogen in 12 (29.3%) participants; methicillin-resistant Staphylococcus aureus was most common. Additionally, 98% (49/50) of shoes worn outdoors showed positive bacterial cultures compared to 56% (28/50) of shoes reserved for the OR only.5 In a study examining ventilation effects on airborne pathogens in the OR, 15% of OR airborne bacteria originated from OR floors, and higher bacterial counts correlated with a higher number of steps in the OR.2 In another study designed to evaluate SARS-CoV-2 distribution on hospital floors, 70% (7/10) of quantitative polymerase chain reaction assays performed on floor samples from intensive care units were positive. In addition, 100% (3/3) of swabs taken from hospital pharmacy floors with no COVID-19 patients were positive for SARS-CoV-2, meaning contaminated shoes likely served as vectors.6 Middle East respiratory syndrome, SARS-CoV-2, and influenza viruses may survive on porous and nonporous materials for hours to days.7Enterococcus, Candida, and Aspergillus may survive on textiles for up to 90 days.3

Recommendations for Hair and Shoe Coverings

We recommend that physicians utilize disposable skullcaps to cover the hair and consider a hooded gown or coverall for neck/ear coverage. We also recommend that physicians designate shoes that remain in the workplace and can be easily washed or disinfected at least weekly; physicians may choose to wash or disinfect shoes more often if they frequently are performing procedures that generate aerosols. Additionally, physicians should always wear shoe coverings when caring for patients (Table 1).

Our hair and shoe covering recommendations may serve to protect dermatologists when caring for patients. These protocols may be particularly important for dermatologists performing high-risk procedures, including facial surgery, intraoral/intranasal procedures, and treatment with ablative lasers and facial injectables, especially when the patient is unmasked. These recommendations may limit viral transmission to dermatologists and also protect individuals living in their households. Additional established guidelines by the American Academy of Dermatology, American Society for Dermatologic Surgery, and World Health Organization are listed in Table 2.8-10

Current PPE recommendations that do not include hair and shoe coverings may be inadequate for limiting SARS-CoV-2 exposure between and among physicians and patients. Adherence to head covering and shoe recommendations may aid in reducing unwanted SARS-CoV-2 transmission in the health care setting, even as the pandemic continues.

References
  1. Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
  2. Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
  3. Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001 
  4. Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
  5. Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
  6. Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
  7. Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
  8. Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
  9. American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
  10. Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
  11. World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
References
  1. Feldman O, Meir M, Shavit D, et al. Exposure to a surrogate measure of contamination from simulated patients by emergency department personnel wearing personal protective equipment. JAMA. 2020;323:2091-2093. doi:10.1001/jama.2020.6633
  2. Alexander JW, Van Sweringen H, Vanoss K, et al. Surveillance of bacterial colonization in operating rooms. Surg Infect (Larchmt). 2013;14:345-351. doi:10.1089/sur.2012.134
  3. Blanchard J. Clinical issues—August 2010. AORN Journal. 2010;92:228-232. doi:10.1016/j.aorn.2010.06.001 
  4. Markel TA, Gormley T, Greeley D, et al. Hats off: a study of different operating room headgear assessed by environmental quality indicators. J Am Coll Surg. 2017;225:573-581. doi:10.1016/j.jamcollsurg.2017.08.014
  5. Kanwar A, Thakur M, Wazzan M, et al. Clothing and shoes of personnel as potential vectors for transfer of health care-associated pathogens to the community. Am J Infect Control. 2019;47:577-579. doi:10.1016/j.ajic.2019.01.028
  6. Guo ZD, Wang ZY, Zhang SF, et al. Aerosol and surface distribution of severe acute respiratory syndrome coronavirus 2 in hospital wards, Wuhan, China, 2020. Emerg Infect Dis. 2020;26:1583-1591. doi:10.3201/eid2607.200885
  7. Otter JA, Donskey C, Yezli S, et al. Transmission of SARS and MERS coronaviruses and influenza virus in healthcare settings: the possible role of dry surface contamination. J Hosp Infect. 2016;92:235-250. doi:10.1016/j.jhin.2015.08.027
  8. Centers for Disease Control and Prevention. Science Brief: SARS-CoV-2 and Surface (Fomite) Transmission for Indoor Community Environments. https://www.cdc.gov/coronavirus/2019-ncov/more/science-and-research/surface-transmission.html#ref10
  9. American Academy of Dermatology. Clinical guidance for COVID-19. Accessed March 15, 2021. https://www.aad.org/member/practice/coronavirus/clinical-guidance
  10. Narla S, Alam M, Ozog DM, et al. American Society of Dermatologic Surgery Association (ASDSA) and American Society for Laser Medicine & Surgery (ASLMS) guidance for cosmetic dermatology practices during COVID-19. Updated January 11, 2021. Accessed March 15, 2021. https://www.asds.net/Portals/0/PDF/asdsa/asdsa-aslms-cosmetic-reopening-guidance.pdf
  11. World Health Organization. Country & technical guidance—coronavirus disease (COVID-19). Accessed March 15, 2021. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-guidance-publications
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  • Consistent use of personal protective equipment, including masks, face shields, goggles, and gloves, may limit transmission of SARS-CoV-2.
  • Hair and shoes also may transmit SARS-CoV-2, but recommendations for hair and shoe coverings to prevent SARS-CoV-2 are lacking.
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Psoriasis associated with an increased risk of COVID-19 in real-world study

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People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

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People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

 

People with psoriasis have a higher risk of infection with COVID-19 than the general population, but some systemic treatments appear to lower risk in patients, compared with those on topical therapy, a new study finds.

“Our study results suggest that psoriasis is an independent risk factor for COVID-19 illness,” study coauthor Jeffrey Liu, a medical student at the University of Southern California, Los Angeles, said in an interview after he presented the findings at the American Academy of Dermatology Virtual Meeting Experience. “And our findings are consistent with the hypothesis that certain systemic agents may confer a protective effect against COVID-19 illness.”

Mr. Liu and coinvestigators used a Symphony Health dataset to analyze the health records of 167,027 U.S. patients diagnosed with psoriasis and a control group of 1,002,162 patients. The participants, all at least 20 years old, had been treated for psoriasis or psoriatic arthritis from May 2019 through Jan. 1, 2020, and were tracked until Nov. 11, 2020.

The ages and races of peoples in the two groups were roughly similar. Overall, 55% were women and 75% were White, and their average age was 58 years. Type 2 diabetes was more common in the psoriasis group than the control group (23% vs. 16%), as was obesity (27% vs. 15%). Of the patients with psoriasis, 60% were on topical treatments, 19% were on oral therapies, and 22% were on biologic therapy, with only a few taking both oral and biologic therapies.

After adjustment for age and gender, patients with psoriasis were 33% more likely than the control group to develop COVID-19 (adjusted incidence rate ratio, 1.33; 95% confidence interval, 1.23-1.38; P < .0001).

In a separate analysis, the gap persisted after adjustment for demographics and comorbidities: Patients with psoriasis had a higher rate of COVID-19 infection vs. controls (adjusted odds ratio, 1.18; 95% CI, 1.13-1.23; P < .0001). Among all patients, non-White race, older age, and comorbidities were all linked to higher risk of COVID-19 (all P < .0001).

Psoriasis might make patients more vulnerable to COVID-19 because the presence of up-regulated genes in psoriatic skin “may lead to systemic hyperinflammation and sensitization of patients with psoriasis to proinflammatory cytokine storm,” Mr. Liu said. This, in turn, may trigger more severe symptomatic disease that requires medical treatment, he said.

Reduced risk, compared with topical therapies

After adjustment for age and gender, those treated with TNF-alpha inhibitors, methotrexate, and apremilast (Otezla) all had statistically lower risks of COVID-19 vs. those on topical therapy (aIRR, 0.82; 95% CI, 0.69-0.95; P < .0029 for TNF-alpha inhibitors; aIRR, 0.75; 95% CI, 0.67-0.86; P < .0001 for methotrexate; and aIRR, 0.69; 95% CI, 0.55-0.85; P < .0006 for apremilast).

Reduced risk held true for those in the separate analysis after adjustment for comorbidities and demographics (respectively, aOR, 0.87; 95% CI, 0.77-1.00; P < .0469; aOR, 0.81; 95% CI, 0.71-0.92; P < .0011; and aOR, 0.70; 95% CI, 0.57-0.87; P < .0014).

Apremilast and methotrexate may boost protection against COVID-19 by inhibiting the body’s production of cytokines, Mr. Liu said.

One message of the study is that “dermatologists should not be scared of prescribing biologics or oral therapies for psoriasis,” the study’s lead author Jashin J. Wu, MD, of the Dermatology Research and Education Foundation in Irvine, Calif., said in an interview.

However, the results on the effects of systemic therapies were not all positive. Interleukin (IL)–17 inhibitors were an outlier: After adjustment for age and gender, patients treated with this class of drugs were 36% more likely to develop COVID-19 than those on oral agents (aIRR, 1.36; 95% CI, 1.13-1.63; P < .0009).

Among patients on biologics, those taking IL-17 inhibitors had the highest risk of COVID-19, Mr. Liu said. “The risk was higher in this class regardless of reference group – general population, the topical cohort, and the oral cohort,” he said. “This may relate to the observation that this biologic class exerts more broad immunosuppressive effects on antiviral host immunity. Notably, large meta-estimates of pivotal trials have observed increased risk of respiratory tract infections for patients on IL-17 inhibitors.”

In an interview, Erica Dommasch, MD, MPH, of the department of dermatology at Beth Israel Deaconess Medical Center, Boston, cautioned that “the data from this study is very hard to interpret.”

It’s likely that some patients with psoriasis on systemic medications “may have been the most careful about limiting exposures,” she said. “Thus, it’s hard to account for behavioral changes in individuals that may have led to the decreased incidence in psoriasis in patients on systemic agents versus topical therapy alone.”

Patients with psoriasis may also be tested more often for COVID-19, and unmeasured comorbidities like chronic kidney disease may play a role too, she said. Still, she added, “it’s reassuring that the authors did not find an increased rate of COVID among psoriasis patients on systemic agents versus topicals alone.” And she agreed with Dr. Wu about the importance of treating psoriasis with therapy beyond topical treatments during the pandemic: “Providers should feel comfortable prescribing systemic medications to psoriasis patients when otherwise appropriate.”

As for the next steps, Dr. Wu said, “we will be exploring more about the prognosis of COVID-19 infection in psoriasis patients. In addition, we will be exploring the relationship of COVID-19 infection with other inflammatory skin diseases, such as atopic dermatitis.”

No study funding is reported. Dr. Wu discloses investigator, consultant, or speaker relationships with AbbVie, Almirall, Amgen, Arcutis, Aristea Therapeutics, Boehringer Ingelheim, Bristol-Myers Squibb, Dermavant, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Janssen, LEO Pharma, Mindera, Novartis, Regeneron, Sanofi Genzyme, Solius, Sun Pharmaceutical, UCB, Valeant Pharmaceuticals North America, and Zerigo Health. Mr. Liu and Dr. Dommasch have no disclosures.

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CDC: Vaccinated people can mostly drop masks outdoors

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Thu, 08/26/2021 - 15:47

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

A version of this article originally appeared on
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After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

After hinting that new guidelines on outdoor mask-wearing were coming, the Centers for Disease Control and Prevention on April 27 officially gave a green light to fully vaccinated people gathering outside in uncrowded activities without the masks that have become so common during the COVID-19 pandemic.

It is a minor – but still significant – step toward the end of pandemic restrictions.

“Over the past year, we have spent a lot of time telling Americans what they cannot do, what they should not do,” CDC director Rochelle Walensky, MD, MPH, said at a White House press briefing. “Today, I’m going to tell you some of the things you can do if you are fully vaccinated.”

President Joe Biden affirmed the new guidelines at a press conference soon after the CDC briefing ended.

“Starting today, if you are fully vaccinated and you’re outdoors and not in a big crowd, you no longer need to wear a mask,” he said, adding “the bottom line is clear: If you’re vaccinated, you can do more things, more safely, both outdoors as well as indoors.”

President Biden emphasized the role science played in the decision, saying “The CDC is able to make this announcement because our scientists are convinced by the data that the odds of getting or giving the virus to others is very, very low if you’ve both been fully vaccinated and are out in the open air.”

President Biden also said these new guidelines should be an incentive for more people to get vaccinated. “This is another great reason to go get vaccinated now. Now,” he said.

The CDC has long advised that outdoor activities are safer than indoor activities.

“Most of transmission is happening indoors rather than outdoors. Less than 10% of documented transmissions in many studies have occurred outdoors,” said Dr. Walensky. “We also know there’s almost a 20-fold increased risk of transmission in the indoor setting, than the outdoor setting.”

Dr. Walensky said the lower risks outdoors, combined with growing vaccination coverage and falling COVID cases around the country, motivated the change.

The new guidelines come as the share of people in the United States who are vaccinated is growing. About 37% of all eligible Americans are fully vaccinated, according to the CDC. Nearly 54% have had at least one dose.

The new guidelines say unvaccinated people should continue to wear masks outdoors when gathering with others or dining at an outdoor restaurant.

And vaccinated people should continue to wear masks outdoors in crowded settings where social distancing might not always be possible, like a concert or sporting event. People are considered fully vaccinated when they are 2 weeks past their last shot

The CDC guidelines say people who live in the same house don’t need to wear masks if they’re exercising or hanging out together outdoors.

You also don’t need a mask if you’re attending a small, outdoor gathering with fully vaccinated family and friends, whether you’re vaccinated or not.

The new guidelines also say it’s OK for fully vaccinated people to take their masks off outdoors when gathering in a small group of vaccinated and unvaccinated people, but suggest that unvaccinated people should still wear a mask.



Reporter Marcia Frellick contributed to this report.

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

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Pfizer and Moderna vaccines appear safe, effective during pregnancy

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Thu, 08/26/2021 - 15:47

 

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

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The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

 

The Pfizer and Moderna COVID-19 vaccines appear to be safe in pregnant patients, according to preliminary findings published in the New England Journal of Medicine.

The Centers for Disease Control and Prevention have said pregnant people have an increased risk of being severely ill from COVID-19; however, this group was excluded from major clinical trials that led up to the current vaccine approvals.

But based on the new findings, Rochelle Walensky, MD, director of the CDC, announced during a White House COVID-19 briefing that the CDC recommends that pregnant people receive the COVID-19 vaccine.

The new study, which analyzed data between Dec. 14, 2020, and Feb. 28, 2021, from three federal databases, adds to a pool of limited data about the safety and efficacy of the vaccine in pregnant persons. Researchers did not include people who received the Johnson & Johnson vaccine because it received emergency use authorization on Feb. 27, just 1 day before they study’s cutoff.

“Our hope is that these initial data will be reassuring to pregnant people and their health care providers as well as the public, and contribute to increasing vaccination rates,” study author Christine Olson, MD, said in an interview. “While the data are preliminary and will continue to be analyzed as more reports become available, our findings are reassuring.”

For the study, Dr. Olson and colleagues analyzed v-safe survey data, data from those enrolled in the v-safe pregnancy registry, and Vaccine Adverse Event Reporting System (VAERS) reports.

Researchers found that 86% of pregnancies resulted in a live birth, 12.6 % resulted in spontaneous abortions, and 0.1% resulted in stillbirth. They also found that, among the live births, 9.4% were preterm, 3.2% of babies were small for their gestational age, and 2.2% had congenital anomalies.

Researchers also found that injection-site pain, fatigue, and headaches were reported more frequently in pregnant patients than among those who were not pregnant. Among VAERS reports, they found that 70% of adverse events were nonpregnancy specific. Nearly 30% involved pregnancy- or neonatal-specific adverse events. The most frequently reported pregnancy-related events were spontaneous abortions, followed by stillbirths, premature rupture of membranes and vaginal bleeding.

“I think the results are actually quite reassuring as the proportion of the pregnancy outcomes, such as pregnancy loss and health effects to the newborns, are really quite consistent with what we’d expect in the background rate of the population,” Dr. Walensky said in a podcast accompanying the study. “So this study adds to growing evidence confirming that pregnant people develop a robust immune response to COVID-19 vaccination without so far seeing any adverse events to the mom or the fetus.”

Researchers said limitations of the study include the accuracy of self-reported data, and there being limited information on other potential risk factors for adverse pregnancies and neonatal outcomes. They acknowledged that continuous monitoring is needed to look at maternal safety and pregnancy outcomes in earlier stages of pregnancy and during the preconception period.

David Jaspan, DO, chair of the department of obstetrics and gynecology at Einstein Medical Center, Philadelphia, who was not involved with the study, said in an interview that, despite the limitations, the study provides much-needed insight on the vaccine’s safety and efficacy in pregnant patients.

“In December we had no data for any pregnant patient,” Dr. Jaspan said. “And now just 4 short months later, this paper [has data from] at least had 35,000 people. We can’t answer every question, but we have more answers today than we had just 4 months ago.”

Dr. Olson hopes the present data is enough to help inform decision-making of pregnant patients and their health care providers when it comes to deciding to get the COVID-19 vaccination.

The study author and experts interviewed disclosed no relevant financial relationships.

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FROM THE NEW ENGLAND JOURNAL OF MEDICINE

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