COVID-19 Updates

If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.

The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.

It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.

Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.

Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.

COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.

Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.

Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”

The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.

“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”

Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.

Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.

“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.

But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”

While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.

Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.

Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.

Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.

Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.

But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”

In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.

Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.

In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.

“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”

And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.

“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”

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.

If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.

The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.

It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.

Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.

Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.

COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.

Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.

Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”

The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.

“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”

Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.

Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.

“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.

But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”

While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.

Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.

Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.

Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.

Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.

But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”

In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.

Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.

In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.

“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”

And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.

“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”

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.

If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.

The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.

It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.

Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.

Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.

COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.

Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.

Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”

The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.

“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”

Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.

Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.

“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.

But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”

While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.

Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.

Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.

Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.

Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.

But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”

In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.

Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.

In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.

“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”

And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.

“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”

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.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.

scyther5/thinkstock

The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.

At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.

In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”

That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.

“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
 

Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”

Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”

However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.

The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.


 

COVID-19 vaccines

Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.

But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.

In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.

The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.

“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”

Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.

It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.

According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.

As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?


 

Risk vs. benefit

Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.

“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”

The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”

That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”

Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”

So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.

“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
 

No waiting needed

Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.

“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”

However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”

Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.

The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.

He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.

Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”

He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”


 

Boosting efficacy

Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”

With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”

As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”

There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”

The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”

Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”

Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”

Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”

Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”

He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”

The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
 

*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.

Parents of school-aged children were generally more comfortable with full-time virtual learning in schools in the fall of 2020, compared with full-capacity in-person attendance, according to a survey conducted in July.

Those of racial/ethnic minorities, however, “were less likely to feel that schools should reopen for all students and were more concerned about” several aspects of in-person instruction than were White parents, Leah K. Gilbert, MD, and associates at the Centers for Disease Control and Prevention’s COVID-19 Response Team said in the Morbidity and Mortality Weekly Report.

A slim majority, just under 53% of the 858 parents surveyed, said that they were very or somewhat comfortable with their children returning to schools that were reopening at full capacity, while almost 70% said they were very/somewhat comfortable with schools going exclusively with virtual learning, the investigators reported.

The question about full-capacity attendance in particular showed considerable variation by race and ethnicity, with 57% of White parents saying they were very/somewhat comfortable, versus 53% of Hispanic or Latino parents, 43% of Black parents, and 32.5% of parents of other races/ethnicities (American Indian/Alaska Native, Asian, or multiracial).

Comfort levels were closer regarding virtual learning: Parents of other races/ethnicities were lowest at 67% and Black parents were highest at 73%. When asked about schools reopening at 50% capacity and 50% virtual learning, Black parents were again lowest at 58% with strong or moderate comfort and White parents were highest at 68%, Dr. Gilbert and associates said.

“Although the majority of parent respondents had concerns about both school reopening for in-person instruction and virtual learning, the perceived risk for SARS-CoV-2 infection and poor health outcomes might account for the differences in parental attitudes and concerns by race and ethnicity,” they wrote.

rfranki@mdedge.com

SOURCE: Gilbert LK et al. MMWR. 2020 Dec 11;69(49):1848-52.

Parents of school-aged children were generally more comfortable with full-time virtual learning in schools in the fall of 2020, compared with full-capacity in-person attendance, according to a survey conducted in July.

Those of racial/ethnic minorities, however, “were less likely to feel that schools should reopen for all students and were more concerned about” several aspects of in-person instruction than were White parents, Leah K. Gilbert, MD, and associates at the Centers for Disease Control and Prevention’s COVID-19 Response Team said in the Morbidity and Mortality Weekly Report.

A slim majority, just under 53% of the 858 parents surveyed, said that they were very or somewhat comfortable with their children returning to schools that were reopening at full capacity, while almost 70% said they were very/somewhat comfortable with schools going exclusively with virtual learning, the investigators reported.

The question about full-capacity attendance in particular showed considerable variation by race and ethnicity, with 57% of White parents saying they were very/somewhat comfortable, versus 53% of Hispanic or Latino parents, 43% of Black parents, and 32.5% of parents of other races/ethnicities (American Indian/Alaska Native, Asian, or multiracial).

Comfort levels were closer regarding virtual learning: Parents of other races/ethnicities were lowest at 67% and Black parents were highest at 73%. When asked about schools reopening at 50% capacity and 50% virtual learning, Black parents were again lowest at 58% with strong or moderate comfort and White parents were highest at 68%, Dr. Gilbert and associates said.

“Although the majority of parent respondents had concerns about both school reopening for in-person instruction and virtual learning, the perceived risk for SARS-CoV-2 infection and poor health outcomes might account for the differences in parental attitudes and concerns by race and ethnicity,” they wrote.

rfranki@mdedge.com

SOURCE: Gilbert LK et al. MMWR. 2020 Dec 11;69(49):1848-52.

Parents of school-aged children were generally more comfortable with full-time virtual learning in schools in the fall of 2020, compared with full-capacity in-person attendance, according to a survey conducted in July.

Those of racial/ethnic minorities, however, “were less likely to feel that schools should reopen for all students and were more concerned about” several aspects of in-person instruction than were White parents, Leah K. Gilbert, MD, and associates at the Centers for Disease Control and Prevention’s COVID-19 Response Team said in the Morbidity and Mortality Weekly Report.

A slim majority, just under 53% of the 858 parents surveyed, said that they were very or somewhat comfortable with their children returning to schools that were reopening at full capacity, while almost 70% said they were very/somewhat comfortable with schools going exclusively with virtual learning, the investigators reported.

The question about full-capacity attendance in particular showed considerable variation by race and ethnicity, with 57% of White parents saying they were very/somewhat comfortable, versus 53% of Hispanic or Latino parents, 43% of Black parents, and 32.5% of parents of other races/ethnicities (American Indian/Alaska Native, Asian, or multiracial).

Comfort levels were closer regarding virtual learning: Parents of other races/ethnicities were lowest at 67% and Black parents were highest at 73%. When asked about schools reopening at 50% capacity and 50% virtual learning, Black parents were again lowest at 58% with strong or moderate comfort and White parents were highest at 68%, Dr. Gilbert and associates said.

“Although the majority of parent respondents had concerns about both school reopening for in-person instruction and virtual learning, the perceived risk for SARS-CoV-2 infection and poor health outcomes might account for the differences in parental attitudes and concerns by race and ethnicity,” they wrote.

rfranki@mdedge.com

SOURCE: Gilbert LK et al. MMWR. 2020 Dec 11;69(49):1848-52.

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

The Food and Drug Administration has issued an emergency-use authorization (EUA) for the first COVID-19 diagnostic test that can be completed at home without a prescription.

Authorization of the Ellume COVID-19 Home Test is “a major milestone in diagnostic testing for COVID-19,” FDA Commissioner Stephen M. Hahn, MD, said in a news release.

“By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test, and find out their results in as little as 20 minutes,” said Dr. Hahn.

The Ellume COVID-19 Home Test is a rapid antigen test that detects fragments of the SARS-CoV-2 virus from a nasal swab sample taken from anyone aged 2 years and older, including those not showing any symptoms.

In testing, the Ellume COVID-19 Home Test correctly identified 96% of positive samples and 100% of negative samples in individuals with symptoms.

In people without symptoms, the test correctly identified 91% of positive samples and 96% of negative samples, the FDA said.

The test includes a sterile nasal swab, a dropper, processing fluid, and a Bluetooth-connected analyzer for use with an app on the user’s smartphone. The sample is analyzed and results are automatically transmitted to the user’s smartphone.

“The Ellume COVID-19 home test’s core technology combines ultra-sensitive optics, electronics, and proprietary software to leverage best-in-class digital immunoassay technology with next-generation multi-quantum dot fluorescence technology,” the company said in a news release.

The mobile app requires individuals to input their ZIP code and date of birth, with optional fields including name and email address. The app automatically reports the results as appropriate to public health authorities to monitor disease prevalence.

Ellume expects to produce more than 3 million tests in January 2021. The company said the test will cost around $30.

FDA authorization of this first fully at-home nonprescription COVID-19 diagnostic test follows last month’s EUA for the first prescription COVID-19 test for home use, as reported this news organization.

Since the start of the pandemic, the FDA has authorized more than 225 diagnostic tests for COVID-19, including more than 25 tests that allow for home collection of samples, which are then sent to a lab for testing.

“As we continue to authorize additional tests for home use, we are helping expand Americans’ access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes,” Dr. Hahn said.

“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” said Jeffrey Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in the release. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

As with other antigen tests, a small percentage of positive and negative results from the Ellume test may be false. In patients without symptoms, positive results should be treated as presumptively positive until confirmed by another test as soon as possible, the FDA advised.

This is especially true if there are fewer infections in a particular community, as false-positive results can be more common when antigen tests are used in populations where there is a low prevalence of COVID-19, the agency said.

Because all tests can give false-negative and false-positive results, individuals with positive results should self-isolate and seek additional care from their health care provider.

Individuals who test negative and have symptoms of COVID-19 should follow up with their health care provider, as negative results don’t preclude an individual from SARS-CoV-2 infection.

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

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

There is a link between liver injury and a tendency toward excessive clotting in patients with COVID-19, and the organ’s own blood vessels could be responsible, new research shows.

The effect of IL-6 on the liver sinusoidal endothelial cells lining the liver blood vessels creates a prothrombotic environment that includes the release of factor VIII, said investigator Matthew McConnell, MD, from the Yale University, New Haven, Conn.

Dr. McConnell presented the results at the virtual annual meeting of the American Association for the Study of Liver Diseases.

These associations offer insights into why COVID-19 patients with underlying liver disease can experience “devastating complications” related to improper blood vessel function in the organ, he added.

For their study, Dr. McConnell and colleagues analyzed data on ALT and hypercoagulability from 68 adults treated at the Yale–New Haven Hospital. The liver and coagulation tests were administered within 5 days of each other.

The team set the ALT cutoff for liver injury at three times the upper limit of normal. Patients with two or more parameters indicating excessive clotting were considered to have a hypercoagulable profile, which Dr. McConnell called “a signature clinical finding of COVID-19 infection.”

Patients with high levels of ALT also experienced elevations in clotting-related factors, such as fibrinogen levels and the activity of factor VIII and factor II. Furthermore, liver injury was significantly associated with hypercoagulability (P < .05).

Because COVID-19 is linked to the proinflammatory IL-6, the investigators examined how this cytokine and its receptor affect human liver sinusoidal cells. Cells exposed to IL-6 and its receptor pumped out factor VIII at levels that were significantly higher than in unexposed cells (P < .01). Exposed cells also produced significantly more von Willebrand factor (P < .05), another prothrombotic molecule, and showed increased expression of genes that induce the expression of factor VIII.There is utility in the findings beyond COVID-19, said Dr. McConnell. They provide “insights into complications of critical illness, in general, in the liver blood vessels” of patients with underlying liver disease.

Dr. McConnell has no conflicts.

For the latest clinical guidance, education, research, and physician resources about coronavirus, visit the AGA COVID-19 Resource Center at www.gastro.org/COVID.

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

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

Editor’s note: This article has been provided by The Doctors Company, the exclusively endorsed medical malpractice carrier for the Society of Hospital Medicine.

As the pandemic hits its third nationwide surge, families are gathering for the holidays, and medical practices are preparing for a potential increase in cases. Medical offices in states that were not strongly affected by the first and second waves of the virus may now be facing an influx of COVID-19 patients. Therefore, medical offices must remain very attentive to the widespread outbreak of COVID-19, continuing to proactively take steps to safely manage patients while protecting clinical staff.

Here are tips and resources for this season of the pandemic:

• Documentation: Maintain administrative records of how you have adapted to the evolving crisis, including the challenges you faced. For details, see Keep a COVID-19 Diary: Document Now in Case of Future Lawsuits.
• Legislation and Guidance: Reference the CDC; your state medical board; professional societies; and federal, state, and local authorities daily for public health guidance and new legislation, as this continues to be a fluid situation.
• Screening Criteria: Follow the CDC’s patient assessment protocol for early disease detection for patients presenting to your practice. Patients should be screened using these guidelines: Overview of Testing for SARS-CoV-2 (COVID-19). Essential visitors to your facility should also be assessed for symptoms of coronavirus and contact exposure and redirected to remain outside if suspect.
• Accepting Patients: Do not turn patients away simply because a patient calls with acute respiratory symptoms. Refusing assessment/care may lead to concerns of patient abandonment.
• Designated Triage Location: Check with your local public health authorities for locations designated to triage suspected patients, so exposure is limited in general medical offices.
• Telehealth Triage: Licensed staff should be trained in triage protocol to determine which patients can be managed safely at home. See Healthcare Facilities: Managing Operations During the COVID-19 Pandemic. The Doctors Company offers resources on telemedicine in our COVID-19 Telehealth Resource Center.
• Patient Testing: When there is a reasonable presumption that a patient may have been exposed to COVID-19, contact the local or state health department to coordinate testing using available community resources. See the CDC’s Testing for COVID-19 , the COVID-19 Testing Overview, and the Clinician Call Center.
• Elective Services: Check with regional governmental and health authorities on the provision of nonessential and elective health care visits and group-related activities. Many states continue or have reinstated restrictions on the provision of nonurgent, elective surgeries and procedures.
• Patient Precautions: Educational resources, including posters for use in the medical office, are available from the WHO and for health care workers from the CDC (Contact Precautions, Droplet Precautions, and Airborne Precautions). Reference the CDC’s and Interim Clinical Guidance for Management of Patients with Confirmed Coronavirus Disease (COVID-19) for patient management guidance.
• Provider/Staff Precautions: Follow Standard Precautions and Transmission-Based Precautions, including gloves, gowns, protective eyewear, and NIOSH-certified N95 respirators that have been properly fit-tested. If there is a shortage of N95 respirators in your facility, access current CDC respirator recommendations and review Optimizing Personal Protective Equipment (PPE) Supplies.
• Limit Exposure: Limit staff exposure to suspected patients, with the exam room door kept closed. Ideally, the designated exam room should be at the back of the office, far away from other staff and patients.
• Surface Disinfection: Once the patient exits the room, conduct surface disinfection while staff continues to wear PPE.
• Patient Education: Provide up-to-date, factual information on the virus to suspected COVID-19–positive patients and their close contacts.
• Provider/Staff Exposure: Screen health care personnel daily for symptoms/contacts relevant to COVID-19. Any unprotected occupational exposure by staff members should be assessed and monitored. See Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19. Should providers and/or staff test positive within your facility, conduct and document a risk assessment identifying contacts, type of interaction, and PPE in use, then contact local health authorities for additional instruction. The CDC provides guidance here under the section “Infection Control.” The health department may assist with patient notification if determined to be necessary. For return-to-work guidance, review the Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance).
• Staff Training: Provide and document additional staff training as protocols change. Maintain training records in administrative files.

Ms. Hill is senior patient safety risk manager at The Doctors Company. The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each health care provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

All pediatricians are relieved that the rates of children smoking cigarettes has dropped steadily since 2011. This decline seems to be associated with education on the dangers of cigarettes and fewer parents smoking. Perhaps less modeling of cigarette use in movies (although it increased again from 2010 to 2019) and lawsuits against advertisements targeting children also has helped.

licsiren/iStock/Getty Images

Vaping increases the risk of severe COVID-19 disease

While EVALI deaths dropped in months after being explained, the COVID-19 epidemic is now a much greater threat to vapers. Vaping, smoking, and even second-hand smoke are associated with a greater likelihood of infection with COVID-19. Vaping increases risk of severe COVID-19 disease because of its immediate paralysis of lung cilia. Sharing vape devices and touching one’s lips while using also increase the risk of virus transmission. Vaping and smoking increase the number of ACE2 receptors to which the SARS-CoV-2 virus attaches causing the characteristic cell damage, and suppresses macrophages and neutrophils, resulting in more smokers testing positive, being twice as likely to develop a severe illness and get hospitalized because of pneumonia from COVID-19, and being less likely to recover. Unfortunately, addressing this new threat to the immediate and long-term health of our patients appears to be more complicated than for addressing smoking tobacco. First of all, vaping is much more difficult to detect than smelly cigarettes sending smoke signals from behind the garage or in the school bathrooms. Many, if not most, adults do not recognize the vaping devices when they see them, as many are tiny and some look like computer thumb drives. The aerosol emitted when in use, while containing dangerous toxins, has less odor than tobacco smoke. Vaping equipment and ads have been designed to attract youth, including linking them to sports and music events. Vaping has been advertised as a way to wean off nicotine addiction, a claim that has some scientific evidence in adults, but at a lower dose of nicotine. Warning children about the dangers of marijuana vaping has been made less credible by the rapid expansion of legalization of marijuana around the United States, eliciting “I told you it was fine” reactions from youth. And the person vaping does not know what or how much of the psychoactive components are being delivered into their bodies. One Juul pod, for example, has the equivalent in nicotine of an entire pack of 20 cigarettes. They are highly addictive, especially to the developing brain, such that youth who vape are more likely to become addicted and to smoke cigarettes in the future.

Help from federal regulation has been weak

While all 50 states ban sales to youth, adults can still buy. Food and Drug Administration limitations on kid-friendly ads, and use of sweet, fruity, and mint flavorings that are most preferred by children, apply only to new producers. The FDA does not yet regulate content of vaping solutions.

So we pediatricians are on the front line for this new threat to prevent vaping or convince youth to cut down or quit. The first step in addressing vaping is being knowledgeable about its many known and emerging health risks. It may seem obvious that the dangers of vaping microscopic particles depends on the contents. Water vapor alone is not dangerous; in fact, we prescribe it in nebulizers. Unfortunately, the contents of different vaping products vary and are not well defined in different vape products. The process of using an electric current to vaporize a substance can make it more toxic than the precursor, and teens have little idea about the substances they are inhaling. The psychoactive components vary from nicotine to tetrahydrocannabinol in varying amounts. These have the well known effects of stimulation or a high, but also the potential adverse effects of poor concentration, agitation, and even psychosis. Most e-cigarettes contain nicotine, which is highly addictive and can harm adolescent brain development, which continues into the early- to mid-20s. About two-thirds of Juul users aged 15-24 years did not know that it always contains nicotine, as do 99% of all vape solutions (Centers for Disease Control and Prevention, 2020). Earlier use of nicotine is more highly associated with later addiction to tobacco products that cause lung damage, acid reflux, insulin resistance, harm to the testes, harm to fetuses, cancer, and heart disease.

E-cigarette aerosols also contain dozens of other harmful substances besides nicotine ranging from acetone, propylene glycol, and metals to formaldehyde and ethyl benzene. These same chemicals are part of familiar toxic substances such as antifreeze, paint thinner, and pesticides. These cause ear, eye and throat irritation, and impairments in the cardiovascular system reducing athletic ability – at the least. Some flavorings in vape fluids also are toxic. Even the residual left on furniture and floors is harmful to those coming in contact, including pets.
 

How to encourage teens not to vaping

Trying to scare youth about health hazards is not generally effective in stopping risk behaviors since adolescence is a time of perceived singularity (it does not apply to me) and even a sense of immortality. Teens also see peers who vape as being unaffected and decide on using based on this small personal sample instead of valid statistics.

But teens do pay some attention to peer models or influencers saying why they do not use. One source of such testimony you can refer to is videos of inspiring athletes, musicians, and other “cool” young adults found on the naturalhigh.org website. You may know other examples of community teens desisting you can reference.

Parent rules, and less so advice, against smoking have been shown to be effective in deterring youth cigarette smoking. Because parents are less aware of vaping and its dangers, another step we can take is educating parents in our practices about vaping, its variable forms, its effects, and dangers, supplying authoritative materials, and advising them to talk with their children. Other steps the American Academy of Pediatrics recommends regarding smoking is for parents to be a role model of not using or try to quit, designate the house and car as smoking free, avoid children viewing smoking in media, tell their children about the side effects, and encourage their children who use to quit. Parents also can encourage schools to teach and have rules about smoking and vaping (e.g., med.stanford.edu/tobaccopreventiontoolkit.html).

Another approach we have been using is to not only screen for all substance use, but also to gather information about the teen’s strengths, activities, and life goals both to enhance rapport and to reference during motivational interviewing as reasons to avoid, reduce, or quit vaping. Motivational interviewing has been shown to help patients make healthier lifestyle choices by nonjudgmentally exploring their pros and cons in a conversation that takes into account readiness to change. This fits well with the stage of developing autonomy when teens want above all to make their own decisions. The cons of using can be discussed as including the effects and side effects of vaping interfering with their favored activities and moving towards their identified goals. Praising abstinence and asking them to show you how they could decline offers to vape are valuable reinforcement you can provide.

Finally, we all know that teens hate being manipulated. Vaping education we provide can make it clear that youth are being tricked by companies – most being large cigarette producers who know the dangers of vaping – into getting addicted so these companies can get rich on their money.

Dr. Howard is assistant professor of pediatrics at Johns Hopkins University, Baltimore, and creator of CHADIS (www.CHADIS.com). She has no other relevant disclosures. Dr. Howard’s contribution to this publication is as a paid expert to MDedge News. Email her at pdnews@mdedge.com.

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

Gastroenterologists at the Advances in Inflammatory Bowel Disease 2020 annual meeting said they will strongly advise their patients to take the COVID-19 vaccines as they become available.

Announcement that the first vaccine, Pfizer’s, was recommended for emergency use authorization came in the middle of AIBD’s Thursday evening COVID-19 session.

Miguel Regueiro, MD, chair of the department of gastroenterology, hepatology, and nutrition at Cleveland Clinic in Ohio, said, “We’re uniformly recommending this to all our patients.”

“The [vaccines] leading the pack do not have any replicating virus and thus can be used in immunocompromised people,” Maria Abreu, MD, director of the Crohn’s & colitis center at the University of Miami, told this news organization. “Although it is true that we don’t know – and won’t know for a while – whether the high levels of efficacy seen with the mRNA vaccines so far will be achieved in patients who are immunocompromised, there is every reason to believe that [the vaccine] will still be enough to protect them from complications of COVID-19.”

The bottom line, she said, is that “it’s much safer to get a vaccine than it is to take your chances of getting COVID-19.”

David T. Rubin, MD, chief of gastroenterology, hepatology, and nutrition at UChicago Medicine, said in a session earlier in the day, “Emerging information about the messenger RNA looks like it’s going to be safe for our population, but of course we want to see more. Messenger RNA degrades within days of giving it, so it’s not expected to linger or generate any other problems we can think of.”

Dr. Abreu said there’s no evidence that inflammatory bowel disease (IBD) patients are more susceptible to COVID-19 infection even though the entry molecules are expressed in the GI tract. “They are really not differentially expressed in IBD and, if anything, some of our more potent therapies reduce the expression of these molecules in the GI tract,” she said.

Regarding how IBD medications affect outcomes if patients are infected with COVID-19, Dr. Abreu pointed out that corticosteroids seem to be associated with worse outcomes. “I would posit that it has to do with initially allowing there to be a lot of very rapid viral replication,” she said.

And she also noted that any of the mainstay drugs for IBD – the anti–tumor necrosis factor (TNF) therapies – are showing promise as treatments for COVID-19.
 

Updates from the IBD-COVID-19 registry

Michael Kappelman, MD, MPH, from the University of North Carolina at Chapel Hill said information from the Secure-IBD registry, which collects real-time global information on how COVID-19 affects IBD patients, suggests that these patients “may have a more severe course than the general population, but not by much.”

He reported the registry had logged more than 3,300 reported COVID-19 cases among IBD patients from 62 countries.

Registry outcomes through the end of November have found a mean age of reported cases of 40 years, and that 21% of patients were hospitalized with an average length of stay of 10.2 days, 4% required intensive care unit admission, and 2% died.

The majority of the deaths reported to Secure-IBD occurred in patients older than 60 years, Dr. Kappelman said, adding that the hospitalizations and death rates in IBD patients with no comorbidities were relatively low.

“My belief is that available data are actually more reassuring than alarming,” he said.

Dr. Kappelman and other investigators found that combination therapy that includes thiopurines and thiopurine monotherapy are “associated with about a fourfold risk of the requirement for intensive care or mortality from COVID,” compared with anti-TNF monotherapy.

In cases reported to Secure-IBD, about 25% of IBD patients with COVID-19 developed new GI symptoms, primarily diarrhea and abdominal pain, he said.

In his practice, Dr. Kappelman said, he minimizes use of steroids and has found that COVID-19 adds a reason to favor anti-TNF over 6-mercaptopurine (6-MP) plus azathioprine.

He also advises “a high alert for COVID-19 in patients with new GI symptoms.”

Dr. Abreu has relationships with Boehringer Ingelheim, Cosmo Biopharma, Eli Lilly, Gilead, Janssen, Landos Biopharma, Prometheus Bioscience, Takeda, UCB Biopharma, Pfizer, and Prometheus Laboratories. Dr. Rubin has served as a director, officer, partner, employee, adviser, consultant, or trustee for AbbVie, Abgenomics, Allergan, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Dizal Pharmaceuticals, GalenPharma/Atlantica, Genentech/Roche, Gilead Sciences, Ichnos Sciences, GlaxoSmithKline, Janssen, Eli Lilly, Pfizer, Prometheus Laboratories, Reistone, Shire, Takeda Pharmaceutical, and Techlab. In addition, he has received research grants from AbbVie, Genentech/Roche, Janssen Pharmaceuticals, Prometheus Laboratories, Shire, and Takeda Pharmaceutical Company; and holds stock options in Abgenomics and Biomica. Regueiro and Kappelman  have disclosed no relevant financial relationships.

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

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com