Journal of Clinical Outcomes Management

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.

The product, ciltacabtagene autoleucel (cilta-cel), will be marketed as Carvykti by Janssen and Legend Biotech. It is a chimeric antigen receptor (CAR) T-cell therapy directed against B-cell maturation antigen (BCMA), which is a new target for therapies for multiple myeloma.

There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.

The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.

The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.

“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.

“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.

Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.

The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.

The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.

At a median of 18 months’ follow-up, the median duration of response was 21.8 months.

“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.

“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.

As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.

The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.

The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

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

Two preprint studies released on Feb. 26 offer additional evidence that the coronavirus pandemic started at a market in Wuhan, China.

By analyzing data from several sources, scientists concluded that the virus came from animals and spread to humans in late 2019 at the Huanan Seafood Market. They added that no evidence supported a theory that the virus came from a laboratory in Wuhan.

“When you look at all the evidence together, it’s an extraordinarily clear picture that the pandemic started at the Huanan market,” Michael Worobey, D.Phil., a co-author on both studies and an evolutionary biologist at the University of Arizona, told the New York Times.

The two reports haven’t yet been peer-reviewed or published in a scientific journal. They were posted on Zenodo, an open-access research repository operated by CERN.

In one study, researchers used spatial analysis to show that the earliest COVID-19 cases, which were diagnosed in December 2019, were linked to the market. Researchers also found that environmental samples that tested positive for the SARS-CoV-2 virus were associated with animal vendors.

In another study, researchers found that two major viral lineages of the coronavirus resulted from at least two events when the virus spread from animals into humans. The first transmission most likely happened in late November or early December 2019, they wrote, and the other likely happened a few weeks later.

Several of the researchers behind the new studies also published a review last summer that said the pandemic originated in an animal, likely at a wildlife market. At that time, they said the first known case was a vendor at the Huanan market.

The new findings provide the strongest evidence yet that the pandemic had animal-related origins, Dr. Worobey told CNN. He called the results a “game, set and match” for the theory that the pandemic began in a lab.

“It’s no longer something that makes sense to imagine that this started any other way,” he said.

In a separate line of research, scientists at the Chinese CDC conducted a new analysis of samples collected at the market in January. They found that the samples included the two main lineages of the coronavirus. They posted the results in a report on the Research Square preprint server Feb. 26.

“The beauty of it is how simply it all adds up now,” Jeremy Kamil, a virologist at Louisiana State University Health Sciences, who wasn’t involved with the new studies, told the New York Times.

The initial spread of the coronavirus was like a firework, Dr. Worobey told CNN, starting at the market and exploding outward. The “overwhelming majority” of cases were specifically linked to the western section of the market, where most of the live-mammal vendors were located, the study authors wrote. Then COVID-19 cases spread into the community from there, and the pattern of transmission changed by January or February 2020.

When researchers tested surfaces at the market for coronavirus genetic material, one stall had the most positives, including a cage where raccoon dogs had been kept.

The study authors said the findings highlight the urgent need to pay attention to situations where wild animals and humans interact closely on a daily basis.

“We need to do a better job of farming and regulating these wild animals,” Robert Garry, one of the co-authors and a professor of microbiology and immunology at the Tulane University School of Medicine, told CNN.

That could include better infrastructure in places like markets where viruses spill over from animals to humans, he said. Surveillance is also key in preventing future pandemics by detecting new respiratory diseases in humans, isolating patients, and sequencing new virus strains.

“This is not the last time this happens,” he said.

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

Two preprint studies released on Feb. 26 offer additional evidence that the coronavirus pandemic started at a market in Wuhan, China.

By analyzing data from several sources, scientists concluded that the virus came from animals and spread to humans in late 2019 at the Huanan Seafood Market. They added that no evidence supported a theory that the virus came from a laboratory in Wuhan.

“When you look at all the evidence together, it’s an extraordinarily clear picture that the pandemic started at the Huanan market,” Michael Worobey, D.Phil., a co-author on both studies and an evolutionary biologist at the University of Arizona, told the New York Times.

The two reports haven’t yet been peer-reviewed or published in a scientific journal. They were posted on Zenodo, an open-access research repository operated by CERN.

In one study, researchers used spatial analysis to show that the earliest COVID-19 cases, which were diagnosed in December 2019, were linked to the market. Researchers also found that environmental samples that tested positive for the SARS-CoV-2 virus were associated with animal vendors.

In another study, researchers found that two major viral lineages of the coronavirus resulted from at least two events when the virus spread from animals into humans. The first transmission most likely happened in late November or early December 2019, they wrote, and the other likely happened a few weeks later.

Several of the researchers behind the new studies also published a review last summer that said the pandemic originated in an animal, likely at a wildlife market. At that time, they said the first known case was a vendor at the Huanan market.

The new findings provide the strongest evidence yet that the pandemic had animal-related origins, Dr. Worobey told CNN. He called the results a “game, set and match” for the theory that the pandemic began in a lab.

“It’s no longer something that makes sense to imagine that this started any other way,” he said.

In a separate line of research, scientists at the Chinese CDC conducted a new analysis of samples collected at the market in January. They found that the samples included the two main lineages of the coronavirus. They posted the results in a report on the Research Square preprint server Feb. 26.

“The beauty of it is how simply it all adds up now,” Jeremy Kamil, a virologist at Louisiana State University Health Sciences, who wasn’t involved with the new studies, told the New York Times.

The initial spread of the coronavirus was like a firework, Dr. Worobey told CNN, starting at the market and exploding outward. The “overwhelming majority” of cases were specifically linked to the western section of the market, where most of the live-mammal vendors were located, the study authors wrote. Then COVID-19 cases spread into the community from there, and the pattern of transmission changed by January or February 2020.

When researchers tested surfaces at the market for coronavirus genetic material, one stall had the most positives, including a cage where raccoon dogs had been kept.

The study authors said the findings highlight the urgent need to pay attention to situations where wild animals and humans interact closely on a daily basis.

“We need to do a better job of farming and regulating these wild animals,” Robert Garry, one of the co-authors and a professor of microbiology and immunology at the Tulane University School of Medicine, told CNN.

That could include better infrastructure in places like markets where viruses spill over from animals to humans, he said. Surveillance is also key in preventing future pandemics by detecting new respiratory diseases in humans, isolating patients, and sequencing new virus strains.

“This is not the last time this happens,” he said.

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

Two preprint studies released on Feb. 26 offer additional evidence that the coronavirus pandemic started at a market in Wuhan, China.

By analyzing data from several sources, scientists concluded that the virus came from animals and spread to humans in late 2019 at the Huanan Seafood Market. They added that no evidence supported a theory that the virus came from a laboratory in Wuhan.

“When you look at all the evidence together, it’s an extraordinarily clear picture that the pandemic started at the Huanan market,” Michael Worobey, D.Phil., a co-author on both studies and an evolutionary biologist at the University of Arizona, told the New York Times.

The two reports haven’t yet been peer-reviewed or published in a scientific journal. They were posted on Zenodo, an open-access research repository operated by CERN.

In one study, researchers used spatial analysis to show that the earliest COVID-19 cases, which were diagnosed in December 2019, were linked to the market. Researchers also found that environmental samples that tested positive for the SARS-CoV-2 virus were associated with animal vendors.

In another study, researchers found that two major viral lineages of the coronavirus resulted from at least two events when the virus spread from animals into humans. The first transmission most likely happened in late November or early December 2019, they wrote, and the other likely happened a few weeks later.

Several of the researchers behind the new studies also published a review last summer that said the pandemic originated in an animal, likely at a wildlife market. At that time, they said the first known case was a vendor at the Huanan market.

The new findings provide the strongest evidence yet that the pandemic had animal-related origins, Dr. Worobey told CNN. He called the results a “game, set and match” for the theory that the pandemic began in a lab.

“It’s no longer something that makes sense to imagine that this started any other way,” he said.

In a separate line of research, scientists at the Chinese CDC conducted a new analysis of samples collected at the market in January. They found that the samples included the two main lineages of the coronavirus. They posted the results in a report on the Research Square preprint server Feb. 26.

“The beauty of it is how simply it all adds up now,” Jeremy Kamil, a virologist at Louisiana State University Health Sciences, who wasn’t involved with the new studies, told the New York Times.

The initial spread of the coronavirus was like a firework, Dr. Worobey told CNN, starting at the market and exploding outward. The “overwhelming majority” of cases were specifically linked to the western section of the market, where most of the live-mammal vendors were located, the study authors wrote. Then COVID-19 cases spread into the community from there, and the pattern of transmission changed by January or February 2020.

When researchers tested surfaces at the market for coronavirus genetic material, one stall had the most positives, including a cage where raccoon dogs had been kept.

The study authors said the findings highlight the urgent need to pay attention to situations where wild animals and humans interact closely on a daily basis.

“We need to do a better job of farming and regulating these wild animals,” Robert Garry, one of the co-authors and a professor of microbiology and immunology at the Tulane University School of Medicine, told CNN.

That could include better infrastructure in places like markets where viruses spill over from animals to humans, he said. Surveillance is also key in preventing future pandemics by detecting new respiratory diseases in humans, isolating patients, and sequencing new virus strains.

“This is not the last time this happens,” he said.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Circulating antiphospholipid autoantibodies may contribute to endothelial cell activation and dysfunction in severe COVID-19, researchers report.

In 2020, the same researchers reported results from a preclinical study demonstrating that autoantibodies from patients with active COVID-19 caused clotting in mice.

The new study, published in Arthritis and Rheumatology, found higher-than-expected levels of antiphospholipid autoantibodies in the blood samples of 244 patients hospitalized with COVID-19.

“While endothelial dysfunction has been implicated in the widespread thromboinflammatory complications of COVID-19, the upstream mediators of endotheliopathy remain for the most part cryptic,” write Hui Shi, MD, PhD, and coauthors from the University of Michigan, Ann Arbor, and the National Heart, Lung, and Blood Institute.

When asked for comment on the study, Eline T. Luning Prak, MD, PhD, professor of pathology and laboratory medicine at the Hospital of the University of Pennsylvania in Philadelphia, said, “The autopsy cases for COVID-19 strongly point to thromboembolic complications in many individuals who succumbed to sequelae of the infection.

“Importantly, however, many factors can contribute to this pathology, including the inflammatory milieu, monocyte activation, neutrophil extracellular traps, immune complexes, complement, as well as effects on endothelial cells,” explained Dr. Luning Prak, who was not involved in the study.

“The findings in this paper nicely complement another study by Schmaier et al. that came out recently in JCI Insight that also suggests that endothelial cells can be activated by antibodies, she said.
 

‘Even stronger connection between autoantibody formation and clotting in COVID-19’

Dr. Shi and her team cultured human endothelial cells in serum or plasma from 244 patients hospitalized with COVID-19 and plasma from 100 patients with non-COVID sepsis. Using in-cell enzyme-linked immunosorbent assay, they measured levels of key cell adhesion molecules.

After analysis, the researchers found that serum from COVID-19 patients activated cultured endothelial cells to express surface adhesion molecules essential to inflammation and thrombosis, particularly E-selectin, ICAM-1, and VCAM-1.

“The presence of circulating antiphospholipid antibodies was a strong marker of the ability of COVID-19 serum to activate endothelium,” they explain.

Further analyses revealed that, for a subset of serum samples from patients with severe infection, this activation could be mitigated by depleting total immunoglobulin G.

In addition, supplementation of control serum with patient IgG was adequate to trigger endothelial activation.

On the basis of these results, the researchers hypothesize that antiphospholipid autoantibodies may characterize antibody profiles in severe COVID-19 that activate the endothelium and transition the usually quiescent blood-vessel wall interface toward inflammation and coagulation.

“[These findings] provide an even stronger connection between autoantibody formation and clotting in COVID-19,” Dr. Shi said in an accompanying press release.

Clinical implications

From a clinical perspective, Dr. Shi and her team question whether patients with severe COVID-19 should be tested for antiphospholipid antibodies to assess their risk of thrombosis and progression to respiratory failure.

Moreover, they question whether patients with high antiphospholipid antibody titers might benefit from therapies used in conventional cases of severe antiphospholipid syndrome, such as plasmapheresis, anticoagulation therapy, and complement inhibition, Dr. Shi added.

The researchers hope to answer these and other remaining questions in future studies. “Eventually, we may be able to repurpose treatments used in traditional cases of antiphospholipid syndrome for COVID-19.

“As we await definitive solutions to the pandemic, these findings add important context to the complex interplay between SARS-CoV-2 infection, the human immune system, and vascular immunobiology,” she concluded.

The study was supported by grants from the Rheumatology Research Foundation, the Michigan Medicine Frankel Cardiovascular Center, and the A. Alfred Taubman Medical Research Institute. One author is an inventor on an unrelated pending patent to the University of Michigan. The other authors and Dr. Luning Prak have disclosed no relevant financial relationships.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Universal screening for presymptomatic type 1 diabetes among schoolchildren would cost approximately 22 euros (about $25) per child screened, and about 7,000 euros (about $7,900) per child diagnosed, a new analysis of data from a German program finds.

The data come from the Fr1da study, in which a blood test for type 1 diabetes–associated islet autoantibodies is offered to all children aged 21 months to 6 years old in Bavaria.

Families of those who test positive are offered participation in a program of diabetes education, metabolic staging, psychological evaluation for stress, and prospective follow-up.

The researchers explain that, worldwide, 4 in 1,000 people under the age of 20 years have type 1 diabetes. It is the most common metabolic disease in children and adolescents. Only about 1 in 10 of those affected has a close relative with the disease. This means that type 1 diabetes can affect any child.

However, in many cases, the disease does not become known until a severe to life-threatening metabolic derailment known as diabetic ketoacidosis (DKA) occurs. This often leads to intensive medical treatment, a longer hospitalization, and poorer blood glucose control, which can result in an increased risk of secondary diseases and very high costs for the health care system.

“We want to protect as many children as possible from serious metabolic derailments. This is only possible with type 1 diabetes screenings. Therefore, we strongly support to include early detection tests in standard medical care,” Peter Achenbach, DrMed, senior author of the study, said in a statement from his institution, Helmholtz Zentrum München in Neuherberg, Germany.

The new findings were published in Diabetes Care by Florian M. Karl, also of Helmholtz Zentrum München, and colleagues.

In 2020, the Fr1da investigators reported that, of 90,632 children who participated from February 2015 to May 2019, 0.31% (280) were diagnosed with presymptomatic type 1 diabetes through the presence of two or more islet autoantibodies.

This news organization asked Brett McQueen, PhD, who led a similar study examining cost and cost-effectiveness in the Autoimmunity Screening for Kids (ASK) program, in which Denver-area children aged 2-17 years are offered autoantibody screening for both type 1 diabetes and celiac disease, for comment.

“If we have a chance to change a child’s life from when they’re 2 or 3 years old and there’s even a small chance that this thing potentially improves health outcomes for a decent price, what are we waiting for?” said Dr. McQueen, who is assistant professor in the department of clinical pharmacy at the University of Colorado, Aurora.
 

Is DKA prevention enough to justify universal screening?

Although identifying type 1 diabetes before symptoms arise could help avoid DKA, currently no therapeutic interventions are available to prevent or delay the trajectory from presymptomatic to clinical type 1 diabetes.

A possible future intervention – the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) – had a setback in July 2021 when the Food and Drug Administration declined to approve it for the delay of type 1 diabetes in at-risk individuals.

However, on Feb. 22 Provention Bio announced that it has resubmitted the Biologics License Application for teplizumab for the delay of clinical type 1 diabetes in at-risk individuals. The FDA now has 30 days to review the resubmission, determine whether it is complete and acceptable for review, and provide a review goal date, according to a company statement.

But even without the ability to forestall the development of type 1 diabetes, screening proponents point to the potential benefit from educating families about early signs of diabetes onset and thereby preventing progression to DKA and both its short-term and possible long-term sequelae.

Prevention of DKA at diagnosis has been linked to improved long-term glycemic control and other potential health benefits.

And the frequency of DKA at the onset of type 1 diabetes has increased in recent years, to more than 20% in Germany and over 45% in the United States.

But, prior data have suggested that universal screening for presymptomatic type 1 diabetes is unlikely to be cost effective if only the health and economic benefits of prevention of DKA at type 1 diabetes onset is considered, unless the screening costs are exceedingly low.
 

What will it take to implement universal screening?

“What this paper does is contribute really to our understanding of more around resource utilization,” noted Dr. McQueen. “As they correctly identify, it’s really hard to compare country prices. It’s easier to compare utilization.”

In Dr. McQueen’s ASK program, the cost per child screened and per case detected in that program were similar to those found in the German study, even though the cost of the antibody testing itself was considerably lower in Germany than in the United States.

Fr1da included more components of screening and monitoring than did ASK, Dr. McQueen told this news organization.

The conclusions of the ASK study were that “presymptomatic type 1 diabetes screening may be cost effective in areas with a high prevalence of DKA and an infrastructure facilitating screening and monitoring if the benefits of avoiding DKA events and improved [hemoglobin] A1c persist over long-run time horizons.”

Nonetheless, Dr. McQueen thinks it’s unlikely that universal screening will be recommended by professional societies or covered by payers in the United States until a pharmacologic intervention to forestall disease progression is available.“Teplizumab approval could move this along. ... We’re just trying to take one factor, the economics of it, to create the most efficient scenario so that if it were to be adopted we would catch the most cases, prevent the most complications, benefit children the most in terms of their lifetime health outcomes – all at the minimum cost possible.”
 

‘A benchmark for the expected implementation cost of screening’

Mr. Karl and colleagues simulated the cost of implementation of this screening as standard care in Germany – assuming the same 0.31% prevalence found in Fr1da – the average cost per child was estimated at 21.73 euros, including 9.34 euros for laboratory costs, 12.25 euros for pediatrician costs, and 0.14 euros for local diabetes clinics to perform metabolic staging and education for children diagnosed with presymptomatic type 1 diabetes.

The model included 50% of the costs incurred in Fr1da for obtaining informed consent. Negative autoantibody results from the initial screening were not communicated to families, and all children with presymptomatic type 1 diabetes received staging and education. The estimated average cost per diagnosed child was 7,035 euros.

“Although our analyses are subject to some level of uncertainty, they provide a benchmark for the expected implementation cost of screening,” said coauthor Michael Laxy, MSc, PhD, also at Helmholtz Zentrum München.

“Next, we aim to evaluate the long-term ratio of screening costs, potential cost savings through the prevention of metabolic derailment and its consequences, and potentially increased quality of life with a type 1 diabetes screening compared to the costs and quality of life without a screening.”

Dr. McQueen is working along similar lines in Colorado, attempting to create a model that incorporates all the different possibilities including DKA monitoring, teplizumab availability, screening children at different ages, and the effect of including blood glucose monitoring in children identified with presymptomatic type 1 diabetes.

“There are so many different potential answers and avenues and no one has really put it all together,” he observed.

But he believes that economics shouldn’t be the only factor used in deciding whether to institute widespread screening.

This study was supported by grants from the German Federal Ministry of Education and Research to the German Center for Diabetes Research (DZD). The Fr1da study was supported by grants from the LifeScience-Stiftung, JDRF International, the Bavarian State Ministry of Health and Care, the Leona M. and Harry B. Helmsley Charitable Trust, Deutsche Diabetes-Stiftung, Landesverband Bayern der Betriebskrankenkassen, B. Braun-Stiftung, Deutsche Diabetes Hilfe, and the German Federal Ministry of Education and Research to the DZD. The authors disclosed no relevant financial relationships. The ASK study was funded by JDRF International, the Leona M. and Harry B. Helmsley Charitable Trust, and Janssen Research and Development. Dr. McQueen has received institutional funding for value assessment applications from the Institute for Clinical and Economic Review, the PhRMA Foundation, and PhRMA.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots. 

The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that the incidence of sudden onset hearing loss was not elevated – and might even be a bit lower than expected – in the first few weeks after the injections.

“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.

Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.

They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.

Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.

When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.

“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.

Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.

They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.

“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.

“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.

But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.

Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

Nasogastric tubes. Foley catheter kits. Hydrogel anti-burn bandages and transfusion bags. Heparin, atropine, tramadol.

These items are just a few of some two dozen critical medical supplies that physicians in Ukraine desperately need, according to Leo Wolansky, MD, a Ukrainian-American radiologist and president of the Ukrainian Medical Association of North America (UMANA).

Dr. Wolansky founded a teaching program with an organization called Friends of Radiology in Ukraine in 1996 and has been running courses for specialists there ever since. He last visited the country in 2019, before the COVID-19 pandemic, but has remained in contact with his medical colleagues by phone and email. Over the weekend of Feb. 26-27, UMANA held a fundraiser for Ukraine, raising more than $17,000.

This news organization spoke with Dr. Wolansky about the situation for his fellow physicians in the war-torn country.

Question: Where is your family from, and do you have relatives in the country now?

Dr. Wolansky: My family is from two different parts of Ukraine. My mother was from central Ukraine. Her father, Ivan Sharyj, was part of the students’ militia that fought at the famous battle of Kruty in 1918. Four hundred Ukrainian militia fought against 5,000 professional Russian soldiers and were massacred. He later wrote the first eye-witness account. Afterwards, he had the opportunity to flee Ukraine but chose to stay under a pseudonym. Eventually, during Stalin’s purges [1929-1933], the regime found him, arrested him, tortured him, and executed him. My mother was seven when she saw her father arrested, never to return home. My father was from Western Ukraine, which did not have a long history of Russian occupation. His mother’s family was very patriotic; her first cousin, Stepan Vytvytskyi, eventually became the president of Ukraine in exile from 1955-1964.

I have second and more distant cousins in Kyiv. My wife has first cousins in Western Ukraine. They and my doctor colleagues are suffering greatly but are ready to die for their freedom.

Question: The Russian invasion of Ukraine has put tremendous stress on the Ukrainian people, including the country’s medical professionals. How do doctors in these kinds of situations handle casualties they can’t prevent? How do they work around that sense that everything is out of their control?

Dr. Wolansky: A lot of infrastructural things are being disrupted; there are limitations that you wouldn’t normally encounter. Ukraine has been developing a lot of sophisticated medical technology, but it still has room to grow. Under these circumstances, when there are bombs going off and transportation is being disrupted, it creates very new and significant obstacles to surmount. It still has not risen to massive casualties, and we can just pray that it does not, but in times of war, a very different kind of medicine is practiced.

But remember, Ukraine has been at war since 2014, when Russia took Crimea and invaded the Eastern provinces. The doctors there are not unfamiliar with war injuries. At our conferences in Ukraine, I have seen radiological presentations of injuries sustained in war – gunshots, fractures, and amputations – as well as other kinds of traumatic injuries. You’re going for a kind of more emergent treatment: to transfuse, to maintain peoples’ blood pressure, put bandages on, sterilize and sanitize wounds to prevent infections. I imagine there will be many field hospitals set up between now and the next few weeks to deal with the acute injuries.

Question: Ukraine has struggled with high rates of HIV and multidrug-resistant tuberculosis, as well as a lack of resources for treating patients with mental illness. Meanwhile, the country has had more that 5 million cases of COVID-19 and an estimated 112,000 deaths from the disease. Are you concerned about an exacerbation of infection rates, including of COVID, particularly among refugees and those who become homeless?

Dr. Wolansky: Because COVID ran pretty rampant in Ukraine, I think that – at a high cost – there is a level of natural immunity in the population. And the weather is going to be getting warmer soon, and respiratory viruses are cyclic in nature, so I don’t know if that’s going to be a big complicating factor. However, people get sick all the time, and the prognosis for them is going to be much worse than it otherwise might be. If you have a heart attack, your chances were way better when the roads were clear and people weren’t shooting at you.

Right now, it’s very regional where the infrastructure is being destroyed. The West, where I used to go, is in much better shape than the East because it has not been the focus of Russian attacks. But Kyiv could turn into a very big humanitarian crisis very quickly if there’s no electricity, no water. All sorts of medical conditions could be greatly exacerbated, and some new health crises could arise from water contamination, bombs causing buildings to collapse, and other problems. Whatever the illness is, it’s going to be harder to take care of it.

Questions: Doctors Without Borders announced that it was suspending its operations in Ukraine because of the invasion – missions that included HIV care in Severodonetsk, tuberculosis care in Zhytomyr, and improving health care access in Donetsk in eastern Ukraine, according to the aid group. What do doctors in Ukraine need most acutely now, other than peace?

Dr. Wolansky: Obviously, money is valuable, and military protection, which would prevent additional damage to their infrastructure. One thing that bears mentioning. There’s been a fair amount of coverage of this, but I’ve witnessed it first-hand: The Ukrainian people are fiercely patriotic, and there’s really no way their spirit can be conquered. The USSR invaded Afghanistan, and after years of thinking they were in command, they left because they could no longer take the guerilla warfare and the constant sniper attacks. Ukraine’s population is many times larger than Afghanistan’s; there’s no way they can be subdued. And remember, the Ukrainian people have been free for 30 years – generations of young people have known no other way of life. They are not going to give that up.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

About 5% of people who are eligible to receive lung cancer screening do not live close to a facility and have limited or no access to screening,a recent analysis shows.

That percentage, although quite small, still translates to more than 750,000 individuals who are eligible to receive lung cancer screening but live at least 40 miles from a facility.

Overall, a larger proportion of eligible individuals in rural areas had no access to a facility, but a greater number of people in urban areas had no access, especially at shorter distances.

Understanding access issues is important given that “lung cancer screening with low-dose computed tomography scanning (LDCT) reduces mortality among high-risk adults, ... [but] annual screening rates remain low,” write study authors Liora Sahar, PhD, of the American Cancer Society in Atlanta, and colleagues.

The study was published online Feb. 15 in the journal Cancer.

It expands on a previous report, which found that “less than 6% of those 55 to 79 years of age do not have access to registry screening facilities”.

The new analysis incorporates the most recent guidelines from the U.S. Preventive Services Task Force, which lowered the screening age to 50 years and compares access across urban and rural areas.

Dr. Sahar and colleagues calculated the distances from population centers to screening facilities and estimated the number of individuals living within different distances of those facilities – 10, 20, 40, 50, and 100 miles. Geographical subdivisions, or census tracts, were also classified along a spectrum of rural to urban.

The authors found that, overall, about 14.8 million people aged 50-80 years are eligible for lung cancer screening, and 5.1% of that population – or 753,038 individuals – do not live within 40 miles of a facility and have no access to screening.

The proportion of people affected by access issues varies by geographic location. For eligible people living 40 miles or more from a facility, almost 25% (n = 287,803) in rural counties had no access, compared with 1.6% (n = 195,120) in metropolitan areas.

At greater distances to facilities (50 and 100 miles), these proportions diminish. In rural counties, for instance, 16% of eligible individuals (n = 186,401) living 50 or more miles away and 2.8% (n = 33,504) living 100 or more miles away had no access to a facility.

Not surprisingly, across all distances, “there is a significantly higher percentage of rural residents who do not have access to facilities in comparison with those in urban settings,” the authors write. “There are fewer facilities in rural areas, so residents need to travel longer distances to reach a facility.”

Notably, however, distance to a facility was not necessarily the greatest barrier to screening. The authors found a greater number of eligible individuals living in or close to urban areas were not getting screening when facilities were 10 miles away – more than 2.8 million in metropolitan areas versus just over 1 million in rural areas.

“The total number of individuals with no access in urban areas exceeds that of rural individuals, particularly at shorter distances ... [which] reveals an additional underserved population.”

Identifying geographic areas with greater access issues can help researchers address barriers to screening and improve uptake. 

“Areas and local pockets with persistently low or no access across short and long distances should be considered for tailored interventions, such as implementing mobile units, repurposing existing imaging or health facilities, and adding appropriate navigation, radiology, and screening program staff to better support the communities,” the authors conclude.

The study was supported in part by the National Lung Cancer Roundtable. Coauthor Debra S. Dyer, MD, serves on the clinical advisory board for computer software company Imidex and on the GO2 Foundation scientific advisory board; she also serves as a consultant for Lung Ambition Alliance. Coauthor Ella A. Kazerooni, MD, reports past participation on the Bristol Myers Squibb Foundation advisory board. The other authors have disclosed no relevant financial relationships.

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

This study was published on Medrxiv.org as a preprint and has not yet been peer reviewed.

Key takeaways

• in analyses of more than 100,000 women that used Mendelian randomization (MR) as a tool to reduce residual confounding.
• The MR analyses showed no significant association between ANM and breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.
• The clear lack of a causal effect of ANM on the outcomes of coronary heart disease and ischemic stroke in the MR analyses despite a strong inverse association seen in the observational data of this study (without MR) suggests residual confounding plays a substantial role in driving the observed outcomes.

Why this matters

• The authors said that, to their knowledge, this is the first study that has shown a causal association between older ANM and higher risk of postmenopausal lung cancer.
• This finding was directionally opposite to the significant protective effect of increased ANM documented in an observational analysis of roughly the same data as well as prior reports that did not use MR. This “notable inconsistency” suggests very substantial residual confounding without MR that could be driven by factors such as smoking, diet, and exercise.
• If these results are replicated in additional datasets, it would highlight a need for randomized, controlled trials of antiestrogen therapies in postmenopausal women for the prevention or treatment of lung cancer.

Study design

• The study included data from 106,853 postmenopausal women enrolled in the Women’s Health Initiative (WHI) and 95,464 women who were 37-73 years old included in the UK Biobank (UKB). Analyses for each outcome also included data from smaller numbers of women obtained from several additional datasets.
• The MR analysis used up to 55 single-nucleotide polymorphisms previously discovered through a genome-wide association study of about 70,000 women of European ancestry and independent of all datasets analyzed in the current study. The authors included all single-nucleotide polymorphisms with a consistent direction of effect on ANM.
• The MR analysis for lung cancer included 113,371 women from the two primary datasets and an additional 3012 women from six additional datasets.
• The MR analysis for bone fracture involved 113,239 women from the WHI and UKB only. The MR analysis for osteoporosis involved 137,080 women from the WHI, UKB, and one additional external dataset.

Key results

• Results from a meta-analysis of the MR results using data from the WHI, UKB, and the additional datasets showed ANM was causally associated with an increased risk of lung cancer by an odds ratio of 1.35 for each 5-year increase in ANM. In contrast, the adjusted observational analysis of data just from the WHI and UKB showed a significant 11% relative risk reduction in the incidence of lung cancer for each 5-year increase in ANM.
• The MR results also showed causally protective effects for fracture, with a 24% relative risk reduction, and for osteoporosis, with a 19% relative risk reduction for each 5-year increase in ANM.
• The MR analyses showed no significant association between AMN and outcome for breast cancer, endometrial cancer, ovarian cancer, coronary heart disease, ischemic stroke, and Alzheimer’s disease.

Limitations

The main limitation of the MR study was the potential for inadequate power for assessing some outcomes despite the large overall size of the study cohort. Lack of adequate power may be responsible for some of the nonsignificant associations seen in the study, such as for breast and endometrial cancers, where substantial prior evidence has implicated increased risk through the effects of prolonged exposure to endogenous or exogenous estrogens.

The healthy cohort effect in the UKB is a known weakness of this dataset that may have limited the number of cases and generalizability of findings.

Osteoporosis and Alzheimer’s disease were self-reported.

The study only included participants of European ancestry because most subjects in most of the cohorts examined were White women and the applied MR instruments were found by genome-wide association studies run predominantly in White women. The authors said the causal effects of ANM need study in more diverse populations.
 

Disclosures

• The study received no commercial funding.
• None of the authors had disclosures.

This is a summary of a preprint research study, “Genetic evidence for causal relationships between age at natural menopause and the risk of aging-associated adverse health outcomes,” written by authors primarily based at Stanford University School of Medicine i

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

LAS VEGAS – Long after the acute phase of the COVID-19 pandemic subsides, the psychological sequelae and behavioral effects of persistent distress will likely persist for health care workers, according to Jon A. Levenson, MD.

“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).

Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”

Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).

“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”

At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.

The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”

A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.

According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”

Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.

To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”

Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”

Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”

He reported having no relevant financial disclosures related to his presentation.

Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.

LAS VEGAS – Long after the acute phase of the COVID-19 pandemic subsides, the psychological sequelae and behavioral effects of persistent distress will likely persist for health care workers, according to Jon A. Levenson, MD.

“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).

Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”

Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).

“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”

At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.

The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”

A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.

According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”

Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.

To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”

Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”

Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”

He reported having no relevant financial disclosures related to his presentation.

Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.

LAS VEGAS – Long after the acute phase of the COVID-19 pandemic subsides, the psychological sequelae and behavioral effects of persistent distress will likely persist for health care workers, according to Jon A. Levenson, MD.

“We can learn from previous pandemics and epidemics, which will be important for us going forward from COVID-19,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

During the severe acute respiratory syndrome (SARS) epidemic in 2005, 68% of health care workers reported significant job-related stress, including increased workload, changing work duties, redeployment, shortage of medical supplies, concerns about insufficient personal protective equipment (PPE), lack of safety at work, absence of effective treatment protocols, inconsistent organizational support and information and misinformation from hospital management, and witnessing intense pain, isolation, and loss on a daily basis with few opportunities to take breaks (Psychiatr Serv. 2020 Oct 6. doi: 10.1176/appi.ps.202000274).

Personal concerns associated with psychopathological symptoms included spreading infection to family members; feeling responsibility for family members’ social isolation; self-isolating to avoid infecting family, which can lead to increased loneliness and sadness. “For those who were working remotely, this level of work is hard and challenging,” Dr. Levenson said. “For those who are parents, the 24-hour childcare responsibilities exist on top of work. They often found they can’t unwind with friends.”

Across SARS, MERS, Ebola, and swine flu, a wide range of prevalence in symptoms of distress, stress, anxiety, depressive symptoms, and substance use emerged, he continued. During COVID-19, at least three studies reported significant percentages of distress, depression, anxiety, insomnia, and PTSD among health care workers (JAMA Netw Open. 2020;3[3]:e203976, Front Psychol. 2020 Dec 8;11:608986., and Gen Hosp Psychiatry. Sep-Oct 2020;66:1-8).

“Who is at most-increased risk?” Dr. Levenson asked. “Women; those who are younger and have fewer years of work experience; those working on the front lines such as nurses and advanced practice professionals; and people with preexisting vulnerabilities to psychiatric disorders including anxiety, depression, obsessional symptoms, substance use, suicidal behavior, and impulse control disorders are likely to be especially vulnerable to stress-related symptoms.”

At CUIMC, there were certain “tipping points,” to the vulnerability of health care worker well-being in the early stage of the COVID-19 pandemic, he said, including the loss of an emergency medicine physician colleague from death by suicide. “On the national level there were so many other issues going on such as health care disparities of the COVID-19 infection itself, the murder of George Floyd in Minneapolis, other issues of racial injustice, a tense political climate with an upcoming election at the time, and other factors related to the natural climate concerns,” he said. This prompted several faculty members in the CUIMC department of psychiatry including Claude Ann Mellins, PhD, Laurel S. Mayer, MD, and Lourival Baptista-Neto, MD, to partner with ColumbiaDoctors and New York-Presbyterian Hospital and develop a model of care for health care workers known as CopeColumbia, a virtual program intended to address staff burnout and fatigue, with an emphasis on prevention and promotion of resilience.* It launched in March of 2020 and consists of 1:1 peer support, a peer support group program, town halls/webinars, and an active web site.

The 1:1 peer support sessions typically last 20-30 minutes and provide easy access for all distressed hospital and medical center staff. “We have a phone line staffed by Columbia psychiatrists and psychologists so that a distressed staff member can reach support directly,” he said. The format of these sessions includes a brief discussion of challenges and brainstorming around potential coping strategies. “This is not a psychotherapy session,” Dr. Levenson said. “Each session can be individualized to further assess the type of distress or to implement rating scales such as the Generalized Anxiety Disorder-7 scale to assess for signs and symptoms consistent with GAD. There are options to schedule a second or third peer support session, or a prompt referral within Columbia psychiatry when indicated.”

A typical peer support group meeting lasts about 30 minutes and comprises individual divisions or departments. Some goals of the peer groups are to discuss unique challenges of the work environment and to encourage the members of the group to come up with solutions; to promote team support and coping; to teach resilience-enhancing strategies from empirically based treatments such as CBT, “and to end each meeting with expressions of gratitude and of thanks within the group,” he said.

According to Dr. Levenson, sample questions CopeColumbia faculty use to facilitate coping, include “which coping skills are working for you?”; “Are you able to be present?”; “Have you honored loss with any specific ways or traditions?”; “Do you have any work buddies who support you and vice versa?”; “Can your work community build off each other’s individual strengths to help both the individual and the work group cope optimally?”; and “How can your work team help facilitate each other to best support each other?”

Other aspects of the CopeColumbia program include town halls/grand rounds that range from 30 to 60 minutes in length. “It may be a virtual presentation from a mental health professional on specific aspects of coping such as relaxation techniques,” he said. “The focus is how to manage stress, anxiety, trauma, loss, and grief. It also includes an active Q&A to engage staff participants. The advantage of this format is that you can reach many staff in an entire department.” The program also has an active web site for staff with both internal and external support links including mindfulness, meditation, exercise, parenting suggestions/caregiving, and other resources to promote well-being and resilience for staff and family.

To date, certain themes emerged from the 1:1 and peer support group sessions, including expressions of difficulty adapting to “such a new reality,” compared with the pre-COVID era. “Staff would often express anticipatory anxiety and uncertainty, such as is there going to be another surge of COVID-19 cases, and will there be a change in policies?” Dr. Levenson said. “There was a lot of expression of stress and frustration related to politicizing the virus and public containment strategies, both on a local and national level.”

Staff also mentioned the loss of usual coping strategies because of prolonged social isolation, especially for those doing remote work, and the loss of usual support resources that have helped them in the past. “They also reported delayed trauma and grief reactions, including symptoms of depression, anxiety, and posttraumatic stress,” he said. “Health care workers with children mentioned high levels of stress related to childcare, increased workload, and what seems like an impossible work-life balance.” Many reported exhaustion and irritability, “which could affect and cause tension within the work group and challenges to effective team cohesion,” he said. “There were also stressors related to the impact of racial injustices and the [presidential] election that could exacerbate the impact of COVID-19.”

Dr. Levenson hopes that CopeColumbia serves as a model for other health care systems looking for ways to support the mental well-being of their employees. “We want to promote the message that emotional health should have the same priority level as physical health,” he said. “The term that I like to use is total health. Addressing the well-being of health care workers is critical for a healthy workforce and for delivering high-quality patient care.”

He reported having no relevant financial disclosures related to his presentation.

Correction, 2/28/22: An earlier version of this article misstated Dr. Lourival Baptista-Neto's name.

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Kia Slade was 7 months pregnant, unvaccinated, and fighting for breath, her oxygen levels plummeting, when her son came into the world last May.

A severe case of COVID-19 pneumonia had left Ms. Slade delirious. When the intensive care team tried to place an oxygen mask on her face, she snatched it away, she recalled. Her baby’s heart rate began to drop.

Ms. Slade’s doctor performed an emergency cesarean section at her bedside in the intensive care unit, delivering baby Tristan 10 weeks early. He weighed just 2 pounds, 14 ounces, about half the size of small full-term baby.

But Ms. Slade wouldn’t meet him until July. She was on a ventilator in a medically-induced coma for 8 weeks, and she developed a serious infection and blood clot while unconscious. It was only after a perilous 2½ months in the hospital, during which her heart stopped twice, that Ms. Slade was vaccinated against COVID-19.

“I wish I had gotten the vaccine earlier,” said Ms. Slade, 42, who remains too sick to return to work as a special education teacher in Baltimore. Doctors “kept pushing me to get vaccinated, but there just wasn’t enough information out there for me to do it.”

A year ago, there was little to no vaccine safety data for pregnant people like Ms. Slade, because they had been excluded from clinical trials run by Pfizer, Moderna, and other vaccine makers.

Lacking data, health experts were unsure and divided about how to advise expectant parents. Although U.S. health officials permitted pregnant people to be vaccinated, the World Health Organization in January 2021 actually discouraged them from doing so; it later reversed that recommendation.

The uncertainty led many women to delay vaccination, and only about two-thirds of the pregnant people who have been tracked by the Centers for Disease Control and Prevention were fully vaccinated as of Feb. 5, 2022, leaving many expectant moms at a high risk of infection and life-threatening complications.

More than 29,000 pregnant people have been hospitalized with COVID-19 and 274 have died, according to the CDC.

“There were surely women who were hospitalized because there wasn’t information available to them,” said Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Vaccine developers say that pregnant people – who have special health needs and risks – were excluded from clinical trials to protect them from potential side effects of novel technologies, including the Pfizer and Moderna mRNA vaccines and formulations made with cold viruses, such as the Johnson & Johnson vaccine.

But a KHN analysis also shows that pregnant people were left behind because including them in vaccine studies would have complicated and potentially delayed the delivery of COVID-19 vaccines to the broader population.

A growing number of women’s health researchers and advocates say that excluding pregnant people – and the months-long delay in recommending that they be immunized – helped fuel widespread vaccine hesitancy in this vulnerable group.

“Women and their unborn fetuses are dying of COVID infection,” said Jane Van Dis, MD, an ob.gyn. at the University of Rochester (N.Y.) Medical Center who has treated many patients like Ms. Slade. “Our failure as a society to vaccinate women in pregnancy will be remembered by the children and families who lost their mothers to this disease.”
 

New technology, uncertain risks

At the time COVID-19 vaccines were being developed, scientists had very little experience using mRNA vaccines in pregnant women, said Jacqueline Miller, MD, a senior vice president involved in vaccine research at Moderna.

“When you study anything in pregnant women, you have two patients, the mom and the unborn child,” Dr. Miller said. “Until we had more safety data on the platform, it wasn’t something we wanted to undertake.”

But Dr. Offit noted that vaccines have a strong record of safety in pregnancy and he sees no reason to have excluded pregnant people. None of the vaccines currently in use – including the chickenpox and rubella vaccines, which contain live viruses – have been shown to harm fetuses, he said. Doctors routinely recommend that pregnant people receive pertussis and flu vaccinations.

Dr. Offit, the coinventor of a rotavirus vaccine, said that some concerns about vaccines stem from commercial, not medical, interests. Drug makers don’t want to risk that their product will be blamed for any problems occurring in pregnant people, even if coincidental, he said.

“These companies don’t want bad news,” Dr. Offit said.

In the United States, health officials typically would have told expectant mothers not to take a vaccine that was untested during pregnancy, said Dr. Offit, a member of a committee that advises the Food and Drug Administration on vaccines.

Due to the urgency of the pandemic, health agencies instead permitted pregnant people to make up their own minds about vaccines without recommending them.

Women’s medical associations were also hampered by the lack of data. Neither the American College of Obstetricians and Gynecologists nor the Society for Maternal-Fetal Medicine actively encouraged pregnant people to be vaccinated until July 30, 2021, after the first real-world vaccine studies had been published. The CDC followed suit in August of 2021.

“If we had had this data in the beginning, we would have been able to vaccinate more women,” said Kelli Burroughs, MD, the department chair of obstetrics and gynecology at Memorial Hermann Sugar Land Hospital near Houston.

Yet anti-vaccine groups wasted no time in scaring pregnant people, flooding social media with misinformation about impaired fertility and harm to the fetus.

In the first few months after the COVID-19 vaccines were approved, some doctors were ambivalent about recommending them, and some still advise pregnant patients against vaccination.

An estimated 67% of pregnant people today are fully vaccinated, compared with about 89% of people 65 and older, another high-risk group, and 65% of Americans overall. Vaccination rates are lower among minorities, with 65% of expectant Hispanic mothers and 53% of pregnant African Americans fully vaccinated, according to the CDC.

Vaccination is especially important during pregnancy, because of increased risks of hospitalization, ICU admission, and mechanical ventilation, Dr. Burroughs said. A study released in February from the National Institutes of Health found that pregnant people with a moderate to severe COVID-19 infection also were more likely to have a C-section, deliver preterm, or develop a postpartum hemorrhage.

Black moms such as Ms. Slade were already at higher risk of maternal and infant mortality before the pandemic, because of higher underlying risks, unequal access to health care, and other factors. COVID-19 has magnified those risks, said Dr. Burroughs, who has persuaded reluctant patients by revealing that she had a healthy pregnancy and child after being vaccinated.

Ms. Slade said she has never opposed vaccines and had no hesitation about receiving other vaccines while pregnant. But she said she “just wasn’t comfortable” with COVID-19 shots.

“If there had been data out there saying the COVID shot was safe, and that nothing would happen to my baby and there was no risk of birth defects, I would have taken it,” said Ms. Slade, who has had type 2 diabetes for 12 years.
 

Working at warp speed

Government scientists at the NIH were concerned about the risk of COVID-19 to pregnant people from the very beginning and knew that expectant moms needed vaccines as much or more than anyone else, said Larry Corey, MD, a leader of the COVID-19 Prevention Network, which coordinated COVID-19 vaccine trials for the federal government.

But including pregnant volunteers in the larger vaccine trials could have led to interruptions and delays, Dr. Corey said. Researchers would have had to enroll thousands of pregnant volunteers to achieve statistically robust results that weren’t due to chance, he said.

Pregnancy can bring on a wide range of complications: gestational diabetes, hypertension, anemia, bleeding, blood clots, or problems with the placenta, for example. Up to 20% of people who know they’re pregnant miscarry. Because researchers would have been obliged to investigate any medical problem to make sure it wasn’t caused by one of the COVID-19 vaccines, including pregnant people might have meant having to hit pause on those trials, Dr. Corey said.

With death tolls from the pandemic mounting, “we had a mission to do this as quickly and as thoroughly as possible,” Dr. Corey said. Making COVID-19 vaccines available within a year “saved hundreds of thousands of lives.”

The first data on COVID-19 vaccine safety in pregnancy was published in April of 2021 when the CDC released an analysis of nearly 36,000 vaccinated pregnant people who had enrolled in a registry called V-safe, which allows users to log the dates of their vaccinations and any subsequent symptoms.

Later research showed that COVID-19 vaccines weren’t associated with increased risk of miscarriage or premature delivery.

Brenna Hughes, MD, a maternal-fetal medicine specialist and member of the American College of Obstetricians and Gynecologists’ COVID-19 expert group, agrees that adding pregnant people to large-scale COVID-19 vaccine and drug trials may have been impractical. But researchers could have launched parallel trials of pregnant women, once early studies showed the vaccines were safe in humans, she said.

“Would it have been hard? Everything with COVID is hard,” Dr. Hughes said. “But it would have been feasible.”

The FDA requires that researchers perform additional animal studies – called developmental and reproductive toxicity studies – before testing vaccines in pregnant people. Although these studies are essential, they take 5-6 months, and weren’t completed until late 2020, around the time the first COVID-19 vaccines were authorized for adults, said Emily Erbelding, MD, director of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases, part of the NIH.

Pregnancy studies “were an afterthought,” said Irina Burd, MD, director of Johns Hopkins’ Integrated Research Center for Fetal Medicine and a professor of gynecology and obstetrics. “They should have been done sooner.”

The NIH is conducting a study of pregnant and postpartum people who decided on their own to be vaccinated, Dr. Erbelding said. The study is due to be completed by July 2023.

Janssen and Moderna are also conducting studies in pregnant people, both due to be completed in 2024.

Pfizer scientists encountered problems when they initiated a clinical trial, which would have randomly assigned pregnant people to receive either a vaccine or placebo. Once vaccines were widely available, many patients weren’t willing to take a chance on being unvaccinated until after delivery.

Pfizer has stopped recruiting patients and has not said whether it will publicly report any data from the trial.

Dr. Hughes said vaccine developers need to include pregnant people from the very beginning.

“There is this notion of protecting pregnant people from research,” Dr. Hughes said. “But we should be protecting patients through research, not from research.”
 

Recovering physically and emotionally

Ms. Slade still regrets being deprived of time with her children while she fought the disease.

Being on a ventilator kept her from spending those early weeks with her newborn, or from seeing her 9-year-old daughter, Zoe.

Even when Ms. Slade was finally able to see her son, she wasn’t able to tell him she loved him or sing a lullaby, or even talk at all, because of a breathing tube in her throat.

Today, Ms. Slade is a strong advocate of COVID-19 vaccinations, urging her friends and family to get their shots to avoid suffering the way she has.

Ms. Slade had to relearn to walk after being bedridden for weeks. Her many weeks on a ventilator may have contributed to her stomach paralysis, which often causes intense pain, nausea, and even vomiting when she eats or drinks. Ms. Slade weighs 50 pounds less today than before she became pregnant and has resorted to going to the emergency department when the pain is unbearable. “Most days, I’m just miserable,” she said.

Her family suffered as well. Like many babies born prematurely, Tristan, now nearly 9 months old and crawling, receives physical therapy to strengthen his muscles. At 15 pounds, Tristan is largely healthy, although his doctor said he has symptoms of asthma.

Ms. Slade said she would like to attend family counseling with Zoe, who rarely complains and tends to keep her feelings to herself. Ms. Slade said she knows her illness must have been terrifying for her little girl.

“The other day she was talking to me,” Ms. Slade said, “and she said, ‘You know, I almost had to bury you.’ ”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.