Journal of Clinical Outcomes Management

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

BERLIN — To date, mRNA vaccines have had their largest global presence in combating the COVID-19 pandemic. Intensive research is underway on many other potential applications for this vaccine technology, which suggests a promising future. Martina Prelog, MD, a pediatric and adolescent medicine specialist at the University Hospital of Würzburg in Germany, reported on the principles, research status, and perspectives for these vaccines at the 25th Travel and Health Forum of the Center for Travel Medicine in Berlin.

To understand the future, the immunologist first examined the past. “The induction of cellular and humoral immune responses by externally injected mRNA was discovered in the 1990s,” she said.
 

Instability Challenge

Significant hurdles in mRNA vaccinations included the instability of mRNA and the immune system’s ability to identify foreign mRNA as a threat and destroy mRNA fragments. “The breakthrough toward vaccination came through Dr. Katalin Karikó, who, along with Dr. Drew Weissman, both of the University of Pennsylvania School of Medicine, discovered in 2005 that modifications of mRNA (replacing the nucleoside uridine with pseudouridine) enable better stability of mRNA, reduced immunogenicity, and higher translational capacity at the ribosomes,” said Dr. Prelog.

With this discovery, the two researchers paved the way for the development of mRNA vaccines against COVID-19 and other diseases. They were awarded the Nobel Prize in medicine for their discovery last year.
 

Improved Scalability

“Since 2009, mRNA vaccines have been studied as a treatment option for cancer,” said Dr. Prelog. “Since 2012, they have been studied for the influenza virus and respiratory syncytial virus [RSV].” Consequently, several mRNA vaccines are currently in development or in approval studies. “The mRNA technology offers the advantage of quickly and flexibly responding to new variants of pathogens and the ability to scale up production when there is high demand for a particular vaccine.”

Different forms and designations of mRNA vaccines are used, depending on the application and desired effect, said Dr. Prelog.

In nucleoside-modified mRNA vaccines, modifications in the mRNA sequence enable the mRNA to remain in the body longer and to induce protein synthesis more effectively.

Lipid nanoparticle (LNP)–encapsulated mRNA vaccines protect the coding mRNA sequences against degradation by the body’s enzymes and facilitate the uptake of mRNA into cells, where it then triggers the production of the desired protein. In addition, LNPs are involved in cell stimulation and support the self-adjuvant effect of mRNA vaccines, thus eliminating the need for adjuvants.

Self-amplifying mRNA vaccines include a special mRNA that replicates itself in the cell and contains a sequence for RNA replicase, in addition to the coding sequence for the protein. This composition enables increased production of the target protein without the need for a high amount of external mRNA administration. Such vaccines could trigger a longer and stronger immune response because the immune system has more time to interact with the protein.
 

Cancer Immunotherapy

Dr. Prelog also discussed personalized vaccines for cancer immunotherapy. Personalized mRNA vaccines are tailored to the patient’s genetic characteristics and antigens. They could be used in cancer immunotherapy to activate the immune system selectively against tumor cells.

Multivalent mRNA vaccines contain mRNA that codes for multiple antigens rather than just one protein to generate an immune response. These vaccines could be particularly useful in fighting pathogens with variable or changing surface structures or in eliciting protection against multiple pathogens simultaneously.

The technology of mRNA-encoded antibodies involves introducing mRNA into the cell, which creates light and heavy chains of antibodies. This step leads to the formation of antibodies targeted against toxins (eg, diphtheria and tetanus), animal venoms, infectious agents, or tumor cells.
 

Genetic Engineering

Dr. Prelog also reviewed genetic engineering techniques. In regenerative therapy or protein replacement therapy, skin fibroblasts or other cells are transfected with mRNA to enable conversion into induced pluripotent stem cells. This approach avoids the risk for DNA integration into the genome and associated mutation risks.

Another approach is making post-transcriptional modifications through RNA interference. For example, RNA structures can be used to inhibit the translation of disease-causing proteins. This technique is currently being tested against HIV and tumors such as melanoma.

In addition, mRNA technologies can be combined with CRISPR/Cas9 technology (“gene scissors”) to influence the creation of gene products even more precisely. The advantage of this technique is that mRNA is only transiently expressed, thus preventing unwanted side effects. Furthermore, mRNA is translated directly in the cytoplasm, leading to a faster initiation of gene editing.

Of the numerous ongoing clinical mRNA vaccine studies, around 70% focus on infections, about 12% on cancer, and the rest on autoimmune diseases and neurodegenerative disorders, said Dr. Prelog.
 

Research in Infections

Research in the fields of infectious diseases and oncology is the most advanced: mRNA vaccines against influenza and RSV are already in advanced clinical trials, Dr. Prelog told this news organization.

“Conventional influenza vaccines contain immunogenic surface molecules against hemagglutinin and neuraminidase in various combinations of influenza strains A and B and are produced in egg or cell cultures,” she said. “This is a time-consuming manufacturing process that takes months and, particularly with the egg-based process, bears the risk of changing the vaccine strain.”

“Additionally, influenza viruses undergo antigenic shift and drift through recombination, thus requiring annual adjustments to the vaccines. Thus, these influenza vaccines often lose accuracy in targeting circulating seasonal influenza strains.”

Several mRNA vaccines being tested contain not only coding sequences against hemagglutinin and neuraminidase but also for structural proteins of influenza viruses. “These are more conserved and mutate less easily, meaning they could serve as the basis for universal pandemic influenza vaccines,” said Dr. Prelog.

An advantage of mRNA vaccines, she added, is the strong cellular immune response that they elicit. This response is intended to provide additional protection alongside specific antibodies. An mRNA vaccine with coding sequences for the pre-fusion protein of RSV is in phase 3 trials for approval for vaccination in patients aged 60 years and older. It shows high effectiveness even in older patients and those with comorbidities.
 

Elaborate Purification Process

Bacterial origin plasmid DNA is used to produce mRNA vaccines. The mRNA vaccines for COVID-19 raised concerns that production-related DNA residues could pose a safety risk and cause autoimmune diseases.

These vaccines “typically undergo a very elaborate purification process,” said Dr. Prelog. “This involves enzymatic digestion with DNase to fragment and deplete plasmid DNA, followed by purification using chromatography columns, so that no safety-relevant DNA fragments should remain afterward.”

Thus, the Paul-Ehrlich-Institut also pointed out the very small, fragmented plasmid DNA residues of bacterial origin in mRNA COVID-19 vaccines pose no risk, unlike residual DNA from animal cell culture might pose in other vaccines.
 

Prevention and Therapy

In addition to the numerous advantages of mRNA vaccines (such as rapid adaptability to new or mutated pathogens, scalability, rapid production capability, self-adjuvant effect, strong induction of cellular immune responses, and safety), there are also challenges in RNA technology as a preventive and therapeutic measure, according to Dr. Prelog.

“Stability and storability, as well as the costs of new vaccine developments, play a role, as do the long-term effects regarding the persistence of antibody and cellular responses,” she said. The COVID-19 mRNA vaccines, for example, showed a well-maintained cellular immune response despite a tendency toward a rapid decline in humoral immune response.

“The experience with COVID-19 mRNA vaccines and the new vaccine developments based on mRNA technology give hope for an efficient and safe preventive and therapeutic use, particularly in the fields of infectious diseases and oncology,” Dr. Prelog concluded.

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.

Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.

Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, wrote the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran.

The findings were published online in JAMA Neurology.

Mixed Results

Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.

To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.

While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.

Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.

The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.

No Link Found

After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)

Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn’t observe significant differences in new-onset data.

The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.

After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)

Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.

“The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate,” the authors wrote.

There were no study funding sources or disclosures reported.

A version of this article appeared on Medscape.com.

There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.

Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.

Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, wrote the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran.

The findings were published online in JAMA Neurology.

Mixed Results

Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.

To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.

While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.

Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.

The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.

No Link Found

After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)

Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn’t observe significant differences in new-onset data.

The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.

After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)

Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.

“The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate,” the authors wrote.

There were no study funding sources or disclosures reported.

A version of this article appeared on Medscape.com.

There is no association between the SARS-CoV-2 vaccine and the risk for new-onset seizure, data from a new meta-analysis of six randomized, placebo-controlled clinical trials (RCTs) showed.

Results of the pooled analysis that included 63,500 individuals vaccinated with SARS-CoV-2 and 55,000 who received a placebo vaccine showed there was no significant difference between the two groups with respect to new-onset seizures at 28- or 43-day follow-up.

Regarding new-onset seizures in the general population, there was no statistically significant difference in risk for seizure incidence among vaccinated individuals vs placebo recipients, according to our meta-analysis, wrote the investigators, led by Ali Rafati, MD, MPH, Iran University of Medical Sciences in Tehran.

The findings were published online in JAMA Neurology.

Mixed Results

Results from previous research have been mixed regarding the link between the SARS-CoV-2 vaccination and new-onset seizures, with some showing an association.

To learn more about the possible association between the vaccines and new-onset seizures, the researchers conducted a literature review and identified six RCTs that measured adverse events following SARS-CoV-2 vaccinations (including messenger RNA, viral vector, and inactivated virus) vs placebo or other vaccines.

While five of the studies defined new-onset seizures according to the Medical Dictionary for Regulatory Activities, trial investigators in the sixth RCT assessed and determined new-onset seizures in participants.

Participants received two vaccinations 28 days apart in five RCTs and only one vaccine in the sixth trial.

The research team searched the data for new-onset seizure in the 28 days following one or both COVID vaccinations.

No Link Found

After comparing the incidence of new-onset seizure between the 63,500 vaccine (nine new-onset seizures, 0.014%) and 55,000 placebo recipients (one new-onset seizure, 0.002%), investigators found no significant difference between the two groups (odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12)

Investigators also sliced the data several ways to see if it would yield different results. When they analyzed data by vaccine platform (viral vector) and age group (children), they didn’t observe significant differences in new-onset data.

The researchers also searched for data beyond the month following the injection to encompass the entire blinded phase, so they analyzed the results of three RCTs that reported adverse events up to 162 days after the vaccine.

After pooling the results from the three studies, investigators found no statistical difference between the vaccine and placebo groups in terms of the new-onset seizure (OR, 2.31; 95% CI, 0.86%-3.23; P > .99)

Study limitations included the missing information on vaccine doses or risk factors for the development of seizures. Also, the RCTs included in the meta-analysis were conducted at different times, so the SARS-CoV-2 vaccines may have differed in their composition and efficacy.

“The global vaccination drive against SARS-CoV-2 has been a monumental effort in combating the pandemic. SARS-CoV-2 vaccinations that are now available appear safe and appropriate,” the authors wrote.

There were no study funding sources or disclosures reported.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Dhaval Desai, MD, was teaching his 4-year-old to ride a bike after another exhausting shift at the hospital during the summer after the first COVID-19 surge. He was putting on a happy face and forcing out a “Yay!” he did not feel. The pandemic had taken its toll, and he just wanted to lie down and be alone. Realizing that he was “scraping to find joy” was when he knew something was wrong.

“I was giving, giving, giving at work a lot, and I had little left to give at home,” said Dr. Desai, director of hospital medicine at Emory Saint Joseph’s Hospital and an assistant professor of medicine at Emory University in Atlanta, Georgia.

At work, he worried about his wife managing two kids — including a newborn — during the pandemic. At home, he stressed about work and the crush of patients with COVID the hospital was grappling to handle. He was exhausted, resentful, and angry, and it was jeopardizing what mattered most to him: His home life.

“It was all colliding…I realized, OK, I’m struggling,” he said.

Dr. Desai is one of thousands of physicians across the United States who have experienced burnout and depression, exacerbated by the pandemic. After 4 years, the impact is still being felt. Medscape’s 2024 annual report on this issue found that burnout and depression among doctors — while encouragingly better than the prior year — remain higher than before COVID. For doctors caring for patients with long COVID, those suffering from the debilitating aftereffects of an infection, the sense of helplessness when recovery is elusive can also weigh heavily.

Overall, more female physicians reported feeling burned out and depressed. Experts attributed this gap to issues including fewer women in supportive leadership and mentoring roles, compensation disparities, fewer career advancement opportunities, and more responsibilities caring for children and elders.

Multiple international studies and reports have highlighted the surge in burnout experienced by physicians and healthcare workers globally during the pandemic. Even before COVID, studies found the suicide rate among male and female US physicians was higher than the general population and higher than any other profession, including the military. The risk among female physicians, in particular, was 250%-400% higher.

“That’s really, on average, one a day, and that’s really unacceptable. No one should die by suicide, but a physician who knows the risks and knows that, should never do that,” said Dr. Desai about suicides overall among doctors.

The story of Lorna Breen had rattled Dr. Desai. Dr. Breen was a Manhattan physician who died by suicide in April 2020 after grappling with the city’s devastating first wave and then contracting COVID-19 herself. While Dr. Desai did not have thoughts of suicide, he was facing his own battles. Those experiences and the stigma around mental health prompted him to write his book, Burning Out on the Covid Front Lines: A Doctor’s Memoir of Fatherhood, Race and Perseverance in the Pandemic, with the hope that it can help others like him.
 

Mental Health Stigma

But despite the body of research and growing awareness toward addressing mental health among physicians, almost four in 10 doctors are wary of revealing their personal struggles.

More than half of those surveyed in the Medscape Medical News report said they had not consulted a mental health professional before and would not do so going forward either. The fear of tarnishing their reputation or even losing their license keeps doctors silent. Advocates and groups like the Dr. Lorna Breen Heroes’ Foundation are pushing for hospitals and healthcare systems to remove and rephrase invasive and stigmatizing language around mental health in licensure, credentialing, or insurance applications.
 

Burnout Triggers: Systemic Problems, Social Tensions

Burnout can make a person feel “depleted and used up” and is characterized by extreme tiredness, low energy, frustration about work, emotional distance or numbness, and difficulty with concentration, responsibilities, or creativity. It can make an individual feel helpless, alone, defeated, cynical, and without purpose and can also cause physical symptoms such as headaches, loss of appetite, insomnia, and body aches. Unaddressed, it can lead to depression, anxiety, and a variety of physical health issues.

“We can still be highly functional and not okay,” said Dr. Desai.

For doctors, burnout often builds over time from large and small systemic problems and inefficiencies, multiplied by a dozen or more patients each day: Not enough time for documentation, complicated paperwork, navigating byzantine health and insurance systems, and hitting roadblocks. The administrative work, combined with an enormous patient load, and staffing and resource shortages create barriers to care and cuts into the amount of time they can spend providing actual care.

These existing problems worsened as patients with COVID overwhelmed hospitals and clinics. At the same time, healthcare workers worried about caring for the sick, getting infected themselves, or having multiple staff falling ill at once. As each surge came and went, backlash, hostility, abuse, and even violence toward healthcare workers also increased. The discrimination some medical staff were subjected to compounded the burnout.

“When we’re not getting the support we need as physicians and healthcare workers, that adds to burnout, and I saw that in my colleagues,” said Dr. Desai.
 

Impact of Burnout

At the Mount Sinai Center for Post-COVID Care in New York City, doctors grapple with feelings of helplessness in caring for patients with long COVID who show little sign of recovery. That emotional toll can also be difficult, said director Zijian Chen, MD, who helped launch the clinic in May 2020.

“Sometimes you’re faced with patients who you’re trying to do everything for, but they’re not just not getting better,” said Dr. Chen. “It’s really frustrating because we want everybody to get better. So, there’s that lack of fulfillment there that can cause a sense of burnout.”

While the worst outcomes and death rates initially brought on by acute infections have lessened, long COVID clinics exemplify some of the ongoing challenges within healthcare. Many operate with insufficient financial and staffing resources despite wait-lists and a steady flow of new and returning patients. Even with the demand, a number of these clinics have shuttered, leaving patients without access to much-needed medical help.

“There are clinicians who are burning out. That is definitely something that I’ve seen,” said Monica Verduzco-Gutierrez, MD, a professor and chair of the Department of Rehabilitation Medicine at the University of Texas Health Science Center in San Antonio, Texas.

“[It] takes a lot of resources for a successful long COVID clinic. A lot of special funding may be drying up and couple that with clinicians burning out, then they’re going to shut their doors.”

And it’s not just long COVID clinics. Data have shown an overall exodus in healthcare, especially during the pandemic. One study found burnout was one of the “most impactful” predictors of a physician’s intention to leave the profession during the pandemic. The loss of talent and skills during a major health crisis can put the entire system under stress, with patients ultimately suffering from poorer care.

“Healthcare system fragility and the chaos is far worse than it was before. We are continuing to be forced to do more with less,” said Dr. Desai.
 

Alleviating Burnout

While it is difficult to assess whether burnout from the pandemic is transient, experts say this is an opportunity for health institutions to learn from these experiences and implement policies and actions that can help reduce the mental health strain on staff. One study found that changes made by organizations had a bigger positive impact on reducing burnout than individual changes.

Advocates say more support staff, more work flexibility, and higher compensation would significantly ease the burden that drives burnout and depression.

In addition, half the physicians surveyed in the Medscape Medical News report felt their employers were not acknowledging how pervasive burnout is at their workplace. Having a trusted peer or leader set an example by sharing his or her own challenging experiences and saying it›s time to address these struggles can be an enormously validating step forward, said Dr. Desai. Acknowledging his own difficulties was not only a huge weight off his shoulders but also helped surpris colleagues who sought him out for counsel.

“I’m not suggesting everybody get on medication,” he said. “But talking to a therapist, acknowledging there’s issues, restructuring your life to realize something’s off, and just knowing that you’re not alone? That’s huge.”

Dr. Desai said he still faces personal challenges but is in a much better place, doing well at work and at home. He talks to a therapist, is taking medication, and has developed better coping mechanisms. He is spending more time with his family, detaching for a few hours from work-related emails, learning to draw boundaries and say no, and trying to be more present and “intentional” in connecting with colleagues and patients.

“It’s okay to not be okay,” said Dr. Desai. “It’s okay to be vulnerable and acknowledge when we can’t do more.”

Are you in a crisis? Call or text 988 or text TALK to 741741. For immediate support for healthcare professionals, as well as resources for institutions and organizations, visit: afsp.org/suicide-prevention-for-healthcare-professionals/#facts-about-mental-health-and-suicide.

A version of this article appeared on Medscape.com.

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

Paxlovid does not significantly alleviate symptoms of COVID-19 compared with placebo among nonhospitalized adults, a new study published April 3 in The New England Journal of Medicine found. 

The results suggest that the drug, a combination of nirmatrelvir and ritonavir, may not be particularly helpful for patients who are not at high risk for severe COVID-19. However, although the rate of hospitalization and death from any cause was low overall, the group that received Paxlovid had a reduced rate compared with people in the placebo group, according to the researchers. 

“Clearly, the benefit observed among unvaccinated high-risk persons does not extend to those at lower risk for severe COVID-19,” Rajesh T. Gandhi, MD, and Martin Hirsch, MD, of Massachusetts General Hospital in Boston, wrote in an editorial accompanying the journal article. “This result supports guidelines that recommend nirmatrelvir–ritonavir only for persons who are at high risk for disease progression.”

The time from onset to relief of COVID-19 symptoms — including cough, shortness of breath, body aches, and chills — did not differ significantly between the two study groups, the researchers reported. The median time to sustained alleviation of symptoms was 12 days for the Paxlovid group compared with 13 days in the placebo group (P = .60).

However, the phase 2/3 trial found a 57.6% relative reduction in the risk for hospitalizations or death among people who took Paxlovid and were vaccinated but were at high risk for poor outcomes, according to Jennifer Hammond, PhD, head of antiviral development for Pfizer, which makes the drug, and the corresponding author on the study.

Paxlovid has “an increasing body of evidence supporting the strong clinical value of the treatment in preventing hospitalization and death among eligible patients across age groups, vaccination status, and predominant variants,” Dr. Hammond said. 

She and her colleagues analyzed data from 1250 adults with symptomatic COVID-19. Participants were fully vaccinated and had a high risk for progression to severe disease or were never vaccinated or had not been in the previous year and had no risk factors for progression to severe disease.

More than half of participants were women, 78.5% were White and 41.4% identified as Hispanic or Latinx. Almost three quarters underwent randomization within 3 days of the start of symptoms, and a little over half had previously received a COVID-19 vaccination. Almost half had one risk factor for severe illness, the most common of these being hypertension (12.3%). 

In a subgroup analysis of high-risk participants, hospitalization or death occurred in 0.9% of patients in the Paxlovid group and 2.2% in the placebo group (95% CI, -3.3 to 0.7). 

The study’s limitations include that the statistical analysis of COVID-19–related hospitalizations or death from any cause was only descriptive, “because the results for the primary efficacy end point were not significant,” the authors wrote. 

Participants who were vaccinated and at high risk were also enrolled regardless of when they had last had a vaccine dose. Furthermore, Paxlovid has a telltale taste, which may have affected the blinding. Finally, the trial was started when the B.1.617.2 (Delta) variant was predominant.

Dr. Gandhi and Dr. Hirsch pointed out that only 5% of participants in the trial were older than 65 years and that other than risk factors such as obesity and smoking, just 2% of people had heart or lung disease. 

“As with many medical interventions, there is likely to be a gradient of benefit for nirmatrelvir–ritonavir, with the patients at highest risk for progression most likely to derive the greatest benefit,” Dr. Gandhi and Dr. Hirsch wrote in the editorial. “Thus, it appears reasonable to recommend nirmatrelvir–ritonavir primarily for the treatment of COVID-19 in older patients (particularly those ≥ 65 years of age), those who are immunocompromised, and those who have conditions that substantially increase the risk of severe COVID-19, regardless of previous vaccination or infection status.”

The study was supported by Pfizer. 

A version of this article appeared on Medscape.com .

TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

• This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
• The possibility of infected ED personnel reporting to work
• The burden of COVID-19 symptoms on an ED personnel’s work status
• The association between SARS-CoV-2 infection levels and ED staffing
• Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
• The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
• Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

• Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
• Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
• The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
• During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

• This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
• The possibility of infected ED personnel reporting to work
• The burden of COVID-19 symptoms on an ED personnel’s work status
• The association between SARS-CoV-2 infection levels and ED staffing
• Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
• The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
• Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

• Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
• Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
• The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
• During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

There were few cases of SARS-CoV-2 infections among emergency department (ED) healthcare personnel and no substantial changes in the delivery of emergency medical care during the initial phase of the COVID-19 pandemic.

METHODOLOGY:

• This multicenter prospective cohort study of US ED healthcare personnel called Project COVERED was conducted from May to December 2020 to evaluate the following outcomes:
• The possibility of infected ED personnel reporting to work
• The burden of COVID-19 symptoms on an ED personnel’s work status
• The association between SARS-CoV-2 infection levels and ED staffing
• Project COVERED enrolled 1673 ED healthcare personnel with 29,825 person weeks of observational data from 25 geographically diverse EDs.
• The presence of any SARS-CoV-2 infection was determined using reverse transcription polymerase chain reaction or IgG antibody testing at baseline, week 2, week 4, and every four subsequent weeks through week 20.
• Investigators also collected weekly data on ED staffing and the incidence of SARS-CoV-2 infections in healthcare facilities.

TAKEAWAY:

• Despite the absence of widespread natural immunity or COVID-19 vaccine availability during the time of this study, only 4.5% of ED healthcare personnel tested positive for SARS-CoV-2 infections, with more than half (57.3%) not experiencing any symptoms.
• Most personnel (83%) who experienced symptoms associated with COVID-19 reported working at least one shift in the ED and nearly all of them continued to work until they received laboratory confirmation of their infection.
• The working time lost as a result of COVID-19 and related concerns was minimal, as 89 healthcare personnel reported 90 person weeks of missed work (0.3% of all weeks).
• During this study, physician-staffing levels ranged from 98.7% to 102.0% of normal staffing, with similar values noted for nursing and nonclinical staffs. Reduced staffing was rare, even during COVID-19 surges.

IN PRACTICE:

“Our findings suggest that the cumulative interaction between infected healthcare personnel and others resulted in a negligible risk of transmission on the scale of public health emergencies,” the authors wrote.

SOURCE:

This study was led by Kurt D. Weber, MD, Department of Emergency Medicine, Orlando Health, Orlando, Florida, and published online in Annals of Emergency Medicine.

LIMITATIONS:

Data regarding the Delta variant surges that occurred toward the end of December and the ED status after the advent of the COVID-19 vaccine were not recorded. There may also have been a selection bias risk in this study because the volunteer participants may have exhibited behaviors like social distancing and use of protective equipment, which may have decreased their risk for infections.

DISCLOSURES:

This study was funded by a cooperative agreement from the Centers for Disease Control and Prevention and the Institute for Clinical and Translational Science at the University of Iowa through a grant from the National Center for Advancing Translational Sciences at the National Institutes of Health. The authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

TOPLINE:

Hospitalization for influenza is linked to a greater risk for subsequent neurologic disorders including migraine, stroke, or epilepsy than is hospitalization for COVID-19, results of a large study show.

METHODOLOGY:

• Researchers used healthcare claims data to compare 77,300 people hospitalized with COVID-19 with 77,300 hospitalized with influenza. The study did not include individuals with long COVID.
• In the final sample of 154,500 participants, the mean age was 51 years, and more than half (58%) were female.
• Investigators followed participants from both cohorts for a year to find out how many of them had medical care for six of the most common neurologic disorders: migraine, epilepsy, stroke, neuropathy, movement disorders, and dementia.
• If participants had one of these neurologic disorders prior to the original hospitalization, the primary outcome involved subsequent healthcare encounters for the neurologic diagnosis.

TAKEAWAY:

• Participants hospitalized with COVID-19 versus influenza were significantly less likely to require care in the following year for migraine (2% vs 3.2%), epilepsy (1.6% vs 2.1%), neuropathy (1.9% vs 3.6%), movement disorders (1.5% vs 2.5%), stroke (2% vs 2.4%), and dementia (2% vs 2.3%) (all P < .001).
• After adjusting for age, sex, and other health conditions, researchers found that people hospitalized with COVID-19 had a 35% lower risk of receiving care for migraine, a 22% lower risk of receiving care for epilepsy, and a 44% lower risk of receiving care for neuropathy than those with influenza. They also had a 36% lower risk of receiving care for movement disorders, a 10% lower risk for stroke (all P < .001), as well as a 7% lower risk for dementia (P = .0007).
• In participants who did not have a preexisting neurologic condition at the time of hospitalization for either COVID-19 or influenza, 2.8% hospitalized with COVID-19 developed one in the next year compared with 5% of those hospitalized with influenza.

IN PRACTICE:

“While the results were not what we expected to find, they are reassuring in that we found being hospitalized with COVID did not lead to more care for common neurologic conditions when compared to being hospitalized with influenza,” study investigator Brian C. Callaghan, MD, of University of Michigan, Ann Arbor, said in a press release.

SOURCE:

Adam de Havenon, MD, of Yale University in New Haven, Connecticut, led the study, which was published online on March 20 in Neurology.

LIMITATIONS:

The study relied on ICD codes in health claims databases, which could introduce misclassification bias. Also, by selecting only individuals who had associated hospital-based care, there may have been a selection bias based on disease severity.

DISCLOSURES:

The study was funded by the American Academy of Neurology. Dr. De Havenon reported receiving consultant fees from Integra and Novo Nordisk and royalty fees from UpToDate and has equity in Titin KM and Certus. Dr. Callaghan has consulted for DynaMed and the Vaccine Injury Compensation Program. Other disclosures were noted in the original article.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Hospitalization for influenza is linked to a greater risk for subsequent neurologic disorders including migraine, stroke, or epilepsy than is hospitalization for COVID-19, results of a large study show.

METHODOLOGY:

• Researchers used healthcare claims data to compare 77,300 people hospitalized with COVID-19 with 77,300 hospitalized with influenza. The study did not include individuals with long COVID.
• In the final sample of 154,500 participants, the mean age was 51 years, and more than half (58%) were female.
• Investigators followed participants from both cohorts for a year to find out how many of them had medical care for six of the most common neurologic disorders: migraine, epilepsy, stroke, neuropathy, movement disorders, and dementia.
• If participants had one of these neurologic disorders prior to the original hospitalization, the primary outcome involved subsequent healthcare encounters for the neurologic diagnosis.

TAKEAWAY:

• Participants hospitalized with COVID-19 versus influenza were significantly less likely to require care in the following year for migraine (2% vs 3.2%), epilepsy (1.6% vs 2.1%), neuropathy (1.9% vs 3.6%), movement disorders (1.5% vs 2.5%), stroke (2% vs 2.4%), and dementia (2% vs 2.3%) (all P < .001).
• After adjusting for age, sex, and other health conditions, researchers found that people hospitalized with COVID-19 had a 35% lower risk of receiving care for migraine, a 22% lower risk of receiving care for epilepsy, and a 44% lower risk of receiving care for neuropathy than those with influenza. They also had a 36% lower risk of receiving care for movement disorders, a 10% lower risk for stroke (all P < .001), as well as a 7% lower risk for dementia (P = .0007).
• In participants who did not have a preexisting neurologic condition at the time of hospitalization for either COVID-19 or influenza, 2.8% hospitalized with COVID-19 developed one in the next year compared with 5% of those hospitalized with influenza.

IN PRACTICE:

“While the results were not what we expected to find, they are reassuring in that we found being hospitalized with COVID did not lead to more care for common neurologic conditions when compared to being hospitalized with influenza,” study investigator Brian C. Callaghan, MD, of University of Michigan, Ann Arbor, said in a press release.

SOURCE:

Adam de Havenon, MD, of Yale University in New Haven, Connecticut, led the study, which was published online on March 20 in Neurology.

LIMITATIONS:

The study relied on ICD codes in health claims databases, which could introduce misclassification bias. Also, by selecting only individuals who had associated hospital-based care, there may have been a selection bias based on disease severity.

DISCLOSURES:

The study was funded by the American Academy of Neurology. Dr. De Havenon reported receiving consultant fees from Integra and Novo Nordisk and royalty fees from UpToDate and has equity in Titin KM and Certus. Dr. Callaghan has consulted for DynaMed and the Vaccine Injury Compensation Program. Other disclosures were noted in the original article.
 

A version of this article appeared on Medscape.com.

TOPLINE:

Hospitalization for influenza is linked to a greater risk for subsequent neurologic disorders including migraine, stroke, or epilepsy than is hospitalization for COVID-19, results of a large study show.

METHODOLOGY:

• Researchers used healthcare claims data to compare 77,300 people hospitalized with COVID-19 with 77,300 hospitalized with influenza. The study did not include individuals with long COVID.
• In the final sample of 154,500 participants, the mean age was 51 years, and more than half (58%) were female.
• Investigators followed participants from both cohorts for a year to find out how many of them had medical care for six of the most common neurologic disorders: migraine, epilepsy, stroke, neuropathy, movement disorders, and dementia.
• If participants had one of these neurologic disorders prior to the original hospitalization, the primary outcome involved subsequent healthcare encounters for the neurologic diagnosis.

TAKEAWAY:

• Participants hospitalized with COVID-19 versus influenza were significantly less likely to require care in the following year for migraine (2% vs 3.2%), epilepsy (1.6% vs 2.1%), neuropathy (1.9% vs 3.6%), movement disorders (1.5% vs 2.5%), stroke (2% vs 2.4%), and dementia (2% vs 2.3%) (all P < .001).
• After adjusting for age, sex, and other health conditions, researchers found that people hospitalized with COVID-19 had a 35% lower risk of receiving care for migraine, a 22% lower risk of receiving care for epilepsy, and a 44% lower risk of receiving care for neuropathy than those with influenza. They also had a 36% lower risk of receiving care for movement disorders, a 10% lower risk for stroke (all P < .001), as well as a 7% lower risk for dementia (P = .0007).
• In participants who did not have a preexisting neurologic condition at the time of hospitalization for either COVID-19 or influenza, 2.8% hospitalized with COVID-19 developed one in the next year compared with 5% of those hospitalized with influenza.

IN PRACTICE:

“While the results were not what we expected to find, they are reassuring in that we found being hospitalized with COVID did not lead to more care for common neurologic conditions when compared to being hospitalized with influenza,” study investigator Brian C. Callaghan, MD, of University of Michigan, Ann Arbor, said in a press release.

SOURCE:

Adam de Havenon, MD, of Yale University in New Haven, Connecticut, led the study, which was published online on March 20 in Neurology.

LIMITATIONS:

The study relied on ICD codes in health claims databases, which could introduce misclassification bias. Also, by selecting only individuals who had associated hospital-based care, there may have been a selection bias based on disease severity.

DISCLOSURES:

The study was funded by the American Academy of Neurology. Dr. De Havenon reported receiving consultant fees from Integra and Novo Nordisk and royalty fees from UpToDate and has equity in Titin KM and Certus. Dr. Callaghan has consulted for DynaMed and the Vaccine Injury Compensation Program. Other disclosures were noted in the original article.
 

A version of this article appeared on Medscape.com.

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

No matter how much we’d like to leave it in the dust, COVID-19 remains prevalent and potent. Tens of thousands of people still contract COVID per week in the United States. Hundreds die. And those who don’t may still develop long COVID.

Pleas from public health officials for people to get a COVID vaccine or booster shot have been ignored by many people. About 80% of eligible Americans haven’t taken any kind of COVID booster. Meantime, the virus continues to mutate, eroding the efficacy of the vaccine’s past versions.

How to get more people to get the jab? Vaccine hesitancy, said infectious disease specialist William Schaffner, MD, is likely rooted in a lack of trust in authority, whether it’s public health officials or politicians.

Dr. Schaffner, professor of infectious diseases at the Vanderbilt University School of Medicine, Nashville, Tennessee, and former medical director of the National Foundation for Infectious Diseases, recommended five strategies physicians can try when discussing the importance of staying up to date on COVID vaccines with patients.
 

#1: Be Patient With Your Patient

First and foremost, if doctors are feeling reluctance from their patients, they need to know “what they shouldn’t do,” Dr. Schaffner said.

When a patient initially doesn’t want the vaccine, doctors shouldn’t express surprise. “Do not scold or berate or belittle. Do not give the impression the patient is somehow wrong or has failed a test of some sort,” Dr. Schaffner said.

Step back and affirm that they understand what the patient is saying so they feel reassured, even if they don’t agree or it’s based on falsehoods about the vaccine.

He said patients need to feel “the doctor heard them; it’s okay to tell the doctor this.” When you affirm what the patient says, it puts them at ease and provides a smoother road to eventually getting them to say “yes.”

But if there’s still a roadblock, don’t bulldoze them. “You don’t want to punish the patient ... let them know you’ll continue to hear them,” Dr. Schaffner said.
 

#2: Always Acknowledge a Concern

Fear of side effects is great among some patients, even if the risks are low, Dr. Schaffner said. Patients may be hesitant because they’re afraid they’ll become one of the “two or three in a million” who suffer extremely rare side effects from the vaccine, Dr. Schaffner said.

In that case, doctors should acknowledge their concern is valid, he said. Never be dismissive. Ask the patients how they feel about the vaccine, listen to their responses, and let them know “I hear you. This is a new mRNA vaccine…you have concern about that,” Dr. Schaffner said.

Doctors can segue into how there’s little reason to wait for some elusive perfectly risk-free vaccine when they can help themselves right now.

“The adverse events that occur with vaccines occur within 2 months [and are typically mild]. I don’t know of a single vaccine that has genuinely long-term implications,” Dr. Schaffner said. “We should remember that old French philosopher Voltaire. He admonished us: Waiting for perfection is the great enemy of the current good.”
 

#3: Make a Strong Recommendation

Here’s something that may seem obvious: Don’t treat the vaccine as an afterthought. “Survey after survey tells us this ... it has everything to do with the strength of the recommendation,” Dr. Schaffner said.

Doctors typically make strong treatment recommendations such conditions as diabetes or high blood pressure, but “when it comes to vaccines, they’re often rather nonchalant,” he said.

If a patient is eligible for a vaccine, doctors should tell the patient they need to get it — not that you think they should get it. “Doctors have to make a firm recommendation: ‘You’re eligible for a vaccine ... and you need to get it ... you’ll receive it on your way out.’ It then becomes a distinct and strong recommendation,” he said.
 

#4: Appeal to Patients’ Hearts, Not Their Minds

In the opening of Charles Dickens’s novel “Hard Times,” the stern school superintendent, Mr. Gradgrind, scolds his students by beating their brow with the notion that, “Facts alone are wanted in life. Plant nothing else and root out everything else.”

The idea that facts alone can sway a vaccine-resistant patient is wrong. “It often doesn’t happen that way,” Dr. Schaffner said. “I don’t think facts do that. Psychologists tell us, yes, information is important, but it’s rarely sufficient to change behavior.”

Data and studies are foundational to medicine, but the key is to change how a patient feels about the data they’re presented with, not how they think about it. “Don’t attack their brain so much but their heart,” Dr. Schaffner said.

Dr. Schaffner has stressed with his patients that the COVID vaccine has become “the social norm,” suggesting virtually everyone he knows has received it and had no problem.

Once questions have been answered about whether the vaccine works and its various side effects, doctors could remind the patient, “You know, everyone in my office is getting the vaccine, and we’re trying to provide this protection to every patient,” he said.

You’re then delving deeper into their emotions and crossing a barrier that facts alone can’t breach.
 

#5: Make it Personal

Lead by example and personalize the fight against the virus. This allows doctors to act as if they’re building an alliance with their patients by framing the vaccine not as something that only affects them but can also confer benefits to a broader social circle.

Even after using these methods, patients may remain resistant, apprehensive, or even indifferent. In cases like these, Dr. Schaffner said it’s a good idea to let it go for the time being.

Let the patient know they “have access to you and can keep speaking with you about it” in the future, he said. “It takes more time, and you have to be cognizant of the nature of the conversation.”

Everybody is unique, but with trust, patience, and awareness of the patient’s feelings, doctors have a better shot at finding common ground with their patients and convincing them the vaccine is in their best interest, he said.

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

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE: 

The results of a recent study suggest that biologics and small molecule inhibitors (SMIs) do not impair the protective effect of COVID-19 vaccine against hospitalization in patients with psoriasis and hidradenitis suppurativa (HS).

METHODOLOGY:

• It remains unknown whether immunomodulatory therapies impair COVID-19 vaccine efficacy and increase hospitalization rates linked to COVID-19 in patients with inflammatory skin conditions such as psoriasis or HS.
• Researchers conducted a cross-sectional study using data from the Epic Cosmos database from January 2020 to October 2023, identifying 30,845 patients with psoriasis or HS.
• Overall, 22,293 patients with documented completion of their primary COVID-19 vaccine series were included in the analysis.
• Of the vaccinated patients, they compared 7046 patients with psoriasis on SMIs and 2033 with psoriasis or HS on biologics with 13,214 patients who did not receive biologics or SMIs.
• The primary outcome was the COVID-19 hospitalization rate.
• Treatment with biologics did not increase COVID-19-related hospitalization rates in vaccinated patients with psoriasis or HS (hospitalization rate, 6.0% for both those taking and those not taking a biologic; P > .99).
• Similarly, hospitalization rates did not significantly differ between vaccinated patients who received SMIs vs those who did not (7.1% vs 6.0%; P = .0596).

IN PRACTICE:

These findings “encourage dermatologists to continue treating [psoriasis]/HS confidently despite the ongoing COVID-19 pandemic,” the authors concluded.

SOURCE:

The study led by Bella R. Lee from Ohio State University Wexner Medical Center, Columbus, was published online on March 13, 2024, in the Journal of the American Academy of Dermatology. 

LIMITATIONS:

Multivariable adjustments could not be performed in this study due to unavailability of individual-level data, and hospital admissions that occurred outside the Epic system were not captured.

DISCLOSURES:

The study did not receive any funding. All authors declared no conflicts of interest.

A version of this article appeared on Medscape.com.

Stefan Bornstein, MD, PhD, professor, made it clear during a press conference at the 67th Congress of the German Society of Endocrinology (DGE) that there is more than one interaction between them. Nowadays, one can almost speak of an “endocrine virology and even of the virome as an additional, hormonally metabolically active gland,” said Dr. Bornstein, who will receive the Berthold Medal from the DGE in 2024.

Many questions remain unanswered: “We need a better understanding of the interaction of hormone systems with infectious agents — from basics to therapeutic applications,” emphasized the director of the Medical Clinic and Polyclinic III and the Center for Internal Medicine at the Carl Gustav Carus University Hospital, Dresden, Germany.

If infectious diseases could trigger diabetes and other metabolic diseases, this means that “through vaccination programs, we may be able to prevent the occurrence of common metabolic diseases such as diabetes,” said Dr. Bornstein. He highlighted that many people who experienced severe COVID-19 during the pandemic, or died from it, exhibited diabetes or a pre-metabolic syndrome.

“SARS-CoV-2 has utilized an endocrine signaling pathway to invade our cells and cause damage in the organ systems and inflammation,” said Dr. Bornstein. Conversely, it is now known that infections with coronaviruses or other infectious agents like influenza can significantly worsen metabolic status, diabetes, and other endocrine diseases.
 

SARS-CoV-2 Infects the Beta Cells

Data from the COVID-19 pandemic showed that the likelihood of developing type 1 diabetes significantly increases with a SARS-CoV-2 infection. Researchers led by Dr. Bornstein demonstrated in 2021 that SARS-CoV-2 can infect the insulin-producing cells of the organ. They examined pancreatic tissue from 20 patients who died from COVID-19 using immunofluorescence, immunohistochemistry, RNA in situ hybridization, and electron microscopy.

They found viral SARS-CoV-2 infiltration of the beta cells in all patients. In 11 patients with COVID-19, the expression of ACE2, TMPRSS, and other receptors and factors like DPP4, HMBG1, and NRP1 that can facilitate virus entry was examined. They found that even in the absence of manifest newly onset diabetes, necroptotic cell death, immune cell infiltration, and SARS-CoV-2 infection of the pancreas beta cells can contribute to varying degrees of metabolic disturbance in patients with COVID-19.

In a report published in October 2020, Tim Hollstein, MD, from the Institute for Diabetology and Clinical Metabolic Research at UKSH in Kiel, Germany, and colleagues described the case of a 19-year-old man who developed symptoms of insulin-dependent diabetes after a SARS-CoV-2 infection, without the presence of autoantibodies typical for type 1 diabetes.

The man presented to the emergency department with diabetic ketoacidosis, a C-peptide level of 0.62 µg/L, a blood glucose concentration of 30.6 mmol/L (552 mg/dL), and an A1c level of 16.8%. The patient’s history revealed a probable SARS-CoV-2 infection 5-7 weeks before admission, based on a positive antibody test against SARS-CoV-2.
 

Some Viruses Produce Insulin-Like Proteins

Recent studies have shown that some viruses can produce insulin-like proteins or hormones that interfere with the metabolism of the affected organism, reported Dr. Bornstein. In addition to metabolic regulation, these “viral hormones” also seem to influence cell turnover and cell death.

Dr. Bornstein pointed out that antiviral medications can delay the onset of type 1 diabetes by preserving the function of insulin-producing beta cells. It has also been shown that conventional medications used to treat hormonal disorders can reduce the susceptibility of the organism to infections — such as antidiabetic preparations like DPP-4 inhibitors or metformin.

In a review published in 2023, Nikolaos Perakakis, MD, professor, research group leader at the Paul Langerhans Institute Dresden, Dresden, Germany, Dr. Bornstein, and colleagues discussed scientific evidence for a close mutual dependence between various virus infections and metabolic diseases. They discussed how viruses can lead to the development or progression of metabolic diseases and vice versa and how metabolic diseases can increase the severity of a virus infection.
 

Viruses Favor Metabolic Diseases...

Viruses can favor metabolic diseases by, for example, influencing the regulation of cell survival and specific signaling pathways relevant for cell death, proliferation, or dedifferentiation in important endocrine and metabolic organs. Viruses are also capable of controlling cellular glucose metabolism by modulating glucose transporters, altering glucose uptake, regulating signaling pathways, and stimulating glycolysis in infected cells.

Due to the destruction of beta cells, enteroviruses, but also the mumps virus, parainfluenza virus, or human herpes virus 6, are associated with the development of diabetes. The timing of infection often precedes or coincides with the peak of development of islet autoantibodies. The fact that only a small proportion of patients actually develop type 1 diabetes suggests that genetic background, and likely the timing of infection, play an important role.
 

...And Metabolic Diseases Influence the Course of Infection

Infection with hepatitis C virus (HCV), on the other hand, is associated with an increased risk for type 2 diabetes, with the risk being higher for older individuals with a family history of diabetes. The negative effects of HCV on glucose balance are mainly attributed to increased insulin resistance in the liver. HCV reduces hepatic glucose uptake by downregulating the expression of glucose transporters and additionally impairs insulin signal transduction by inhibiting the PI3K/Akt signaling pathway.

People with obesity, diabetes, or insulin resistance show significant changes in the innate and adaptive functions of the immune system. Regarding the innate immune system, impaired chemotaxis and phagocytosis of neutrophils have been observed in patients with type 2 diabetes.

In the case of obesity, the number of natural killer T cells in adipose tissue decreases, whereas B cells accumulate in adipose tissue and secrete more proinflammatory cytokines. Longitudinal multiomics analyses of various biopsies from individuals with insulin resistance showed a delayed immune response to respiratory virus infections compared with individuals with normal insulin sensitivity.

This story was translated from Medscape Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Stefan Bornstein, MD, PhD, professor, made it clear during a press conference at the 67th Congress of the German Society of Endocrinology (DGE) that there is more than one interaction between them. Nowadays, one can almost speak of an “endocrine virology and even of the virome as an additional, hormonally metabolically active gland,” said Dr. Bornstein, who will receive the Berthold Medal from the DGE in 2024.

Many questions remain unanswered: “We need a better understanding of the interaction of hormone systems with infectious agents — from basics to therapeutic applications,” emphasized the director of the Medical Clinic and Polyclinic III and the Center for Internal Medicine at the Carl Gustav Carus University Hospital, Dresden, Germany.

If infectious diseases could trigger diabetes and other metabolic diseases, this means that “through vaccination programs, we may be able to prevent the occurrence of common metabolic diseases such as diabetes,” said Dr. Bornstein. He highlighted that many people who experienced severe COVID-19 during the pandemic, or died from it, exhibited diabetes or a pre-metabolic syndrome.

“SARS-CoV-2 has utilized an endocrine signaling pathway to invade our cells and cause damage in the organ systems and inflammation,” said Dr. Bornstein. Conversely, it is now known that infections with coronaviruses or other infectious agents like influenza can significantly worsen metabolic status, diabetes, and other endocrine diseases.
 

SARS-CoV-2 Infects the Beta Cells

Data from the COVID-19 pandemic showed that the likelihood of developing type 1 diabetes significantly increases with a SARS-CoV-2 infection. Researchers led by Dr. Bornstein demonstrated in 2021 that SARS-CoV-2 can infect the insulin-producing cells of the organ. They examined pancreatic tissue from 20 patients who died from COVID-19 using immunofluorescence, immunohistochemistry, RNA in situ hybridization, and electron microscopy.

They found viral SARS-CoV-2 infiltration of the beta cells in all patients. In 11 patients with COVID-19, the expression of ACE2, TMPRSS, and other receptors and factors like DPP4, HMBG1, and NRP1 that can facilitate virus entry was examined. They found that even in the absence of manifest newly onset diabetes, necroptotic cell death, immune cell infiltration, and SARS-CoV-2 infection of the pancreas beta cells can contribute to varying degrees of metabolic disturbance in patients with COVID-19.

In a report published in October 2020, Tim Hollstein, MD, from the Institute for Diabetology and Clinical Metabolic Research at UKSH in Kiel, Germany, and colleagues described the case of a 19-year-old man who developed symptoms of insulin-dependent diabetes after a SARS-CoV-2 infection, without the presence of autoantibodies typical for type 1 diabetes.

The man presented to the emergency department with diabetic ketoacidosis, a C-peptide level of 0.62 µg/L, a blood glucose concentration of 30.6 mmol/L (552 mg/dL), and an A1c level of 16.8%. The patient’s history revealed a probable SARS-CoV-2 infection 5-7 weeks before admission, based on a positive antibody test against SARS-CoV-2.
 

Some Viruses Produce Insulin-Like Proteins

Recent studies have shown that some viruses can produce insulin-like proteins or hormones that interfere with the metabolism of the affected organism, reported Dr. Bornstein. In addition to metabolic regulation, these “viral hormones” also seem to influence cell turnover and cell death.

Dr. Bornstein pointed out that antiviral medications can delay the onset of type 1 diabetes by preserving the function of insulin-producing beta cells. It has also been shown that conventional medications used to treat hormonal disorders can reduce the susceptibility of the organism to infections — such as antidiabetic preparations like DPP-4 inhibitors or metformin.

In a review published in 2023, Nikolaos Perakakis, MD, professor, research group leader at the Paul Langerhans Institute Dresden, Dresden, Germany, Dr. Bornstein, and colleagues discussed scientific evidence for a close mutual dependence between various virus infections and metabolic diseases. They discussed how viruses can lead to the development or progression of metabolic diseases and vice versa and how metabolic diseases can increase the severity of a virus infection.
 

Viruses Favor Metabolic Diseases...

Viruses can favor metabolic diseases by, for example, influencing the regulation of cell survival and specific signaling pathways relevant for cell death, proliferation, or dedifferentiation in important endocrine and metabolic organs. Viruses are also capable of controlling cellular glucose metabolism by modulating glucose transporters, altering glucose uptake, regulating signaling pathways, and stimulating glycolysis in infected cells.

Due to the destruction of beta cells, enteroviruses, but also the mumps virus, parainfluenza virus, or human herpes virus 6, are associated with the development of diabetes. The timing of infection often precedes or coincides with the peak of development of islet autoantibodies. The fact that only a small proportion of patients actually develop type 1 diabetes suggests that genetic background, and likely the timing of infection, play an important role.
 

...And Metabolic Diseases Influence the Course of Infection

Infection with hepatitis C virus (HCV), on the other hand, is associated with an increased risk for type 2 diabetes, with the risk being higher for older individuals with a family history of diabetes. The negative effects of HCV on glucose balance are mainly attributed to increased insulin resistance in the liver. HCV reduces hepatic glucose uptake by downregulating the expression of glucose transporters and additionally impairs insulin signal transduction by inhibiting the PI3K/Akt signaling pathway.

People with obesity, diabetes, or insulin resistance show significant changes in the innate and adaptive functions of the immune system. Regarding the innate immune system, impaired chemotaxis and phagocytosis of neutrophils have been observed in patients with type 2 diabetes.

In the case of obesity, the number of natural killer T cells in adipose tissue decreases, whereas B cells accumulate in adipose tissue and secrete more proinflammatory cytokines. Longitudinal multiomics analyses of various biopsies from individuals with insulin resistance showed a delayed immune response to respiratory virus infections compared with individuals with normal insulin sensitivity.

This story was translated from Medscape Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Stefan Bornstein, MD, PhD, professor, made it clear during a press conference at the 67th Congress of the German Society of Endocrinology (DGE) that there is more than one interaction between them. Nowadays, one can almost speak of an “endocrine virology and even of the virome as an additional, hormonally metabolically active gland,” said Dr. Bornstein, who will receive the Berthold Medal from the DGE in 2024.

Many questions remain unanswered: “We need a better understanding of the interaction of hormone systems with infectious agents — from basics to therapeutic applications,” emphasized the director of the Medical Clinic and Polyclinic III and the Center for Internal Medicine at the Carl Gustav Carus University Hospital, Dresden, Germany.

If infectious diseases could trigger diabetes and other metabolic diseases, this means that “through vaccination programs, we may be able to prevent the occurrence of common metabolic diseases such as diabetes,” said Dr. Bornstein. He highlighted that many people who experienced severe COVID-19 during the pandemic, or died from it, exhibited diabetes or a pre-metabolic syndrome.

“SARS-CoV-2 has utilized an endocrine signaling pathway to invade our cells and cause damage in the organ systems and inflammation,” said Dr. Bornstein. Conversely, it is now known that infections with coronaviruses or other infectious agents like influenza can significantly worsen metabolic status, diabetes, and other endocrine diseases.
 

SARS-CoV-2 Infects the Beta Cells

Data from the COVID-19 pandemic showed that the likelihood of developing type 1 diabetes significantly increases with a SARS-CoV-2 infection. Researchers led by Dr. Bornstein demonstrated in 2021 that SARS-CoV-2 can infect the insulin-producing cells of the organ. They examined pancreatic tissue from 20 patients who died from COVID-19 using immunofluorescence, immunohistochemistry, RNA in situ hybridization, and electron microscopy.

They found viral SARS-CoV-2 infiltration of the beta cells in all patients. In 11 patients with COVID-19, the expression of ACE2, TMPRSS, and other receptors and factors like DPP4, HMBG1, and NRP1 that can facilitate virus entry was examined. They found that even in the absence of manifest newly onset diabetes, necroptotic cell death, immune cell infiltration, and SARS-CoV-2 infection of the pancreas beta cells can contribute to varying degrees of metabolic disturbance in patients with COVID-19.

In a report published in October 2020, Tim Hollstein, MD, from the Institute for Diabetology and Clinical Metabolic Research at UKSH in Kiel, Germany, and colleagues described the case of a 19-year-old man who developed symptoms of insulin-dependent diabetes after a SARS-CoV-2 infection, without the presence of autoantibodies typical for type 1 diabetes.

The man presented to the emergency department with diabetic ketoacidosis, a C-peptide level of 0.62 µg/L, a blood glucose concentration of 30.6 mmol/L (552 mg/dL), and an A1c level of 16.8%. The patient’s history revealed a probable SARS-CoV-2 infection 5-7 weeks before admission, based on a positive antibody test against SARS-CoV-2.
 

Some Viruses Produce Insulin-Like Proteins

Recent studies have shown that some viruses can produce insulin-like proteins or hormones that interfere with the metabolism of the affected organism, reported Dr. Bornstein. In addition to metabolic regulation, these “viral hormones” also seem to influence cell turnover and cell death.

Dr. Bornstein pointed out that antiviral medications can delay the onset of type 1 diabetes by preserving the function of insulin-producing beta cells. It has also been shown that conventional medications used to treat hormonal disorders can reduce the susceptibility of the organism to infections — such as antidiabetic preparations like DPP-4 inhibitors or metformin.

In a review published in 2023, Nikolaos Perakakis, MD, professor, research group leader at the Paul Langerhans Institute Dresden, Dresden, Germany, Dr. Bornstein, and colleagues discussed scientific evidence for a close mutual dependence between various virus infections and metabolic diseases. They discussed how viruses can lead to the development or progression of metabolic diseases and vice versa and how metabolic diseases can increase the severity of a virus infection.
 

Viruses Favor Metabolic Diseases...

Viruses can favor metabolic diseases by, for example, influencing the regulation of cell survival and specific signaling pathways relevant for cell death, proliferation, or dedifferentiation in important endocrine and metabolic organs. Viruses are also capable of controlling cellular glucose metabolism by modulating glucose transporters, altering glucose uptake, regulating signaling pathways, and stimulating glycolysis in infected cells.

Due to the destruction of beta cells, enteroviruses, but also the mumps virus, parainfluenza virus, or human herpes virus 6, are associated with the development of diabetes. The timing of infection often precedes or coincides with the peak of development of islet autoantibodies. The fact that only a small proportion of patients actually develop type 1 diabetes suggests that genetic background, and likely the timing of infection, play an important role.
 

...And Metabolic Diseases Influence the Course of Infection

Infection with hepatitis C virus (HCV), on the other hand, is associated with an increased risk for type 2 diabetes, with the risk being higher for older individuals with a family history of diabetes. The negative effects of HCV on glucose balance are mainly attributed to increased insulin resistance in the liver. HCV reduces hepatic glucose uptake by downregulating the expression of glucose transporters and additionally impairs insulin signal transduction by inhibiting the PI3K/Akt signaling pathway.

People with obesity, diabetes, or insulin resistance show significant changes in the innate and adaptive functions of the immune system. Regarding the innate immune system, impaired chemotaxis and phagocytosis of neutrophils have been observed in patients with type 2 diabetes.

In the case of obesity, the number of natural killer T cells in adipose tissue decreases, whereas B cells accumulate in adipose tissue and secrete more proinflammatory cytokines. Longitudinal multiomics analyses of various biopsies from individuals with insulin resistance showed a delayed immune response to respiratory virus infections compared with individuals with normal insulin sensitivity.

This story was translated from Medscape Germany using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.