Clinician Reviews

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In this study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used "to reduce risk of ADAs and enhance efficacy of anti-TNF therapy."

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In this study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used "to reduce risk of ADAs and enhance efficacy of anti-TNF therapy."

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

The use fluoroquinolones or macrolides reduced immunogenicity risk in inflammatory bowel disease (IBD) patients on anti–tumor necrosis factor (anti-TNF) therapy, according to data from nearly 2,000 individuals.

luchschen/Thinkstock

Anti-TNF therapy with monoclonal antibodies is an established treatment for Crohn’s disease and ulcerative colitis, but approximately 40% of patients fail to respond initially and even more fail to achieve complete remission, wrote Yuri Gorelik, MD, of Rambam Health Care Campus, Haifa, Israel, and colleagues.

“Immunogenicity, which refers to the development of antidrug antibodies [ADA] is considered as the main factor driving secondary loss of response and is likely involved in primary nonresponse as well,” but data on how to predict the risk for ADA formation are limited, they said.

In a study published in Gut, the researchers identified data from 1,946 IBD patients using the epi-IIRN (epidemiology group of the Israeli IBD research nucleus), a nationwide registry of all IBD patients in Israel.

A total of 363 patients had positive ADA after a median follow-up period of 651 days after starting therapy. Overall, the risk of ADA development was significantly higher in patients on cephalosporins (adjusted hazard ratio, 1.97; 95% confidence interval, 1.58-2.44) or penicillin with beta-lactamase inhibitors (BLIs) (aHR, 1.38; 95% CI, 1.13-1.74) during anti-TNF therapy, and it was higher still for patients using both. By contrast, the risk was lower in patients on macrolides (aHR, 0.36; 95% CI, 0.16-0.82) or fluoroquinolones (aHR, 0.20; 95% CI; 95% CI, 0.12-0.35). All P values were less than .05 when compared with nontreated groups.

In the same study, the researchers reported data on mice treated with antibiotics and challenged with infliximab to evaluate the causative effect of antibiotics and the associated disruption to the gut microbiome on the formation of ADA. After 14 days, the researchers found significantly increased ADA production in mice treated with cephalosporins, compared with those treated with macrolides, but germ-free mice produced no ADA, which supports the role of microbial composition on ADA production.

The investigators cited previous research into the microbiome as a biomarker for prediction response to anti-TNF therapy; past results have also suggested that the effect of cephalosporins and penicillin-BLIs could be explained by the particular dysbiosis induced by those agents.

The study findings were limited by several factors including the retrospective design and potential for selection bias, as well as the inability to adjust antibiotic exposure according to type and severity of infection, they noted. However, “this is the first large scale study that extensively evaluated the effect of different antibiotic classes on immunogenicity of anti-TNF therapy,” and the results suggest that ADA development during anti-TNF therapy may to reduced by the use of fluoroquinolones and macrolides.

“Specific microbial manipulation may serve as a tool to modify immunogenicity which is preferably turned on for protective immunizations and off for biological therapy,” they noted. “Further studies involving detailed analysis of the antibiotic effects on the human microbiome and immune milieu are needed, as well as comparative experiments with other medications used to reduce immunogenicity.”
 

Unexpected findings may drive future drug choices

“Development of antidrug antibodies in patients on biologics for inflammatory bowel disease is an important mechanism for loss of response to a therapeutic agent,” Kim L. Isaacs, MD, AGAF, of the University of North Carolina at Chapel Hill, said in an interview. “To date the causes of development of ADAs is relatively understudied. Our approach to prevent ADA includes increasing immunosuppression in patients most commonly with combination therapy with thiopurines. If factors that provoke or prevent antibody formation are elucidated, therapy can be tailored to prevent ADAs and maximize the duration of response of many of our biologic therapies.”

A prior study performed by the ABIRISK European consortium demonstrated associations with antibiotics. “In this study, there was a differential effect of cephalosporins/penicillins (increased immunogenicity) and macrolides (decreased immunogenicity),” she said. “These studies suggest that the microbiome may be important in ADA formation to biologics – this is a concept that is novel and unexpected.

“The rationale for the choice of antibiotics in the population studied is not known, and it is possible that different infections may have led to different antibiotic choices, which in turn may have affected immunogenicity,” said Dr. Isaacs. However, clinicians might be able to tailor antibiotic choice in the future if the microbiome is playing a major role in risk for development of ADA.

“Further research is needed to further correlate microbiome changes with immunogenicity, to look at other classes of antibiotics and their role in immunogenicity, and to clarify the infections or reasons that these patients are receiving antibiotics,” Dr. Isaacs concluded.
 

Understanding the microbiome

Recent observations have shown associations between clinical response to anti-TNF and gut microbiota composition, noted Jatin Roper, MD, of Duke University, Durham, N.C. “More broadly, a growing body of evidence suggests that the gut microbiota modulates the metabolism of many therapeutic agents, as well as immune responses to infections.”

That said, Dr. Roper was surprised that “clinical use of different antibiotics, often short term, had such distinct effects on ADA levels.” Furthermore, “these findings suggest that distinct microbiota or microbial metabolic products impact antibody development to common immunomodulatory therapies in opposite ways,” which is itself a surprising finding.

Such antibodies to anti-TNF therapy are common in IBD, he said, but one implication of the study is how antibiotics could be carefully used "to reduce risk of ADAs and enhance efficacy of anti-TNF therapy."

However, because any antibiotic therapy will modify the gut microbiome and lead to unwanted effects, “further research is needed on how these agents impact the gut microbiome, with the ultimate goal of identifying specific microbiota or microbial metabolic products that can reproduce the intriguing findings of this paper.”

The study was supported in part by the Leona M. and Harry B. Helmsley Charitable Trust and the Israeli Ministry of Science and Technology. Dr. Gorelik had no financial conflicts to disclose. Several coauthors disclosed relationships with multiple pharmaceutical companies including AbbVie, CytoReason, Takeda, and Pfizer. Dr. Isaacs had no financial conflicts to disclose, but serves on the GI&Hepatology News board of editors. Dr. Roper had no relevant disclosures.

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

With the Delta variant surging across the country, already spread-thin health care workers are facing even sicker –and younger – Americans affected by COVID-19 than at the start of the pandemic.

While the exact toll the pandemic will take on essential workers will remain unknown, one thing is clear: The COVID-19 outbreak they’re experiencing right now on the front lines is a far cry from the original strain. They’re scared, exasperated, and crying out for us to pay attention and get vaccinated.

Five health care workers told this news organization about their experiences working the front lines amid the recent surge and what they think needs to happen – fast.
 

COVID-19 perspective from a paramedic in Connecticut

Michael Battistelli has been an emergency medical services worker for over 20 years and a licensed paramedic in Stratford, Conn., for a decade. He’s also the father of a 5-year-old daughter who isn’t eligible for a vaccination yet. For him, every day has been the same since the start of the pandemic: Surgical mask, N95 mask, face shield, change clothes before going home, and shower as soon as he walks in the door. He’s worried about Delta right now and wants you to be, too.

What keeps him up at night: “It seems like the last time, COVID-19 hit the Pacific Northwest and Northeast first. I hope it’s not the reverse and that it isn’t working its way back up to us here in Connecticut. I’ll add that if we start seeing young people dying, that might be it for me. That might be my final stand as an EMS.”

Why he’s frustrated: “For people to say COVID-19 isn’t real is mind-blowing. I’ve been at this for over a year, and all I think about is how to keep my daughter safe and protect my parents, especially my mom, who is a cancer survivor. When this first started, I brought people into the hospital who thought they would be fine after a day or week in the hospital. They ended up being on ventilators for months – and these were healthy people.”

What he wants to see: “I try not to judge people, but please understand how hard health care workers are working. We’re fatigued and burned out, and we are begging you: Please get vaccinated.”
 

COVID-19 perspective from an ICU director in Tennessee

Todd Rice, MD, FCCP, is an associate professor of medicine in the division of allergy, pulmonary and critical care at Vanderbilt Medical Center in Nashville, Tenn. While this father of two – ages 15 and 17 – trained for a pandemic, specifically Ebola and H1N1, the sheer volume of young COVID-19 patients in the ICU right now is taking a huge toll on him and his staff.

Why he’s frustrated: “First, there are a group of people that are adamantly against getting vaccinated. It doesn’t matter what we do or say. Second, a lot of people are confused and tell me that they don’t have somebody they trust to answer their questions about the vaccine. Third, some of this is driven by our colleagues: In the last 2 weeks, eight pregnant women with COVID-19 were admitted to our ICU. At least six said that their [obstetrician] told them not to get the vaccine while pregnant. That myth is still out there.”

What’s going on in the ICU: “I want people to know that our unvaccinated infected COVID-19 patients are the sickest patients we take care of. Their condition can change on a dime. We think they’re getting better, and suddenly we turn around and they’re near death or they die in seconds. What’s hard for our staff is that many of these patients have been with us for several weeks, and we get to know them. So when this happens, it hurts us even more because we’ve gotten to know them.”

What we need to do: “While it may take time, we have to talk to vaccine-hesitant people one by one and ask them what questions they have and then provide them with the answers they need. I think the next 6 months is going to be all about getting people who are still movable on this and get them to be comfortable that the vaccine is safe, that we didn’t cut corners. Yes, it was developed faster than anything we’ve ever done before, but that’s because it had to be.”
 

COVID-19 perspective from a cardiopulmonary doctor in Florida

Yvonne Billings, MD, director of cardiopulmonary medicine at Cleveland Clinic Martin Health in Stuart, Fla., says the “explosion” of COVID-19 cases right after July 4 has left her and her staff emotionally and physically overwhelmed.

What worries her: “We have great PPE, but we’re all worries because Delta is so contagious, and our colleagues have gotten it. We’ll eat lunch next to each other – socially distanced, of course – and we won’t know if we’ve gotten it by just sitting down to eat.”

What she wants us to do – now: “Everyone needs to listen to the real medical science and understand how much this is impacting everyone’s care. For example, if you need to come to the hospital for something other than COVID-19, you will receive slower care because everyone is so tied up caring for COVID-19 patients.”

Health care workers need to get on board, too: “I look at some of my respiratory therapists who chose not to be vaccinated until this last surge. Many told me that when the younger patients started coming in, they could relate to that. One said: ‘I see this gentleman is 27. I’m 27. I could be in the exact same position.’ I don’t want to see anyone get sick, but I’m hoping that when people see that this affects anyone at any age, they can push politics and what they thought was true about the vaccine aside, and make different choices and move forward.”
 

COVID-19 perspective from a registered nurse in Louisiana

Gina McNemar, 37, an ICU nurse at Baton Rouge General Medical Center in Baton Rouge, La., is wiped out. Her ICU unit is currently full of COVID-19 patients. This mom of 5-year-old twins is so upset about the onslaught of patients in her unit that she sent an email to the CEO of the hospital, which he then shared on Facebook with hundreds of followers. From the email: “This Covid is different. Let me repeat myself: THIS COVID IS NOT THE SAME. ... For the first time since April 2020, I kneeled on top of a patient in the middle of CPR and saw myself. She was 41 years old, no comorbidities, a full life ahead of her. The first time we fought Covid, everyone was old and sickly. They weren’t ‘me.’ This sweet woman was ‘me.’ We ran a full code on her for 1 hour and 26 minutes in front of her fiancé. He cried out to God to save her. He cried out to us to save her. We did everything in our power to save her. We weren’t able to. Three nurses, a pharmacy tech, an x-ray tech, and our HMG doctor hugged, prayed, and cried together after. She was living her life, got Covid, and died.”

Why she wants people to pay attention: “Our COVID-19 patients are young, they’re healthy, they’re able to answer our questions and immediately crash. We don’t have time to catch our breath between one code to the next. This COVID-19 is a much more violent disease, and I can no longer keep quiet. Someone has to say it. Someone has to say, ‘You can believe what you want to believe,’ but I’m seeing it with my own eyes, I’m holding their hands while they die, I’m bagging their body for the morgue. See this crisis through my eyes – please!”

What’s happening with her coworkers: “We’ve had some pretty bad days. We’re all crying and we’re afraid for each other now. We feel like it could be any of us at any point. I’m feeling that I don’t want to let it get to me, but it is. At home, we pray every night. The other night, one of my twins said: ‘I pray that you don’t get coronavirus and die.’ I can’t help but think: 5-year-olds should pray for unicorns and rainbows, not that their mom could die at work.”

Please stop playing politics: “America has become so divided and the vaccine somehow became the evil thing instead of the fact that the vaccine is the savior. I waited in line to get my vaccine because the scientists came up with something to end all this, but not everyone sees it that way. I feel like people don’t want to see and it shouldn’t matter if you’re a Republican or Democrat – after all, Biden is vaccinated [and] Trump is vaccinated.”
 

COVID-19 perspective from an ED doctor in New York City

Amanda Smith, MD, an ED doctor at Staten Island University Hospital in New York, says she’s sensing a “slow wave coming” when it comes to the Delta variant. The mom of three kids (she has 10-year-old twins and a 12-year-old) thinks often of the first signs of COVID-19 in 2020 and hopes that there won’t be a repeat surge like the initial one in New York City.

It’s hard not to feel frustrated: “I’m annoyed about the Delta variant. Of course, I’ve experienced the ‘I’m not getting the vaccine’ argument, and I’ve been at this long enough that I’m able to compartmentalize my own feelings, but I’m worn down, and I’m aware that I have compassion fatigue. When people complain about their COVID-19 symptoms and say things like ‘If I knew I would feel this horrible, I would have gotten the vaccine,’ I can’t help but feel that this was avoidable. It’s hard to talk to those people. I want to say ‘600,000 dead people weren’t enough to get vaccinated?’ ”

The people avoiding the vaccine: “There are the absolute deniers who will never get vaccinated and aren’t going to change their minds. Then there are the people who feel invincible, and then there are the folks who think that COVID-19 isn’t that bad, it’s just like the flu, it’s only old people dying and they’re not getting information from an appropriate source. It’s not the flu, it does kill you. Delta kills younger people, and it’s very easy to spread. Every one person who was infected with the original strain could infect two to three others. The Delta variant can infect 8-9, and measles, at 13, is the most contagious, so we need to keep reminding people about this.”

It’s not just about you: “Vaccination campaigns were never about the individual. We live together in a civilized society, and the vaccine is something you do for each other. People don’t understand the importance of breaking the chain of transmission and doing this to help each other and eradicate the spread. I just don’t understand what happened to us that we forgot this.”

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

With the Delta variant surging across the country, already spread-thin health care workers are facing even sicker –and younger – Americans affected by COVID-19 than at the start of the pandemic.

While the exact toll the pandemic will take on essential workers will remain unknown, one thing is clear: The COVID-19 outbreak they’re experiencing right now on the front lines is a far cry from the original strain. They’re scared, exasperated, and crying out for us to pay attention and get vaccinated.

Five health care workers told this news organization about their experiences working the front lines amid the recent surge and what they think needs to happen – fast.
 

COVID-19 perspective from a paramedic in Connecticut

Michael Battistelli has been an emergency medical services worker for over 20 years and a licensed paramedic in Stratford, Conn., for a decade. He’s also the father of a 5-year-old daughter who isn’t eligible for a vaccination yet. For him, every day has been the same since the start of the pandemic: Surgical mask, N95 mask, face shield, change clothes before going home, and shower as soon as he walks in the door. He’s worried about Delta right now and wants you to be, too.

What keeps him up at night: “It seems like the last time, COVID-19 hit the Pacific Northwest and Northeast first. I hope it’s not the reverse and that it isn’t working its way back up to us here in Connecticut. I’ll add that if we start seeing young people dying, that might be it for me. That might be my final stand as an EMS.”

Why he’s frustrated: “For people to say COVID-19 isn’t real is mind-blowing. I’ve been at this for over a year, and all I think about is how to keep my daughter safe and protect my parents, especially my mom, who is a cancer survivor. When this first started, I brought people into the hospital who thought they would be fine after a day or week in the hospital. They ended up being on ventilators for months – and these were healthy people.”

What he wants to see: “I try not to judge people, but please understand how hard health care workers are working. We’re fatigued and burned out, and we are begging you: Please get vaccinated.”
 

COVID-19 perspective from an ICU director in Tennessee

Todd Rice, MD, FCCP, is an associate professor of medicine in the division of allergy, pulmonary and critical care at Vanderbilt Medical Center in Nashville, Tenn. While this father of two – ages 15 and 17 – trained for a pandemic, specifically Ebola and H1N1, the sheer volume of young COVID-19 patients in the ICU right now is taking a huge toll on him and his staff.

Why he’s frustrated: “First, there are a group of people that are adamantly against getting vaccinated. It doesn’t matter what we do or say. Second, a lot of people are confused and tell me that they don’t have somebody they trust to answer their questions about the vaccine. Third, some of this is driven by our colleagues: In the last 2 weeks, eight pregnant women with COVID-19 were admitted to our ICU. At least six said that their [obstetrician] told them not to get the vaccine while pregnant. That myth is still out there.”

What’s going on in the ICU: “I want people to know that our unvaccinated infected COVID-19 patients are the sickest patients we take care of. Their condition can change on a dime. We think they’re getting better, and suddenly we turn around and they’re near death or they die in seconds. What’s hard for our staff is that many of these patients have been with us for several weeks, and we get to know them. So when this happens, it hurts us even more because we’ve gotten to know them.”

What we need to do: “While it may take time, we have to talk to vaccine-hesitant people one by one and ask them what questions they have and then provide them with the answers they need. I think the next 6 months is going to be all about getting people who are still movable on this and get them to be comfortable that the vaccine is safe, that we didn’t cut corners. Yes, it was developed faster than anything we’ve ever done before, but that’s because it had to be.”
 

COVID-19 perspective from a cardiopulmonary doctor in Florida

Yvonne Billings, MD, director of cardiopulmonary medicine at Cleveland Clinic Martin Health in Stuart, Fla., says the “explosion” of COVID-19 cases right after July 4 has left her and her staff emotionally and physically overwhelmed.

What worries her: “We have great PPE, but we’re all worries because Delta is so contagious, and our colleagues have gotten it. We’ll eat lunch next to each other – socially distanced, of course – and we won’t know if we’ve gotten it by just sitting down to eat.”

What she wants us to do – now: “Everyone needs to listen to the real medical science and understand how much this is impacting everyone’s care. For example, if you need to come to the hospital for something other than COVID-19, you will receive slower care because everyone is so tied up caring for COVID-19 patients.”

Health care workers need to get on board, too: “I look at some of my respiratory therapists who chose not to be vaccinated until this last surge. Many told me that when the younger patients started coming in, they could relate to that. One said: ‘I see this gentleman is 27. I’m 27. I could be in the exact same position.’ I don’t want to see anyone get sick, but I’m hoping that when people see that this affects anyone at any age, they can push politics and what they thought was true about the vaccine aside, and make different choices and move forward.”
 

COVID-19 perspective from a registered nurse in Louisiana

Gina McNemar, 37, an ICU nurse at Baton Rouge General Medical Center in Baton Rouge, La., is wiped out. Her ICU unit is currently full of COVID-19 patients. This mom of 5-year-old twins is so upset about the onslaught of patients in her unit that she sent an email to the CEO of the hospital, which he then shared on Facebook with hundreds of followers. From the email: “This Covid is different. Let me repeat myself: THIS COVID IS NOT THE SAME. ... For the first time since April 2020, I kneeled on top of a patient in the middle of CPR and saw myself. She was 41 years old, no comorbidities, a full life ahead of her. The first time we fought Covid, everyone was old and sickly. They weren’t ‘me.’ This sweet woman was ‘me.’ We ran a full code on her for 1 hour and 26 minutes in front of her fiancé. He cried out to God to save her. He cried out to us to save her. We did everything in our power to save her. We weren’t able to. Three nurses, a pharmacy tech, an x-ray tech, and our HMG doctor hugged, prayed, and cried together after. She was living her life, got Covid, and died.”

Why she wants people to pay attention: “Our COVID-19 patients are young, they’re healthy, they’re able to answer our questions and immediately crash. We don’t have time to catch our breath between one code to the next. This COVID-19 is a much more violent disease, and I can no longer keep quiet. Someone has to say it. Someone has to say, ‘You can believe what you want to believe,’ but I’m seeing it with my own eyes, I’m holding their hands while they die, I’m bagging their body for the morgue. See this crisis through my eyes – please!”

What’s happening with her coworkers: “We’ve had some pretty bad days. We’re all crying and we’re afraid for each other now. We feel like it could be any of us at any point. I’m feeling that I don’t want to let it get to me, but it is. At home, we pray every night. The other night, one of my twins said: ‘I pray that you don’t get coronavirus and die.’ I can’t help but think: 5-year-olds should pray for unicorns and rainbows, not that their mom could die at work.”

Please stop playing politics: “America has become so divided and the vaccine somehow became the evil thing instead of the fact that the vaccine is the savior. I waited in line to get my vaccine because the scientists came up with something to end all this, but not everyone sees it that way. I feel like people don’t want to see and it shouldn’t matter if you’re a Republican or Democrat – after all, Biden is vaccinated [and] Trump is vaccinated.”
 

COVID-19 perspective from an ED doctor in New York City

Amanda Smith, MD, an ED doctor at Staten Island University Hospital in New York, says she’s sensing a “slow wave coming” when it comes to the Delta variant. The mom of three kids (she has 10-year-old twins and a 12-year-old) thinks often of the first signs of COVID-19 in 2020 and hopes that there won’t be a repeat surge like the initial one in New York City.

It’s hard not to feel frustrated: “I’m annoyed about the Delta variant. Of course, I’ve experienced the ‘I’m not getting the vaccine’ argument, and I’ve been at this long enough that I’m able to compartmentalize my own feelings, but I’m worn down, and I’m aware that I have compassion fatigue. When people complain about their COVID-19 symptoms and say things like ‘If I knew I would feel this horrible, I would have gotten the vaccine,’ I can’t help but feel that this was avoidable. It’s hard to talk to those people. I want to say ‘600,000 dead people weren’t enough to get vaccinated?’ ”

The people avoiding the vaccine: “There are the absolute deniers who will never get vaccinated and aren’t going to change their minds. Then there are the people who feel invincible, and then there are the folks who think that COVID-19 isn’t that bad, it’s just like the flu, it’s only old people dying and they’re not getting information from an appropriate source. It’s not the flu, it does kill you. Delta kills younger people, and it’s very easy to spread. Every one person who was infected with the original strain could infect two to three others. The Delta variant can infect 8-9, and measles, at 13, is the most contagious, so we need to keep reminding people about this.”

It’s not just about you: “Vaccination campaigns were never about the individual. We live together in a civilized society, and the vaccine is something you do for each other. People don’t understand the importance of breaking the chain of transmission and doing this to help each other and eradicate the spread. I just don’t understand what happened to us that we forgot this.”

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

With the Delta variant surging across the country, already spread-thin health care workers are facing even sicker –and younger – Americans affected by COVID-19 than at the start of the pandemic.

While the exact toll the pandemic will take on essential workers will remain unknown, one thing is clear: The COVID-19 outbreak they’re experiencing right now on the front lines is a far cry from the original strain. They’re scared, exasperated, and crying out for us to pay attention and get vaccinated.

Five health care workers told this news organization about their experiences working the front lines amid the recent surge and what they think needs to happen – fast.
 

COVID-19 perspective from a paramedic in Connecticut

Michael Battistelli has been an emergency medical services worker for over 20 years and a licensed paramedic in Stratford, Conn., for a decade. He’s also the father of a 5-year-old daughter who isn’t eligible for a vaccination yet. For him, every day has been the same since the start of the pandemic: Surgical mask, N95 mask, face shield, change clothes before going home, and shower as soon as he walks in the door. He’s worried about Delta right now and wants you to be, too.

What keeps him up at night: “It seems like the last time, COVID-19 hit the Pacific Northwest and Northeast first. I hope it’s not the reverse and that it isn’t working its way back up to us here in Connecticut. I’ll add that if we start seeing young people dying, that might be it for me. That might be my final stand as an EMS.”

Why he’s frustrated: “For people to say COVID-19 isn’t real is mind-blowing. I’ve been at this for over a year, and all I think about is how to keep my daughter safe and protect my parents, especially my mom, who is a cancer survivor. When this first started, I brought people into the hospital who thought they would be fine after a day or week in the hospital. They ended up being on ventilators for months – and these were healthy people.”

What he wants to see: “I try not to judge people, but please understand how hard health care workers are working. We’re fatigued and burned out, and we are begging you: Please get vaccinated.”
 

COVID-19 perspective from an ICU director in Tennessee

Todd Rice, MD, FCCP, is an associate professor of medicine in the division of allergy, pulmonary and critical care at Vanderbilt Medical Center in Nashville, Tenn. While this father of two – ages 15 and 17 – trained for a pandemic, specifically Ebola and H1N1, the sheer volume of young COVID-19 patients in the ICU right now is taking a huge toll on him and his staff.

Why he’s frustrated: “First, there are a group of people that are adamantly against getting vaccinated. It doesn’t matter what we do or say. Second, a lot of people are confused and tell me that they don’t have somebody they trust to answer their questions about the vaccine. Third, some of this is driven by our colleagues: In the last 2 weeks, eight pregnant women with COVID-19 were admitted to our ICU. At least six said that their [obstetrician] told them not to get the vaccine while pregnant. That myth is still out there.”

What’s going on in the ICU: “I want people to know that our unvaccinated infected COVID-19 patients are the sickest patients we take care of. Their condition can change on a dime. We think they’re getting better, and suddenly we turn around and they’re near death or they die in seconds. What’s hard for our staff is that many of these patients have been with us for several weeks, and we get to know them. So when this happens, it hurts us even more because we’ve gotten to know them.”

What we need to do: “While it may take time, we have to talk to vaccine-hesitant people one by one and ask them what questions they have and then provide them with the answers they need. I think the next 6 months is going to be all about getting people who are still movable on this and get them to be comfortable that the vaccine is safe, that we didn’t cut corners. Yes, it was developed faster than anything we’ve ever done before, but that’s because it had to be.”
 

COVID-19 perspective from a cardiopulmonary doctor in Florida

Yvonne Billings, MD, director of cardiopulmonary medicine at Cleveland Clinic Martin Health in Stuart, Fla., says the “explosion” of COVID-19 cases right after July 4 has left her and her staff emotionally and physically overwhelmed.

What worries her: “We have great PPE, but we’re all worries because Delta is so contagious, and our colleagues have gotten it. We’ll eat lunch next to each other – socially distanced, of course – and we won’t know if we’ve gotten it by just sitting down to eat.”

What she wants us to do – now: “Everyone needs to listen to the real medical science and understand how much this is impacting everyone’s care. For example, if you need to come to the hospital for something other than COVID-19, you will receive slower care because everyone is so tied up caring for COVID-19 patients.”

Health care workers need to get on board, too: “I look at some of my respiratory therapists who chose not to be vaccinated until this last surge. Many told me that when the younger patients started coming in, they could relate to that. One said: ‘I see this gentleman is 27. I’m 27. I could be in the exact same position.’ I don’t want to see anyone get sick, but I’m hoping that when people see that this affects anyone at any age, they can push politics and what they thought was true about the vaccine aside, and make different choices and move forward.”
 

COVID-19 perspective from a registered nurse in Louisiana

Gina McNemar, 37, an ICU nurse at Baton Rouge General Medical Center in Baton Rouge, La., is wiped out. Her ICU unit is currently full of COVID-19 patients. This mom of 5-year-old twins is so upset about the onslaught of patients in her unit that she sent an email to the CEO of the hospital, which he then shared on Facebook with hundreds of followers. From the email: “This Covid is different. Let me repeat myself: THIS COVID IS NOT THE SAME. ... For the first time since April 2020, I kneeled on top of a patient in the middle of CPR and saw myself. She was 41 years old, no comorbidities, a full life ahead of her. The first time we fought Covid, everyone was old and sickly. They weren’t ‘me.’ This sweet woman was ‘me.’ We ran a full code on her for 1 hour and 26 minutes in front of her fiancé. He cried out to God to save her. He cried out to us to save her. We did everything in our power to save her. We weren’t able to. Three nurses, a pharmacy tech, an x-ray tech, and our HMG doctor hugged, prayed, and cried together after. She was living her life, got Covid, and died.”

Why she wants people to pay attention: “Our COVID-19 patients are young, they’re healthy, they’re able to answer our questions and immediately crash. We don’t have time to catch our breath between one code to the next. This COVID-19 is a much more violent disease, and I can no longer keep quiet. Someone has to say it. Someone has to say, ‘You can believe what you want to believe,’ but I’m seeing it with my own eyes, I’m holding their hands while they die, I’m bagging their body for the morgue. See this crisis through my eyes – please!”

What’s happening with her coworkers: “We’ve had some pretty bad days. We’re all crying and we’re afraid for each other now. We feel like it could be any of us at any point. I’m feeling that I don’t want to let it get to me, but it is. At home, we pray every night. The other night, one of my twins said: ‘I pray that you don’t get coronavirus and die.’ I can’t help but think: 5-year-olds should pray for unicorns and rainbows, not that their mom could die at work.”

Please stop playing politics: “America has become so divided and the vaccine somehow became the evil thing instead of the fact that the vaccine is the savior. I waited in line to get my vaccine because the scientists came up with something to end all this, but not everyone sees it that way. I feel like people don’t want to see and it shouldn’t matter if you’re a Republican or Democrat – after all, Biden is vaccinated [and] Trump is vaccinated.”
 

COVID-19 perspective from an ED doctor in New York City

Amanda Smith, MD, an ED doctor at Staten Island University Hospital in New York, says she’s sensing a “slow wave coming” when it comes to the Delta variant. The mom of three kids (she has 10-year-old twins and a 12-year-old) thinks often of the first signs of COVID-19 in 2020 and hopes that there won’t be a repeat surge like the initial one in New York City.

It’s hard not to feel frustrated: “I’m annoyed about the Delta variant. Of course, I’ve experienced the ‘I’m not getting the vaccine’ argument, and I’ve been at this long enough that I’m able to compartmentalize my own feelings, but I’m worn down, and I’m aware that I have compassion fatigue. When people complain about their COVID-19 symptoms and say things like ‘If I knew I would feel this horrible, I would have gotten the vaccine,’ I can’t help but feel that this was avoidable. It’s hard to talk to those people. I want to say ‘600,000 dead people weren’t enough to get vaccinated?’ ”

The people avoiding the vaccine: “There are the absolute deniers who will never get vaccinated and aren’t going to change their minds. Then there are the people who feel invincible, and then there are the folks who think that COVID-19 isn’t that bad, it’s just like the flu, it’s only old people dying and they’re not getting information from an appropriate source. It’s not the flu, it does kill you. Delta kills younger people, and it’s very easy to spread. Every one person who was infected with the original strain could infect two to three others. The Delta variant can infect 8-9, and measles, at 13, is the most contagious, so we need to keep reminding people about this.”

It’s not just about you: “Vaccination campaigns were never about the individual. We live together in a civilized society, and the vaccine is something you do for each other. People don’t understand the importance of breaking the chain of transmission and doing this to help each other and eradicate the spread. I just don’t understand what happened to us that we forgot this.”

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

Weekly cases of COVID-19 in children topped 100,000 for the first time since early February, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A 29% increase in reported cases over the previous week brought the count for Aug. 6-12 to over 121,000, making it the worst week for new infections in children since Jan. 29 to Feb. 4, the AAP and CHA said in their weekly COVD-19 report. The recent surge in child COVID has also brought a record high in hospitalizations and shortages of pediatric ICU beds in some areas.

The 121,000 new cases represent an increase of almost 1,400% since June 18-24, when the weekly tally was just 8,447 and at its lowest point in over a year, the AAP/CHA data show.

On the vaccination front in the last week (Aug. 10-16), vaccine initiation for 12- to 17-year-olds was fairly robust but still down slightly, compared with the previous week. Just over 402,000 children aged 12-15 years received a first vaccination, which was down slightly from 411,000 the week before but still higher than any of the 6 weeks from June 22 to Aug. 2, based on data from the Centers for Disease Control and Prevention. Vaccinations were down by a similar margin for 15- to-17-year-olds.

Over 10.9 million children aged 12-17 have had at least one dose of COVID-19 vaccine administered, of whom 8.1 million are fully vaccinated. Among those aged 12-15 years, 44.5% have gotten at least one dose and 31.8% are fully vaccinated, with corresponding figures of 53.9% and 42.5% for 16- and 17-year-olds, according to the CDC’s COVID Data Tracker.

The number of COVID-19 cases reported in children since the start of the pandemic is up to 4.4 million, which makes up 14.4% of all cases in the United States, the AAP and CHA said. Other cumulative figures through Aug. 12 include almost 18,000 hospitalizations – reported by 23 states and New York City – and 378 deaths – reported by 43 states, New York City, Puerto Rico, and Guam.

In the latest edition of their ongoing report, compiled using state data since the summer of 2020, the two groups noted that, “in the summer of 2021, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported.” Among those states are Nebraska, which shut down its online COVID dashboard in late June, and Alabama, which stopped reporting cumulative cases and deaths after July 29.

[email protected]

Weekly cases of COVID-19 in children topped 100,000 for the first time since early February, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A 29% increase in reported cases over the previous week brought the count for Aug. 6-12 to over 121,000, making it the worst week for new infections in children since Jan. 29 to Feb. 4, the AAP and CHA said in their weekly COVD-19 report. The recent surge in child COVID has also brought a record high in hospitalizations and shortages of pediatric ICU beds in some areas.

The 121,000 new cases represent an increase of almost 1,400% since June 18-24, when the weekly tally was just 8,447 and at its lowest point in over a year, the AAP/CHA data show.

On the vaccination front in the last week (Aug. 10-16), vaccine initiation for 12- to 17-year-olds was fairly robust but still down slightly, compared with the previous week. Just over 402,000 children aged 12-15 years received a first vaccination, which was down slightly from 411,000 the week before but still higher than any of the 6 weeks from June 22 to Aug. 2, based on data from the Centers for Disease Control and Prevention. Vaccinations were down by a similar margin for 15- to-17-year-olds.

Over 10.9 million children aged 12-17 have had at least one dose of COVID-19 vaccine administered, of whom 8.1 million are fully vaccinated. Among those aged 12-15 years, 44.5% have gotten at least one dose and 31.8% are fully vaccinated, with corresponding figures of 53.9% and 42.5% for 16- and 17-year-olds, according to the CDC’s COVID Data Tracker.

The number of COVID-19 cases reported in children since the start of the pandemic is up to 4.4 million, which makes up 14.4% of all cases in the United States, the AAP and CHA said. Other cumulative figures through Aug. 12 include almost 18,000 hospitalizations – reported by 23 states and New York City – and 378 deaths – reported by 43 states, New York City, Puerto Rico, and Guam.

In the latest edition of their ongoing report, compiled using state data since the summer of 2020, the two groups noted that, “in the summer of 2021, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported.” Among those states are Nebraska, which shut down its online COVID dashboard in late June, and Alabama, which stopped reporting cumulative cases and deaths after July 29.

[email protected]

Weekly cases of COVID-19 in children topped 100,000 for the first time since early February, according to the American Academy of Pediatrics and the Children’s Hospital Association.

A 29% increase in reported cases over the previous week brought the count for Aug. 6-12 to over 121,000, making it the worst week for new infections in children since Jan. 29 to Feb. 4, the AAP and CHA said in their weekly COVD-19 report. The recent surge in child COVID has also brought a record high in hospitalizations and shortages of pediatric ICU beds in some areas.

The 121,000 new cases represent an increase of almost 1,400% since June 18-24, when the weekly tally was just 8,447 and at its lowest point in over a year, the AAP/CHA data show.

On the vaccination front in the last week (Aug. 10-16), vaccine initiation for 12- to 17-year-olds was fairly robust but still down slightly, compared with the previous week. Just over 402,000 children aged 12-15 years received a first vaccination, which was down slightly from 411,000 the week before but still higher than any of the 6 weeks from June 22 to Aug. 2, based on data from the Centers for Disease Control and Prevention. Vaccinations were down by a similar margin for 15- to-17-year-olds.

Over 10.9 million children aged 12-17 have had at least one dose of COVID-19 vaccine administered, of whom 8.1 million are fully vaccinated. Among those aged 12-15 years, 44.5% have gotten at least one dose and 31.8% are fully vaccinated, with corresponding figures of 53.9% and 42.5% for 16- and 17-year-olds, according to the CDC’s COVID Data Tracker.

The number of COVID-19 cases reported in children since the start of the pandemic is up to 4.4 million, which makes up 14.4% of all cases in the United States, the AAP and CHA said. Other cumulative figures through Aug. 12 include almost 18,000 hospitalizations – reported by 23 states and New York City – and 378 deaths – reported by 43 states, New York City, Puerto Rico, and Guam.

In the latest edition of their ongoing report, compiled using state data since the summer of 2020, the two groups noted that, “in the summer of 2021, some states have revised cases counts previously reported, begun reporting less frequently, or dropped metrics previously reported.” Among those states are Nebraska, which shut down its online COVID dashboard in late June, and Alabama, which stopped reporting cumulative cases and deaths after July 29.

[email protected]

Hospitals are reporting record numbers of COVID-19 patients in their 30s, largely because of the contagious Delta variant, according to The Wall Street Journal.

The rate of new hospitalizations for ages 30-39 reached 2.5 per 100,000 people last week, according to the latest CDC data, which is up from the previous peak of 2 per 100,000 people in January.

What’s more, new hospital admissions for patients in their 30s reached an average of 1,113 a day during the last week, which was up from 908 the week before.

“It means Delta is really bad,” James Lawler, MD, an infectious disease doctor and codirector of the Global Center for Health Security at the University of Nebraska Medical Center, told the newspaper.

People in the age group mostly avoided hospitalization throughout the pandemic because of their relatively good health and young age, the newspaper reported. But in recent weeks, those between ages 30 and 39 are contracting the coronavirus because of their active lifestyle – for many in their 30s, these are prime years for working, parenting, and socializing.

Hospitalizations are mostly among unvaccinated adults, according to the Wall Street Journal. Nationally, less than half of those ages 25-39 are fully vaccinated, compared with 61% of all adults, according to CDC data updated Sunday.

“It loves social mobility,” James Fiorica, MD, chief medical officer of Sarasota Memorial Health Care System in Florida, told the newspaper.

“An unvaccinated 30-year-old can be a perfect carrier,” he said.

On top of that, COVID-19 patients in their 30s are arriving at hospitals with more severe disease than in earlier waves, the Journal reported. At the University of Arkansas for Medical Sciences hospital, for instance, doctors are now monitoring younger patients daily with a scoring system for possible organ failure. That wasn’t necessary earlier in the pandemic for people in their 30s.

“This age group pretty much went unscathed,” Nikhil Meena, MD, director of the hospital’s Medical Intensive Care Unit, told the newspaper.

Now, he said, “they’re all out there doing their thing and getting infected and getting sick enough to be in this hospital.”

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

Hospitals are reporting record numbers of COVID-19 patients in their 30s, largely because of the contagious Delta variant, according to The Wall Street Journal.

The rate of new hospitalizations for ages 30-39 reached 2.5 per 100,000 people last week, according to the latest CDC data, which is up from the previous peak of 2 per 100,000 people in January.

What’s more, new hospital admissions for patients in their 30s reached an average of 1,113 a day during the last week, which was up from 908 the week before.

“It means Delta is really bad,” James Lawler, MD, an infectious disease doctor and codirector of the Global Center for Health Security at the University of Nebraska Medical Center, told the newspaper.

People in the age group mostly avoided hospitalization throughout the pandemic because of their relatively good health and young age, the newspaper reported. But in recent weeks, those between ages 30 and 39 are contracting the coronavirus because of their active lifestyle – for many in their 30s, these are prime years for working, parenting, and socializing.

Hospitalizations are mostly among unvaccinated adults, according to the Wall Street Journal. Nationally, less than half of those ages 25-39 are fully vaccinated, compared with 61% of all adults, according to CDC data updated Sunday.

“It loves social mobility,” James Fiorica, MD, chief medical officer of Sarasota Memorial Health Care System in Florida, told the newspaper.

“An unvaccinated 30-year-old can be a perfect carrier,” he said.

On top of that, COVID-19 patients in their 30s are arriving at hospitals with more severe disease than in earlier waves, the Journal reported. At the University of Arkansas for Medical Sciences hospital, for instance, doctors are now monitoring younger patients daily with a scoring system for possible organ failure. That wasn’t necessary earlier in the pandemic for people in their 30s.

“This age group pretty much went unscathed,” Nikhil Meena, MD, director of the hospital’s Medical Intensive Care Unit, told the newspaper.

Now, he said, “they’re all out there doing their thing and getting infected and getting sick enough to be in this hospital.”

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

Hospitals are reporting record numbers of COVID-19 patients in their 30s, largely because of the contagious Delta variant, according to The Wall Street Journal.

The rate of new hospitalizations for ages 30-39 reached 2.5 per 100,000 people last week, according to the latest CDC data, which is up from the previous peak of 2 per 100,000 people in January.

What’s more, new hospital admissions for patients in their 30s reached an average of 1,113 a day during the last week, which was up from 908 the week before.

“It means Delta is really bad,” James Lawler, MD, an infectious disease doctor and codirector of the Global Center for Health Security at the University of Nebraska Medical Center, told the newspaper.

People in the age group mostly avoided hospitalization throughout the pandemic because of their relatively good health and young age, the newspaper reported. But in recent weeks, those between ages 30 and 39 are contracting the coronavirus because of their active lifestyle – for many in their 30s, these are prime years for working, parenting, and socializing.

Hospitalizations are mostly among unvaccinated adults, according to the Wall Street Journal. Nationally, less than half of those ages 25-39 are fully vaccinated, compared with 61% of all adults, according to CDC data updated Sunday.

“It loves social mobility,” James Fiorica, MD, chief medical officer of Sarasota Memorial Health Care System in Florida, told the newspaper.

“An unvaccinated 30-year-old can be a perfect carrier,” he said.

On top of that, COVID-19 patients in their 30s are arriving at hospitals with more severe disease than in earlier waves, the Journal reported. At the University of Arkansas for Medical Sciences hospital, for instance, doctors are now monitoring younger patients daily with a scoring system for possible organ failure. That wasn’t necessary earlier in the pandemic for people in their 30s.

“This age group pretty much went unscathed,” Nikhil Meena, MD, director of the hospital’s Medical Intensive Care Unit, told the newspaper.

Now, he said, “they’re all out there doing their thing and getting infected and getting sick enough to be in this hospital.”

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

Young children are more likely than are their older siblings to transmit SARS-CoV-2 in their households, according to an analysis of public health records in Ontario, Canada – a finding that upends the common belief that children play a minimal role in COVID-19 spread.

The study by researchers from Public Health Ontario, published online in JAMA Pediatrics, found that teenagers (14- to 17-year-olds) were more likely than were their younger siblings to bring the virus into the household, while infants and toddlers (up to age 3) were about 43% more likely than were the older teens to spread it to others in the home.

Children or teens were the source of SARS-CoV-2 in about 1 in 13 Ontario households between June and December 2020, the study shows. The researchers analyzed health records from 6,280 households with a pediatric COVID-19 case and a subset of 1,717 households in which a child up to age 17 was the source of transmission in a household.

When analyzing the data, the researchers controlled for gender differences, month of disease onset, testing delay, and mean family size.

The role of young children in transmission seemed logical to some experts who have been tracking the evolution of the pandemic. “I think what was more surprising was how long the narrative persisted that children weren’t transmitting SARS-CoV-2,” said Samuel Scarpino, PhD, managing director of pathogen surveillance at the Rockefeller Foundation.

Meanwhile, less mask-wearing, the return to school and activities, and the onslaught of the Delta variant have changed the dynamics of spread, said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah.

“Adolescents and high-school-aged kids have had much, much higher rates of infection in the past,” he said. “Now when we look at the rates of school-aged kids, they are the same as high-school-aged kids, and we’re seeing more and more in the preschool age groups.”
 

Cases may be underestimated

If anything, the study may underestimate the role young children play in spreading COVID-19 in families, since it included only symptomatic cases as the initial source and young children are more likely to be asymptomatic, Dr. Pavia said.

The Delta variant heightens the concern; it is more than twice as infectious as previous strains and has spurred a rise in pediatric cases, including some coinfection with other circulating respiratory diseases, such as respiratory syncytial virus (RSV).

The Ontario study covers a period before vaccination and the spread of the Delta variant. “As the number of pediatric cases increases worldwide, the role of children in household transmission will continue to grow,” the authors concluded.

Following recommended respiratory hygiene is clearly more difficult with very young children. For example, parents, caregivers, and older siblings aren’t going to stay 6 feet away from a sick baby or toddler, Susan Coffin, MD, MPH, a pediatric infectious disease physician, and David Rubin, MD, a pediatrician and director of PolicyLab at Children’s Hospital of Philadelphia, noted in an accompanying commentary.

“Cuddling and touching are part and parcel of taking care of a sick young child, and that will obviously come with an increased risk of transmission to parents as well as to older siblings who may be helping to care for their sick brother or sister,” they wrote.

While parents may wash their hands more frequently when caring for a sick child, they aren’t likely to wear a mask, said William Schaffner, MD, an infectious disease specialist at Vanderbilt University, Nashville, Tenn.

“I imagine some moms even take a sick child into bed with them,” he said. “It’s probably just the extensive contact one has with a sick, very small child that augments their capacity to transmit this infection.”
 

What can be done

What can be done, then, to reduce the household spread of COVID-19? “The obvious solution to protect a household with a sick young infant or toddler is to make sure that all eligible members of the household are vaccinated,” Dr. Coffin and Dr. Rubin stated in their commentary.

The American Academy of Pediatrics recently wrote to Janet Woodcock, MD, acting commissioner of the Food and Drug Administration, asking for the agency to authorize use of SARS-CoV-2 vaccines for children under age 12 “as soon as possible,” noting that “the Delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults.”

The FDA reportedly asked vaccine makers Pfizer and Moderna to expand the clinical trials of children, which may delay authorization for younger age groups. Pfizer has said it plans to submit a request for emergency use authorization of its vaccine for 5- to 11-year-olds in September or October.

As with adult vaccination, hesitancy is likely to be a barrier. Less than half of parents said they are very or somewhat likely to have their children get a COVID-19 vaccine, according to a national survey conducted by researchers at the University of California, Los Angeles.

The Ontario study provides valuable evidence to support taking steps to protect children from transmission in schools, including mask requirements, frequent testing, and improved ventilation, said Dr. Scarpino.

“We’re not going to be able to control COVID without vaccinating younger individuals,” he said.

Dr. Pavia has consulted for GlaxoSmithKline on non–COVID-19–related issues. Sarah Buchan, PhD, study author and scientist at Public Health Ontario, reported grants from the Canadian Institutes of Health Research for research on influenza, RSV, and COVID-19, and grants from the Canadian Immunity Task Force for COVID-19 outside the submitted work. Dr. Coffin reported grants as a Centers for Disease Control and Prevention coinvestigator at a Vaccine and Treatment Evaluation Unit site conducting COVID-19 vaccine trials in children. Dr. Scarpino holds unexercised options in ILiAD Biotechnologies, which is focused on the prevention and treatment of pertussis. Dr. Schaffner is a consultant for VBI Vaccines.

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

Young children are more likely than are their older siblings to transmit SARS-CoV-2 in their households, according to an analysis of public health records in Ontario, Canada – a finding that upends the common belief that children play a minimal role in COVID-19 spread.

The study by researchers from Public Health Ontario, published online in JAMA Pediatrics, found that teenagers (14- to 17-year-olds) were more likely than were their younger siblings to bring the virus into the household, while infants and toddlers (up to age 3) were about 43% more likely than were the older teens to spread it to others in the home.

Children or teens were the source of SARS-CoV-2 in about 1 in 13 Ontario households between June and December 2020, the study shows. The researchers analyzed health records from 6,280 households with a pediatric COVID-19 case and a subset of 1,717 households in which a child up to age 17 was the source of transmission in a household.

When analyzing the data, the researchers controlled for gender differences, month of disease onset, testing delay, and mean family size.

The role of young children in transmission seemed logical to some experts who have been tracking the evolution of the pandemic. “I think what was more surprising was how long the narrative persisted that children weren’t transmitting SARS-CoV-2,” said Samuel Scarpino, PhD, managing director of pathogen surveillance at the Rockefeller Foundation.

Meanwhile, less mask-wearing, the return to school and activities, and the onslaught of the Delta variant have changed the dynamics of spread, said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah.

“Adolescents and high-school-aged kids have had much, much higher rates of infection in the past,” he said. “Now when we look at the rates of school-aged kids, they are the same as high-school-aged kids, and we’re seeing more and more in the preschool age groups.”
 

Cases may be underestimated

If anything, the study may underestimate the role young children play in spreading COVID-19 in families, since it included only symptomatic cases as the initial source and young children are more likely to be asymptomatic, Dr. Pavia said.

The Delta variant heightens the concern; it is more than twice as infectious as previous strains and has spurred a rise in pediatric cases, including some coinfection with other circulating respiratory diseases, such as respiratory syncytial virus (RSV).

The Ontario study covers a period before vaccination and the spread of the Delta variant. “As the number of pediatric cases increases worldwide, the role of children in household transmission will continue to grow,” the authors concluded.

Following recommended respiratory hygiene is clearly more difficult with very young children. For example, parents, caregivers, and older siblings aren’t going to stay 6 feet away from a sick baby or toddler, Susan Coffin, MD, MPH, a pediatric infectious disease physician, and David Rubin, MD, a pediatrician and director of PolicyLab at Children’s Hospital of Philadelphia, noted in an accompanying commentary.

“Cuddling and touching are part and parcel of taking care of a sick young child, and that will obviously come with an increased risk of transmission to parents as well as to older siblings who may be helping to care for their sick brother or sister,” they wrote.

While parents may wash their hands more frequently when caring for a sick child, they aren’t likely to wear a mask, said William Schaffner, MD, an infectious disease specialist at Vanderbilt University, Nashville, Tenn.

“I imagine some moms even take a sick child into bed with them,” he said. “It’s probably just the extensive contact one has with a sick, very small child that augments their capacity to transmit this infection.”
 

What can be done

What can be done, then, to reduce the household spread of COVID-19? “The obvious solution to protect a household with a sick young infant or toddler is to make sure that all eligible members of the household are vaccinated,” Dr. Coffin and Dr. Rubin stated in their commentary.

The American Academy of Pediatrics recently wrote to Janet Woodcock, MD, acting commissioner of the Food and Drug Administration, asking for the agency to authorize use of SARS-CoV-2 vaccines for children under age 12 “as soon as possible,” noting that “the Delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults.”

The FDA reportedly asked vaccine makers Pfizer and Moderna to expand the clinical trials of children, which may delay authorization for younger age groups. Pfizer has said it plans to submit a request for emergency use authorization of its vaccine for 5- to 11-year-olds in September or October.

As with adult vaccination, hesitancy is likely to be a barrier. Less than half of parents said they are very or somewhat likely to have their children get a COVID-19 vaccine, according to a national survey conducted by researchers at the University of California, Los Angeles.

The Ontario study provides valuable evidence to support taking steps to protect children from transmission in schools, including mask requirements, frequent testing, and improved ventilation, said Dr. Scarpino.

“We’re not going to be able to control COVID without vaccinating younger individuals,” he said.

Dr. Pavia has consulted for GlaxoSmithKline on non–COVID-19–related issues. Sarah Buchan, PhD, study author and scientist at Public Health Ontario, reported grants from the Canadian Institutes of Health Research for research on influenza, RSV, and COVID-19, and grants from the Canadian Immunity Task Force for COVID-19 outside the submitted work. Dr. Coffin reported grants as a Centers for Disease Control and Prevention coinvestigator at a Vaccine and Treatment Evaluation Unit site conducting COVID-19 vaccine trials in children. Dr. Scarpino holds unexercised options in ILiAD Biotechnologies, which is focused on the prevention and treatment of pertussis. Dr. Schaffner is a consultant for VBI Vaccines.

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

Young children are more likely than are their older siblings to transmit SARS-CoV-2 in their households, according to an analysis of public health records in Ontario, Canada – a finding that upends the common belief that children play a minimal role in COVID-19 spread.

The study by researchers from Public Health Ontario, published online in JAMA Pediatrics, found that teenagers (14- to 17-year-olds) were more likely than were their younger siblings to bring the virus into the household, while infants and toddlers (up to age 3) were about 43% more likely than were the older teens to spread it to others in the home.

Children or teens were the source of SARS-CoV-2 in about 1 in 13 Ontario households between June and December 2020, the study shows. The researchers analyzed health records from 6,280 households with a pediatric COVID-19 case and a subset of 1,717 households in which a child up to age 17 was the source of transmission in a household.

When analyzing the data, the researchers controlled for gender differences, month of disease onset, testing delay, and mean family size.

The role of young children in transmission seemed logical to some experts who have been tracking the evolution of the pandemic. “I think what was more surprising was how long the narrative persisted that children weren’t transmitting SARS-CoV-2,” said Samuel Scarpino, PhD, managing director of pathogen surveillance at the Rockefeller Foundation.

Meanwhile, less mask-wearing, the return to school and activities, and the onslaught of the Delta variant have changed the dynamics of spread, said Andrew Pavia, MD, chief of the division of pediatric infectious diseases at the University of Utah.

“Adolescents and high-school-aged kids have had much, much higher rates of infection in the past,” he said. “Now when we look at the rates of school-aged kids, they are the same as high-school-aged kids, and we’re seeing more and more in the preschool age groups.”
 

Cases may be underestimated

If anything, the study may underestimate the role young children play in spreading COVID-19 in families, since it included only symptomatic cases as the initial source and young children are more likely to be asymptomatic, Dr. Pavia said.

The Delta variant heightens the concern; it is more than twice as infectious as previous strains and has spurred a rise in pediatric cases, including some coinfection with other circulating respiratory diseases, such as respiratory syncytial virus (RSV).

The Ontario study covers a period before vaccination and the spread of the Delta variant. “As the number of pediatric cases increases worldwide, the role of children in household transmission will continue to grow,” the authors concluded.

Following recommended respiratory hygiene is clearly more difficult with very young children. For example, parents, caregivers, and older siblings aren’t going to stay 6 feet away from a sick baby or toddler, Susan Coffin, MD, MPH, a pediatric infectious disease physician, and David Rubin, MD, a pediatrician and director of PolicyLab at Children’s Hospital of Philadelphia, noted in an accompanying commentary.

“Cuddling and touching are part and parcel of taking care of a sick young child, and that will obviously come with an increased risk of transmission to parents as well as to older siblings who may be helping to care for their sick brother or sister,” they wrote.

While parents may wash their hands more frequently when caring for a sick child, they aren’t likely to wear a mask, said William Schaffner, MD, an infectious disease specialist at Vanderbilt University, Nashville, Tenn.

“I imagine some moms even take a sick child into bed with them,” he said. “It’s probably just the extensive contact one has with a sick, very small child that augments their capacity to transmit this infection.”
 

What can be done

What can be done, then, to reduce the household spread of COVID-19? “The obvious solution to protect a household with a sick young infant or toddler is to make sure that all eligible members of the household are vaccinated,” Dr. Coffin and Dr. Rubin stated in their commentary.

The American Academy of Pediatrics recently wrote to Janet Woodcock, MD, acting commissioner of the Food and Drug Administration, asking for the agency to authorize use of SARS-CoV-2 vaccines for children under age 12 “as soon as possible,” noting that “the Delta variant has created a new and pressing risk to children and adolescents across this country, as it has also done for unvaccinated adults.”

The FDA reportedly asked vaccine makers Pfizer and Moderna to expand the clinical trials of children, which may delay authorization for younger age groups. Pfizer has said it plans to submit a request for emergency use authorization of its vaccine for 5- to 11-year-olds in September or October.

As with adult vaccination, hesitancy is likely to be a barrier. Less than half of parents said they are very or somewhat likely to have their children get a COVID-19 vaccine, according to a national survey conducted by researchers at the University of California, Los Angeles.

The Ontario study provides valuable evidence to support taking steps to protect children from transmission in schools, including mask requirements, frequent testing, and improved ventilation, said Dr. Scarpino.

“We’re not going to be able to control COVID without vaccinating younger individuals,” he said.

Dr. Pavia has consulted for GlaxoSmithKline on non–COVID-19–related issues. Sarah Buchan, PhD, study author and scientist at Public Health Ontario, reported grants from the Canadian Institutes of Health Research for research on influenza, RSV, and COVID-19, and grants from the Canadian Immunity Task Force for COVID-19 outside the submitted work. Dr. Coffin reported grants as a Centers for Disease Control and Prevention coinvestigator at a Vaccine and Treatment Evaluation Unit site conducting COVID-19 vaccine trials in children. Dr. Scarpino holds unexercised options in ILiAD Biotechnologies, which is focused on the prevention and treatment of pertussis. Dr. Schaffner is a consultant for VBI Vaccines.

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

The Diagnosis: Disseminated Coccidioidomycosis

A6-mm punch biopsy was performed at the periphery of the ulcerated cutaneous lesion on the chest revealing extensive spherules. Serum antibody immunodiffusion for histoplasmosis and blastomycoses both were negative; however, B-D-glucan assay was positive at 364 pg/mL (reference range: <60 pg/mL, negative). Initial HIV-1 and HIV-2 antibody and antigen testing was negative as well as repeat testing at 3 weeks. Immunodiffusion for Coccidioides IgM and IgG was positive, and cocci antibody IgG complement fixation assays were positive at titers of 1:64 (reference range: <1:2, negative). A computed tomography needle-guided biopsy of the paravertebral soft tissue was performed. Gram stains and bacterial cultures of the biopsies were negative; however, fungal cultures were notable for growth of Coccidioides. Given the pertinent testing, a diagnosis of disseminated coccidioidomycosis was made.

Cutaneous coccidioidomycosis can occur in 3 situations: direct inoculation (primary cutaneous coccidioidomycosis), disseminated infection (disseminated cutaneous coccidioidomycosis), or as a reactive component of pulmonary infection.^1,2 Of them, primary and disseminated cutaneous coccidioidomycosis are organism specific and display characteristic spherules and fungus on histopathology and cultures, respectively. Reactive coccidioidomycosis differs from organism-specific disease, as it does not contain spherules in histopathologic sections of tissue biopsies.¹ Reactive skin manifestations occur in 12% to 50% of patients with primary pulmonary infection and include erythema nodosum, erythema multiforme, acute generalized exanthema, reactive interstitial granulomatous dermatitis, and Sweet syndrome.³

Organism-specific cutaneous coccidioidomycosis most often is correlated with hematogenous dissemination of primary pulmonary disease rather than direct inoculation of skin.¹ The skin is the most common site of extrapulmonary involvement in disseminated coccidioidomycosis, and cutaneous lesions have been reported in 15% to 67% of cases of disseminated disease.^1,4 In cutaneous disseminated disease, nodules, papules, macules, and verrucous plaques have been described. In a case series of disseminated cutaneous coccidioidomycosis, nodules were the most common cutaneous presentation and occurred in 39% (7/18) of patients, while verrucous plaques were the rarest and occurred in only 6% (1/18) of patients.⁵

The rate of coccidioidomycosis dissemination varies based on exposure and patient characteristics. Increased rates of dissemination have been reported in patients of African and Filipino descent, along with individuals that are immunosuppressed due to disease or medical therapy. Dissemination is clinically significant, as patients with multifocal dissemination have a greater than 50% risk for mortality.⁶

Disseminated coccidioidomycosis is a relatively rare manifestation of Coccidioides infection; approximately 1.6% of patients exposed to and infected with Coccidioides ultimately will develop systemic or disseminated disease.^7,8 Although the rates of primary pulmonary infection are similar between patients of varying ethnicities, the rates of dissemination are higher in patients of African and Filipino ethnicity.⁸ In population studies of coccidioidomycosis (N=332), Black patients represented 33.3% (4/12) of disseminated cases but only 8.7% of Coccidioides cases overall.⁷

Population studies of Black patients with coccidioidomycosis have shown a 4-fold higher predisposition for severe disease compared to mild disease.⁹ Spondylitis and meningitis also are disproportionately more common in Black patients.⁸ Black patients comprised 75% of all spondylitis cases in a cohort where only 25% of patients were Black. Additionally, 33% of all meningitis cases occurred in Black patients in a cohort where 8% of total cases were Black patients.⁸ Within the United States, the highest rates of coccidioidomycosis meningitis are seen in Black patients.¹⁰

The pathophysiology underlying the increased susceptibility of individuals of African or Filipino descent to disseminated and severe coccidioidomycosis remains unknown.⁸ The level of vulnerability within this patient population has no association with increased environmental exposure or poor immunologic response to Coccidioides, as demonstrated by the ability of these populations to respond to experimental vaccination and skin testing (spherulin, coccidioidin) to a similar extent as other ethnicities.⁸ Class II HLA-DRB1*1301 alleles have been associated with an increased risk for severe disseminated Coccidioides infection regardless of ethnicity; however, these alleles are not overrepresented in these patient populations.⁸

In patients with primary pulmonary coccidioidomycosis with no evidence of dissemination, guidelines generally recommend offering treatment to groups at high risk of dissemination, such as pregnant women and patients with diabetes mellitus. Given the high incidence of disseminated and severe disease in Black and Filipino patients, some guidelines endorse treatment of all cases of coccidioidomycosis in this patient population.⁸ No current data are available to help determine whether this broad treatment approach reduces the development of disseminated infection in these populations. Frequent monitoring for disease progression and/or dissemination involving clinical and laboratory reevaluation every 3 months for 2 years is highly recommended.⁸

Treatment generally is based on location and severity of infection, with disseminated nonmeningeal infection being treated with oral azole therapy (ketoconazole, itraconazole, or fluconazole).¹¹ If there is involvement of the central nervous system structures or rapidly worsening disease despite azole therapy, amphotericin B is recommended at 0.5 to 0.7 mg/kg daily. In patients with disseminated meningeal infection, oral fluconazole (800–1000 mg/d) or a combination of an azole with intrathecal amphotericin B (0.01–1.5 mg/dose, interval ranging from daily to 1 week) is recommended to improve response.¹¹

The differential diagnosis of cutaneous disseminated coccidioidomycosis is broad and includes other systemic endemic mycoses (histoplasmosis, blastomycosis) and infections (mycobacteria, leishmania). Lupus vulgaris, a form of cutaneous tuberculosis, presents as a palpable tubercular lesion that may coalesce into erythematous plaques, which may mimic endemic mycoses, especially in patients with risk factors for both infectious etiologies such as our patient.¹² Disseminated histoplasmosis may present as polymorphic plaques, pustules, nodules, and ulcerated skin lesions, whereas disseminated blastomycosis characteristically presents as a crusted verrucous lesion with raised borders and painful ulcers, both of which may mimic coccidioidomycosis.¹³ Biopsy would reveal the characteristic intracellular yeast in Histoplasma capsulatum and broad-based budding yeast form of Blastomyces dermatitidis in histoplasmosis and blastomycosis, respectively, in contrast to the spherules seen in our patient’s biopsy.¹³ Localized cutaneous leishmaniasis initially develops as a nodular or papular lesion and can progress to open ulcerations with raised borders. Biopsy and histopathology would reveal round protozoal amastigotes.¹⁴ Other diagnoses that should be considered include mycetoma, nocardiosis, and sporotrichosis.¹⁵ As the cutaneous manifestations of Coccidioides infections are varied, a broad differential diagnosis should be maintained, and probable environmental and infectious exposures should be considered prior to ordering diagnostic studies.

The Diagnosis: Disseminated Coccidioidomycosis

A6-mm punch biopsy was performed at the periphery of the ulcerated cutaneous lesion on the chest revealing extensive spherules. Serum antibody immunodiffusion for histoplasmosis and blastomycoses both were negative; however, B-D-glucan assay was positive at 364 pg/mL (reference range: <60 pg/mL, negative). Initial HIV-1 and HIV-2 antibody and antigen testing was negative as well as repeat testing at 3 weeks. Immunodiffusion for Coccidioides IgM and IgG was positive, and cocci antibody IgG complement fixation assays were positive at titers of 1:64 (reference range: <1:2, negative). A computed tomography needle-guided biopsy of the paravertebral soft tissue was performed. Gram stains and bacterial cultures of the biopsies were negative; however, fungal cultures were notable for growth of Coccidioides. Given the pertinent testing, a diagnosis of disseminated coccidioidomycosis was made.

Cutaneous coccidioidomycosis can occur in 3 situations: direct inoculation (primary cutaneous coccidioidomycosis), disseminated infection (disseminated cutaneous coccidioidomycosis), or as a reactive component of pulmonary infection.^1,2 Of them, primary and disseminated cutaneous coccidioidomycosis are organism specific and display characteristic spherules and fungus on histopathology and cultures, respectively. Reactive coccidioidomycosis differs from organism-specific disease, as it does not contain spherules in histopathologic sections of tissue biopsies.¹ Reactive skin manifestations occur in 12% to 50% of patients with primary pulmonary infection and include erythema nodosum, erythema multiforme, acute generalized exanthema, reactive interstitial granulomatous dermatitis, and Sweet syndrome.³

Organism-specific cutaneous coccidioidomycosis most often is correlated with hematogenous dissemination of primary pulmonary disease rather than direct inoculation of skin.¹ The skin is the most common site of extrapulmonary involvement in disseminated coccidioidomycosis, and cutaneous lesions have been reported in 15% to 67% of cases of disseminated disease.^1,4 In cutaneous disseminated disease, nodules, papules, macules, and verrucous plaques have been described. In a case series of disseminated cutaneous coccidioidomycosis, nodules were the most common cutaneous presentation and occurred in 39% (7/18) of patients, while verrucous plaques were the rarest and occurred in only 6% (1/18) of patients.⁵

The rate of coccidioidomycosis dissemination varies based on exposure and patient characteristics. Increased rates of dissemination have been reported in patients of African and Filipino descent, along with individuals that are immunosuppressed due to disease or medical therapy. Dissemination is clinically significant, as patients with multifocal dissemination have a greater than 50% risk for mortality.⁶

Disseminated coccidioidomycosis is a relatively rare manifestation of Coccidioides infection; approximately 1.6% of patients exposed to and infected with Coccidioides ultimately will develop systemic or disseminated disease.^7,8 Although the rates of primary pulmonary infection are similar between patients of varying ethnicities, the rates of dissemination are higher in patients of African and Filipino ethnicity.⁸ In population studies of coccidioidomycosis (N=332), Black patients represented 33.3% (4/12) of disseminated cases but only 8.7% of Coccidioides cases overall.⁷

Population studies of Black patients with coccidioidomycosis have shown a 4-fold higher predisposition for severe disease compared to mild disease.⁹ Spondylitis and meningitis also are disproportionately more common in Black patients.⁸ Black patients comprised 75% of all spondylitis cases in a cohort where only 25% of patients were Black. Additionally, 33% of all meningitis cases occurred in Black patients in a cohort where 8% of total cases were Black patients.⁸ Within the United States, the highest rates of coccidioidomycosis meningitis are seen in Black patients.¹⁰

The pathophysiology underlying the increased susceptibility of individuals of African or Filipino descent to disseminated and severe coccidioidomycosis remains unknown.⁸ The level of vulnerability within this patient population has no association with increased environmental exposure or poor immunologic response to Coccidioides, as demonstrated by the ability of these populations to respond to experimental vaccination and skin testing (spherulin, coccidioidin) to a similar extent as other ethnicities.⁸ Class II HLA-DRB1*1301 alleles have been associated with an increased risk for severe disseminated Coccidioides infection regardless of ethnicity; however, these alleles are not overrepresented in these patient populations.⁸

In patients with primary pulmonary coccidioidomycosis with no evidence of dissemination, guidelines generally recommend offering treatment to groups at high risk of dissemination, such as pregnant women and patients with diabetes mellitus. Given the high incidence of disseminated and severe disease in Black and Filipino patients, some guidelines endorse treatment of all cases of coccidioidomycosis in this patient population.⁸ No current data are available to help determine whether this broad treatment approach reduces the development of disseminated infection in these populations. Frequent monitoring for disease progression and/or dissemination involving clinical and laboratory reevaluation every 3 months for 2 years is highly recommended.⁸

Treatment generally is based on location and severity of infection, with disseminated nonmeningeal infection being treated with oral azole therapy (ketoconazole, itraconazole, or fluconazole).¹¹ If there is involvement of the central nervous system structures or rapidly worsening disease despite azole therapy, amphotericin B is recommended at 0.5 to 0.7 mg/kg daily. In patients with disseminated meningeal infection, oral fluconazole (800–1000 mg/d) or a combination of an azole with intrathecal amphotericin B (0.01–1.5 mg/dose, interval ranging from daily to 1 week) is recommended to improve response.¹¹

The differential diagnosis of cutaneous disseminated coccidioidomycosis is broad and includes other systemic endemic mycoses (histoplasmosis, blastomycosis) and infections (mycobacteria, leishmania). Lupus vulgaris, a form of cutaneous tuberculosis, presents as a palpable tubercular lesion that may coalesce into erythematous plaques, which may mimic endemic mycoses, especially in patients with risk factors for both infectious etiologies such as our patient.¹² Disseminated histoplasmosis may present as polymorphic plaques, pustules, nodules, and ulcerated skin lesions, whereas disseminated blastomycosis characteristically presents as a crusted verrucous lesion with raised borders and painful ulcers, both of which may mimic coccidioidomycosis.¹³ Biopsy would reveal the characteristic intracellular yeast in Histoplasma capsulatum and broad-based budding yeast form of Blastomyces dermatitidis in histoplasmosis and blastomycosis, respectively, in contrast to the spherules seen in our patient’s biopsy.¹³ Localized cutaneous leishmaniasis initially develops as a nodular or papular lesion and can progress to open ulcerations with raised borders. Biopsy and histopathology would reveal round protozoal amastigotes.¹⁴ Other diagnoses that should be considered include mycetoma, nocardiosis, and sporotrichosis.¹⁵ As the cutaneous manifestations of Coccidioides infections are varied, a broad differential diagnosis should be maintained, and probable environmental and infectious exposures should be considered prior to ordering diagnostic studies.

The Diagnosis: Disseminated Coccidioidomycosis

A6-mm punch biopsy was performed at the periphery of the ulcerated cutaneous lesion on the chest revealing extensive spherules. Serum antibody immunodiffusion for histoplasmosis and blastomycoses both were negative; however, B-D-glucan assay was positive at 364 pg/mL (reference range: <60 pg/mL, negative). Initial HIV-1 and HIV-2 antibody and antigen testing was negative as well as repeat testing at 3 weeks. Immunodiffusion for Coccidioides IgM and IgG was positive, and cocci antibody IgG complement fixation assays were positive at titers of 1:64 (reference range: <1:2, negative). A computed tomography needle-guided biopsy of the paravertebral soft tissue was performed. Gram stains and bacterial cultures of the biopsies were negative; however, fungal cultures were notable for growth of Coccidioides. Given the pertinent testing, a diagnosis of disseminated coccidioidomycosis was made.

Cutaneous coccidioidomycosis can occur in 3 situations: direct inoculation (primary cutaneous coccidioidomycosis), disseminated infection (disseminated cutaneous coccidioidomycosis), or as a reactive component of pulmonary infection.^1,2 Of them, primary and disseminated cutaneous coccidioidomycosis are organism specific and display characteristic spherules and fungus on histopathology and cultures, respectively. Reactive coccidioidomycosis differs from organism-specific disease, as it does not contain spherules in histopathologic sections of tissue biopsies.¹ Reactive skin manifestations occur in 12% to 50% of patients with primary pulmonary infection and include erythema nodosum, erythema multiforme, acute generalized exanthema, reactive interstitial granulomatous dermatitis, and Sweet syndrome.³

Organism-specific cutaneous coccidioidomycosis most often is correlated with hematogenous dissemination of primary pulmonary disease rather than direct inoculation of skin.¹ The skin is the most common site of extrapulmonary involvement in disseminated coccidioidomycosis, and cutaneous lesions have been reported in 15% to 67% of cases of disseminated disease.^1,4 In cutaneous disseminated disease, nodules, papules, macules, and verrucous plaques have been described. In a case series of disseminated cutaneous coccidioidomycosis, nodules were the most common cutaneous presentation and occurred in 39% (7/18) of patients, while verrucous plaques were the rarest and occurred in only 6% (1/18) of patients.⁵

The rate of coccidioidomycosis dissemination varies based on exposure and patient characteristics. Increased rates of dissemination have been reported in patients of African and Filipino descent, along with individuals that are immunosuppressed due to disease or medical therapy. Dissemination is clinically significant, as patients with multifocal dissemination have a greater than 50% risk for mortality.⁶

Disseminated coccidioidomycosis is a relatively rare manifestation of Coccidioides infection; approximately 1.6% of patients exposed to and infected with Coccidioides ultimately will develop systemic or disseminated disease.^7,8 Although the rates of primary pulmonary infection are similar between patients of varying ethnicities, the rates of dissemination are higher in patients of African and Filipino ethnicity.⁸ In population studies of coccidioidomycosis (N=332), Black patients represented 33.3% (4/12) of disseminated cases but only 8.7% of Coccidioides cases overall.⁷

Population studies of Black patients with coccidioidomycosis have shown a 4-fold higher predisposition for severe disease compared to mild disease.⁹ Spondylitis and meningitis also are disproportionately more common in Black patients.⁸ Black patients comprised 75% of all spondylitis cases in a cohort where only 25% of patients were Black. Additionally, 33% of all meningitis cases occurred in Black patients in a cohort where 8% of total cases were Black patients.⁸ Within the United States, the highest rates of coccidioidomycosis meningitis are seen in Black patients.¹⁰

The pathophysiology underlying the increased susceptibility of individuals of African or Filipino descent to disseminated and severe coccidioidomycosis remains unknown.⁸ The level of vulnerability within this patient population has no association with increased environmental exposure or poor immunologic response to Coccidioides, as demonstrated by the ability of these populations to respond to experimental vaccination and skin testing (spherulin, coccidioidin) to a similar extent as other ethnicities.⁸ Class II HLA-DRB1*1301 alleles have been associated with an increased risk for severe disseminated Coccidioides infection regardless of ethnicity; however, these alleles are not overrepresented in these patient populations.⁸

In patients with primary pulmonary coccidioidomycosis with no evidence of dissemination, guidelines generally recommend offering treatment to groups at high risk of dissemination, such as pregnant women and patients with diabetes mellitus. Given the high incidence of disseminated and severe disease in Black and Filipino patients, some guidelines endorse treatment of all cases of coccidioidomycosis in this patient population.⁸ No current data are available to help determine whether this broad treatment approach reduces the development of disseminated infection in these populations. Frequent monitoring for disease progression and/or dissemination involving clinical and laboratory reevaluation every 3 months for 2 years is highly recommended.⁸

Treatment generally is based on location and severity of infection, with disseminated nonmeningeal infection being treated with oral azole therapy (ketoconazole, itraconazole, or fluconazole).¹¹ If there is involvement of the central nervous system structures or rapidly worsening disease despite azole therapy, amphotericin B is recommended at 0.5 to 0.7 mg/kg daily. In patients with disseminated meningeal infection, oral fluconazole (800–1000 mg/d) or a combination of an azole with intrathecal amphotericin B (0.01–1.5 mg/dose, interval ranging from daily to 1 week) is recommended to improve response.¹¹

The differential diagnosis of cutaneous disseminated coccidioidomycosis is broad and includes other systemic endemic mycoses (histoplasmosis, blastomycosis) and infections (mycobacteria, leishmania). Lupus vulgaris, a form of cutaneous tuberculosis, presents as a palpable tubercular lesion that may coalesce into erythematous plaques, which may mimic endemic mycoses, especially in patients with risk factors for both infectious etiologies such as our patient.¹² Disseminated histoplasmosis may present as polymorphic plaques, pustules, nodules, and ulcerated skin lesions, whereas disseminated blastomycosis characteristically presents as a crusted verrucous lesion with raised borders and painful ulcers, both of which may mimic coccidioidomycosis.¹³ Biopsy would reveal the characteristic intracellular yeast in Histoplasma capsulatum and broad-based budding yeast form of Blastomyces dermatitidis in histoplasmosis and blastomycosis, respectively, in contrast to the spherules seen in our patient’s biopsy.¹³ Localized cutaneous leishmaniasis initially develops as a nodular or papular lesion and can progress to open ulcerations with raised borders. Biopsy and histopathology would reveal round protozoal amastigotes.¹⁴ Other diagnoses that should be considered include mycetoma, nocardiosis, and sporotrichosis.¹⁵ As the cutaneous manifestations of Coccidioides infections are varied, a broad differential diagnosis should be maintained, and probable environmental and infectious exposures should be considered prior to ordering diagnostic studies.