Infectious Diseases

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

Almost 36% of students and faculty at George Washington University with a history of COVID-19 reported symptoms consistent with long COVID in a new study.

With a median age of 23 years, the study is unique for evaluating mostly healthy, young adults and for its rare look at long COVID in a university community. 

The more symptoms during a bout with COVID, the greater the risk for long COVID, the researchers found. That lines up with previous studies. Also, the more vaccinations and booster shots against SARS-CoV-2, the virus that causes COVID, the lower the long COVID risk.

Women were more likely than men to be affected. Current or prior smoking, seeking medical care for COVID, and receiving antibody treatment also were linked to higher chances for developing long COVID. 

Lead author Megan Landry, DrPH, MPH, and colleagues were already assessing students, staff, and faculty at George Washington University, Washington, who tested positive for COVID. Then they started seeing symptoms that lasted 28 days or more after their 10-day isolation period. 

“We were starting to recognize that individuals ... were still having symptoms longer than the typical isolation period,” said Dr. Landry. So they developed a questionnaire to figure out the how long these symptoms last and how many people are affected by them. 

The list of potential symptoms was long and included trouble thinking, fatigue, loss of smell or taste, shortness of breath, and more. 

The study was published online in Emerging Infectious Diseases. Results are based on records and responses from 1,388 students, faculty, and staff from July 2021 to March 2022.

People had a median of four long COVID symptoms, about 63% were women, and 56% were non-Hispanic White. About three-quarters were students and the remainder were faculty and staff. 

The finding that 36% of people with a history of COVID reported long COVID symptoms did not surprise Dr. Landry.

“Based on the literature that’s currently out there, it ranges from a 10% to an 80% prevalence of long COVID,” she said. “We kind of figured that we would fall somewhere in there.”

In contrast, that figure seemed high to Eric Topol, MD.

“That’s really high,” said Dr. Topol, founder and director of the Scripps Research Translational Institute in La Jolla, Calif. He added most studies estimate that about 10% of people with a history of acute infection develop long COVID. 

Even at 10%, which could be an underestimate, that’s a lot of affected people globally. 

“At least 65 million individuals around the world have long COVID, based on a conservative estimated incidence of 10% of infected people and more than 651 million documented COVID-19 cases worldwide; the number is likely much higher due to many undocumented cases,” Dr. Topol and colleagues wrote in a long COVID review article published in Nature Reviews Microbiology.

Research continues

“Long COVID is still evolving and we continue to learn more about it every day,” Landry said. “It’s just so new and there are still a lot of unknowns. That’s why it’s important to get this information out.” 

People with long COVID often have a hard time with occupational, educational, social, or personal activities, compared with before COVID, with effects that can last for more than 6 months, the authors noted. 

“I think across the board, universities in general need to consider the possibility of folks on their campuses are having symptoms of long COVID,” Dr. Landry said.

Moving forward, Dr. Landry and colleagues would like to continue investigating long COVID. For example, in the current study, they did not ask about severity of symptoms or how the symptoms affected daily functioning. 

“I would like to continue this and dive deeper into how disruptive their symptoms of long COVID are to their everyday studying, teaching, or their activities to keeping a university running,” Dr. Landry said.

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

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.

ILLUSTRATIVE CASE

A 52-year-old woman presents to the emergency department complaining of dysuria and a fever. Her work-up yields a diagnosis of sepsis secondary to pyelonephritis and bacteremia. She is admitted and started on broad-spectrum antimicrobial therapy. The patient’s symptoms improve significantly over the next 48 hours of treatment. When should antibiotic therapy be discontinued to reduce the patient’s risk for antibiotic-associated AEs and to optimize antimicrobial stewardship?

Antimicrobial resistance is a growing public health risk associated with considerable morbidity and mortality, extended hospitalization, and increased medical expenditures.^2-4 Antibiotic stewardship is vital in curbing antimicrobial resistance. The predictive biomarker PCT has emerged as both a diagnostic and prognostic agent for numerous infectious diseases. It has recently received much attention as an adjunct to clinical judgment for discontinuation of antibiotic therapy in hospitalized patients with lower respiratory tract infections and/or sepsis.^5-11 Indeed, use of PCT guidance in these patients has resulted in decreased AEs, as well as an enhanced survival benefit.^5-15

The utility of PCT-guided early discontinuation of antibiotics had yet to be studied in an expanded population of hospitalized patients with sepsis—especially with regard to AEs associated with multidrug-resistant organisms (MDROs) and Clostridioides difficile (formerly Clostridium difficile). The Surviving Sepsis Campaign’s 2021 international guidelines support the use of PCT in conjunction with clinical evaluation for shortening the duration of antibiotic therapy (“weak recommendation, low quality of evidence”).¹⁶ They also suggest daily reassessment for de-­escalation of antibiotic use (“weak recommendation, very low quality of evidence”) as a possible way to decrease MDROs and AEs but state that more and better trials are needed.¹⁵

STUDY SUMMARY

PCT-guided intervention reduced infection-associated AEs

This pragmatic, real-world, multicenter, randomized clinical trial evaluated the use of PCT-guided early discontinuation of antibiotic therapy in patients with sepsis, in hopes of decreasing infection-associated AEs related to prolonged antibiotic exposure.¹ The trial took place in 7 hospitals in Athens, Greece, with 266 patients randomized to the PCT-guided intervention or the standard of care (SOC)—the 2016 international guidelines for the management of sepsis and septic shock from the Surviving Sepsis campaign.¹⁷ Study participants had sepsis, as defined by a sequential organ failure assessment (SOFA) score ≥ 2, and infections that included pneumonia, pyelonephritis, or bacteremia.¹⁶ Pregnancy, lactation, HIV infection with a low CD4 count, neutropenia, cystic fibrosis, and viral, parasitic, or tuberculosis infections were exclusion criteria. Of note, all patients were managed on general medical wards and not in intensive care units.

This trial demonstrated the benefit of PCT-guided antimicrobial therapy in reducing infection-associated AEs, length of antibiotic treatment, and 28-day mortality for patients with sepsis.

Serum PCT samples were collected at baseline and then at Day 5 of therapy. ­Discontinuation of antibiotic therapy in the PCT trial arm occurred once PCT levels were ≤ 0.5 mcg/L or were reduced by at least 80%. If PCT levels did not meet one of these criteria, the lab test would be repeated daily and antibiotic therapy would continue until the rule was met. Neither patients nor investigators were blinded to the treatment assignments, but investigators in the SOC arm were kept unaware of Day 5 PCT results. In the PCT arm, 71% of participants met Day 5 criteria for stopping antibiotics, and a retrospective analysis indicated that a near-identical 70% in the SOC arm also would have met the same criteria.

The assessment of stool colonization with either C difficile or MDROs was done by stool cultures at baseline and on Days 7, 28, and 180.

The primary outcome of infection-­associated AEs, which was evaluated at 180 days, was defined as new cases of C difficile or MDRO infection, or death associated with baseline infection with either C difficile or an MDRO. Of the 133 participants allocated to each trial arm, 8 patients in the intervention group and 2 in the SOC group withdrew consent prior to treatment in the intervention group, with the remaining 125 and 131 participants, respectively, completing the interventions and not lost to follow-up.

Continue to: In an intention-to-treat analysis...

In an intention-to-treat analysis, 9 participants (7.2%; 95% CI, 3.8%-13.1%) in the PCT group compared with 20 participants (15.3%; 95% CI, 10.1%-22.4%) in the SOC group experienced the primary outcome of an antibiotic-associated AE at 180 days, resulting in a hazard ratio (HR) of 0.45 (95% CI, 0.2-0.98).

Secondary outcomes also favored the PCT arm regarding 28-day mortality (19 vs 37 patients; HR = 0.51; 95% CI, 0.29-0.89), median length of antibiotic treatment (5 days in the PCT group and 10 days in the SOC group; P < .001), and median hospitalization cost (24% greater in the SOC group; P = .05). Results for 180-day mortality were 30.4% in the PCT arm and 38.2% in the SOC arm (HR = 0.71; 95% CI, 0.42-1.19), thereby not achieving statistical significance.

WHAT'S NEW

An effective tool in reducing AEs in patients with sepsis

In this multicenter trial, PCT proved successful as a clinical decision tool for discontinuing antibiotic therapy and decreasing infection-associated AEs in patients with sepsis.

Caveats

A promising approach but its superiority is uncertain

The confidence interval for the AE hazard ratio was very wide, but significant, suggesting greater uncertainty and less precision in the chance of obtaining improved outcomes with PCT-guided intervention. However, these data also clarify that outcomes should (at least) not be worse with PCT-directed therapy.

CHALLENGES TO IMPLEMENTATION

Assay limitations and potential resistance to a new decision tool

The primary challenge to implementation is likely the availability of the PCT assay and the immediacy of turnaround time to enable physicians to make daily decisions regarding antibiotic therapy de-escalation. Additionally, as with any new knowledge, local culture and physician buy-in may limit implementation of this ever-more-valuable patient care tool.

People hospitalized with viral infections like the flu are more likely to have disorders that degrade the nervous system, like Alzheimer’s or Parkinson’s, later in life, a new analysis shows. 

Researchers found 22 links between viruses and common neurologic conditions often seen in older people. The viruses included influenza, encephalitis, herpes, hepatitis, pneumonia, meningitis, and shingles. Those viruses were linked to one or more of these conditions: Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), dementia, and multiple sclerosis.

The authors of the study, which was published this month in the journal Neuron, cautioned that their findings stopped short of saying the viruses caused the disorders. 

“Neurodegenerative disorders are a collection of diseases for which there are very few effective treatments and many risk factors,” study author and National Institutes of Health researcher Andrew B. Singleton, PhD, said in a news release from the NIH. “Our results support the idea that viral infections and related inflammation in the nervous system may be common – and possibly avoidable – risk factors for these types of disorders.”

For the study, two data sets were analyzed with a combined 800,000 medical records for people in Finland and the United Kingdom. People who were hospitalized with COVID-19 were excluded from the study.

Generalized dementia was the condition linked to the most viruses. People exposed to viral encephalitis, which causes brain inflammation, were 20 times more likely to be diagnosed with Alzheimer’s, compared with those who were not diagnosed with that virus.

Both influenza and pneumonia were also associated with all of the neurodegenerative disorder diagnoses studied, with the exception of multiple sclerosis. The researchers found that severe flu cases were linked to the most risks.

“Keep in mind that the individuals we studied did not have the common cold. Their infections made them so sick that they had to go to the hospital,” said study author and NIH researcher Michael Nalls, PhD. “Nevertheless, the fact that commonly used vaccines reduce the risk or severity of many of the viral illnesses observed in this study raises the possibility that the risks of neurodegenerative disorders might also be mitigated.”

The researchers examined the time from when someone was infected with a virus to the time when they were diagnosed with one of the neurodegenerative disorders. They found that most had a high risk within 1 year of infection. But in six scenarios, there were significant links that showed up after 5-15 years.

The authors wrote that vaccines that are available for some of the viruses studied may be a way to reduce the risk of getting diseases that degrade the nervous system.

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

People hospitalized with viral infections like the flu are more likely to have disorders that degrade the nervous system, like Alzheimer’s or Parkinson’s, later in life, a new analysis shows. 

Researchers found 22 links between viruses and common neurologic conditions often seen in older people. The viruses included influenza, encephalitis, herpes, hepatitis, pneumonia, meningitis, and shingles. Those viruses were linked to one or more of these conditions: Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), dementia, and multiple sclerosis.

The authors of the study, which was published this month in the journal Neuron, cautioned that their findings stopped short of saying the viruses caused the disorders. 

“Neurodegenerative disorders are a collection of diseases for which there are very few effective treatments and many risk factors,” study author and National Institutes of Health researcher Andrew B. Singleton, PhD, said in a news release from the NIH. “Our results support the idea that viral infections and related inflammation in the nervous system may be common – and possibly avoidable – risk factors for these types of disorders.”

For the study, two data sets were analyzed with a combined 800,000 medical records for people in Finland and the United Kingdom. People who were hospitalized with COVID-19 were excluded from the study.

Generalized dementia was the condition linked to the most viruses. People exposed to viral encephalitis, which causes brain inflammation, were 20 times more likely to be diagnosed with Alzheimer’s, compared with those who were not diagnosed with that virus.

Both influenza and pneumonia were also associated with all of the neurodegenerative disorder diagnoses studied, with the exception of multiple sclerosis. The researchers found that severe flu cases were linked to the most risks.

“Keep in mind that the individuals we studied did not have the common cold. Their infections made them so sick that they had to go to the hospital,” said study author and NIH researcher Michael Nalls, PhD. “Nevertheless, the fact that commonly used vaccines reduce the risk or severity of many of the viral illnesses observed in this study raises the possibility that the risks of neurodegenerative disorders might also be mitigated.”

The researchers examined the time from when someone was infected with a virus to the time when they were diagnosed with one of the neurodegenerative disorders. They found that most had a high risk within 1 year of infection. But in six scenarios, there were significant links that showed up after 5-15 years.

The authors wrote that vaccines that are available for some of the viruses studied may be a way to reduce the risk of getting diseases that degrade the nervous system.

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

People hospitalized with viral infections like the flu are more likely to have disorders that degrade the nervous system, like Alzheimer’s or Parkinson’s, later in life, a new analysis shows. 

Researchers found 22 links between viruses and common neurologic conditions often seen in older people. The viruses included influenza, encephalitis, herpes, hepatitis, pneumonia, meningitis, and shingles. Those viruses were linked to one or more of these conditions: Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis (ALS), dementia, and multiple sclerosis.

The authors of the study, which was published this month in the journal Neuron, cautioned that their findings stopped short of saying the viruses caused the disorders. 

“Neurodegenerative disorders are a collection of diseases for which there are very few effective treatments and many risk factors,” study author and National Institutes of Health researcher Andrew B. Singleton, PhD, said in a news release from the NIH. “Our results support the idea that viral infections and related inflammation in the nervous system may be common – and possibly avoidable – risk factors for these types of disorders.”

For the study, two data sets were analyzed with a combined 800,000 medical records for people in Finland and the United Kingdom. People who were hospitalized with COVID-19 were excluded from the study.

Generalized dementia was the condition linked to the most viruses. People exposed to viral encephalitis, which causes brain inflammation, were 20 times more likely to be diagnosed with Alzheimer’s, compared with those who were not diagnosed with that virus.

Both influenza and pneumonia were also associated with all of the neurodegenerative disorder diagnoses studied, with the exception of multiple sclerosis. The researchers found that severe flu cases were linked to the most risks.

“Keep in mind that the individuals we studied did not have the common cold. Their infections made them so sick that they had to go to the hospital,” said study author and NIH researcher Michael Nalls, PhD. “Nevertheless, the fact that commonly used vaccines reduce the risk or severity of many of the viral illnesses observed in this study raises the possibility that the risks of neurodegenerative disorders might also be mitigated.”

The researchers examined the time from when someone was infected with a virus to the time when they were diagnosed with one of the neurodegenerative disorders. They found that most had a high risk within 1 year of infection. But in six scenarios, there were significant links that showed up after 5-15 years.

The authors wrote that vaccines that are available for some of the viruses studied may be a way to reduce the risk of getting diseases that degrade the nervous system.

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

U.S. health officials want to simplify the recommended COVID-19 vaccine protocol, making it more like the process for annual flu shots.

The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases. 

Some people, such as those who are older or immunocompromised, may need more than one dose.

A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.

People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.

About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.

The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.

COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.

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

U.S. health officials want to simplify the recommended COVID-19 vaccine protocol, making it more like the process for annual flu shots.

The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases. 

Some people, such as those who are older or immunocompromised, may need more than one dose.

A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.

People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.

About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.

The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.

COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.

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

U.S. health officials want to simplify the recommended COVID-19 vaccine protocol, making it more like the process for annual flu shots.

The U.S. Food and Drug Administration is suggesting a single annual shot. The formulation would be selected in June targeting the most threatening COVID-19 strains, and then people could get a shot in the fall when people begin spending more time indoors and exposure increases. 

Some people, such as those who are older or immunocompromised, may need more than one dose.

A national advisory committee is expected to vote on the proposal at a meeting Jan. 26.

People in the United States have been much less likely to get an updated COVID-19 booster shot, compared with widespread uptake of the primary vaccine series. In its proposal, the FDA indicated it hoped a single annual shot would overcome challenges created by the complexity of the process – both in messaging and administration – attributed to that low booster rate. Nine in 10 people age 12 or older got the primary vaccine series in the United States, but only 15% got the latest booster shot for COVID-19.

About half of children and adults in the U.S. get an annual flu shot, according to Centers for Disease Control and Prevention data.

The FDA also wants to move to a single COVID-19 vaccine formulation that would be used for primary vaccine series and for booster shots.

COVID-19 cases, hospitalizations, and deaths are trending downward, according to the data tracker from the New York Times. Cases are down 28%, with 47,290 tallied daily. Hospitalizations are down 22%, with 37,474 daily. Deaths are down 4%, with an average of 489 per day as of Jan. 22.

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

Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

NIAID

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

NIAID

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Data from a dermatology monkeypox (mpox) registry reveal that patients struck during the 2022 worldwide outbreak experienced two nontraditional findings: Skin lesions that frequently appeared before systemic illness and a much lower overall numbers of lesions.

“Just these two findings alone show how important it is to remain clinically vigilant as dermatologists,” Esther Freeman, MD, PhD, director of global health dermatology at Massachusetts General Hospital, Boston, said in an interview. She is the corresponding author of the study, which analyzed 101 mpox cases from 13 countries and was published online on in the Journal of the American Academy of Dermatology.

NIAID

“Mpox appeared to manifest differently than in previous outbreaks with morphologic and clinical evolutions much different than previously reported in endemic and prior outbreaks,” added Dr. Freeman. “Dermatologists should continue to keep mpox on the differential as it continues to circulate at low levels in the population and is a mimicker of many other common skin diseases.”

According to the Centers for Disease Control and Prevention, as of Jan. 20, 2023, there have been 30,061 cases of mpox in the United States during the outbreak that began in 2022; 23 people died. Worldwide, the number of cases neared 85,000.

In contrast to past outbreaks where patients may have had dozens or hundreds of lesions, 20% had only 1 lesion, while 52% had 2-5 lesions, and 20% had 6-20 lesions. “There may be only a few lesions, so index of suspicion needs to be high,” Dr. Freeman said.

According to the study, “the most common skin lesion morphologies and secondary characteristics reported included papules, vesicles/blisters, pustules, erosions/ulcers and crust/scabs.” Dr. Freeman cautioned that “lesions may not go through the ‘typical’ progression from papule to pustule. The initial lesion could even be an ulceration or a crust. For dermatologists, this means you need to have a high index of suspicion, especially if you see a new onset lesion in the groin or perianal area, though they can also start elsewhere.”

She added that “the lesion you see on exam could be a classic pustule/pseudopustule, but it might not be – it could be a small perianal erosion or ulceration. If you have any concern it could be mpox, it’s a good idea to test by PCR.”

 

Morbilliform rash, scarring reported

The study also highlighted 10 cases of morbilliform rash. “A morbilliform exanthem is pretty nonspecific, and usually cases of mpox have more specific features,” dermatologist and study coauthor Misha Rosenbach, MD, of the University of Pennsylvania, Philadelphia, said in an interview.

“Given the current low rates of mpox, I do not think most dermatologists need to worry about mpox when evaluating morbilliform exanthems. However, in high-risk patients or patients with other morphologies, it is worth noting that there’s a chance that this may be related.”

Emory University dermatologist Howa Yeung, MD, MSc, who wasn’t involved with the study, said in an interview that morbilliform rashes in the mouth/tongue area, mostly on days 1-5, should be considered a possible sign of mpox. “While I didn’t typically think of monkeypox virus as a cause of viral exanthems, I will now add it to my differential diagnoses.”

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

Women infected with COVID-19 during pregnancy are seven times more likely to die during childbirth or during the pregnancy than uninfected pregnant women, a new study shows. The new report also warns of many other severe complications linked with the virus during pregnancy, as well as risks to the baby after birth.

But the researchers said they did not find that COVID-19 infection during pregnancy impacted the risk of stillbirth or a baby’s growth rate during pregnancy.

The study, which was a meta-analysis of previous research, was published Jan. 16 in the journal BMJ Global Health. Data from 12 studies from 12 countries were combined so researchers could analyze outcomes for 13,136 pregnant women.

Babies born to mothers who were infected with COVID during pregnancy had almost double the risk of needing stays in the neonatal intensive care unit and also were more likely to be born preterm, compared with babies who were born to pregnant women who didn’t get COVID.

The researchers also found that pregnant women who got COVID were more likely to be admitted to intensive care units, need a ventilator to help them survive, develop dangerous blood clots, or develop preeclampsia, which is a high blood pressure disorder that can be fatal for the mother or baby.

One of the strengths of the study was that it included women in different trimesters during pregnancy.

“That’s something new here too is that COVID at any time during pregnancy did bring this extra risk onto mom and babies,” said lead author Emily R. Smith, ScD, MPH, assistant professor of global health at the George Washington University, in a video statement. 

The report is prompting calls for improved efforts to convince pregnant women to get vaccinated for COVID-19. The rate among them remains low: About 1 in 5 pregnant women had received the most updated COVID-19 booster as of Jan. 7, according to the CDC.

“The implications here are that it’s really important that if you’re pregnant or if you’re thinking about becoming pregnant, to get vaccinated,” Dr. Smith said. “This can really reduce the risk of having some of these bad outcomes for mom or for baby.”

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

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

Children with hyperdiploid acute lymphoblastic leukemia (ALL) are much more likely to also have congenital cytomegalovirus (CMV) infection, according to an analysis published in JAMA Network Open.

Although researchers found no association between ALL and congenital CMV infection overall, pediatric patients diagnosed with hyperdiploid ALL had sixfold greater odds of being positive for congenital CMV than cancer-free controls.

“These findings suggest mixed evidence for an association between congenital CMV infection and ALL” and that “a CMV-ALL association may be specific to hyperdiploid ALL,” said investigators, led by Jennifer Geris, PhD, a postdoctoral associate at Baylor College of Medicine, Houston.

A growing body of evidence suggests that CMV, a member of the herpesvirus family, may be a risk factor for ALL. Although the mechanism remains unclear, congenital CMV may encourage proliferation of CD34+ hematopoietic progenitor cells in bone marrow that are vulnerable to oncogenic transformation.

Two prior independent studies have suggested that prenatal CMV infection is associated with an increased risk of childhood ALL. However, given how common CMV infection is (more than 80% seropositivity worldwide) and the relatively rarity of pediatric ALL, Joseph Wiemels, PhD, argued in an accompanying editorial that CMV can’t be a direct cause of leukemia.

“Instead, CMV may play a supportive role” with infection in some infants altering immune function in a way that increases vulnerability to more direct causes of ALL, explained Dr. Wiemels, professor of population and public health sciences at the University of Southern California, Los Angeles. In other words, “exposure to CMV early rather than fulminant infection” at birth “may be the key epidemiologic feature.”

In the current study, Dr. Geris and colleagues tested dried newborn blood spots from 1189 children with ALL and 4,756 controls matched on age, sex, and mother’s race and ethnicity for the presence of cytomegalovirus at birth. Children were born in Michigan on or after Oct. 1, 1987.

Across the entire study population, congenital CMV was detected in 6 ALL cases (0.5%) and 21 controls (0.4%), with no difference in the odds of congenital CMV infection between the two groups. Among subjects positive for congenital CMV, it was not clear who had fulminant, clinically recognized disease and who did not.

Overall, 2 of 74 cases (2.7%) of hyperdiploid ALL were positive for congenital CMV. Compared with all controls in an unmatched analysis, those with hyperdiploid ALL were 6.26 times more likely to be CMV positive.

Overall, the investigators concluded that the current findings, in combination with previous evidence showing a similar connection, “strongly suggest CMV is associated specifically to hyperdiploid ALL.”

Although “the evidence supporting an association between CMV and ALL is tantalizing and mounting rapidly,” Dr. Wiemels noted that “much additional research attention is required to mechanistically describe pathways by which CMV may influence leukemia before the virus could be considered a potential target for prevention or clinical management of ALL.”

“We are still in the early chapters of the book describing the role of CMV and ALL,” but the virus might emerge as a clinical target “with much future promise for the health and well-being of our children,” he said.

The work was funded by the National Institutes of Health, the University of Minnesota, and the Department of Defense. The investigators and editorialist have disclosed no relevant financial relationships.

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

Children with hyperdiploid acute lymphoblastic leukemia (ALL) are much more likely to also have congenital cytomegalovirus (CMV) infection, according to an analysis published in JAMA Network Open.

Although researchers found no association between ALL and congenital CMV infection overall, pediatric patients diagnosed with hyperdiploid ALL had sixfold greater odds of being positive for congenital CMV than cancer-free controls.

“These findings suggest mixed evidence for an association between congenital CMV infection and ALL” and that “a CMV-ALL association may be specific to hyperdiploid ALL,” said investigators, led by Jennifer Geris, PhD, a postdoctoral associate at Baylor College of Medicine, Houston.

A growing body of evidence suggests that CMV, a member of the herpesvirus family, may be a risk factor for ALL. Although the mechanism remains unclear, congenital CMV may encourage proliferation of CD34+ hematopoietic progenitor cells in bone marrow that are vulnerable to oncogenic transformation.

Two prior independent studies have suggested that prenatal CMV infection is associated with an increased risk of childhood ALL. However, given how common CMV infection is (more than 80% seropositivity worldwide) and the relatively rarity of pediatric ALL, Joseph Wiemels, PhD, argued in an accompanying editorial that CMV can’t be a direct cause of leukemia.

“Instead, CMV may play a supportive role” with infection in some infants altering immune function in a way that increases vulnerability to more direct causes of ALL, explained Dr. Wiemels, professor of population and public health sciences at the University of Southern California, Los Angeles. In other words, “exposure to CMV early rather than fulminant infection” at birth “may be the key epidemiologic feature.”

In the current study, Dr. Geris and colleagues tested dried newborn blood spots from 1189 children with ALL and 4,756 controls matched on age, sex, and mother’s race and ethnicity for the presence of cytomegalovirus at birth. Children were born in Michigan on or after Oct. 1, 1987.

Across the entire study population, congenital CMV was detected in 6 ALL cases (0.5%) and 21 controls (0.4%), with no difference in the odds of congenital CMV infection between the two groups. Among subjects positive for congenital CMV, it was not clear who had fulminant, clinically recognized disease and who did not.

Overall, 2 of 74 cases (2.7%) of hyperdiploid ALL were positive for congenital CMV. Compared with all controls in an unmatched analysis, those with hyperdiploid ALL were 6.26 times more likely to be CMV positive.

Overall, the investigators concluded that the current findings, in combination with previous evidence showing a similar connection, “strongly suggest CMV is associated specifically to hyperdiploid ALL.”

Although “the evidence supporting an association between CMV and ALL is tantalizing and mounting rapidly,” Dr. Wiemels noted that “much additional research attention is required to mechanistically describe pathways by which CMV may influence leukemia before the virus could be considered a potential target for prevention or clinical management of ALL.”

“We are still in the early chapters of the book describing the role of CMV and ALL,” but the virus might emerge as a clinical target “with much future promise for the health and well-being of our children,” he said.

The work was funded by the National Institutes of Health, the University of Minnesota, and the Department of Defense. The investigators and editorialist have disclosed no relevant financial relationships.

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

Children with hyperdiploid acute lymphoblastic leukemia (ALL) are much more likely to also have congenital cytomegalovirus (CMV) infection, according to an analysis published in JAMA Network Open.

Although researchers found no association between ALL and congenital CMV infection overall, pediatric patients diagnosed with hyperdiploid ALL had sixfold greater odds of being positive for congenital CMV than cancer-free controls.

“These findings suggest mixed evidence for an association between congenital CMV infection and ALL” and that “a CMV-ALL association may be specific to hyperdiploid ALL,” said investigators, led by Jennifer Geris, PhD, a postdoctoral associate at Baylor College of Medicine, Houston.

A growing body of evidence suggests that CMV, a member of the herpesvirus family, may be a risk factor for ALL. Although the mechanism remains unclear, congenital CMV may encourage proliferation of CD34+ hematopoietic progenitor cells in bone marrow that are vulnerable to oncogenic transformation.

Two prior independent studies have suggested that prenatal CMV infection is associated with an increased risk of childhood ALL. However, given how common CMV infection is (more than 80% seropositivity worldwide) and the relatively rarity of pediatric ALL, Joseph Wiemels, PhD, argued in an accompanying editorial that CMV can’t be a direct cause of leukemia.

“Instead, CMV may play a supportive role” with infection in some infants altering immune function in a way that increases vulnerability to more direct causes of ALL, explained Dr. Wiemels, professor of population and public health sciences at the University of Southern California, Los Angeles. In other words, “exposure to CMV early rather than fulminant infection” at birth “may be the key epidemiologic feature.”

In the current study, Dr. Geris and colleagues tested dried newborn blood spots from 1189 children with ALL and 4,756 controls matched on age, sex, and mother’s race and ethnicity for the presence of cytomegalovirus at birth. Children were born in Michigan on or after Oct. 1, 1987.

Across the entire study population, congenital CMV was detected in 6 ALL cases (0.5%) and 21 controls (0.4%), with no difference in the odds of congenital CMV infection between the two groups. Among subjects positive for congenital CMV, it was not clear who had fulminant, clinically recognized disease and who did not.

Overall, 2 of 74 cases (2.7%) of hyperdiploid ALL were positive for congenital CMV. Compared with all controls in an unmatched analysis, those with hyperdiploid ALL were 6.26 times more likely to be CMV positive.

Overall, the investigators concluded that the current findings, in combination with previous evidence showing a similar connection, “strongly suggest CMV is associated specifically to hyperdiploid ALL.”

Although “the evidence supporting an association between CMV and ALL is tantalizing and mounting rapidly,” Dr. Wiemels noted that “much additional research attention is required to mechanistically describe pathways by which CMV may influence leukemia before the virus could be considered a potential target for prevention or clinical management of ALL.”

“We are still in the early chapters of the book describing the role of CMV and ALL,” but the virus might emerge as a clinical target “with much future promise for the health and well-being of our children,” he said.

The work was funded by the National Institutes of Health, the University of Minnesota, and the Department of Defense. The investigators and editorialist have disclosed no relevant financial relationships.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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

A new study likely makes the best estimate yet of the degree of retinopathy risk that patients who take the antimalarial drug hydroxychloroquine (HCQ) can expect, deriving mainly from the cumulative dose taken during the first 5 years of use, according to a study published in Annals of Internal Medicine.

HCQ works to decrease activity in a patient’s immune system, which is effective in many cases of systemic lupus erythematosus, one of the most common indications for the drug. However, an adverse outcome of treatment can be HCQ retinopathy, a progressive form of vision loss in patients taking HCQ over an extended period (mostly for longer than 5 years). The disease is often asymptomatic, although some patients do present a paracentral scotoma and a decrease in color vision. Patients may also notice flashing shapes in their vision and find that they have difficulty reading. Eventually, HCQ retinopathy can lead to loss of visual acuity, loss of peripheral vision, and loss of night vision.

Researchers from Kaiser Permanente Northern California and Harvard Medical School analyzed 3,325 persons who received HCQ for 5 or more years between 2004 and 2020. Their goal was to both characterize the long-term risk for incident HCQ retinopathy and examine the degree to which average HCQ dose within the first 5 years of treatment serves as a prediction of the risk.

The researchers then estimated the risk for developing retinopathy after 15 years, according to patients’ average dosing levels during the first 5 years of therapy. Overall, 81 participants developed HCQ retinopathy with overall cumulative incidences of 2.5% after 10 years and 8.6% after 15 years; the risk was greater for those given a higher dose during the first 5 years of treatment.

The mechanism of how HCQ toxicity may occur is still not completely known. There is evidence that toxicity happens because HCQ binds to melanin in both the retinal pigment epithelium and uvea in high concentrations. HCQ can interfere with lysosomal function, leading to oxidation and accumulation of lysosomes, which can cause dysfunction of the retinal pigment epithelium.

Progressive retinopathy can continue even after the drug is stopped. “It’s thought to be a very mild but important risk,” said Nilanjana Bose, MD, MBA, a rheumatologist with Memorial Hermann Health System in Houston. “Patients taking HCQ must be screened for retinal issues, most certainly elderly patients and patients with any kind of comorbidities.”

“Examination alone is not sufficient to evaluate early changes, and specialized testing must be done. These include color photos, visual field tests, optical coherence tomography, fundus autofluorescence and in some cases, multifocal electroretinogram. Also, the AAO [American Academy of Ophthalmology] has specific recommendations related to Asian patients as they may have a different pattern of retinopathy that must also be considered.”
 

More accurate risk measurements

This news organization asked study coauthor April Jorge, MD, assistant professor of medicine in the division of rheumatology, allergy, and immunology at Massachusetts General Hospital and Harvard Medical School, Boston, to discuss the study, how it correlates to past research, and what it adds that’s new and useful to rheumatologists and ophthalmologists:

Question: Your research found that a higher dose of HCQ in the first 5 years of treatment led to a greater risk of retinopathy. Is there any indication that a lower dose given more frequently, either within that 5-year period or longer, would pose a similar risk?

Answer: In our study, we assessed the HCQ dose in the first 5 years of use but followed patients who continued the medication longer than 5 years, through up to 15 years of use. Therefore, we compared the risk of HCQ retinopathy associated with different HCQ dosages but for the same duration of use. We found that for any dose of HCQ, the risk of retinopathy increases the longer the medication is used. However, patients who used a higher dose of HCQ had a higher risk of developing retinopathy over time.

Also unique to our study, we graded the severity of HCQ retinopathy outcomes. This was important, as we found that the majority of retinopathy cases detected through routine screening are mild and presumed to be asymptomatic. This will likely be reassuring news for patients that we can screen for this adverse event to detect it early and prevent vision loss.

Another important difference was that we assessed the risk of retinopathy associated with using over 6 mg/kg per day, between 5 and 6 mg/kg per day, and less than 5 mg/kg per day, whereas the highest dosing group assessed in the 2014 study included all patients using over 5 mg/kg per day. The risk was considerably higher in the > 6 mg/kg per day group than in the 5-6 mg/kg per day group.

Q: How can rheumatologists and ophthalmologists use this new information specifically to better treat their patients?

A: Our study provides more accurate estimates of the risk of HCQ retinopathy than in prior studies. These risk estimates can be used when rheumatologists (and other clinicians who prescribe HCQ) consider the risks and benefits of this otherwise important and well-tolerated medication. The risk associated with different dose ranges could also inform dosing decisions, since dosing over 6 mg/kg per day may be more of a concern than using doses in the 5-6 mg/kg range. Ophthalmologists can also use these new risk estimates to counsel patients of the importance of HCQ retinopathy screening and can also hopefully provide some reassurance to patients that the risk of severe retinopathy is low as long as they are being monitored.

The study authors were supported by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the Rheumatology Research Foundation. The authors report no relevant financial relationships. Dr. Bose and Dr. Mirza had no relevant disclosures.

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