School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.

There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.

The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.

“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.

The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.

More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.

“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.

“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.

Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.

Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.

At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.

The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.

What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.

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

School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.

There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.

The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.

“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.

The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.

More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.

“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.

“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.

Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.

Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.

At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.

The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.

What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.

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

School shootings from 2020 to 2021 climbed to the highest point in 2 decades, according to a new report from the National Center for Education Statistics and the Bureau of Justice Statistics.

There were 93 shootings with casualties at public and private K-12 schools across the United States from 2020 to 2021, as compared with 23 in the 2000-2001 school year. The latest number included 43 incidents with deaths.

The annual report, which examines crime and safety in schools and colleges, also found a rise in cyberbullying and verbal abuse or disrespect of teachers during the past decade.

“While the lasting impact of these crime and safety issues cannot be measured in statistics alone, these data are valuable to the efforts of our policymakers, school officials and community members to identify and implement preventive and responsive measures,” Peggy Carr, PhD, the commissioner for the National Center for Education Statistics, said in a statement.

The report used a broad definition of shootings, which included instances when guns were fired or flashed on school property, as well as when a bullet hit school grounds for any reason and shootings that happened on school property during remote instruction throughout the COVID-19 pandemic.

More than 311,000 children at 331 schools have gone through gun violence since the shooting at Columbine High School in 1999, according to The Washington Post.

“The increase in shootings in schools is likely a consequence of an overall increase in gun violence and not specific to schools,” Dewey Cornell, PhD, a professor of education at the University of Virginia, Charlottesville, told the newspaper.

“However, most schools will never have a shooting, and their main problems will be fighting and bullying,” he said.

Between 2009 and 2020, the rate of nonfatal criminal victimization, including theft and violent crimes, decreased for ages 12-18, the report found. The rate fell from 51 victimizations per 1,000 students to 11. A major portion of the decline happened during the first year of the pandemic.

Lower percentages of public schools reported certain issues from 2019 to 2020 than from 2009 to 2010, the report found. For instance, 15% of schools reported student bullying at least once a week, as compared with 23% a decade ago. Student sexual harassment of other students dropped from 3% to 2%, and student harassment of other students based on sexual orientation or gender identity dropped from 3% to 2%.

At the same time, teachers faced more hardships, the report found. Schools reporting verbal abuse of teachers at least once a week rose to 10% in the 2019-2020 school year, as compared with 5% in the 2009-2010 school year. Schools reporting acts of disrespect for teachers climbed from 9% to 15%.

The percentage of schools that reported cyberbullying at least once a week doubled during the decade, rising from 8% in 2009-2010 to 16% in 2019-2020, the report found. The prominence of social media has likely added to that increase, the Post reported.

What’s more, about 55% of public schools offered mental health assessments in 2019-2020, and 42% offered mental health treatment services, the report found. The low rates could be linked to not having enough funding or access to licensed professionals, the newspaper reported.

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

COVID-19 has been associated with a threefold increased risk of Alzheimer’s disease and a doubling of Parkinson’s disease risk, a new study suggests. However, the research also showed there was no excess risk of these neurologic disorders following COVID than other respiratory infections such as influenza or community-acquired bacterial pneumonia.

Considering these results, study investigator Pardis Zarifkar, MD, department of neurology, Rigshospitalet, Copenhagen University Hospital, urged doctors to “keep an eye on” COVID patients and use “a critical mindset” if these patients present with neurologic issues.

“They should consider whether the patient’s condition is something new or if there were already signs and symptoms before they had COVID-19,” she said.

The findings were presented at the 2022 congress of the European Academy of Neurology and published online in Frontiers in Neurology.

‘Surprising’ increased risk

Previous research shows more than 80% of patients hospitalized with COVID-19 have neurologic symptoms including anosmia, dysgeusia, headache, dizziness, memory and concentration difficulties, fatigue, and irritability.

However, it’s unclear whether COVID-19 affects the risk for specific neurologic diseases and if so, whether this association differs from other respiratory infections.

From electronic health records covering about half the Danish population, researchers identified adults who were tested for COVID-19 or diagnosed with community-acquired bacterial pneumonia from February 2020 to November 2021. They also flagged individuals with influenza in the corresponding prepandemic period (February 2018–November 2019).

Dr. Zarifkar noted influenza A or B and community-acquired bacterial pneumonia are two of the most common respiratory tract infections.

The investigators tracked neurologic diseases up to 12 months after a positive test. They looked at two neurodegenerative diseases, Alzheimer’s disease and Parkinson’s disease, as well as cerebrovascular disorders including ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage.

The study included 43,262 individuals with a positive COVID test without a history of influenza A/B in the past year and 876,356 without a positive COVID test. It also included 1,474 individuals with community-acquired pneumonia without a history of COVID and 8,102 with influenza A or B.

“We wanted to investigate whether COVID-19 is really that much worse than all these other common respiratory infections that we have had for ages and see every single year,” said Dr. Zarifkar.

After 12 months, the relative risk for Alzheimer’s disease was 3.4 (95% confidence interval, 2.3-5.1) in the COVID-positive group versus the COVID-negative group. The risks were greater among inpatients versus outpatients.

These results were rather unexpected, said Dr. Zarifkar. “I would have expected a small increase, but the extent of the increase was quite surprising.”

However, there was no difference when comparing the COVID-19 group with the influenza or bacterial pneumonia groups, which Dr. Zarifkar said was “very reassuring.”

The findings were similar for Parkinson’s disease, where there was a 2.2-fold increased risk of a Parkinson’s disease diagnosis within the first 12 months in COVID-positive individuals, compared with COVID-negative people (RR, 2.2; 95% CI, 1.5-3.4). Again, there was no excess risk, compared with influenza or bacterial pneumonia.

Potential mechanisms

Dr. Zarifkar believes a “constellation” of factors may explain higher risks of these diagnoses in COVID patients. Part of it could be a result of neuroinflammation, which can lead to a toxic accumulation of beta amyloid in Alzheimer’s disease and alpha-synuclein in Parkinson’s disease.

“It can accelerate a neurodegenerative disease already in the making,” she said. But perhaps the biggest driver of differences between the groups is the “scientific focus” on COVID patients. “In Denmark, almost everyone who has had COVID-19, especially severe COVID-19, is offered some sort of cognitive testing, and if you hand out MoCAs [Montreal Cognitive Assessments] which is the cognitive test we use, to almost everyone you’re meeting, you’re going to catch these disorders earlier than you might have otherwise.”

As for cerebrovascular disorders, the study showed an increased risk of ischemic stroke in COVID-positive versus COVID-negative subjects at 12 months (RR, 2.87; 95% confidence interval, 2.2-3.2).

The relatively strong inflammatory response associated with COVID-19, which may create a hypercoagulable state, may help explain the increased ischemic stroke risk in COVID patients, said Dr. Zarifkar.

The study did not show an increased risk for subarachnoid hemorrhage in COVID-positive, compared with COVID-negative, subjects but did reveal an increased risk of intracerebral hemorrhage after 12 months (RR, 4.8; 95% CI, 1.8-12.9).

This could be explained by COVID-positive subjects having a higher risk for ischemic stroke and receiving thrombolysis that may increase risk for bleeding in the brain. However, an analysis accounting for medication use found differences in thrombolysis rates didn’t change the result, said Dr. Zarifkar.

It’s also possible that extracorporeal membrane oxygenation and mechanical ventilation – interventions more frequently used in COVID-19 patients – may increase the risk for bleeding in brain, she added.

The researchers did not find an increased risk for multiple sclerosis, myasthenia gravis, Guillain-Barré syndrome, or narcolepsy in COVID patients. However, Dr. Zarifkar noted that it can take years to detect an association with autoimmune disorders.

The investigators did not stratify risk by disease severity, although this would be an important step, she said. “The threshold of being admitted to the hospital with COVID-19 has been much lower than for influenza or bacterial pneumonia where you’re typically quite ill before you’re admitted, so this might actually dilute the findings and underestimate our findings.”

A national, registry-based study that includes the entire Danish population and additional information on vaccination status, virus variants, socioeconomic status, and comorbidities is needed, said Dr. Zarifkar.

The study was supported by Lundbeck Foundation and Novo Nordisk. Dr. Zarifkar reported no relevant financial relationships.

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

COVID-19 has been associated with a threefold increased risk of Alzheimer’s disease and a doubling of Parkinson’s disease risk, a new study suggests. However, the research also showed there was no excess risk of these neurologic disorders following COVID than other respiratory infections such as influenza or community-acquired bacterial pneumonia.

Considering these results, study investigator Pardis Zarifkar, MD, department of neurology, Rigshospitalet, Copenhagen University Hospital, urged doctors to “keep an eye on” COVID patients and use “a critical mindset” if these patients present with neurologic issues.

“They should consider whether the patient’s condition is something new or if there were already signs and symptoms before they had COVID-19,” she said.

The findings were presented at the 2022 congress of the European Academy of Neurology and published online in Frontiers in Neurology.

‘Surprising’ increased risk

Previous research shows more than 80% of patients hospitalized with COVID-19 have neurologic symptoms including anosmia, dysgeusia, headache, dizziness, memory and concentration difficulties, fatigue, and irritability.

However, it’s unclear whether COVID-19 affects the risk for specific neurologic diseases and if so, whether this association differs from other respiratory infections.

From electronic health records covering about half the Danish population, researchers identified adults who were tested for COVID-19 or diagnosed with community-acquired bacterial pneumonia from February 2020 to November 2021. They also flagged individuals with influenza in the corresponding prepandemic period (February 2018–November 2019).

Dr. Zarifkar noted influenza A or B and community-acquired bacterial pneumonia are two of the most common respiratory tract infections.

The investigators tracked neurologic diseases up to 12 months after a positive test. They looked at two neurodegenerative diseases, Alzheimer’s disease and Parkinson’s disease, as well as cerebrovascular disorders including ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage.

The study included 43,262 individuals with a positive COVID test without a history of influenza A/B in the past year and 876,356 without a positive COVID test. It also included 1,474 individuals with community-acquired pneumonia without a history of COVID and 8,102 with influenza A or B.

“We wanted to investigate whether COVID-19 is really that much worse than all these other common respiratory infections that we have had for ages and see every single year,” said Dr. Zarifkar.

After 12 months, the relative risk for Alzheimer’s disease was 3.4 (95% confidence interval, 2.3-5.1) in the COVID-positive group versus the COVID-negative group. The risks were greater among inpatients versus outpatients.

These results were rather unexpected, said Dr. Zarifkar. “I would have expected a small increase, but the extent of the increase was quite surprising.”

However, there was no difference when comparing the COVID-19 group with the influenza or bacterial pneumonia groups, which Dr. Zarifkar said was “very reassuring.”

The findings were similar for Parkinson’s disease, where there was a 2.2-fold increased risk of a Parkinson’s disease diagnosis within the first 12 months in COVID-positive individuals, compared with COVID-negative people (RR, 2.2; 95% CI, 1.5-3.4). Again, there was no excess risk, compared with influenza or bacterial pneumonia.

Potential mechanisms

Dr. Zarifkar believes a “constellation” of factors may explain higher risks of these diagnoses in COVID patients. Part of it could be a result of neuroinflammation, which can lead to a toxic accumulation of beta amyloid in Alzheimer’s disease and alpha-synuclein in Parkinson’s disease.

“It can accelerate a neurodegenerative disease already in the making,” she said. But perhaps the biggest driver of differences between the groups is the “scientific focus” on COVID patients. “In Denmark, almost everyone who has had COVID-19, especially severe COVID-19, is offered some sort of cognitive testing, and if you hand out MoCAs [Montreal Cognitive Assessments] which is the cognitive test we use, to almost everyone you’re meeting, you’re going to catch these disorders earlier than you might have otherwise.”

As for cerebrovascular disorders, the study showed an increased risk of ischemic stroke in COVID-positive versus COVID-negative subjects at 12 months (RR, 2.87; 95% confidence interval, 2.2-3.2).

The relatively strong inflammatory response associated with COVID-19, which may create a hypercoagulable state, may help explain the increased ischemic stroke risk in COVID patients, said Dr. Zarifkar.

The study did not show an increased risk for subarachnoid hemorrhage in COVID-positive, compared with COVID-negative, subjects but did reveal an increased risk of intracerebral hemorrhage after 12 months (RR, 4.8; 95% CI, 1.8-12.9).

This could be explained by COVID-positive subjects having a higher risk for ischemic stroke and receiving thrombolysis that may increase risk for bleeding in the brain. However, an analysis accounting for medication use found differences in thrombolysis rates didn’t change the result, said Dr. Zarifkar.

It’s also possible that extracorporeal membrane oxygenation and mechanical ventilation – interventions more frequently used in COVID-19 patients – may increase the risk for bleeding in brain, she added.

The researchers did not find an increased risk for multiple sclerosis, myasthenia gravis, Guillain-Barré syndrome, or narcolepsy in COVID patients. However, Dr. Zarifkar noted that it can take years to detect an association with autoimmune disorders.

The investigators did not stratify risk by disease severity, although this would be an important step, she said. “The threshold of being admitted to the hospital with COVID-19 has been much lower than for influenza or bacterial pneumonia where you’re typically quite ill before you’re admitted, so this might actually dilute the findings and underestimate our findings.”

A national, registry-based study that includes the entire Danish population and additional information on vaccination status, virus variants, socioeconomic status, and comorbidities is needed, said Dr. Zarifkar.

The study was supported by Lundbeck Foundation and Novo Nordisk. Dr. Zarifkar reported no relevant financial relationships.

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

COVID-19 has been associated with a threefold increased risk of Alzheimer’s disease and a doubling of Parkinson’s disease risk, a new study suggests. However, the research also showed there was no excess risk of these neurologic disorders following COVID than other respiratory infections such as influenza or community-acquired bacterial pneumonia.

Considering these results, study investigator Pardis Zarifkar, MD, department of neurology, Rigshospitalet, Copenhagen University Hospital, urged doctors to “keep an eye on” COVID patients and use “a critical mindset” if these patients present with neurologic issues.

“They should consider whether the patient’s condition is something new or if there were already signs and symptoms before they had COVID-19,” she said.

The findings were presented at the 2022 congress of the European Academy of Neurology and published online in Frontiers in Neurology.

‘Surprising’ increased risk

Previous research shows more than 80% of patients hospitalized with COVID-19 have neurologic symptoms including anosmia, dysgeusia, headache, dizziness, memory and concentration difficulties, fatigue, and irritability.

However, it’s unclear whether COVID-19 affects the risk for specific neurologic diseases and if so, whether this association differs from other respiratory infections.

From electronic health records covering about half the Danish population, researchers identified adults who were tested for COVID-19 or diagnosed with community-acquired bacterial pneumonia from February 2020 to November 2021. They also flagged individuals with influenza in the corresponding prepandemic period (February 2018–November 2019).

Dr. Zarifkar noted influenza A or B and community-acquired bacterial pneumonia are two of the most common respiratory tract infections.

The investigators tracked neurologic diseases up to 12 months after a positive test. They looked at two neurodegenerative diseases, Alzheimer’s disease and Parkinson’s disease, as well as cerebrovascular disorders including ischemic stroke, intracerebral hemorrhage, and subarachnoid hemorrhage.

The study included 43,262 individuals with a positive COVID test without a history of influenza A/B in the past year and 876,356 without a positive COVID test. It also included 1,474 individuals with community-acquired pneumonia without a history of COVID and 8,102 with influenza A or B.

“We wanted to investigate whether COVID-19 is really that much worse than all these other common respiratory infections that we have had for ages and see every single year,” said Dr. Zarifkar.

After 12 months, the relative risk for Alzheimer’s disease was 3.4 (95% confidence interval, 2.3-5.1) in the COVID-positive group versus the COVID-negative group. The risks were greater among inpatients versus outpatients.

These results were rather unexpected, said Dr. Zarifkar. “I would have expected a small increase, but the extent of the increase was quite surprising.”

However, there was no difference when comparing the COVID-19 group with the influenza or bacterial pneumonia groups, which Dr. Zarifkar said was “very reassuring.”

The findings were similar for Parkinson’s disease, where there was a 2.2-fold increased risk of a Parkinson’s disease diagnosis within the first 12 months in COVID-positive individuals, compared with COVID-negative people (RR, 2.2; 95% CI, 1.5-3.4). Again, there was no excess risk, compared with influenza or bacterial pneumonia.

Potential mechanisms

Dr. Zarifkar believes a “constellation” of factors may explain higher risks of these diagnoses in COVID patients. Part of it could be a result of neuroinflammation, which can lead to a toxic accumulation of beta amyloid in Alzheimer’s disease and alpha-synuclein in Parkinson’s disease.

“It can accelerate a neurodegenerative disease already in the making,” she said. But perhaps the biggest driver of differences between the groups is the “scientific focus” on COVID patients. “In Denmark, almost everyone who has had COVID-19, especially severe COVID-19, is offered some sort of cognitive testing, and if you hand out MoCAs [Montreal Cognitive Assessments] which is the cognitive test we use, to almost everyone you’re meeting, you’re going to catch these disorders earlier than you might have otherwise.”

As for cerebrovascular disorders, the study showed an increased risk of ischemic stroke in COVID-positive versus COVID-negative subjects at 12 months (RR, 2.87; 95% confidence interval, 2.2-3.2).

The relatively strong inflammatory response associated with COVID-19, which may create a hypercoagulable state, may help explain the increased ischemic stroke risk in COVID patients, said Dr. Zarifkar.

The study did not show an increased risk for subarachnoid hemorrhage in COVID-positive, compared with COVID-negative, subjects but did reveal an increased risk of intracerebral hemorrhage after 12 months (RR, 4.8; 95% CI, 1.8-12.9).

This could be explained by COVID-positive subjects having a higher risk for ischemic stroke and receiving thrombolysis that may increase risk for bleeding in the brain. However, an analysis accounting for medication use found differences in thrombolysis rates didn’t change the result, said Dr. Zarifkar.

It’s also possible that extracorporeal membrane oxygenation and mechanical ventilation – interventions more frequently used in COVID-19 patients – may increase the risk for bleeding in brain, she added.

The researchers did not find an increased risk for multiple sclerosis, myasthenia gravis, Guillain-Barré syndrome, or narcolepsy in COVID patients. However, Dr. Zarifkar noted that it can take years to detect an association with autoimmune disorders.

The investigators did not stratify risk by disease severity, although this would be an important step, she said. “The threshold of being admitted to the hospital with COVID-19 has been much lower than for influenza or bacterial pneumonia where you’re typically quite ill before you’re admitted, so this might actually dilute the findings and underestimate our findings.”

A national, registry-based study that includes the entire Danish population and additional information on vaccination status, virus variants, socioeconomic status, and comorbidities is needed, said Dr. Zarifkar.

The study was supported by Lundbeck Foundation and Novo Nordisk. Dr. Zarifkar reported no relevant financial relationships.

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

Contrary to previous research findings, the stress of the COVID-19 pandemic has been linked to an increased headache burden in teens.

Investigators found factors contributing to headache for preteens and teens during the pandemic included increased screen time for online learning, depression, anxiety, female sex, and weight gain.

“The stressors and pressures of the pandemic may have eventually taken their toll,” lead author Ayşe Nur Özdağ Acarli, MD, Ermenek State Hospital, department of neurology, Karaman, Turkey, told this news organization.

“Limiting screen time and providing more psychosocial supports would help lessen the burden of the COVID-19 pandemic on adolescents with headache.”

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2022.
 

Most common neurological problem in kids

Headache is the most common neurological problem in children and adolescents. Potential factors contributing to headache in this population include lack of sleep and physical activity, mental health problems, and socioeconomic conditions.

The COVID-19 pandemic has had a “striking” impact on every aspect of life for young people, said Dr. Acarli.

Some studies reported an improvement in headache prevalence among adolescents during COVID-19, which was attributed to less school-related stress. However, said Dr. Acarli in her personal clinical experience, young patients suffered more frequent and severe headaches during the pandemic.

She noted previous research examining the impact of the pandemic on headache in youth was conducted only in the early days of the pandemic and examined shorter-term effects. Research examining the long-term effects of the pandemic on headache in this patient population has been “lacking,” she said.

The study included 851 participants aged 10-18 years (mean age 14.9 years and 62% female) who were seen at a neurology or pediatric outpatient clinic from August-December 2021. The study excluded subjects with neurological problems, intellectual deficits, autism spectrum disorder, and epilepsy.

Participants completed detailed questionnaires providing data on demographics, exposure to COVID-19, and electronics, as well as information on depressive symptoms as assessed by the Patient Health Questionnaire-9 and anxiety symptoms using the Generalized Anxiety Disorder-7 and COVID-related anxiety.

“We used two distinct scales for anxiety: one for generalized anxiety and the other for COVID-related anxiety,” said Dr. Acarli.

Of the total study population, 756 (89%) reported headaches. This headache prevalence in children and adolescents is like that found in other studies.

Dr. Acarli noted several differences in the headache group versus the non-headache group. The female/male ratio was 2:1 versus 1:1, the mean age was 15.0 versus 14.4, and depression and generalized anxiety scores were significantly higher. There was no significant difference in COVID-19 history in those with and without headache.

Researchers categorized those with headache into four groups: worsening headaches (27%), improved headaches (3%), new onset headaches (10%), and stable headaches (61%).

Compared with the other groups, the worsened headache group included significantly more females and older individuals with more severe and frequent headaches. This group also had more participants reporting at least 15 headache attacks a month and using painkillers at least once a month.

The study showed headache severity was significantly increased with age, headache duration, depression, generalized anxiety (all P < .001), and COVID-19 anxiety (P < .01). Headache frequency, measured as attacks per month, was significantly increased with age, depression, and generalized anxiety (all P < .001).

Worsening headache outcomes during the pandemic were associated with longer exposure to computer screens (odds ratio, 1.7; 95% confidence interval, 1.2-2.3; P < .01), lack of suitable conditions for online learning (OR, 2.6; 95% CI, 1.8-3.8; P < .001), depression (OR, 2.0; 95% CI, 1.4-2.8; P < .001); and COVID-19 anxiety (OR, 3.2; 95% CI, 1.3-8.0; P < .01). Other contributing factors included school exams, living in a city, female sex, and weight gain.

There may be a link between COVID-related headaches and anxiety or depression, but it’s unclear what’s causing what. “We don’t know which is the chicken and which is the egg,” said Dr. Acarli.
 

Headache triggers

Commenting for this news organization, Raquel Gil-Gouveia, MD, PhD, head of the neurology department, Hospital da Luz, Lisbon, Portugal, who co-chaired the session where the research was presented, said the information collected for the study was “extensive.”

Some results were expected, including the fact that patients with headaches were more anxious and depressed, said Dr. Gil-Gouveia.

“Anxiety and depression are frequent comorbidities of headache and can act as a triggering factor for headache attacks but can also be a consequence of intense or chronic pain,” she said.

She agreed the new results differ from those of studies carried out during the first pandemic lockdown, which showed an improvement in headache, but noted online learning was not fully implemented at that time, “so it was much like being on vacation.”

In addition to isolation, anxiety, and prolonged screen exposure, the lack of peer contact and fewer sports and leisure activities may also have contributed to worsening headaches during the COVID lockdown, but these were not explored in this study, said Dr. Gil-Gouveia.

The study was supported by the Global Migraine and Pain Society. The investigators and Dr. Gil-Gouveia report no relevant financial relationships.

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

Contrary to previous research findings, the stress of the COVID-19 pandemic has been linked to an increased headache burden in teens.

Investigators found factors contributing to headache for preteens and teens during the pandemic included increased screen time for online learning, depression, anxiety, female sex, and weight gain.

“The stressors and pressures of the pandemic may have eventually taken their toll,” lead author Ayşe Nur Özdağ Acarli, MD, Ermenek State Hospital, department of neurology, Karaman, Turkey, told this news organization.

“Limiting screen time and providing more psychosocial supports would help lessen the burden of the COVID-19 pandemic on adolescents with headache.”

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2022.
 

Most common neurological problem in kids

Headache is the most common neurological problem in children and adolescents. Potential factors contributing to headache in this population include lack of sleep and physical activity, mental health problems, and socioeconomic conditions.

The COVID-19 pandemic has had a “striking” impact on every aspect of life for young people, said Dr. Acarli.

Some studies reported an improvement in headache prevalence among adolescents during COVID-19, which was attributed to less school-related stress. However, said Dr. Acarli in her personal clinical experience, young patients suffered more frequent and severe headaches during the pandemic.

She noted previous research examining the impact of the pandemic on headache in youth was conducted only in the early days of the pandemic and examined shorter-term effects. Research examining the long-term effects of the pandemic on headache in this patient population has been “lacking,” she said.

The study included 851 participants aged 10-18 years (mean age 14.9 years and 62% female) who were seen at a neurology or pediatric outpatient clinic from August-December 2021. The study excluded subjects with neurological problems, intellectual deficits, autism spectrum disorder, and epilepsy.

Participants completed detailed questionnaires providing data on demographics, exposure to COVID-19, and electronics, as well as information on depressive symptoms as assessed by the Patient Health Questionnaire-9 and anxiety symptoms using the Generalized Anxiety Disorder-7 and COVID-related anxiety.

“We used two distinct scales for anxiety: one for generalized anxiety and the other for COVID-related anxiety,” said Dr. Acarli.

Of the total study population, 756 (89%) reported headaches. This headache prevalence in children and adolescents is like that found in other studies.

Dr. Acarli noted several differences in the headache group versus the non-headache group. The female/male ratio was 2:1 versus 1:1, the mean age was 15.0 versus 14.4, and depression and generalized anxiety scores were significantly higher. There was no significant difference in COVID-19 history in those with and without headache.

Researchers categorized those with headache into four groups: worsening headaches (27%), improved headaches (3%), new onset headaches (10%), and stable headaches (61%).

Compared with the other groups, the worsened headache group included significantly more females and older individuals with more severe and frequent headaches. This group also had more participants reporting at least 15 headache attacks a month and using painkillers at least once a month.

The study showed headache severity was significantly increased with age, headache duration, depression, generalized anxiety (all P < .001), and COVID-19 anxiety (P < .01). Headache frequency, measured as attacks per month, was significantly increased with age, depression, and generalized anxiety (all P < .001).

Worsening headache outcomes during the pandemic were associated with longer exposure to computer screens (odds ratio, 1.7; 95% confidence interval, 1.2-2.3; P < .01), lack of suitable conditions for online learning (OR, 2.6; 95% CI, 1.8-3.8; P < .001), depression (OR, 2.0; 95% CI, 1.4-2.8; P < .001); and COVID-19 anxiety (OR, 3.2; 95% CI, 1.3-8.0; P < .01). Other contributing factors included school exams, living in a city, female sex, and weight gain.

There may be a link between COVID-related headaches and anxiety or depression, but it’s unclear what’s causing what. “We don’t know which is the chicken and which is the egg,” said Dr. Acarli.
 

Headache triggers

Commenting for this news organization, Raquel Gil-Gouveia, MD, PhD, head of the neurology department, Hospital da Luz, Lisbon, Portugal, who co-chaired the session where the research was presented, said the information collected for the study was “extensive.”

Some results were expected, including the fact that patients with headaches were more anxious and depressed, said Dr. Gil-Gouveia.

“Anxiety and depression are frequent comorbidities of headache and can act as a triggering factor for headache attacks but can also be a consequence of intense or chronic pain,” she said.

She agreed the new results differ from those of studies carried out during the first pandemic lockdown, which showed an improvement in headache, but noted online learning was not fully implemented at that time, “so it was much like being on vacation.”

In addition to isolation, anxiety, and prolonged screen exposure, the lack of peer contact and fewer sports and leisure activities may also have contributed to worsening headaches during the COVID lockdown, but these were not explored in this study, said Dr. Gil-Gouveia.

The study was supported by the Global Migraine and Pain Society. The investigators and Dr. Gil-Gouveia report no relevant financial relationships.

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

Contrary to previous research findings, the stress of the COVID-19 pandemic has been linked to an increased headache burden in teens.

Investigators found factors contributing to headache for preteens and teens during the pandemic included increased screen time for online learning, depression, anxiety, female sex, and weight gain.

“The stressors and pressures of the pandemic may have eventually taken their toll,” lead author Ayşe Nur Özdağ Acarli, MD, Ermenek State Hospital, department of neurology, Karaman, Turkey, told this news organization.

“Limiting screen time and providing more psychosocial supports would help lessen the burden of the COVID-19 pandemic on adolescents with headache.”

The findings were presented at the Congress of the European Academy of Neurology (EAN) 2022.
 

Most common neurological problem in kids

Headache is the most common neurological problem in children and adolescents. Potential factors contributing to headache in this population include lack of sleep and physical activity, mental health problems, and socioeconomic conditions.

The COVID-19 pandemic has had a “striking” impact on every aspect of life for young people, said Dr. Acarli.

Some studies reported an improvement in headache prevalence among adolescents during COVID-19, which was attributed to less school-related stress. However, said Dr. Acarli in her personal clinical experience, young patients suffered more frequent and severe headaches during the pandemic.

She noted previous research examining the impact of the pandemic on headache in youth was conducted only in the early days of the pandemic and examined shorter-term effects. Research examining the long-term effects of the pandemic on headache in this patient population has been “lacking,” she said.

The study included 851 participants aged 10-18 years (mean age 14.9 years and 62% female) who were seen at a neurology or pediatric outpatient clinic from August-December 2021. The study excluded subjects with neurological problems, intellectual deficits, autism spectrum disorder, and epilepsy.

Participants completed detailed questionnaires providing data on demographics, exposure to COVID-19, and electronics, as well as information on depressive symptoms as assessed by the Patient Health Questionnaire-9 and anxiety symptoms using the Generalized Anxiety Disorder-7 and COVID-related anxiety.

“We used two distinct scales for anxiety: one for generalized anxiety and the other for COVID-related anxiety,” said Dr. Acarli.

Of the total study population, 756 (89%) reported headaches. This headache prevalence in children and adolescents is like that found in other studies.

Dr. Acarli noted several differences in the headache group versus the non-headache group. The female/male ratio was 2:1 versus 1:1, the mean age was 15.0 versus 14.4, and depression and generalized anxiety scores were significantly higher. There was no significant difference in COVID-19 history in those with and without headache.

Researchers categorized those with headache into four groups: worsening headaches (27%), improved headaches (3%), new onset headaches (10%), and stable headaches (61%).

Compared with the other groups, the worsened headache group included significantly more females and older individuals with more severe and frequent headaches. This group also had more participants reporting at least 15 headache attacks a month and using painkillers at least once a month.

The study showed headache severity was significantly increased with age, headache duration, depression, generalized anxiety (all P < .001), and COVID-19 anxiety (P < .01). Headache frequency, measured as attacks per month, was significantly increased with age, depression, and generalized anxiety (all P < .001).

Worsening headache outcomes during the pandemic were associated with longer exposure to computer screens (odds ratio, 1.7; 95% confidence interval, 1.2-2.3; P < .01), lack of suitable conditions for online learning (OR, 2.6; 95% CI, 1.8-3.8; P < .001), depression (OR, 2.0; 95% CI, 1.4-2.8; P < .001); and COVID-19 anxiety (OR, 3.2; 95% CI, 1.3-8.0; P < .01). Other contributing factors included school exams, living in a city, female sex, and weight gain.

There may be a link between COVID-related headaches and anxiety or depression, but it’s unclear what’s causing what. “We don’t know which is the chicken and which is the egg,” said Dr. Acarli.
 

Headache triggers

Commenting for this news organization, Raquel Gil-Gouveia, MD, PhD, head of the neurology department, Hospital da Luz, Lisbon, Portugal, who co-chaired the session where the research was presented, said the information collected for the study was “extensive.”

Some results were expected, including the fact that patients with headaches were more anxious and depressed, said Dr. Gil-Gouveia.

“Anxiety and depression are frequent comorbidities of headache and can act as a triggering factor for headache attacks but can also be a consequence of intense or chronic pain,” she said.

She agreed the new results differ from those of studies carried out during the first pandemic lockdown, which showed an improvement in headache, but noted online learning was not fully implemented at that time, “so it was much like being on vacation.”

In addition to isolation, anxiety, and prolonged screen exposure, the lack of peer contact and fewer sports and leisure activities may also have contributed to worsening headaches during the COVID lockdown, but these were not explored in this study, said Dr. Gil-Gouveia.

The study was supported by the Global Migraine and Pain Society. The investigators and Dr. Gil-Gouveia report no relevant financial relationships.

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

The Food and Drug Administration has issued a Class I recall for the CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator batteries. A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.  

Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.

This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.

However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.

To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.

When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.

There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.

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

This article was updated 7/6/22.

The Food and Drug Administration has issued a Class I recall for the CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator batteries. A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.  

Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.

This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.

However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.

To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.

When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.

There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.

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

This article was updated 7/6/22.

The Food and Drug Administration has issued a Class I recall for the CARESCAPE R860/Engstrom Carestation/Engstrom PRO Ventilator batteries. A total of 1,533 complaints allege that the batteries are draining much faster than expected, prompting manufacturer GE Healthcare to initiate the recall. There have been no injuries, and no deaths associated with the use of this device, according to an FDA corrected announcement.  

Health care personnel and those patients who receive breathing support with these ventilators should be cautious about using CARESCAPE battery products moving forward, the agency said.

This type of ventilator is primarily powered by plugging into a wall outlet, but it has the capability to operate on backup batteries. These batteries are not solely for emergency situations such as power outages, but are also for routine situations such as transporting a patient within the hospital. GE Healthcare supplies these backup batteries with the ventilator, and sells replacements when they run out.

However, if the ventilator loses power because of battery malfunction, the patient may lose access to oxygen, leading to hypoxia, which can lead to brain injury and death. Therefore, if these batteries drain quicker than anticipated, it may put the patient at risk.

To prevent this danger, GE Healthcare recommends customers perform a battery performance test after they see this notice and every 3 months following. Consumers should take extra precaution and make sure their batteries are charged following a long period of inactivity. If the device is inactive for a while, the company says users should keep it plugged in to avoid draining the battery. Batteries should be replaced at a minimum of every 3 years.

When these devices are still plugged into the wall, they’re safe to use, according to the FDA. But when using the backup power source, clinicians should make sure to have alternative routes for breathing support on hand, such as with a bag-valve mask system.

There are 4,222 of these possibly defective batteries currently on the market. They were distributed from April 2, 2019, through April 18 of this year, when GE Healthcare stopped distributing these products and began the recall process. Any issues with these products should be reported to the FDA’s MedWatch database or by sending a medical device notification acknowledgment response to GE at the email address listed at the bottom of the recall announcement.

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

This article was updated 7/6/22.

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

The U.S. Food and Drug Administration has unveiled a 5-year strategy aimed at improving and extending the lives of people with rare neurodegenerative diseases.

The agency’s Action Plan for Rare Neurodegenerative Diseases including Amyotrophic Lateral Sclerosis (ALS) aims to advance the development of safe and effective medical products and facilitate patient access to novel treatments.

“The effects of rare neurodegenerative diseases are devastating, with very few effective therapeutic options available to patients. We recognize the urgent need for new treatments that can both improve and extend the lives of people diagnosed with these diseases,” FDA Commissioner Robert M. Califf, MD, said in a news release.

“To face that challenge and to accelerate drug development, we need innovative approaches to better understand these diseases while also building on current scientific and research capabilities,” Dr. Califf acknowledged.

“This action plan, especially including the use of public-private partnerships and direct involvement of patients, will ensure the FDA is working toward meeting the task set forth by Congress to enhance the quality of life for those suffering by facilitating access to new therapies,” Dr. Califf added.
 

Blueprint to ‘aggressively’ move forward

The action plan represents a “blueprint” for how the agency will “aggressively” move forward to address challenges in drug development for rare neurodegenerative diseases to improve patient health, the FDA said.

The plan was created in accordance with provisions in the Accelerating Access to Critical Therapies for ALS Act (ACT for ALS) that President Biden signed into law in late 2021.

Targeted activities include establishing the FDA Rare Neurodegenerative Diseases Task Force and the public-private partnership for rare neurodegenerative diseases, developing disease-specific science strategies over the next 5 years, and leveraging ongoing FDA regulatory science efforts.

The ALS Science Strategy is part of the plan focused specifically on ALS. It provides a “forward-leaning” framework for FDA activities, which include efforts to improve characterization of disease pathogenesis and natural history, boost clinical trial infrastructure and agility to enable early selection of promising therapeutic candidates for further development, optimize clinical trial design, improve access to the trials, streamline clinical trial operations, and reduce the time and cost of drug development.

The FDA says patient engagement, public workshops, research projects, coordination across FDA centers and offices, and collaboration with the National Institutes of Health will be key to the success of implementation of the ALS Science Strategy.

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

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

A federal advisory panel on June 28 recommended updating COVID-19 booster vaccines in the United States to include an Omicron component, while urging the need for more information on how well these shots work on emerging strains of the virus.

The Vaccines and Related Biological Products Advisory Committee of the Food and Drug Administration voted 19-2 in favor of a new formulation – although what that formulation will be is yet to be determined. The FDA often incorporates the views of its advisers into its decisions, although it is not bound to do so.

In this case, though, top FDA staff at the meeting seemed inclined to encourage the development of COVID vaccines modified to keep up with an evolving virus. Two Omicron subvariants, BA.4 and BA.5, which first appeared in South Africa in March 2022, have spread to the United States and have begun to increase rapidly in proportion to the virus population, the FDA said in a briefing for the meeting.

New information from the Centers for Disease Control and Prevention shows the two highly infectious subvariants now make up more than half the number of new COVID cases in the US.
 

Double-duty vaccine

In summarizing the message of the advisory committee, Peter W. Marks, MD, PhD, the director of the FDA’s Center for Biologics Evaluation & Research, said panelists had lent support to modifying vaccines to protect against both the original, or “ancestral” viral strain, and against Omicron, perhaps emphasizing the newly emerging subvariants.

Dr. Marks emphasized that this is a challenging decision, as no one has a “crystal ball” to forecast how SARS-CoV-2 will evolve.

“We are trying to use every last ounce of what we can from predictive modeling and from the data that we have that’s emerging, to try to get ahead of a virus that has been very crafty,” he said.”It’s pretty darn crafty.”
 

Limited data

Voting “no” were Paul Offit, MD, of Children’s Hospital of Philadelphia and Henry Bernstein, DO, MHCM, of Hofstra/Northwell Health in New Hyde Park, N.Y.

Both Dr. Offit and Dr. Bernstein earlier in the meeting expressed doubts about the evidence gathered to date in favor of a strain change. Dr. Offit had noted that protection seems to persist from the vaccines now available.

“To date, the current prototypical vaccines, the ancestral strain vaccines do protect against serious illness,” he said. “We don’t yet have a variant that is resistant to protection against serious illness.“

Dr. Bernstein said he was “struggling” with the question as well, given the limited data gathered to date about the vaccines and emerging strains of the virus.

Other panelists also expressed reservations, while supporting the concept of altering vaccines to teach the body to fight the emerging strains as well as the original one.

Panelist Wayne Marasco, MD, PhD, of Harvard Medical School, Boston, who voted yes, noted the difficulties of keeping up with the rapidly evolving virus, saying it’s possible that Omicron strains BA.4 and BA.5 could peak within months. That could be before the vaccines are even distributed – if all goes to plan – in the fall.

“This is a step in the right direction, but we have to reevaluate this as we move forward,” Dr. Marasco said, adding that a good strategy would be to elicit antibody response to bridge more than one variant of the virus.

Even panelists like Dr. Marasco who voted yes stressed the need for further data collection about how vaccines may be adapted to a changing virus. But they also acknowledged a need to give vaccine makers a clear indication of what the medical community expects in terms of changes to these shots.

“With the waning vaccine efficacy and the confluence of risk this fall, we need to make a move sooner rather than later and direct our sponsors in the proper direction,” said FDA panelist Michael Nelson, MD, PhD, of the University of Virginia, Charlottesville, said before the vote.

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

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

Liver transplantation cures both HCC and the underlying cirrhosis; however, tumor progression while the patient is on the waiting list is an ongoing concern. Couillard and colleagues reported a retrospective study of 88 patients with HCC who underwent percutaneous microwave ablation for 141 tumors while on the liver transplant list. The median follow-up was 61 months. Seventy-one patients (80.7%) underwent liver transplantation after a median wait time of 8.5 months. No tumor seeding was identified. Seventeen patients (19.3%) were removed from the waitlist, four (4.5%) of whom because of tumor progression outside of the Milan criteria. A total of five of 71 (7.0%) patients had posttransplant recurrence of HCC and all died during this time. The 5-year overall survival (OS) following liver transplantation was 76.7% and the disease-specific survival after transplantation was 89.6%. The authors concluded that microwave ablation is a safe and effective treatment that bridges patients to successful transplantation.

Radiation segmentectomy is performed by the administration of radioactive yttrium (⁹⁰Y)-bound microspheres transarterially to the segment of liver containing an unresected tumor. Kim and colleagues described the results of a prospective trial that evaluated the efficacy of radiation segmentectomy with curative intent in patients with Child-Pugh score A–B7 and small (< 3 cm), unresectable HCC, where the tumors were in a location unsuitable for ablation. Of the 44 individuals assessed for eligibility, 29 patients were included in the study. A complete response was observed in 24 (83%) patients, and a partial response was observed in 5 (17%) patients. All patients had an initial objective tumor response, and 26 (90%) had a sustained complete response during 24 months of clinical follow-up. The treatment was well tolerated, with four (14%) patients having grade 3 leukopenia and two (7%) having grade 3 thrombocytopenia. The authors concluded that radiation segmentectomy should be investigated further as a potentially curative option for patients with HCC.

Portal vein thrombosis (PVT) has been considered a contraindication to transarterial chemoembolization (TACE) due to the concern for inadvertent liver ischemia if the hepatic artery becomes obstructed. Several studies have demonstrated that this risk is low. Stereotactic body radiation therapy (SBRT) is used to effectively target HCC (especially when there is a portal vein tumor) while minimizing collateral damage to the liver. Zhang and colleagues performed a meta-analysis of nine studies totaling 938 patients who had HCC with tumor PVT. Of those, 483 received either SBRT or TACE, and 455 were treated with both TACE and SBRT. There were 255 events reported in the monotherapy groups and 174 events in the combination groups. Following statistical analyses of all available data, the authors concluded that SBRT plus TACE yielded significantly higher 1-year OS (RR [relative risk] 1.52; 95% CI 1.33-1.74), 2-year OS (RR 2.00; 95% CI 1.48-2.70), and a lower progressive disease rate (RR 0.45; 95% CI 0.26-0.79) than monotherapy. The combination treatment was both safe and effective.

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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

As the coronavirus continues to evolve, Omicron subvariants such as BA.4 and BA.5 are expected to lead to many COVID-19 cases in the coming months.

Researchers recently reported that the subvariants have mutated for better “immune escape,” or the ability to avoid antibodies from vaccination or previous infection.

“That has changed our view for what will happen this summer,” Ali Mokdad, PhD, an epidemiologist who has developed COVID-19 forecasts for the University of Washington’s Institute for Health Metrics and Evaluation in Seattle, told The Boston Globe.

Until recently, Dr. Mokdad expected the United States to have a “very good summer” in terms of cases, hospitalizations, and deaths through September. The U.S. is reporting about 100,000 new cases per day, according to the data tracker by The New York Times, which has remained flat throughout June. Cases will likely decrease this summer, Dr. Mokdad said, though the decline will be slower and smaller than first thought.

As of June 18, BA.4 and BA.5 accounted for about 35% of cases in the United States, according to the latest CDC data, with BA.5 making up 23.5% and BA.4 making up 11.4%. The two subvariants will likely take over BA.2.12.1 as top subvariants in coming weeks.

“I expect that BA.5 will likely become the dominant virus in the United States this summer,” Dan Barouch, MD, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told the Globe.

Dr. Barouch said the Omicron subvariants will likely create a summer of “substantial infections” but low rates of hospitalization and death. He published a recent study in the New England Journal of Medicine that found BA.4 and BA.5 are better at escaping antibodies than other coronavirus strains – about three times better than the Omicron variants BA.1 and BA.2 and 20 times better than the first coronavirus strain.

“What we’re seeing with each subsequent variant is iteratively higher levels of transmissibility and higher levels of antibody immune escape,” he said. “We’re seeing high levels of infection in populations that are highly vaccinated, as well as populations that have a high level of natural immunity to the prior variants.”

At the same time, current antibodies still appear to protect people against the worst outcomes, Dr. Barouch said.

“If people have vaccine immunity or natural immunity, then they have substantial protection against severe disease,” he said.

So far, researchers have found that Omicron subvariants tend to cause less severe disease than other variants, such as Delta. Dr. Mokdad estimated that 80% of Omicron infections don’t show symptoms.

He said there is a “remote possibility” of another wave during the summer, but he expects cases to rise significantly around the beginning of October, when the seasons change, and most people’s immunity will wane. Other things could play into the predictions this summer, he noted, such as coronavirus mutations and new variants.

“Anybody that models this more than a couple of weeks out is basically just using pixie dust,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, Minneapolis, told the newspaper.

“There is no pattern whatsoever developing from a seasonality standpoint. It’s all being driven by the variants,” he said. “We just have to be humble and acknowledge that we don’t know.”

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