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Age and ferritin levels may predict MIS-C severity

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Tue, 04/19/2022 - 16:48

Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

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

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Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

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

Older age and higher ferritin levels at hospital admission predict severe illness in COVID-related multisystem inflammatory syndrome in children (MIS-C), according to a Canadian multicenter cohort study.

The adjusted absolute risk for admission to an intensive care unit was 43.6% among children aged 6 years and older and 46.2% in children aged 13 to 17 years, compared with 18.4% in children aged 5 years or younger.

“We do not understand why teens get more severe MIS-C than younger children,” senior author Joan Robinson, MD, of the University of Alberta, Edmonton, told this news organization. “It is possible that more exposures to other coronaviruses in the past result in them having a more robust immune response to SARS-CoV-2, which results in more inflammation.”

The data were published  in the Canadian Medical Association Journal.
 

A multinational study

The study included data on 232 children admitted with probable or confirmed MIS-C at 15 hospitals in Canada, Iran, and Costa Rica between March 1, 2020, and March 7, 2021. The median age of the children was 5.8 years, 56.0% were boys, and 21.6% had comorbidities.

Although cardiac involvement was common (58.6%), and almost one-third of the cohort (31.5%) was admitted to an ICU, “recovery was typically rapid, with 85% of patients discharged within 10 days,” said Dr. Robinson, for the Pediatric Investigators Collaborative Network on Infections in Canada (PICNIC).
 

Older age as a risk

The results suggest that older age is associated with increased risk of severe MIS-C. “However, one would then predict that adults would be at even higher risk than teens, whereas the same syndrome in adults (MIS-A) is very, very rare,” said Dr. Robinson.

The study also found that children admitted with ferritin levels greater than 500 μg/L, signaling greater inflammation, also had an increased risk for ICU admission, compared with those with lower levels (adjusted risk difference, 18.4%; relative risk, 1.69). “This is presumably because the more inflammation that the child has, the more likely they are to have inflammation of the heart, which can lead to low blood pressure,” said Dr. Robinson.
 

Features of MIS-C

Among all patients with MIS-C, gastrointestinal involvement was common (89.2%), as were mucocutaneous findings (84.5%). Children with MIS-C had fever for a median duration of 6 days. “Clinicians who see children in their practice commonly have to determine why a child is febrile. Our study shows that one mainly has to consider MIS-C if febrile children have a rash and one or more of vomiting, diarrhea, or abdominal pain,” said Dr. Robinson. 

The study also found that patients with MIS-C who were admitted to the hospital in the latter part of the study period (Nov. 1, 2020, to March 7, 2021) were slightly more likely to require ICU admission, compared with those admitted between March 1 and Oct. 31, 2020. “We cannot provide a clear explanation [for this],” the authors noted. “The features of severe MIS-C were widely publicized by May 2020, so it seems unlikely that severe cases were missed early in the study period. SARS-CoV-2 variants of concern have replaced the wild-type virus. It is possible that the immune response to circulating variants alters the severity of COVID-19 and MIS-C, when compared with wild-type virus.”

Despite initial concerns that pediatric COVID-19 vaccines might cause MIS-C, Dr. Robinson says data suggest this is rarely, if ever, the case, and that vaccines actually prevent the syndrome. She says further studies will be needed to assess MIS-C risk following reinfection with SARS-CoV-2. “I am an optimistic person, and it is my hope that MIS-C following reinfection is rare,” she said. “If this is the case, perhaps we will see very few cases once almost all children have been immunized and/or had SARS-CoV-2 infection.”  
 

 

 

‘Differences across countries’

Adrienne Randolph, MD, a pediatrician at Harvard Medical School, Boston, and senior author of a large case series of patients with MIS-C, said that the Canadian study is valuable because it includes children from three countries. “It’s very interesting that there are differences across countries,” she said. “The patients in Iran had the highest percentage (58.7%) going into the ICU, whereas Costa Rica had the lowest percentage (9.2%), and the percentage going to the ICU in Canada (34.7%) was less than the percentages we see in the U.S. – which is pretty consistently about 60% to 70% of MIS-C patients going into the ICU.” Dr. Randolph was not involved in the current study.

Reasons for differences in the rates of ICU visits will be important to explore in the effort to standardize diagnostic criteria, stratification of severity, and recommendations for treatment of MIS-C, said Dr. Randolph.

“What is consistent is that the younger kids, zero to 5 years, in general are less ill,” she said. “That’s been consistent across multiple countries.” It’s unclear whether the cause of this difference is that parents observe younger patients more closely than they do teenagers, or whether other aspects of adolescence, such as prevalence of obesity and attendant inflammation, are at work, said Dr. Randolph.

What is also unclear is why hospitalized patients with MIS-C had higher percentages of ICU admission in the latter part of the study period, compared with the earlier period. “Did the patients change, or did practice change as we got to understand the disease process?” asked Dr. Randolph. “It could be that they got better at the diagnosis and were weeding out some of the patients who they realized didn’t need to be hospitalized. At the very beginning, we had a very low threshold to admit patients, because we didn’t know, and then, over time, people understood what was going on and felt more comfortable monitoring them as outpatients.”

This study was partially funded by a Janeway Foundation Research Grant to support data collection. Dr. Robinson disclosed no conflicts of interest. Dr. Randolph reported receiving royalties from UpToDate and personal fees from the La Jolla Pharmaceutical Company.

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

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Judge strikes down Biden mask mandate for planes, transit

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Mon, 04/18/2022 - 15:06

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

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A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

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Who doesn’t text in 2022? Most state Medicaid programs

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Mon, 04/18/2022 - 11:07

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

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

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West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

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

West Virginia will use the U.S. Postal Service and an online account in the summer of 2022 to connect with Medicaid enrollees about the expected end of the COVID public health emergency, which will put many recipients at risk of losing their coverage.

What West Virginia won’t do is use a form of communication that’s ubiquitous worldwide: text messaging.

“West Virginia isn’t set up to text its members,” Allison Adler, the state’s Medicaid spokesperson, wrote to KHN in an email.

Indeed, most states’ Medicaid programs won’t text enrollees despite the urgency to reach them about renewing their coverage. A KFF report published in March found just 11 states said they would use texting to alert Medicaid recipients about the end of the COVID public health emergency. In contrast, 33 states plan to use snail mail and at least 20 will reach out with individual or automated phone calls.

“It doesn’t make any sense when texting is how most people communicate today,” said Kinda Serafi, a partner with the consulting firm Manatt Health.

State Medicaid agencies for months have been preparing for the end of the public health emergency. As part of a COVID relief law approved in March 2020, Congress prohibited states from dropping anyone from Medicaid coverage unless they moved out of state during the public health emergency. When the emergency ends, state Medicaid officials must reevaluate each enrollee’s eligibility. Millions of people could lose their coverage if they earn too much or fail to provide the information needed to verify income or residency.

As of November, about 86 million people were enrolled in Medicaid, according to the Centers for Medicare & Medicaid Services. That’s up from 71 million in February 2020, before COVID began to ravage the nation.

West Virginia has more than 600,000 Medicaid enrollees. Adler said about 100,000 of them could lose their eligibility at the end of the public health emergency because either the state has determined they’re ineligible or they’ve failed to respond to requests that they update their income information.

“It’s frustrating that texting is a means to meet people where they are and that this has not been picked up more by states,” said Jennifer Wagner, director of Medicaid eligibility and enrollment for the Center on Budget and Policy Priorities, a Washington-based research group.

The problem with relying on the Postal Service is that a letter can get hidden in “junk” mail or can fail to reach people who have moved or are homeless, Ms. Serafi said. And email, if people have an account, can end up in spam folders.

In contrast, surveys show lower-income Americans are just as likely to have smartphones and cellphones as the general population. And most people regularly use texting.

In Michigan, Medicaid officials started using text messaging to communicate with enrollees in 2020 after building a system with the help of federal COVID relief funding. They said texting is an economical way to reach enrollees.

“It costs us 2 cents per text message, which is incredibly cheap,” said Steph White, an enrollment coordinator for the Michigan Department of Health and Human Services. “It’s a great return on investment.”

CMS officials have told states they should consider texting, along with other communication methods, when trying to reach enrollees when the public health emergency ends. But many states don’t have the technology or information about enrollees to do it.

Efforts to add texting also face legal barriers, including a federal law that bars texting people without their consent. The Federal Communications Commission ruled in 2021 that state agencies are exempt from the law, but whether counties that handle Medicaid duties for some states and Medicaid managed-care organizations that work in more than 40 states are exempt as well is unclear, said Matt Salo, executive director of the National Association of Medicaid Directors.

CMS spokesperson Beth Lynk said the agency is trying to figure out how Medicaid agencies, counties, and health plans can text enrollees within the constraints of federal law.

Several states told KHN that Medicaid health plans will be helping connect with enrollees and that they expect the plans to use text messaging. But the requirement to get consent from enrollees before texting could limit that effort.

That’s the situation in Virginia, where only about 30,000 Medicaid enrollees – out of more than a million – have agreed to receive text messages directly from the state, said spokesperson Christina Nuckols.

In an effort to boost that number, the state plans to ask enrollees if they want to opt out of receiving text messages, rather than ask them to opt in, she said. This way enrollees would contact the state only if they don’t want to be texted. The state is reviewing its legal options to make that happen.

Meanwhile, Ms. Nuckols added, the state expects Medicaid health plans to contact enrollees about updating their contact information. Four of Virginia’s six Medicaid plans, which serve the bulk of the state’s enrollees, have permission to text about 316,000.

Craig Kennedy, CEO of Medicaid Health Plans of America, a trade group, said that most plans are using texting and that Medicaid officials will use multiple strategies to connect with enrollees. “I do not see this as a detriment, that states are not texting information about reenrollment,” he said. “I know we will be helping with that.”

California officials in March directed Medicaid health plans to use a variety of communication methods, including texting, to ensure that members can retain coverage if they remain eligible. The officials told health plans they could ask for consent through an initial text.

California officials say they also plan to ask enrollees for consent to be texted on the enrollment application, although federal approval for the change is not expected until the fall.

A few state Medicaid programs have experimented in recent years with pilot programs that included texting enrollees.

In 2019, Louisiana worked with the nonprofit group Code for America to send text messages that reminded people about renewing coverage and providing income information for verification. Compared with traditional communication methods, the texts led to a 67% increase in enrollees being renewed for coverage and a 56% increase in enrollees verifying their income in response to inquiries, said Medicaid spokesperson Alyson Neel.

Nonetheless, the state isn’t planning to text Medicaid enrollees about the end of the public health emergency because it hasn’t set up a system for that. “Medicaid has not yet been able to implement a text messaging system of its own due to other agency priorities,” Ms. Neel said.

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

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Omicron BA.2: What do we know so far?

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Tue, 04/19/2022 - 16:31

Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

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Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

Since November 2021, the Omicron variant of SARS-CoV-2 has quickly become the most dominant variant worldwide. Early sequencing of Omicron in South Africa alerted researchers to the possibility that Omicron could be a cause for concern because of extensive mutations of the spike protein. Omicron has 30 mutations of the spike protein, compared with the original Wuhan-Hu-1 variant, with 15 mutations of the receptor-binding domain (which are linked to a decrease in antibody binding), mutations at the furin S1/S2 site (which improves furin binding and increases infectiousness), and mutations of the amino terminal domain (which is the main binding site for some of the therapeutic antibodies used to treat COVID-19 infections).

Omicron’s functional characteristics

Non–peer-reviewed studies have shown a replication of Omicron in pulmonary epithelial cells, which was shown to be less efficient, when compared with Delta and Wuhan-Hu-1. The number of viral copies from an Omicron infection in pulmonary epithelial cells was significantly lower, compared with infection with the Delta or Wuhan-Hu-1 variants. The association of these characteristics found an increase in the number of viral copies in human epithelial cells (taken from the nasal airways) infected with Omicron. This supports the understanding that Omicron is more transmissible but results in a less severe manifestation of the disease.

As for the phenotypic expression of the infection, attention has been focused on Omicron’s reduced capacity to cause syncytia in pulmonary tissue cultures, information which is relevant to its clinical significance, if we consider that the formation of syncytia has been associated with a more severe manifestation of the disease. Furthermore, it has emerged that Omicron can use different cellular entry routes, with a preference for endosomal fusion over superficial cellular fusion. This characteristic allows Omicron to significantly increase the number of types of cells it can infect.
 

Omicron BA.2 evolves

Between November and December 2021, Omicron progressed, evolving into a variant with characteristics similar to those of its predecessors (that is, it underwent a gradual and progressive increase in transmissibility). Early studies on the Omicron variant were mainly based on the BA.1 subvariant. Since the start of January 2022, there has been an unexpected increase in BA.2 in Europe and Asia. Since then, continued surveillance on the evolution of Omicron has shown an increased prevalence of two subvariants: BA.1 with a R346K mutation (BA.1 + R346K) and B.1.1.529.2 (BA.2), with the latter containing eight unique spike mutations and 13 missing spike mutations, compared with those found in BA.1.

From these differences, we cannot presume that their antigenic properties are similar or different, but they seem to be antigenically equidistant from wild-type SARS-CoV-2, likely jeopardizing in equal measures the efficacy of current COVID-19 vaccines. Furthermore, BA.2 shows significant resistance to 17 out of 19 neutralizing monoclonal antibodies tested in this study, demonstrating that current monoclonal antibody therapy may have significant limitations in terms of adequate coverage for all subvariants of the Omicron variant.
 

Omicron BA.2 and reinfection

BA.2 initially represented only 13% of Omicron sequences at a global level, quickly becoming the dominant form in some countries, such as Denmark. At the end of 2021, BA.2 represented around 20% of all Danish cases of SARS-CoV-2. Halfway through January 2022, this had increased to around 45%, data that indicate that BA.2 carries an advantage over BA.1 within the highly vaccinated population of Denmark.

BA.2 is associated with an increased susceptibility of infection for unvaccinated individuals (odds ratio, 2.19; 95% confidence interval, 1.58-3.04), fully vaccinated individuals (OR, 2.45; 95% CI, 1.77-3.40), and booster-vaccinated individuals (OR, 2.99; 95% CI, 2.11-4.24), compared with BA.1. The pattern of increased transmissibility in BA.2 households was not observed for fully vaccinated and booster-vaccinated primary cases, where the OR of transmission was below 1 for BA.2, compared with BA.1. These data confirm the immune-evasive properties of BA.2 that further reduce the protective effect of vaccination against infection, but do not increase its transmissibility from vaccinated individuals with breakthrough infections.
 

Omicron, BA.2, and vaccination

The understanding of serum neutralizing activity, in correlation to the efficacy of a vaccine, is a priority of research because of the growing epidemiological significance of BA.2. There is evidence to support the claim that the immune-evasive nature of BA.2 doesn›t seem to be as severe as that of BA.1, and it is possible that there are other viral or host factors that are enabling the rapid diffusion of BA.2. A study published in Science Immunology investigated humoral and cellular immune responses to Omicron and other variants of concern (VOCs), looking to understand how, and to what degree, vaccinated individuals are protected against Omicron. From the results, a very low level of antibody cross-neutralization of Omicron, or a lack thereof, was seen when compared with wild type, Beta, and Delta variants, which could be partially restored by a third booster vaccination. Furthermore, T lymphocytes were shown to recognize Omicron with the same efficacy as seen for the other VOCs, suggesting that vaccinated individuals maintain T lymphocyte immunity, an element that is capable of providing protection in the absence of neutralizing antibodies, limiting the chance of serious disease.

These results are consistent with those available from a study performed in a population from Qatar made up of 2,239,193 people who had received at least two doses of a BNT162b2 or mRNA-1273 vaccine. The efficacy of the booster against a symptomatic Omicron infection, compared with that from the primary series, was 49.4% (95% CI, 47.1-51.6). The efficacy of the booster against hospitalization for COVID-19 and the death rate from Omicron infection, compared with the primary series, was 76.5% (95% CI, 55.9-87.5). The efficacy of the BNT162b2 booster against a symptomatic Delta variant infection (or B.1.617.2), compared with the primary series, was 86.1% (95% CI, 67.3-94.1).

To summarize, the constant increase in the prevalence of BA.2 in more countries over the world has confirmed the growth advantage that this variant has compared with others. BA.2 reduces the protective effect of vaccination against infection. Omicron antibody cross-neutralization can be partially restored by a third booster vaccination, an aspect that becomes problematic in the context of a low vaccination rate, where peaks of Omicron may increase the likelihood of infection in the elderly and in other groups at a higher risk of severe disease. Omicron BA.2 opens up new evolution channels, but what do the experts think will happen?

A version of this article was originally published in Italian on Univadis.

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Fourth Pfizer dose better for severe than symptomatic COVID: Study

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Tue, 04/19/2022 - 17:11

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

 

 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

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A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

 

 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.

However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”

“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
 

Booster confusion

Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.

Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.

The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.

Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.

Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.

In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.

Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
 

Booster advice

Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.

“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.

“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”

People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”

CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.

“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
 

 

 

Focus on the memory cells

Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”

Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.

Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.

“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”

Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.

“At some point we are going to have to get used to mild illness,” Dr. Offit said.

The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.

“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”

The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.

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

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Monoclonal antibodies for COVID – Give IV infusion or an injection?

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Tue, 04/19/2022 - 17:12

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

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New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

New research suggests that the casirivimab-imdevimab monoclonal antibody treatment for COVID-19 could have been delivered via injection instead of intravenously. There was no statistically significant difference in 28-day hospitalization or death in those treated intravenously and via subcutaneous injection.

The findings, published in JAMA Network Open, aren’t directly relevant at the moment, since the casirivimab-imdevimab treatment was abandoned when it failed to work during the Omicron outbreak. However, they point toward the importance of studying multiple routes of administration, said study lead author and pharmacist Erin K. McCreary, PharmD, of the University of Pittsburgh, in an interview.

“It would be beneficial for all future monoclonal antibodies for COVID-19 to be studied subcutaneously or intramuscularly, if possible, since that’s logistically easier than IV in the outpatient setting,” she said.

According to Dr. McCreary, an outpatient casirivimab-imdevimab treatment was used from 2020 to 2022 to treat higher-risk patients with mild to moderate COVID-19. The treatment was typically given intravenously as recommended by the federal government’s Emergency Use Authorization, she said. Clinical trials of the treatment, according to the study, allowed only IV administration.

“However, during the Delta surge, we were faced with so many patient referrals for treatment and staffing shortages that we couldn’t accommodate every patient unless we switched to [the] subcutaneous route,” Dr. McCreary said. This approach shortened appointment times by 30 minutes vs. infusion, she said.

There are many benefits to subcutaneous administration versus IV, Dr. McCreary said. “You don’t need to start an intravenous line, so you avoid the line kit and the nursing time needed for that. You draw up the drug directly into syringes and inject under the skin, so you avoid the need for a fluid bag to mix the drug in and run intravenously,” she said. “The appointment times are shorter, so you can accommodate more patients per day. Pharmacy interns can give subcutaneous injections, so you avoid the need for a nurse trained in placing intravenous lines.”

The researchers prospectively assigned 1,959 matched adults with mild to moderate COVID-19 to subcutaneous or intravenous treatment. Of 969 patients who received the subcutaneous treatment (mean age, 53.8; 56.4% women), the 28-day rate of hospitalization or death was 3.4%. Of 1,216 patients who received intravenous treatment (mean age, 54.3; 54.4% women), the rate was 1.7%. The difference was not statistically significant (P = .16).

Among 1,306 nontreated controls, 7.0% were hospitalized or died within 28 days (risk ratio = 0.48 vs. subcutaneous treatment group; 95% confidence interval, 0.30-0.80; P = .002).

“We did not find any patients where IV is a must,” Dr. McCreary said. “However, our study wasn’t powered to see a difference in certain subgroups.”

In an interview, University of Toronto internal medicine and pharmacology/toxicology physician Peter Wu, MD, said he agrees that the study has value because it emphasizes the importance of testing whether monoclonal antibodies can be administered in ways other than intravenously.

However, in the larger picture, he said, this may be irrelevant since it’s clear that anti-spike treatments are not holding up against COVID-19 variants.

No study funding is reported. Some study authors reported disclosures outside the submitted work. Dr. Wu has disclosed no relevant financial relationships.

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

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COVID-19 cardiovascular complications in children: AHA statement

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Thu, 12/15/2022 - 14:33

Cardiovascular complications are uncommon for children and young adults after COVID-19 disease or SARS-CoV-2 infection, according to a new scientific statement from the American Heart Association.

However, the infection can cause some children and young people to experience arrhythmias, myocarditis, pericarditis, or multisystem inflammatory syndrome (MIS-C), a new condition identified during the pandemic, it notes.

The statement details what has been learned about how to treat, manage, and prevent cardiovascular complications associated with COVID-19 in children and young adults and calls for more research, including studies following the short- and long-term cardiovascular effects.

It also reports that COVID-19 vaccines have been found to prevent severe COVID-19 disease and decrease the risk of developing MIS-C by 91% among children ages 12-18 years.

On returning to sports, it says data suggest it is safe for young people with mild or asymptomatic COVID-19 to resume exercise after recovery from symptoms. For those with more serious infections, it recommends additional tests, including cardiac enzyme levels, electrocardiogram, and echocardiogram, before returning to sports or strenuous physical exercise.

The scientific statement was published online on in Circulation.

“Two years into the pandemic and with vast amounts of research conducted in children with COVID-19, this statement summarizes what we know so far related to COVID-19 in children,” said chair of the statement writing group Pei-Ni Jone, MD, from the Children’s Hospital Colorado, Aurora.

Analysis of the latest research indicates children generally have mild symptoms from SARS-CoV-2 infection. In the U.S., as of Feb. 24, 2022, children under 18 years of age have accounted for 17.6% of total COVID-19 cases and about 0.1% of deaths from the virus, the report states.  

In addition, young adults, ages 18-29 years, have accounted for 21.3% of cases and 0.8% of deaths from COVID-19.

Like adults, children with underlying medical conditions such as chronic lung disease or obesity and those who are immunocompromised are more likely to be hospitalized, to be admitted to an intensive care unit, and to die of COVID-19, the statement notes. There are conflicting reports on the risk of severe COVID-19 in children and young adults with congenital heart disease, with some reports suggesting a slightly increased risk of severe COVID-19.

In terms of cardiovascular complications of COVID-19 in children, arrhythmias have included ventricular tachycardia and atrial tachycardia, as well as first-degree atrioventricular block. Although arrhythmias generally self-resolve without the need for treatment, prophylactic antiarrhythmics have been administered in some cases, and death caused by recurrent ventricular tachycardia in an adolescent with hypertrophic cardiomyopathy has been described.

Elevations of troponin, electrocardiographic abnormalities, including ST-segment changes, and delayed gadolinium enhancement on cardiac magnetic resonance imaging have been seen in those with myocardial involvement. Although death is rare, both sudden cardiac death and death after intensive medical and supportive therapies have occurred in children with severe myocardial involvement.

In a large retrospective pediatric case series of SARS-CoV-2–associated deaths in individuals under 21 years of age, the median age at death was 17 years, 63% were male, 28% were Black, and 46% were Hispanic. Of those who died, 86% had a comorbid condition, with obesity (42%) and asthma (29%) being the most common.

But the report concludes that: “Although children with comorbidities are at increased risk for symptomatic SARS-CoV-2 infection, compared with healthy children, cardiovascular complications, severe illness, and death are uncommon.”
 

 

 

MIS-C: Rare but severe

The authors of the statement explain that children and some young adults may develop MIS-C, a relatively rare but severe inflammatory syndrome generally occurring 2-6 weeks after infection with SARS-CoV-2 that can affect the heart and multiple organ systems.

In the first year of the pandemic, more than 2,600 cases of MIS-C were reported to the Centers for Disease Control and Prevention, at an estimated rate of 1 case per 3,164 cases of SARS-CoV-2 infection in children, with MIS-C disproportionately affecting Hispanic and Black children.

As many as 50% of children with MIS-C have myocardial involvement, including decreased left ventricular function, coronary artery dilation or aneurysms, myocarditis, elevated troponin and BNP or NT-proBNP, or pericardial effusion. Acute-phase reactants, including C-reactive protein, D-dimer, ferritin, and fibrinogen, can be significantly elevated in MIS-C, neutrophil/lymphocyte ratio may be higher, and platelet counts lower than those with non–MIS-C febrile illnesses.

Fortunately, the outcome of MIS-C is generally very good, with resolution of inflammation and cardiovascular abnormalities within 1-4 weeks of diagnosis, the report says.

However, there have been reports of progression of coronary artery aneurysms after discharge, highlighting the potential for long-term complications. Death resulting from MIS-C is rare, with a mortality rate of 1.4%-1.9%.

Compared with children and young adults who died of acute SARS-CoV-2 infection, most of the fatalities from MIS-C were in previously healthy individuals without comorbidities.

The authors recommend structured follow-up of patients with MIS-C because of concern about progression of cardiac complications and an unclear long-term prognosis.

The statement notes that the first-line treatment for MIS-C is typically intravenous immunoglobulin (IVIG) and patients with poor ventricular function may need to have IVIG in divided doses to tolerate the fluid load.  

Supportive treatment for heart failure and vasoplegic shock often requires aggressive management in an ICU for administration of inotropes and vasoactive medications. Antiplatelet therapy with low-dose aspirin is considered in patients with coronary artery involvement, and anticoagulation is added, depending on the degree of coronary artery dilation.
 

COVID-19 vaccination

The statement notes that vaccines can prevent patients from getting COVID-19 and decrease the risk of MIS-C by 91% among children 12-18 years of age.

On vaccine-associated myocarditis, it concludes the benefits of getting the vaccines outweigh the risks.  

For example, for every 1 million doses of the mRNA COVID-19 vaccines in males ages 12-29 years (the highest risk group for vaccine-associated myocarditis), it is estimated that 11,000 COVID-19 cases, 560 hospitalizations, and six deaths would be prevented, whereas 39-47 cases of myocarditis would be expected.

But it adds that the CDC is continuing to follow myocarditis in children and young adults closely, particularly a possible connection to the mRNA COVID-19 vaccines.

The statement says that more research is needed to better understand the mechanisms and optimal treatment approaches for SARS-CoV-2 infection, vaccine-associated myocarditis, the long-term outcomes of both COVID-19 and MIS-C, and the impact of these various conditions on the heart in children and young adults. In addition, any new antiviral therapies need to be tested in clinical trials focused on children.

“Although much has been learned about how the virus impacts children’s and young adult’s hearts, how to best treat cardiovascular complications, and prevent severe illness, continued clinical research trials are needed to better understand the long-term cardiovascular impacts,” Dr. Jone said. “It is also important to address health disparities that have become more apparent during the pandemic. We must work to ensure all children receive equal access to vaccination and high-quality care.”

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

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Cardiovascular complications are uncommon for children and young adults after COVID-19 disease or SARS-CoV-2 infection, according to a new scientific statement from the American Heart Association.

However, the infection can cause some children and young people to experience arrhythmias, myocarditis, pericarditis, or multisystem inflammatory syndrome (MIS-C), a new condition identified during the pandemic, it notes.

The statement details what has been learned about how to treat, manage, and prevent cardiovascular complications associated with COVID-19 in children and young adults and calls for more research, including studies following the short- and long-term cardiovascular effects.

It also reports that COVID-19 vaccines have been found to prevent severe COVID-19 disease and decrease the risk of developing MIS-C by 91% among children ages 12-18 years.

On returning to sports, it says data suggest it is safe for young people with mild or asymptomatic COVID-19 to resume exercise after recovery from symptoms. For those with more serious infections, it recommends additional tests, including cardiac enzyme levels, electrocardiogram, and echocardiogram, before returning to sports or strenuous physical exercise.

The scientific statement was published online on in Circulation.

“Two years into the pandemic and with vast amounts of research conducted in children with COVID-19, this statement summarizes what we know so far related to COVID-19 in children,” said chair of the statement writing group Pei-Ni Jone, MD, from the Children’s Hospital Colorado, Aurora.

Analysis of the latest research indicates children generally have mild symptoms from SARS-CoV-2 infection. In the U.S., as of Feb. 24, 2022, children under 18 years of age have accounted for 17.6% of total COVID-19 cases and about 0.1% of deaths from the virus, the report states.  

In addition, young adults, ages 18-29 years, have accounted for 21.3% of cases and 0.8% of deaths from COVID-19.

Like adults, children with underlying medical conditions such as chronic lung disease or obesity and those who are immunocompromised are more likely to be hospitalized, to be admitted to an intensive care unit, and to die of COVID-19, the statement notes. There are conflicting reports on the risk of severe COVID-19 in children and young adults with congenital heart disease, with some reports suggesting a slightly increased risk of severe COVID-19.

In terms of cardiovascular complications of COVID-19 in children, arrhythmias have included ventricular tachycardia and atrial tachycardia, as well as first-degree atrioventricular block. Although arrhythmias generally self-resolve without the need for treatment, prophylactic antiarrhythmics have been administered in some cases, and death caused by recurrent ventricular tachycardia in an adolescent with hypertrophic cardiomyopathy has been described.

Elevations of troponin, electrocardiographic abnormalities, including ST-segment changes, and delayed gadolinium enhancement on cardiac magnetic resonance imaging have been seen in those with myocardial involvement. Although death is rare, both sudden cardiac death and death after intensive medical and supportive therapies have occurred in children with severe myocardial involvement.

In a large retrospective pediatric case series of SARS-CoV-2–associated deaths in individuals under 21 years of age, the median age at death was 17 years, 63% were male, 28% were Black, and 46% were Hispanic. Of those who died, 86% had a comorbid condition, with obesity (42%) and asthma (29%) being the most common.

But the report concludes that: “Although children with comorbidities are at increased risk for symptomatic SARS-CoV-2 infection, compared with healthy children, cardiovascular complications, severe illness, and death are uncommon.”
 

 

 

MIS-C: Rare but severe

The authors of the statement explain that children and some young adults may develop MIS-C, a relatively rare but severe inflammatory syndrome generally occurring 2-6 weeks after infection with SARS-CoV-2 that can affect the heart and multiple organ systems.

In the first year of the pandemic, more than 2,600 cases of MIS-C were reported to the Centers for Disease Control and Prevention, at an estimated rate of 1 case per 3,164 cases of SARS-CoV-2 infection in children, with MIS-C disproportionately affecting Hispanic and Black children.

As many as 50% of children with MIS-C have myocardial involvement, including decreased left ventricular function, coronary artery dilation or aneurysms, myocarditis, elevated troponin and BNP or NT-proBNP, or pericardial effusion. Acute-phase reactants, including C-reactive protein, D-dimer, ferritin, and fibrinogen, can be significantly elevated in MIS-C, neutrophil/lymphocyte ratio may be higher, and platelet counts lower than those with non–MIS-C febrile illnesses.

Fortunately, the outcome of MIS-C is generally very good, with resolution of inflammation and cardiovascular abnormalities within 1-4 weeks of diagnosis, the report says.

However, there have been reports of progression of coronary artery aneurysms after discharge, highlighting the potential for long-term complications. Death resulting from MIS-C is rare, with a mortality rate of 1.4%-1.9%.

Compared with children and young adults who died of acute SARS-CoV-2 infection, most of the fatalities from MIS-C were in previously healthy individuals without comorbidities.

The authors recommend structured follow-up of patients with MIS-C because of concern about progression of cardiac complications and an unclear long-term prognosis.

The statement notes that the first-line treatment for MIS-C is typically intravenous immunoglobulin (IVIG) and patients with poor ventricular function may need to have IVIG in divided doses to tolerate the fluid load.  

Supportive treatment for heart failure and vasoplegic shock often requires aggressive management in an ICU for administration of inotropes and vasoactive medications. Antiplatelet therapy with low-dose aspirin is considered in patients with coronary artery involvement, and anticoagulation is added, depending on the degree of coronary artery dilation.
 

COVID-19 vaccination

The statement notes that vaccines can prevent patients from getting COVID-19 and decrease the risk of MIS-C by 91% among children 12-18 years of age.

On vaccine-associated myocarditis, it concludes the benefits of getting the vaccines outweigh the risks.  

For example, for every 1 million doses of the mRNA COVID-19 vaccines in males ages 12-29 years (the highest risk group for vaccine-associated myocarditis), it is estimated that 11,000 COVID-19 cases, 560 hospitalizations, and six deaths would be prevented, whereas 39-47 cases of myocarditis would be expected.

But it adds that the CDC is continuing to follow myocarditis in children and young adults closely, particularly a possible connection to the mRNA COVID-19 vaccines.

The statement says that more research is needed to better understand the mechanisms and optimal treatment approaches for SARS-CoV-2 infection, vaccine-associated myocarditis, the long-term outcomes of both COVID-19 and MIS-C, and the impact of these various conditions on the heart in children and young adults. In addition, any new antiviral therapies need to be tested in clinical trials focused on children.

“Although much has been learned about how the virus impacts children’s and young adult’s hearts, how to best treat cardiovascular complications, and prevent severe illness, continued clinical research trials are needed to better understand the long-term cardiovascular impacts,” Dr. Jone said. “It is also important to address health disparities that have become more apparent during the pandemic. We must work to ensure all children receive equal access to vaccination and high-quality care.”

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

Cardiovascular complications are uncommon for children and young adults after COVID-19 disease or SARS-CoV-2 infection, according to a new scientific statement from the American Heart Association.

However, the infection can cause some children and young people to experience arrhythmias, myocarditis, pericarditis, or multisystem inflammatory syndrome (MIS-C), a new condition identified during the pandemic, it notes.

The statement details what has been learned about how to treat, manage, and prevent cardiovascular complications associated with COVID-19 in children and young adults and calls for more research, including studies following the short- and long-term cardiovascular effects.

It also reports that COVID-19 vaccines have been found to prevent severe COVID-19 disease and decrease the risk of developing MIS-C by 91% among children ages 12-18 years.

On returning to sports, it says data suggest it is safe for young people with mild or asymptomatic COVID-19 to resume exercise after recovery from symptoms. For those with more serious infections, it recommends additional tests, including cardiac enzyme levels, electrocardiogram, and echocardiogram, before returning to sports or strenuous physical exercise.

The scientific statement was published online on in Circulation.

“Two years into the pandemic and with vast amounts of research conducted in children with COVID-19, this statement summarizes what we know so far related to COVID-19 in children,” said chair of the statement writing group Pei-Ni Jone, MD, from the Children’s Hospital Colorado, Aurora.

Analysis of the latest research indicates children generally have mild symptoms from SARS-CoV-2 infection. In the U.S., as of Feb. 24, 2022, children under 18 years of age have accounted for 17.6% of total COVID-19 cases and about 0.1% of deaths from the virus, the report states.  

In addition, young adults, ages 18-29 years, have accounted for 21.3% of cases and 0.8% of deaths from COVID-19.

Like adults, children with underlying medical conditions such as chronic lung disease or obesity and those who are immunocompromised are more likely to be hospitalized, to be admitted to an intensive care unit, and to die of COVID-19, the statement notes. There are conflicting reports on the risk of severe COVID-19 in children and young adults with congenital heart disease, with some reports suggesting a slightly increased risk of severe COVID-19.

In terms of cardiovascular complications of COVID-19 in children, arrhythmias have included ventricular tachycardia and atrial tachycardia, as well as first-degree atrioventricular block. Although arrhythmias generally self-resolve without the need for treatment, prophylactic antiarrhythmics have been administered in some cases, and death caused by recurrent ventricular tachycardia in an adolescent with hypertrophic cardiomyopathy has been described.

Elevations of troponin, electrocardiographic abnormalities, including ST-segment changes, and delayed gadolinium enhancement on cardiac magnetic resonance imaging have been seen in those with myocardial involvement. Although death is rare, both sudden cardiac death and death after intensive medical and supportive therapies have occurred in children with severe myocardial involvement.

In a large retrospective pediatric case series of SARS-CoV-2–associated deaths in individuals under 21 years of age, the median age at death was 17 years, 63% were male, 28% were Black, and 46% were Hispanic. Of those who died, 86% had a comorbid condition, with obesity (42%) and asthma (29%) being the most common.

But the report concludes that: “Although children with comorbidities are at increased risk for symptomatic SARS-CoV-2 infection, compared with healthy children, cardiovascular complications, severe illness, and death are uncommon.”
 

 

 

MIS-C: Rare but severe

The authors of the statement explain that children and some young adults may develop MIS-C, a relatively rare but severe inflammatory syndrome generally occurring 2-6 weeks after infection with SARS-CoV-2 that can affect the heart and multiple organ systems.

In the first year of the pandemic, more than 2,600 cases of MIS-C were reported to the Centers for Disease Control and Prevention, at an estimated rate of 1 case per 3,164 cases of SARS-CoV-2 infection in children, with MIS-C disproportionately affecting Hispanic and Black children.

As many as 50% of children with MIS-C have myocardial involvement, including decreased left ventricular function, coronary artery dilation or aneurysms, myocarditis, elevated troponin and BNP or NT-proBNP, or pericardial effusion. Acute-phase reactants, including C-reactive protein, D-dimer, ferritin, and fibrinogen, can be significantly elevated in MIS-C, neutrophil/lymphocyte ratio may be higher, and platelet counts lower than those with non–MIS-C febrile illnesses.

Fortunately, the outcome of MIS-C is generally very good, with resolution of inflammation and cardiovascular abnormalities within 1-4 weeks of diagnosis, the report says.

However, there have been reports of progression of coronary artery aneurysms after discharge, highlighting the potential for long-term complications. Death resulting from MIS-C is rare, with a mortality rate of 1.4%-1.9%.

Compared with children and young adults who died of acute SARS-CoV-2 infection, most of the fatalities from MIS-C were in previously healthy individuals without comorbidities.

The authors recommend structured follow-up of patients with MIS-C because of concern about progression of cardiac complications and an unclear long-term prognosis.

The statement notes that the first-line treatment for MIS-C is typically intravenous immunoglobulin (IVIG) and patients with poor ventricular function may need to have IVIG in divided doses to tolerate the fluid load.  

Supportive treatment for heart failure and vasoplegic shock often requires aggressive management in an ICU for administration of inotropes and vasoactive medications. Antiplatelet therapy with low-dose aspirin is considered in patients with coronary artery involvement, and anticoagulation is added, depending on the degree of coronary artery dilation.
 

COVID-19 vaccination

The statement notes that vaccines can prevent patients from getting COVID-19 and decrease the risk of MIS-C by 91% among children 12-18 years of age.

On vaccine-associated myocarditis, it concludes the benefits of getting the vaccines outweigh the risks.  

For example, for every 1 million doses of the mRNA COVID-19 vaccines in males ages 12-29 years (the highest risk group for vaccine-associated myocarditis), it is estimated that 11,000 COVID-19 cases, 560 hospitalizations, and six deaths would be prevented, whereas 39-47 cases of myocarditis would be expected.

But it adds that the CDC is continuing to follow myocarditis in children and young adults closely, particularly a possible connection to the mRNA COVID-19 vaccines.

The statement says that more research is needed to better understand the mechanisms and optimal treatment approaches for SARS-CoV-2 infection, vaccine-associated myocarditis, the long-term outcomes of both COVID-19 and MIS-C, and the impact of these various conditions on the heart in children and young adults. In addition, any new antiviral therapies need to be tested in clinical trials focused on children.

“Although much has been learned about how the virus impacts children’s and young adult’s hearts, how to best treat cardiovascular complications, and prevent severe illness, continued clinical research trials are needed to better understand the long-term cardiovascular impacts,” Dr. Jone said. “It is also important to address health disparities that have become more apparent during the pandemic. We must work to ensure all children receive equal access to vaccination and high-quality care.”

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

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Breakthrough COVID dangerous for vaccinated cancer patients

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Thu, 12/15/2022 - 17:22

Vaccinated patients with cancer are more likely than those without cancer to contract a breakthrough COVID-19 infection, which puts them at a much higher risk for hospitalization and death, according to a study published in JAMA Oncology.

The risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.

“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.

Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.

Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.

Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.

Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.

Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.

In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.

“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.

Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.

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

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Vaccinated patients with cancer are more likely than those without cancer to contract a breakthrough COVID-19 infection, which puts them at a much higher risk for hospitalization and death, according to a study published in JAMA Oncology.

The risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.

“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.

Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.

Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.

Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.

Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.

Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.

In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.

“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.

Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.

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

Vaccinated patients with cancer are more likely than those without cancer to contract a breakthrough COVID-19 infection, which puts them at a much higher risk for hospitalization and death, according to a study published in JAMA Oncology.

The risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.

“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.

Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.

Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.

Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.

Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.

Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.

In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.

“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.

Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.

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

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Long-term smell loss in COVID-19 tied to damage in the brain’s olfactory bulb

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Tue, 05/24/2022 - 15:58

Patients with COVID-19, especially those with an altered sense of smell, have significantly more axon and microvasculopathy damage in the brain’s olfactory tissue versus non-COVID patients. These new findings from a postmortem study may explain long-term loss of smell in some patients with the virus.

“The striking axonal pathology in some cases indicates that olfactory dysfunction in COVID-19 may be severe and permanent,” the investigators led by Cheng-Ying Ho, MD, PhD, associate professor, department of pathology, Johns Hopkins University School of Medicine, Baltimore, write.

“The results show the damage caused by COVID can extend beyond the nasal cavity and involve the brain,” Dr. Ho told this news organization.

The study was published online April 11 in JAMA Neurology.
 

A more thorough investigation

Patients infected with SARS-CoV-2, which causes COVID-19, present with a wide range of symptoms. In addition to respiratory illnesses, they may exhibit various nonrespiratory manifestations of COVID-19.

One of the most prevalent of these is olfactory dysfunction. Research shows such dysfunction, including anosmia (loss of smell), hyposmia (reduced sense of smell), and parosmia (smells that are distorted or unpleasant), affects 30%-60% of patients with COVID-19, said Dr. Ho.

However, these statistics come from research before the advent of the Omicron variant, which evidence suggests causes less smell loss in patients with COVID, she said.

Previous studies in this area mainly focused on the lining of the nasal cavity. “We wanted to go a step beyond to see how the olfactory bulb was affected by COVID infection,” said Dr. Ho.

The study included 23 deceased patients with confirmed COVID-19 ranging in age from 28 to 93 years at death (median 62 years, 60.9% men). It also included 14 controls who tested negative for COVID-19, ranging in age from 20 to 77 years (median 53.5 years, 50% men).

Researchers collected postmortem tissue from the brain, lung, and other organs and reviewed pertinent clinical information.

Most patients with COVID died of COVID pneumonia or related complications, although some died from a different cause. Some had an active COVID infection and others were “post infection, meaning they were in the recovery stage,” said Dr. Ho.

Six patients with COVID-19 and eight controls had significant brain pathology.

Compared with controls, those with COVID-19 showed significantly worse olfactory axonal damage. The mean axon pathology score (range 1-3 with 3 the worst) was 1.921 in patients with COVID-19 and 1.198 in controls (95% confidence interval, 0.444-1.002; P < .001).

The mean axon density in the lateral olfactory tract was significantly less in patients with COVID-19 than in controls (P = .002), indicating a 23% loss of olfactory axons in the COVID group.

Comparing COVID patients with and without reported loss of smell, researchers found those with an altered sense of smell had significantly more severe olfactory axon pathology.
 

Vascular damage

Patients with COVID also had worse vascular damage. The mean microvasculopathy score (range, 1-3) was 1.907 in patients with COVID-19 and 1.405 in controls (95% CI, 0.259-0.745; P < .001).

There was no evidence of the virus in the olfactory tissue of most patients, suggesting the olfactory pathology was likely caused by vascular damage, said Dr. Ho.

What’s unique about SARS-CoV-2 is that, although it’s a respiratory virus, it’s capable of infecting endothelial cells lining vessels.

“Other respiratory viruses only attack the airways and won’t attack vessels, but vascular damage has been seen in the heart and lung in COVID patients, and our study showed the same findings in the olfactory bulb,” Dr. Ho explained.

The researchers divided patients with COVID by infection severity: mild, moderate, severe, and critical. Interestingly, those with the most severe olfactory pathology were the ones with milder infections, said Dr. Ho.

She noted other studies have reported patients with mild infection are more likely to lose the sense of smell than those with severe infection, but she’s skeptical about this finding.

“Patients with severe COVID are usually hospitalized and intubated, so it’s hard to get them to tell you whether they’ve lost smell or not; they have other more important issues to deal with like respiratory failure,” said Dr. Ho.

Advanced age is associated with neuropathologic changes, such as tau deposits, so the researchers conducted an analysis factoring in age-related brain changes. They found a COVID-19 diagnosis remained associated with increased axonal pathology, reduced axonal density, and increased vascular pathology.

“This means that the COVID patients had more severe olfactory pathology not just because they had more tau pathology,” Dr. Ho added.
 

 

 

New guidance for patients

Commenting for this news organization, Davangere P. Devanand, MD, professor of psychiatry and neurology and director of geriatric psychiatry, Columbia University Irving Medical Center, New York, said the findings indicate the damage from COVID in the olfactory pathway may not be reversible as was previously thought.

“This has been suggested before as a possibility, but the autopsy findings in this case series indicate clearly that there may be permanent damage,” he said.

The results highlight the need to monitor patients with COVID for a smell deficit, said Dr. Devanand. 

“Assuring patients of a full recovery in smell and taste may not be sound advice, although recovery does occur in many patients,” he added.

He praised the study design, especially the blinding of raters, but noted a number of weaknesses, including the small sample size and the age and gender discrepancies between the groups.

Another possible limitation was inclusion of patients with Alzheimer’s and Lewy body pathology, said Dr. Devanand.

“These patients typically already have pathology in the olfactory pathways, which means we don’t know if it was COVID or the underlying brain pathology contributing to smell difficulties in these patients,” he said.

He noted that, unlike deceased COVID cases in the study, patients who survive COVID may not experience axonal and microvascular injury in olfactory neurons and pathways and their sense of smell may make a full return.

Dr. Devanand said he would have liked more detailed information on the clinical history and course of study participants and whether these factors affected the pathology findings.

The study was supported by grants from the National Institutes of Health.

Dr. Ho and Dr. Devanand have reported no relevant financial disclosures.

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

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Patients with COVID-19, especially those with an altered sense of smell, have significantly more axon and microvasculopathy damage in the brain’s olfactory tissue versus non-COVID patients. These new findings from a postmortem study may explain long-term loss of smell in some patients with the virus.

“The striking axonal pathology in some cases indicates that olfactory dysfunction in COVID-19 may be severe and permanent,” the investigators led by Cheng-Ying Ho, MD, PhD, associate professor, department of pathology, Johns Hopkins University School of Medicine, Baltimore, write.

“The results show the damage caused by COVID can extend beyond the nasal cavity and involve the brain,” Dr. Ho told this news organization.

The study was published online April 11 in JAMA Neurology.
 

A more thorough investigation

Patients infected with SARS-CoV-2, which causes COVID-19, present with a wide range of symptoms. In addition to respiratory illnesses, they may exhibit various nonrespiratory manifestations of COVID-19.

One of the most prevalent of these is olfactory dysfunction. Research shows such dysfunction, including anosmia (loss of smell), hyposmia (reduced sense of smell), and parosmia (smells that are distorted or unpleasant), affects 30%-60% of patients with COVID-19, said Dr. Ho.

However, these statistics come from research before the advent of the Omicron variant, which evidence suggests causes less smell loss in patients with COVID, she said.

Previous studies in this area mainly focused on the lining of the nasal cavity. “We wanted to go a step beyond to see how the olfactory bulb was affected by COVID infection,” said Dr. Ho.

The study included 23 deceased patients with confirmed COVID-19 ranging in age from 28 to 93 years at death (median 62 years, 60.9% men). It also included 14 controls who tested negative for COVID-19, ranging in age from 20 to 77 years (median 53.5 years, 50% men).

Researchers collected postmortem tissue from the brain, lung, and other organs and reviewed pertinent clinical information.

Most patients with COVID died of COVID pneumonia or related complications, although some died from a different cause. Some had an active COVID infection and others were “post infection, meaning they were in the recovery stage,” said Dr. Ho.

Six patients with COVID-19 and eight controls had significant brain pathology.

Compared with controls, those with COVID-19 showed significantly worse olfactory axonal damage. The mean axon pathology score (range 1-3 with 3 the worst) was 1.921 in patients with COVID-19 and 1.198 in controls (95% confidence interval, 0.444-1.002; P < .001).

The mean axon density in the lateral olfactory tract was significantly less in patients with COVID-19 than in controls (P = .002), indicating a 23% loss of olfactory axons in the COVID group.

Comparing COVID patients with and without reported loss of smell, researchers found those with an altered sense of smell had significantly more severe olfactory axon pathology.
 

Vascular damage

Patients with COVID also had worse vascular damage. The mean microvasculopathy score (range, 1-3) was 1.907 in patients with COVID-19 and 1.405 in controls (95% CI, 0.259-0.745; P < .001).

There was no evidence of the virus in the olfactory tissue of most patients, suggesting the olfactory pathology was likely caused by vascular damage, said Dr. Ho.

What’s unique about SARS-CoV-2 is that, although it’s a respiratory virus, it’s capable of infecting endothelial cells lining vessels.

“Other respiratory viruses only attack the airways and won’t attack vessels, but vascular damage has been seen in the heart and lung in COVID patients, and our study showed the same findings in the olfactory bulb,” Dr. Ho explained.

The researchers divided patients with COVID by infection severity: mild, moderate, severe, and critical. Interestingly, those with the most severe olfactory pathology were the ones with milder infections, said Dr. Ho.

She noted other studies have reported patients with mild infection are more likely to lose the sense of smell than those with severe infection, but she’s skeptical about this finding.

“Patients with severe COVID are usually hospitalized and intubated, so it’s hard to get them to tell you whether they’ve lost smell or not; they have other more important issues to deal with like respiratory failure,” said Dr. Ho.

Advanced age is associated with neuropathologic changes, such as tau deposits, so the researchers conducted an analysis factoring in age-related brain changes. They found a COVID-19 diagnosis remained associated with increased axonal pathology, reduced axonal density, and increased vascular pathology.

“This means that the COVID patients had more severe olfactory pathology not just because they had more tau pathology,” Dr. Ho added.
 

 

 

New guidance for patients

Commenting for this news organization, Davangere P. Devanand, MD, professor of psychiatry and neurology and director of geriatric psychiatry, Columbia University Irving Medical Center, New York, said the findings indicate the damage from COVID in the olfactory pathway may not be reversible as was previously thought.

“This has been suggested before as a possibility, but the autopsy findings in this case series indicate clearly that there may be permanent damage,” he said.

The results highlight the need to monitor patients with COVID for a smell deficit, said Dr. Devanand. 

“Assuring patients of a full recovery in smell and taste may not be sound advice, although recovery does occur in many patients,” he added.

He praised the study design, especially the blinding of raters, but noted a number of weaknesses, including the small sample size and the age and gender discrepancies between the groups.

Another possible limitation was inclusion of patients with Alzheimer’s and Lewy body pathology, said Dr. Devanand.

“These patients typically already have pathology in the olfactory pathways, which means we don’t know if it was COVID or the underlying brain pathology contributing to smell difficulties in these patients,” he said.

He noted that, unlike deceased COVID cases in the study, patients who survive COVID may not experience axonal and microvascular injury in olfactory neurons and pathways and their sense of smell may make a full return.

Dr. Devanand said he would have liked more detailed information on the clinical history and course of study participants and whether these factors affected the pathology findings.

The study was supported by grants from the National Institutes of Health.

Dr. Ho and Dr. Devanand have reported no relevant financial disclosures.

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

Patients with COVID-19, especially those with an altered sense of smell, have significantly more axon and microvasculopathy damage in the brain’s olfactory tissue versus non-COVID patients. These new findings from a postmortem study may explain long-term loss of smell in some patients with the virus.

“The striking axonal pathology in some cases indicates that olfactory dysfunction in COVID-19 may be severe and permanent,” the investigators led by Cheng-Ying Ho, MD, PhD, associate professor, department of pathology, Johns Hopkins University School of Medicine, Baltimore, write.

“The results show the damage caused by COVID can extend beyond the nasal cavity and involve the brain,” Dr. Ho told this news organization.

The study was published online April 11 in JAMA Neurology.
 

A more thorough investigation

Patients infected with SARS-CoV-2, which causes COVID-19, present with a wide range of symptoms. In addition to respiratory illnesses, they may exhibit various nonrespiratory manifestations of COVID-19.

One of the most prevalent of these is olfactory dysfunction. Research shows such dysfunction, including anosmia (loss of smell), hyposmia (reduced sense of smell), and parosmia (smells that are distorted or unpleasant), affects 30%-60% of patients with COVID-19, said Dr. Ho.

However, these statistics come from research before the advent of the Omicron variant, which evidence suggests causes less smell loss in patients with COVID, she said.

Previous studies in this area mainly focused on the lining of the nasal cavity. “We wanted to go a step beyond to see how the olfactory bulb was affected by COVID infection,” said Dr. Ho.

The study included 23 deceased patients with confirmed COVID-19 ranging in age from 28 to 93 years at death (median 62 years, 60.9% men). It also included 14 controls who tested negative for COVID-19, ranging in age from 20 to 77 years (median 53.5 years, 50% men).

Researchers collected postmortem tissue from the brain, lung, and other organs and reviewed pertinent clinical information.

Most patients with COVID died of COVID pneumonia or related complications, although some died from a different cause. Some had an active COVID infection and others were “post infection, meaning they were in the recovery stage,” said Dr. Ho.

Six patients with COVID-19 and eight controls had significant brain pathology.

Compared with controls, those with COVID-19 showed significantly worse olfactory axonal damage. The mean axon pathology score (range 1-3 with 3 the worst) was 1.921 in patients with COVID-19 and 1.198 in controls (95% confidence interval, 0.444-1.002; P < .001).

The mean axon density in the lateral olfactory tract was significantly less in patients with COVID-19 than in controls (P = .002), indicating a 23% loss of olfactory axons in the COVID group.

Comparing COVID patients with and without reported loss of smell, researchers found those with an altered sense of smell had significantly more severe olfactory axon pathology.
 

Vascular damage

Patients with COVID also had worse vascular damage. The mean microvasculopathy score (range, 1-3) was 1.907 in patients with COVID-19 and 1.405 in controls (95% CI, 0.259-0.745; P < .001).

There was no evidence of the virus in the olfactory tissue of most patients, suggesting the olfactory pathology was likely caused by vascular damage, said Dr. Ho.

What’s unique about SARS-CoV-2 is that, although it’s a respiratory virus, it’s capable of infecting endothelial cells lining vessels.

“Other respiratory viruses only attack the airways and won’t attack vessels, but vascular damage has been seen in the heart and lung in COVID patients, and our study showed the same findings in the olfactory bulb,” Dr. Ho explained.

The researchers divided patients with COVID by infection severity: mild, moderate, severe, and critical. Interestingly, those with the most severe olfactory pathology were the ones with milder infections, said Dr. Ho.

She noted other studies have reported patients with mild infection are more likely to lose the sense of smell than those with severe infection, but she’s skeptical about this finding.

“Patients with severe COVID are usually hospitalized and intubated, so it’s hard to get them to tell you whether they’ve lost smell or not; they have other more important issues to deal with like respiratory failure,” said Dr. Ho.

Advanced age is associated with neuropathologic changes, such as tau deposits, so the researchers conducted an analysis factoring in age-related brain changes. They found a COVID-19 diagnosis remained associated with increased axonal pathology, reduced axonal density, and increased vascular pathology.

“This means that the COVID patients had more severe olfactory pathology not just because they had more tau pathology,” Dr. Ho added.
 

 

 

New guidance for patients

Commenting for this news organization, Davangere P. Devanand, MD, professor of psychiatry and neurology and director of geriatric psychiatry, Columbia University Irving Medical Center, New York, said the findings indicate the damage from COVID in the olfactory pathway may not be reversible as was previously thought.

“This has been suggested before as a possibility, but the autopsy findings in this case series indicate clearly that there may be permanent damage,” he said.

The results highlight the need to monitor patients with COVID for a smell deficit, said Dr. Devanand. 

“Assuring patients of a full recovery in smell and taste may not be sound advice, although recovery does occur in many patients,” he added.

He praised the study design, especially the blinding of raters, but noted a number of weaknesses, including the small sample size and the age and gender discrepancies between the groups.

Another possible limitation was inclusion of patients with Alzheimer’s and Lewy body pathology, said Dr. Devanand.

“These patients typically already have pathology in the olfactory pathways, which means we don’t know if it was COVID or the underlying brain pathology contributing to smell difficulties in these patients,” he said.

He noted that, unlike deceased COVID cases in the study, patients who survive COVID may not experience axonal and microvascular injury in olfactory neurons and pathways and their sense of smell may make a full return.

Dr. Devanand said he would have liked more detailed information on the clinical history and course of study participants and whether these factors affected the pathology findings.

The study was supported by grants from the National Institutes of Health.

Dr. Ho and Dr. Devanand have reported no relevant financial disclosures.

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

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Children and COVID: Cases drop again, admission rate up slightly

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Tue, 04/12/2022 - 16:41

The decline in new cases of child COVID-19 in the last week continued at about the same, somewhat slower pace as the week before, but admissions have moved upward slightly, according to the most recent data.

The total number of new cases came to 25,915 for the week of April 1-7, down by 5.8% from the previous week’s 27,521, which, in turn, was 5.2% lower than a week earlier, according to the American Academy of Pediatrics and the Children’s Hospital Association, which have been collecting COVID-related data from state and territorial health departments since the early stages of the pandemic. New case declines in previous weeks had ranged from 9.3% to 46%.

The nearly 26,000 cases reported during the first week of April represent a fall of 97.7% from the peak of the Omicron surge in mid-January, when weekly cases hit 1.15 million, and they represent the lowest weekly count since mid-July of 2021. Cumulative cases in children now number close to 12.9 million over the course of the pandemic, which is 19.0% of cases among all ages, the AAP and CHA said in their weekly COVID report.

Data on new-case rates from the Centers for Disease Control and Prevention show the same continued decline, but the CDC acknowledges the possibility of reporting delays in recent weeks. The numbers for the latest week, April 3-9, maintain the larger overall decline, but there have been a couple of small, temporary increases over the last month, the CDC reported on its COVID Data Tracker.

Daily new admissions of children aged 0-17 years with confirmed COVID were right around 0.14 per 100,000 population for April 3-9, compared with 0.13 per 100,000 during the week ending April 2, the CDC said, with reporting delays making it possible that the 0.14 figure could be revised upward in the near future. The highest admission rate, 1.25 children per 100,000 population, occurred on Jan. 15 and 16.

The latest on vaccination

New vaccinations slipped a bit in the last week, with the drop slightly larger among those aged 12-17 years – from 47,000 for the week of March 24-30 to 43,000 during March 31 to April 6 – than in children aged 5-11, who went from 70,000 initial doses to 69,000 over the same 2-week period, the AAP said in its weekly report on vaccination trends.

Among the states, Vermont has fully vaccinated more children aged 5-11 (58%) than any other state, while Hawaii is the leader in fully vaccinated 12- to 17-year-olds at 86%. The lowest comparable figures for both groups can be found in Alabama, where 10% of children aged 5-11 are fully vaccinated and 34% of those aged 12-17 have received both doses of the Pfizer-BioNTech vaccine, the AAP said.

National figures show equally large COVID vaccination gaps between the two age groups. As of April 11, 68% of all children aged 12-17 years had received at least one dose, compared with 34.6% of those aged 5-11, and 58.5% of the older group was fully vaccinated, versus 28.0% of the 5- to 11-year-olds, the CDC reported.

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The decline in new cases of child COVID-19 in the last week continued at about the same, somewhat slower pace as the week before, but admissions have moved upward slightly, according to the most recent data.

The total number of new cases came to 25,915 for the week of April 1-7, down by 5.8% from the previous week’s 27,521, which, in turn, was 5.2% lower than a week earlier, according to the American Academy of Pediatrics and the Children’s Hospital Association, which have been collecting COVID-related data from state and territorial health departments since the early stages of the pandemic. New case declines in previous weeks had ranged from 9.3% to 46%.

The nearly 26,000 cases reported during the first week of April represent a fall of 97.7% from the peak of the Omicron surge in mid-January, when weekly cases hit 1.15 million, and they represent the lowest weekly count since mid-July of 2021. Cumulative cases in children now number close to 12.9 million over the course of the pandemic, which is 19.0% of cases among all ages, the AAP and CHA said in their weekly COVID report.

Data on new-case rates from the Centers for Disease Control and Prevention show the same continued decline, but the CDC acknowledges the possibility of reporting delays in recent weeks. The numbers for the latest week, April 3-9, maintain the larger overall decline, but there have been a couple of small, temporary increases over the last month, the CDC reported on its COVID Data Tracker.

Daily new admissions of children aged 0-17 years with confirmed COVID were right around 0.14 per 100,000 population for April 3-9, compared with 0.13 per 100,000 during the week ending April 2, the CDC said, with reporting delays making it possible that the 0.14 figure could be revised upward in the near future. The highest admission rate, 1.25 children per 100,000 population, occurred on Jan. 15 and 16.

The latest on vaccination

New vaccinations slipped a bit in the last week, with the drop slightly larger among those aged 12-17 years – from 47,000 for the week of March 24-30 to 43,000 during March 31 to April 6 – than in children aged 5-11, who went from 70,000 initial doses to 69,000 over the same 2-week period, the AAP said in its weekly report on vaccination trends.

Among the states, Vermont has fully vaccinated more children aged 5-11 (58%) than any other state, while Hawaii is the leader in fully vaccinated 12- to 17-year-olds at 86%. The lowest comparable figures for both groups can be found in Alabama, where 10% of children aged 5-11 are fully vaccinated and 34% of those aged 12-17 have received both doses of the Pfizer-BioNTech vaccine, the AAP said.

National figures show equally large COVID vaccination gaps between the two age groups. As of April 11, 68% of all children aged 12-17 years had received at least one dose, compared with 34.6% of those aged 5-11, and 58.5% of the older group was fully vaccinated, versus 28.0% of the 5- to 11-year-olds, the CDC reported.

The decline in new cases of child COVID-19 in the last week continued at about the same, somewhat slower pace as the week before, but admissions have moved upward slightly, according to the most recent data.

The total number of new cases came to 25,915 for the week of April 1-7, down by 5.8% from the previous week’s 27,521, which, in turn, was 5.2% lower than a week earlier, according to the American Academy of Pediatrics and the Children’s Hospital Association, which have been collecting COVID-related data from state and territorial health departments since the early stages of the pandemic. New case declines in previous weeks had ranged from 9.3% to 46%.

The nearly 26,000 cases reported during the first week of April represent a fall of 97.7% from the peak of the Omicron surge in mid-January, when weekly cases hit 1.15 million, and they represent the lowest weekly count since mid-July of 2021. Cumulative cases in children now number close to 12.9 million over the course of the pandemic, which is 19.0% of cases among all ages, the AAP and CHA said in their weekly COVID report.

Data on new-case rates from the Centers for Disease Control and Prevention show the same continued decline, but the CDC acknowledges the possibility of reporting delays in recent weeks. The numbers for the latest week, April 3-9, maintain the larger overall decline, but there have been a couple of small, temporary increases over the last month, the CDC reported on its COVID Data Tracker.

Daily new admissions of children aged 0-17 years with confirmed COVID were right around 0.14 per 100,000 population for April 3-9, compared with 0.13 per 100,000 during the week ending April 2, the CDC said, with reporting delays making it possible that the 0.14 figure could be revised upward in the near future. The highest admission rate, 1.25 children per 100,000 population, occurred on Jan. 15 and 16.

The latest on vaccination

New vaccinations slipped a bit in the last week, with the drop slightly larger among those aged 12-17 years – from 47,000 for the week of March 24-30 to 43,000 during March 31 to April 6 – than in children aged 5-11, who went from 70,000 initial doses to 69,000 over the same 2-week period, the AAP said in its weekly report on vaccination trends.

Among the states, Vermont has fully vaccinated more children aged 5-11 (58%) than any other state, while Hawaii is the leader in fully vaccinated 12- to 17-year-olds at 86%. The lowest comparable figures for both groups can be found in Alabama, where 10% of children aged 5-11 are fully vaccinated and 34% of those aged 12-17 have received both doses of the Pfizer-BioNTech vaccine, the AAP said.

National figures show equally large COVID vaccination gaps between the two age groups. As of April 11, 68% of all children aged 12-17 years had received at least one dose, compared with 34.6% of those aged 5-11, and 58.5% of the older group was fully vaccinated, versus 28.0% of the 5- to 11-year-olds, the CDC reported.

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