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FDA panel votes to approve Pfizer’s vaccine for children
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Seventeen of the 18 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Oct. 26 voted to recommend the 10-microgram shot for kids, which is one-third the dose given to adults.
One member, Michael Kurilla, MD, director of the division of clinical innovation at the National Institutes of Health, Bethesda, Md., abstained from voting.
If the FDA follows the recommendation, as it typically does, and issues an Emergency Use Authorization for the vaccine, the shots could be available within days.
After the FDA’s final decision, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make specific recommendations for its use. The CDC committee must stick closely to the conditions for use spelled out in the EUA, so their recommendations are likely to be similar to those made by the FDA. Their next meeting is scheduled for Nov. 2 and 3.
In the end, some on the panel felt uneasy with their decision.
“I voted yes primarily because I wanted to make sure that children who really need this vaccine, the Black and brown children of our country, get the vaccine,” said James Hildreth, MD, PhD, president and CEO of Meharry Medical College in Nashville.
“But to be honest, the best way to protect the health of some children will be to do nothing because they will be just fine,” he said.
Others said they were surprised by how difficult the decision had been.
“This is a much tougher one than we had expected going into it,” said committee member Eric Rubin, MD, editor and chief of the New England Journal of Medicine, during the FDA advisory committee’s meeting.
Ahead of the vote, the committee heard presentations outlining the expected benefits of vaccinating children along with potential risks.
“Children have been greatly impacted by the pandemic,” said Fiona Havers, MD, a medical officer with the CDC in Atlanta who reviewed the epidemiology of COVID-19 in kids.
In the second year of the pandemic, as more seniors have been vaccinated against the virus, COVID cases have largely shifted from older to younger age groups.
So far, there have been more than 1.9 million COVID-19 cases in children ages 5 through 11 in the United States.. Cases in kids saw a big jump in July and August with summer travel, schools reopening, and the dominance of the Delta variant.
And those are just the cases reported to the CDC. Regular testing of anonymous blood samples collected at sites across the United States indicates that 6 times as many kids have had COVID than what is reflected in official counts.
Last winter, blood sample testing showed about 13% of children had antibodies against the virus, suggesting they’d been infected. By this summer, that number had risen to 42%.
That figure clearly made an impression on many members of the committee who asked the FDA’s vaccine reviewers if they had tried to account for immunity from past infections in their modeling. They had not.
Some felt that even with a highly effective vaccine — new data presented by Pfizer showed the children’s dose was 90% effective at preventing symptomatic infections in kids — caution was warranted as much is still unknown about myocarditis, a rare side effect of the mRNA vaccines.
Myocarditis has been more common in younger age groups. It usually goes away over time but requires hospital care. It’s not known if myocarditis could have lingering effects for those who experience it.
There were no cases of myocarditis seen in Pfizer’s studies of the vaccine in children, and no other serious events were seen. Vaccine side effects reported in the Pfizer studies were mostly mild and included fatigue, headache, and pain at the injection site.
“We think we have optimized the immune response and minimized our reactions,” said William Gruber, MD, senior vice president vaccine research and clinical development at Pfizer.
But the studies didn’t include enough participants to pick up rare, but serious adverse events like myocarditis.
“We’re worried about a side effect that we can’t measure yet, but it’s probably real, and we see a benefit that isn’t the same as it is in older age groups,” said Dr. Rubin.
Benefits vs. risks
FDA modeled the benefits and risks for children under a variety of scenarios. The benefits of the vaccines to children very much depend on the amount of transmission in the community.
When transmission is high, the benefits to children — in terms of infections, hospitalizations, ICU admissions — clearly outweigh its risks.
But when COVID-19 rates are low in the community, as they were in June, FDA analysts predicted the vaccines might send more children to the hospital for myocarditis than the virus would.
The FDA noted that kids who are hospitalized for myocarditis tend not to be as ill as children with COVID-19, however.
“If the trends continue the way they are going, the emergency for children is not what we might think it would be. That was my concern,” Dr. Hildreth said.
But others warned against complacency.
“Thinking that this is going to be the end of the wave permanently may be a little overly optimistic,” said committee chairman Arnold Monto, MD, a professor of public health and epidemiology at the University of Michigan, Ann Arbor.
The majority of COVID-19 cases in children are mild. Only about 1% of kids are hospitalized for their infections, according to CDC data. But the rates of hospitalizations in kids are about 3 times higher for people of color — including Blacks, Hispanics, and Native Americans, as compared to Whites and Asian Americans.
Since the start of the pandemic, 94 children ages 5 to 11 have died, making it the eighth leading cause of death for kids this age last year.
More than 5,200 children have developed a delayed complication from their infections called Multi-System Inflammatory Syndrome (MIS-C).
MIS-C can be severe and require hospital care and can lead to myocarditis. Children ages 5 to 11 are the age group at greatest risk for this complication.
Kids can also get long COVID. There’s not a lot of data on how often this happens, though it appears to be less frequent in children than in adults.
But a survey in the United Kingdom found that 7%-8% of kids have symptoms from their infections that last longer than 12 weeks, Dr. Havers said. Symptoms that can linger for kids include fatigue, cough, muscle and joint pain, headaches, and insomnia.
More than 1 million children have been impacted by school closures so far this year, and quarantines have had lasting impacts on learning, social development, and mental health.
Even though kids aren’t usually COVID superspreaders, they can still pass the infection on to others.
“What is clear is that secondary transmission from children, both to other children and to adults, does occur,” Dr. Havers said.
For that reason, they can continue the spread of the virus and give it opportunities to mutate and become more dangerous.
Safety monitoring to continue
Some committee members referenced thousands of letters they had received within the past few days urging them to vote against the vaccine.
Jay Portnoy, MD, a professor of pediatrics at Children’s Mercy Hospital in Kansas City, Mo., said he had personally received about 4,000 emails.
“But I feel like I need to also represent the consumers, the parents that I see every day in the clinic who are terrified of sending their children to school because they’re not protected against COVID,” he said, explaining his vote to recommend authorization.
“Our kids are going to be dealing with this virus for many years to come. It’s going to come repeatedly. Getting this vaccine is just the first step that they can take to protect themselves from having bad outcomes,” Dr. Portnoy said.
Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, reminded members of the committee that there were several government surveillance systems in place to catch any potential safety issues in near real time.
“I really appreciate very much the concern here. The safety monitoring of this vaccine will continue,” Dr. Marks said. “I do view this as one of our greatest responsibilities.”
“I really am so grateful that we had this discussion and voted to approve,” said Capt. Amanda Cohn, MD, chief medical officer at the National Center for Immunization and Respiratory Diseases.
“I think the benefits in this age group really are super important even if they are lower than for other age groups.”
This article was updated 10/27/21.
A version of this article first appeared on WebMD.com.
Pandemic drives uptick in need for mental health services
In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.
Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.
The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.
Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).
This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.
Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.
The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
Social and emotional support
Despite rising mental health care needs, period of July to Dec. 2020, also based on NHIS data.
Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.
However, social and emotional support varies by age and race/ethnicity.
Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.
“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.
As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.
The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.
One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.
A version of this article first appeared on Medscape.com.
In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.
Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.
The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.
Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).
This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.
Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.
The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
Social and emotional support
Despite rising mental health care needs, period of July to Dec. 2020, also based on NHIS data.
Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.
However, social and emotional support varies by age and race/ethnicity.
Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.
“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.
As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.
The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.
One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.
A version of this article first appeared on Medscape.com.
In 2020, amid the COVID-19 pandemic, about 1 in 5 (20.3%) U.S. adults received mental health treatment, up slightly from 19.2% in 2019, new data from the U.S. Centers for Disease Control and Prevention show.
Compared with 2019, the pandemic year of 2020 also saw an uptick in adults receiving prescription medication for a mental health problem (from 15.8% to 16.5%) or counseling or therapy from a mental health professional (from 9.5% to 10.1%), the CDC says.
The percentage of adults who had received mental health treatment in the prior year decreased with age, from 20.9% among people aged 18-44 to 20.5% among those aged 45-64 to 18.7% among those aged 65 and older.
Women were more likely than men to have received any mental health treatment (25.6% vs 14.6%), according to an analysis of 2020 data from the National Health Interview Survey (NHIS).
This is consistent with their higher prevalence of common mental health conditions, including anxiety and depression, and their greater willingness to seek out mental health care, Emily Terlizzi, MPH, and Tina Norris, PhD, with the CDC’s National Center for Health Statistics (NCHS), note in their data brief published online Oct. 20.
Non-Hispanic White adults (24.4%) were more likely than non-Hispanic Black (15.3%), Hispanic (12.65) and non-Hispanic Asian (7.7%) adults to be treated with a mental health issue.
The percentage of adults treated for a mental health problem increased as their place of residence became more rural, from 19.3% for those living in large urban areas to 21.7% among those residing in nonmetropolitan areas.
Social and emotional support
Despite rising mental health care needs, period of July to Dec. 2020, also based on NHIS data.
Social and emotional support is associated with well-being and a reduced risk of early death, NCHS researchers Peter Boersma, MPH, and Anjel Vahratian, PhD, MPH, note in their data brief.
However, social and emotional support varies by age and race/ethnicity.
Groups with lower levels of social and emotional support are Hispanic, non-Hispanic Black, and non-Hispanic Asian adults; adults neither married nor living with a partner; adults without another adult in the home; adults with less than a high school education; and adults with disabilities.
“While most adults always or usually had the emotional support they needed, 1 in 10 adults rarely or never received the social and emotional support they needed,” the authors report.
As reported by this news organization, 2020 data from the National Academies of Sciences, Engineering, and Medicine (NAS) show social isolation in older adults is a major public health concern that contributes to heart disease, depression, and premature death.
The report urged health care systems to take urgent action to address social isolation and loneliness in older adults and proposed a series of recommendations for addressing social isolation.
One recommendation was to improve awareness by including measures of social isolation and loneliness in health surveys, such as the NHIS, which began asking about perceived social and emotional support in July 2020.
A version of this article first appeared on Medscape.com.
FDA clears 5-minute test for early dementia
The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.
Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.
“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.
Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.
According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.
“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.
The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.
Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.
“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.
Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.
According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.
“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.
The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has given marketing clearance to CognICA, an artificial intelligence–powered integrated cognitive assessment for the early detection of dementia.
Developed by Cognetivity Neurosciences, CognICA is a 5-minute, computerized cognitive assessment that is completed using an iPad. The test offers several advantages over traditional pen-and-paper–based cognitive tests, the company said in a news release.
“These include its high sensitivity to early-stage cognitive impairment, avoidance of cultural or educational bias, and absence of learning effect upon repeat testing,” the company notes.
Because the test runs on a computer, it can support remote, self-administered testing at scale and is geared toward seamless integration with existing electronic health record systems, they add.
According to the latest Alzheimer’s Disease Facts and Figures, published by the Alzheimer’s Association, more than 6 million Americans are now living with Alzheimer’s disease. That number is projected to increase to 12.7 million by 2050.
“We’re excited about the opportunity to revolutionize the way cognitive impairment is assessed and managed in the U.S. and make a positive impact on the health and wellbeing of millions of Americans,” Sina Habibi, PhD, cofounder and CEO of Cognetivity, said in the news release.
The test has already received European regulatory approval as a CE-marked medical device and has been deployed in both primary and specialist clinical care in the U.K.’s National Health Service.
A version of this article first appeared on Medscape.com.
FDA authorizes boosters for Moderna, J&J, allows mix-and-match
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
in people who are eligible to get them.
The move to amend the Emergency Use Authorization for these vaccines gives the vaccine experts on the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices latitude to recommend a mix-and-match strategy if they feel the science supports it.
The committee convenes Oct. 21 for a day-long meeting to make its recommendations for additional doses.
People who’ve previously received two doses of the Moderna mRNA vaccine, which is now called Spikevax, are eligible for a third dose of any COVID-19 vaccine if they are 6 months past their second dose and are:
- 65 years of age or older
- 18 to 64 years of age, but at high risk for severe COVID-19 because of an underlying health condition
- 18 to 64 years of age and at high risk for exposure to the SARS-CoV-2 virus because they live in a group setting, such as a prison or care home, or work in a risky occupation, such as healthcare
People who’ve previously received a dose of the Johnson & Johnson vaccine are eligible for a second dose of any COVID-19 vaccine if they are over the age of 18 and at least 2 months past their vaccination.
“Today’s actions demonstrate our commitment to public health in proactively fighting against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD, in a news release. “As the pandemic continues to impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.
“The available data suggest waning immunity in some populations who are fully vaccinated. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
A version of this article was first published on Medscape.com.
White House announces vaccination plans for younger children
States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.
“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.
Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.
“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.
“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.
Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.
An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
Laying the groundwork
Doctors applauded the advance planning.
“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.
The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.
The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.
The White House says 25,000 doctors have already signed up to give the vaccines.
The vaccination campaign will get underway at a tough moment for pediatricians.
The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.
“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.
Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.
“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”
Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.
“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.
Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.
He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.
“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.
A version of this article first appeared on WebMD.com.
States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.
“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.
Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.
“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.
“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.
Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.
An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
Laying the groundwork
Doctors applauded the advance planning.
“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.
The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.
The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.
The White House says 25,000 doctors have already signed up to give the vaccines.
The vaccination campaign will get underway at a tough moment for pediatricians.
The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.
“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.
Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.
“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”
Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.
“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.
Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.
He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.
“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.
A version of this article first appeared on WebMD.com.
States were allowed to begin preordering the shots this week. But they can’t be delivered into kids’ arms until the FDA and CDC sign off. The shots could be available in early November.
“We know millions of parents have been waiting for COVID-19 vaccine for kids in this age group, and should the FDA and CDC authorize the vaccine, we will be ready to get shots in arms,” Jeff Zients, the White House COVID-19 response coordinator, said at a briefing Oct. 20.
Asked whether announcing plans to deliver a vaccine to children might put pressure on the agencies considering the evidence for their use, Mr. Zients defended the Biden administration’s plans.
“This is the right way to do things: To be operationally ready,” he said. Mr. Zients said they had learned a lesson from the prior administration.
“The decision was made by the FDA and CDC, and the operations weren’t ready. And that meant that adults at the time were not able to receive their vaccines as efficiently, equitably as possible. And this will enable us to be ready for kids,” he said.
Pfizer submitted data to the FDA in late September from its test of the vaccine in 2,200 children. The company said the shots had a favorable safety profile and generated “robust” antibody responses.
An FDA panel is scheduled to meet on Oct. 26 to consider Pfizer’s application. The CDC’s Advisory Committee on Immunization Practices will meet the following week, on Nov. 2 and 3.
Laying the groundwork
Doctors applauded the advance planning.
“Laying this advance groundwork, ensuring supply is available at physician practices, and that a patient’s own physician is available to answer questions, is critical to the continued success of this rollout,” Gerald Harmon, MD, president of the American Medical Association, said in a written statement.
The shots planned for children are 10 micrograms, a smaller dose than is given to adults. To be fully immunized, kids get two doses, spaced about 21 days apart. Vaccines for younger children are packaged in smaller vials and injected through smaller needles, too.
The vaccine for younger children will roll out slightly differently than it has for adults and teens. While adults mostly got their COVID-19 vaccines through pop-up mass vaccination sites, health departments, and other community locations, the strategy to get children immunized against COVID is centered on the offices of pediatricians and primary care doctors.
The White House says 25,000 doctors have already signed up to give the vaccines.
The vaccination campaign will get underway at a tough moment for pediatricians.
The voicemail message at Roswell Pediatrics Center in the suburbs north of Atlanta, for instance, warns parents to be patient.
“Due to the current, new COVID-19 surge, we are experiencing extremely high call volume, as well as suffering from the same staffing shortages that most businesses are having,” the message says, adding that they’re working around the clock to answer questions and return phone calls.
Jesse Hackell, MD, says he knows the feeling. He’s the chief operating officer of Pomona Pediatrics in Pomona, N.Y., and a spokesperson for the American Academy of Pediatrics.
“We’re swamped now by kids who get sent home from school because they sneezed once and they have to be cleared before they can go back to school,” he said. “We’re seeing kids who we don’t need to see in terms of the degree of illness because the school requires them to be cleared [of COVID-19].”
Dr. Hackell has been offering the vaccines to kids ages 12 and up since May. He’s planning to offer it to younger children too.
“Adding the vaccines to it is going to be a challenge, but you know we’ll get up to speed and we’ll make it happen,” he said, adding that pediatricians have done many large-scale vaccination campaigns, like those for the H1N1 influenza vaccine in 2009.
Dr. Hackell helped to draft a new policy in New York that will require COVID-19 vaccines for schoolchildren once they are granted full approval from the FDA. Other states may follow with their own vaccination requirements.
He said ultimately, vaccinating school-age children is going to make them safer, will help prevent the virus from mutating and spreading, and will help society as a whole get back to normal.
“We’re the vaccine experts in pediatrics. This is what we do. It’s a huge part of our practice like no other specialty. If we can’t get it right, how can anyone else be expected to?” he said.
A version of this article first appeared on WebMD.com.
FDA proposes new rule for over-the-counter hearing aids
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
The action comes nearly 5 years after Congress passed a law to allow over-the-counter sales for people with mild to moderate hearing loss.
Those with severe hearing loss or people under 18 years old would still need to see a doctor or specialist for a hearing device.
In the United States, access to hearing aids can be difficult and expensive. Usually, patients have to go see their health care providers for a prescription. Then, they go to an audiologist, or a hearing aid specialist, to get the devices fitted.
With the proposed rule, patients could skip both of those steps and buy hearing aids in retail stores or online. This would make the process easier and more cost-friendly, as well increase access to specialists for many Americans who don’t have it.
“This allows us to put hearing devices more in reach of communities that have often been left out. Communities of color and the underserved typically and traditionally lacked access to hearing aids,” Xavier Becerra, secretary of the U.S. Department of Health and Human Services, said at a news briefing.
The FDA says it’s unclear exactly when the new products will be in stores, but finalizing the ruling is a top priority.
For new products, the ruling is expected to go into effect 60 days after it is finalized. Current products would have 180 days to make changes, according to the FDA.
The American Academy of Audiology said in a statement that it is reviewing the proposed rules and will provide comments to the FDA. But in July, Angela Shoup, PhD, a professor at the School of Behavioral and Brain Sciences at the University of Texas at Dallas, wrote to Mr. Becerra with concerns about over-the-counter sales of hearing aids.
“While we certainly support efforts to lower costs and improve access to hearing aids, we have grave concerns about the oversimplification of hearing loss and treatment in the advancement of OTC devices,” she wrote.
“It is through involvement of an audiologist that consumers will achieve the best possible outcomes with OTC hearing aids and avoid the risks of under- or untreated hearing loss,” Dr. Shoup said.
This new category would apply to certain air conduction hearing aids, which are worn inside of the ear and improve hearing by boosting sound into the ear canal.
The FDA is proposing labeling requirements for the hearing devices, including warnings, age restrictions, and information on severe hearing loss and other medical conditions that would prompt patients to seek treatment from their doctors.
The FDA said that it would closely monitor the marketplace to make sure companies advertising hearing loss products follow federal regulations.
There are a number of reasons for hearing loss, including exposure to extremely loud noises, aging, and various medical conditions. Approximately 38 million Americans 18 years old and older report having hearing trouble, said Janet Woodcock, MD, acting commissioner of the FDA.
About 20% of people who could benefit from hearing aids are using them, with barriers to access being a major factor, she added.
“Hearing loss can have a profound impact on daily communication, social interaction, and overall health and quality of life for millions of Americans,” Dr. Woodcock said.
The FDA has updated its guidance on hearing devices and personal sound amplification products.
Personal sound amplification products (PSAPs) are nonmedical devices designed to amplify sounds for people with normal hearing and are usually used for activities such as bird-watching and hunting.
Amplification devices are not regulated by the FDA.
A version of this article first appeared on WebMD.com.
FDA approves combo pill for severe, acute pain
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
FDA OKs new high-dose naloxone product for opioid overdose
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
FDA approves cell-based flu shot for ages 6 months and older
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
Adalimumab biosimilar Cyltezo gets interchangeability designation
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.
The Food and Drug Administration approved a supplement to the biologics license application of the adalimumab biosimilar drug Cyltezo (adalimumab-adbm) that makes it the first interchangeable biosimilar with Humira (adalimumab), the original branded version of the drug, its manufacturer Boehringer Ingelheim announced Oct. 15.
The FDA originally approved Cyltezo in 2017 for the treatment of multiple chronic inflammatory diseases, including seven of Humira’s nine indications for adults and pediatric patients: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The interchangeability designation means that Cyltezo was tested in an additional clinical trial in which patients were successfully switched back and forth multiple times from Humira to Cyltezo and allows pharmacists to autosubstitute Humira with Cyltezo. In these cases, individual state laws control how and whether physicians will be notified of this switch.
Cyltezo is just the second biosimilar to be designated as interchangeable with its originator biologic product. The first approval, announced July 28, was for the interchangeability of Semglee (insulin glargine-yfgn) with the originator Lantus.
The agency based its decision on positive data from the VOLTAIRE-X study of 238 patients with moderate to severe chronic plaque psoriasis in which Cyltezo had no meaningful clinical differences from Humira in pharmacokinetics, efficacy, immunogenicity, and safety between the switching and continuous treatment groups.
Cyltezo will not be commercially available in the United States until July 1, 2023, according to Boehringer Ingelheim.