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FDA approves intravenous immunoglobulin for dermatomyositis
, according to a statement from manufacturer Octapharma USA.
Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.
There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.
The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.
“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.
Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.
The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.
Read the full prescribing information here.
, according to a statement from manufacturer Octapharma USA.
Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.
There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.
The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.
“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.
Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.
The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.
Read the full prescribing information here.
, according to a statement from manufacturer Octapharma USA.
Dermatomyositis is a rare, idiopathic autoimmune disorder that affects approximately 10 out of every million people in the United States, mainly adults in their late 40s to early 60s, according to the company, but children aged 5-15 years can be affected. The disease is characterized by skin rashes, chronic muscle inflammation, progressive muscle weakness, and risk for mortality that is three times higher than for the general population.
There are no previously approved treatments for dermatomyositis prior to Octagam 10%, which also is indicated for chronic immune thrombocytopenic purpura in adults.
The approval for dermatomyositis was based on the results of a phase 3 randomized, double-blind, placebo-controlled clinical trial (the ProDERM trial) that included 95 adult patients at 36 sites worldwide, with 17 sites in the United States. In the trial, 78.7% of patients with dermatomyositis who were randomized to receive 2 g/kg of Octagam 10% every 4 weeks showed response at 16 weeks, compared with 43.8% of patients who received placebo. Response was based on the 2016 American College of Rheumatology/European Alliance of Associations for Rheumatology myositis response criteria. Placebo patients who switched to intravenous immunoglobulin (IVIG) during a trial extension had response rates at week 40 similar to the original patients at week 16.
“The study gives clinicians much more confidence in the efficacy and safety of intravenous immunoglobulin and provides valuable information about what type of patient is best suited for the treatment,” Rohit Aggarwal, MD, medical director of the Arthritis and Autoimmunity Center at the University of Pittsburgh and a member of the ProDERM study Steering Committee, said in the Octapharma statement.
Safety and tolerability were similar to profiles seen with other IVIG medications, according to the statement. The medication does carry a boxed warning from its chronic ITP approval, cautioning about the potential for thrombosis, renal dysfunction, and acute renal failure.
The most common adverse reactions reported by dermatomyositis patients in the ProDERM trial were headache, fever, nausea, vomiting, increased blood pressure, chills, musculoskeletal pain, increased heart rate, dyspnea, and reactions at the infusion sites.
Read the full prescribing information here.
Children and COVID: New vaccinations increase as cases continue to climb
Children aged 12-15 years represented 13.5% of all first vaccinations received during the 2 weeks ending July 19, compared with 11.5% for the 2 weeks ending July 12, marking the first increase since the end of May. First vaccinations in 16- and 17-year-olds, who make up a much smaller share of the U.S. population, also went up, topping 5%, the Centers for Disease Control and Prevention said in its COVID Data Tracker.
The total number of vaccine initiations was almost 250,000 for the week ending July 19, after dropping to a low of 201,000 the previous week. Before that, first vaccinations had fallen in 5 of the previous 6 weeks, going from 1.4 million on May 24 to 307,000 on July 5, the CDC said.
New cases of COVID-19, unfortunately, continued to follow the trend among the larger population: As of July 15, weekly cases in children were up by 179% since dropping to 8,400 on June 24, the American Academy of Pediatrics and the Children’s Hospital Association said in a joint report. The 23,551 new cases in children for the week ending July 15 were 15.9% of all cases reported.
With those new cases, the total number of children infected with COVID-19 comes to almost 4.1 million since the start of the pandemic, the AAP and CHA said. The CDC data indicate that just over 5.35 million children aged 12-15 years and 3.53 million 16- and 17-year-olds have received at least one dose of the COVID-19 vaccine and that 6.8 million children aged 12-17 are fully vaccinated.
Fully vaccinated children represent 26.4% of all 12- to 15-year-olds and 38.3% of the 16- 17-year-olds as of July 19. The corresponding numbers for those who have received at least one dose are 35.2% (ages 12-15) and 46.8% (16-17), the CDC said.
The AAP recently recommended in-person learning with universal masking in schools this fall “because a significant portion of the student population is not yet eligible for vaccines. ... Many schools will not have a system to monitor vaccine status of students, teachers and staff, and some communities overall have low vaccination uptake where the virus may be circulating more prominently.”
Children aged 12-15 years represented 13.5% of all first vaccinations received during the 2 weeks ending July 19, compared with 11.5% for the 2 weeks ending July 12, marking the first increase since the end of May. First vaccinations in 16- and 17-year-olds, who make up a much smaller share of the U.S. population, also went up, topping 5%, the Centers for Disease Control and Prevention said in its COVID Data Tracker.
The total number of vaccine initiations was almost 250,000 for the week ending July 19, after dropping to a low of 201,000 the previous week. Before that, first vaccinations had fallen in 5 of the previous 6 weeks, going from 1.4 million on May 24 to 307,000 on July 5, the CDC said.
New cases of COVID-19, unfortunately, continued to follow the trend among the larger population: As of July 15, weekly cases in children were up by 179% since dropping to 8,400 on June 24, the American Academy of Pediatrics and the Children’s Hospital Association said in a joint report. The 23,551 new cases in children for the week ending July 15 were 15.9% of all cases reported.
With those new cases, the total number of children infected with COVID-19 comes to almost 4.1 million since the start of the pandemic, the AAP and CHA said. The CDC data indicate that just over 5.35 million children aged 12-15 years and 3.53 million 16- and 17-year-olds have received at least one dose of the COVID-19 vaccine and that 6.8 million children aged 12-17 are fully vaccinated.
Fully vaccinated children represent 26.4% of all 12- to 15-year-olds and 38.3% of the 16- 17-year-olds as of July 19. The corresponding numbers for those who have received at least one dose are 35.2% (ages 12-15) and 46.8% (16-17), the CDC said.
The AAP recently recommended in-person learning with universal masking in schools this fall “because a significant portion of the student population is not yet eligible for vaccines. ... Many schools will not have a system to monitor vaccine status of students, teachers and staff, and some communities overall have low vaccination uptake where the virus may be circulating more prominently.”
Children aged 12-15 years represented 13.5% of all first vaccinations received during the 2 weeks ending July 19, compared with 11.5% for the 2 weeks ending July 12, marking the first increase since the end of May. First vaccinations in 16- and 17-year-olds, who make up a much smaller share of the U.S. population, also went up, topping 5%, the Centers for Disease Control and Prevention said in its COVID Data Tracker.
The total number of vaccine initiations was almost 250,000 for the week ending July 19, after dropping to a low of 201,000 the previous week. Before that, first vaccinations had fallen in 5 of the previous 6 weeks, going from 1.4 million on May 24 to 307,000 on July 5, the CDC said.
New cases of COVID-19, unfortunately, continued to follow the trend among the larger population: As of July 15, weekly cases in children were up by 179% since dropping to 8,400 on June 24, the American Academy of Pediatrics and the Children’s Hospital Association said in a joint report. The 23,551 new cases in children for the week ending July 15 were 15.9% of all cases reported.
With those new cases, the total number of children infected with COVID-19 comes to almost 4.1 million since the start of the pandemic, the AAP and CHA said. The CDC data indicate that just over 5.35 million children aged 12-15 years and 3.53 million 16- and 17-year-olds have received at least one dose of the COVID-19 vaccine and that 6.8 million children aged 12-17 are fully vaccinated.
Fully vaccinated children represent 26.4% of all 12- to 15-year-olds and 38.3% of the 16- 17-year-olds as of July 19. The corresponding numbers for those who have received at least one dose are 35.2% (ages 12-15) and 46.8% (16-17), the CDC said.
The AAP recently recommended in-person learning with universal masking in schools this fall “because a significant portion of the student population is not yet eligible for vaccines. ... Many schools will not have a system to monitor vaccine status of students, teachers and staff, and some communities overall have low vaccination uptake where the virus may be circulating more prominently.”
Children and COVID: New vaccinations drop as the case count rises
With only a quarter of all children aged 12-15 years fully vaccinated against COVID-19, first vaccinations continued to drop and new cases for all children rose for the second consecutive week.
Just under 25% of children aged 12-15 had completed the vaccine regimen as of July 12, and just over one-third (33.5%) had received at least one dose. Meanwhile, that age group represented 11.5% of people who initiated vaccination during the 2 weeks ending July 12, down from 12.1% a week earlier, the Centers for Disease Control and Prevention said. The total number of new vaccinations for the week ending July 12 was just over 201,000, compared with 307,000 for the previous week.
New cases of COVID-19, however, were on the rise in children. The 19,000 new cases reported for the week ending July 8 were up from 12,000 a week earlier and 8,000 the week before that, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That report also shows that children made up 22.3% of all new cases during the week of July 2-8, compared with 16.8% the previous week, and that there were nine deaths in children that same week, the most since March. COVID-related deaths among children total 344 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting such data by age. “It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states,” the two groups noted.
Such data are available from the CDC’s COVID Data Tracker, however, and they show that children aged 16-17 years, who became eligible for COVID vaccination before the younger age group, are further ahead in the process. Among the older children, almost 46% had gotten at least one dose and 37% were fully vaccinated by July 12.
With only a quarter of all children aged 12-15 years fully vaccinated against COVID-19, first vaccinations continued to drop and new cases for all children rose for the second consecutive week.
Just under 25% of children aged 12-15 had completed the vaccine regimen as of July 12, and just over one-third (33.5%) had received at least one dose. Meanwhile, that age group represented 11.5% of people who initiated vaccination during the 2 weeks ending July 12, down from 12.1% a week earlier, the Centers for Disease Control and Prevention said. The total number of new vaccinations for the week ending July 12 was just over 201,000, compared with 307,000 for the previous week.
New cases of COVID-19, however, were on the rise in children. The 19,000 new cases reported for the week ending July 8 were up from 12,000 a week earlier and 8,000 the week before that, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That report also shows that children made up 22.3% of all new cases during the week of July 2-8, compared with 16.8% the previous week, and that there were nine deaths in children that same week, the most since March. COVID-related deaths among children total 344 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting such data by age. “It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states,” the two groups noted.
Such data are available from the CDC’s COVID Data Tracker, however, and they show that children aged 16-17 years, who became eligible for COVID vaccination before the younger age group, are further ahead in the process. Among the older children, almost 46% had gotten at least one dose and 37% were fully vaccinated by July 12.
With only a quarter of all children aged 12-15 years fully vaccinated against COVID-19, first vaccinations continued to drop and new cases for all children rose for the second consecutive week.
Just under 25% of children aged 12-15 had completed the vaccine regimen as of July 12, and just over one-third (33.5%) had received at least one dose. Meanwhile, that age group represented 11.5% of people who initiated vaccination during the 2 weeks ending July 12, down from 12.1% a week earlier, the Centers for Disease Control and Prevention said. The total number of new vaccinations for the week ending July 12 was just over 201,000, compared with 307,000 for the previous week.
New cases of COVID-19, however, were on the rise in children. The 19,000 new cases reported for the week ending July 8 were up from 12,000 a week earlier and 8,000 the week before that, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That report also shows that children made up 22.3% of all new cases during the week of July 2-8, compared with 16.8% the previous week, and that there were nine deaths in children that same week, the most since March. COVID-related deaths among children total 344 in the 46 jurisdictions (43 states, New York City, Puerto Rico, and Guam) that are reporting such data by age. “It is not possible to standardize more detailed age ranges for children based on what is publicly available from the states,” the two groups noted.
Such data are available from the CDC’s COVID Data Tracker, however, and they show that children aged 16-17 years, who became eligible for COVID vaccination before the younger age group, are further ahead in the process. Among the older children, almost 46% had gotten at least one dose and 37% were fully vaccinated by July 12.
Delta becomes dominant coronavirus variant in U.S.
The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.
The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.
Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.
“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.
“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”
So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.
For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.
Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.
The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.
Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.
In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.
A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.
Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.
The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.
In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.
“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.
The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.
“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”
A version of this article first appeared on WebMD.com.
The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.
The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.
Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.
“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.
“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”
So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.
For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.
Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.
The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.
Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.
In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.
A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.
Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.
The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.
In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.
“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.
The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.
“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”
A version of this article first appeared on WebMD.com.
The contagious Delta variant has become the dominant form of the coronavirus in the United States, now accounting for more than 51% of COVID-19 cases in the country, according to new CDC data to updated on July 6.
The variant, also known as B.1.617.2 and first detected in India, makes up more than 80% of new cases in some Midwestern states, including Iowa, Kansas, and Missouri. Delta also accounts for 74% of cases in Western states such as Colorado and Utah and 59% of cases in Southern states such as Louisiana and Texas.
Communities with low vaccination rates are bearing the brunt of new Delta cases. Public health experts are urging those who are unvaccinated to get a shot to protect themselves and their communities against future surges.
“Right now we have two Americas: the vaccinated and the unvaccinated,” Paul Offit, MD, an infectious disease specialist at Children’s Hospital of Philadelphia, told NPR.
“We’re feeling pretty good right now because it’s the summer,” he said. “But come winter, if we still have a significant percentage of the population that is unvaccinated, we’re going to see this virus surge again.”
So far, COVID-19 vaccines appear to protect people against the Delta variant. But health officials are watching other variants that could evade vaccine protection and lead to major outbreaks this year.
For instance, certain mutations in the Epsilon variant may allow it to evade the immunity from past infections and current COVID-19 vaccines, according to a new study published July 1 in the Science. The variant, also known as B.1.427/B.1.429 and first identified in California, has now been reported in 34 countries and could become widespread in the United States.
Researchers from the University of Washington and clinics in Switzerland tested the variant in blood samples from vaccinated people, as well as those who were previously infected with COVID-19. They found that the neutralizing power was reduced by about 2 to 3½ times.
The research team also visualized the variant and found that three mutations on Epsilon’s spike protein allow the virus to escape certain antibodies and lower the strength of vaccines.
Epsilon “relies on an indirect and unusual neutralization-escape strategy,” they wrote, saying that understanding these escape routes could help scientists track new variants, curb the pandemic, and create booster shots.
In Australia, for instance, public health officials have detected the Lambda variant, which could be more infectious than the Delta variant and resistant to vaccines, according to Sky News.
A hotel quarantine program in New South Wales identified the variant in someone who had returned from travel, the news outlet reported. Also known as C.37, Lambda was named a “variant of interest” by the World Health Organization in June.
Lambda was first identified in Peru in December and now accounts for more than 80% of the country’s cases, according to the Financial Times. It has since been found in 27 countries, including the U.S., U.K., and Germany.
The variant has seven mutations on the spike protein that allow the virus to infect human cells, the news outlet reported. One mutation is like another mutation on the Delta variant, which could make it more contagious.
In a preprint study published July 1, researchers at the University of Chile at Santiago found that Lambda is better able to escape antibodies created by the CoronaVac vaccine made by Sinovac in China. In the paper, which hasn’t yet been peer-reviewed, researchers tested blood samples from local health care workers in Santiago who had received two doses of the vaccine.
“Our data revealed that the spike protein ... carries mutations conferring increased infectivity and the ability to escape from neutralizing antibodies,” they wrote.
The research team urged countries to continue testing for contagious variants, even in areas with high vaccination rates, so scientists can identify mutations quickly and analyze whether new variants can escape vaccines.
“The world has to get its act together,” Saad Omer, PhD, director of the Yale Institute for Global Health, told NPR. “Otherwise yet another, potentially more dangerous, variant could emerge.”
A version of this article first appeared on WebMD.com.
Small uptick in children’s COVID vaccinations can’t change overall decline
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.
the CDC reported on its COVID Data Tracker site.
As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.
Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.
The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.
New COVID-19 vaccinations decline again in 12- to 15-year-olds
Even though less than 21% of all children aged 12-15 years are fully vaccinated against COVID-19, the number seeking first vaccinations continues to decline, according to data from the Centers for Disease Control and Prevention.
and 462,000 during the week ending June 14. Collectively, 30.2% of 12- to 15-year-olds have gotten at least one dose of vaccine so far and 20.7% are now fully vaccinated, the CDC said on its COVID Data Tracker site.
Among children aged 16-17 years, who were able to start the vaccination process earlier, 42.9% have received at least one dose and 34.0% have completed the COVID-19 vaccine regimen. Vaccine initiation – measured as the proportion of all individuals getting a first shot over the previous 2 weeks – has been consistently around 4.8% during the month of June for this age group but has dropped from 17.9% on June 7 to 14.3% on June 28 for those aged 12-15, the CDC data show.
Looking at the same measure for vaccine completion, 16.7% of all those who reached full vaccination status in the 14 days ending June 28 were 12- to 15-years-olds, down from 21.5% on June 21 and 19.6% on June 14. The numbers for those aged 15-16 were, respectively, 4.6%, 4.5%, and 4.2%, the CDC reported.
Fortunately, in the wake of recent vaccination trends, new cases of COVID-19 in children were down to their lowest level – just 8,447 for the week ending June 24 – since May of 2020, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.
New cases had been well over 15,000 the previous week (June 17), following weeks of 14,000 (June 10) and 16,000 (June 3) new cases, so the latest drop down to just four digits represents a 1-week decline of over 46% in the 49 states (excluding New York) that are reporting age distribution, along with the District of Columbia, New York City, Puerto Rico, and Guam.
The cumulative number of child COVID-19 cases in those jurisdictions is about 4.03 million since the beginning of the pandemic, which represents 14.2% of all cases in the United States. At the state level, the cumulative rate of cases in children is highest in Vermont (22.7%) and lowest in Florida (8.9%), which uses an age range of 0-14 years for children, compared with 0-17 or 0-19 for most states, the AAP and CHA said.
Severe illness has been rare in children, which is reflected in the proportion of children among all hospitalizations, 2.2% in 24 jurisdictions, and the proportion of deaths, 0.06% in 46 jurisdictions, since the start of the pandemic, the AAP and CHA said, with a total of 336 COVID-19–related deaths reported.
Even though less than 21% of all children aged 12-15 years are fully vaccinated against COVID-19, the number seeking first vaccinations continues to decline, according to data from the Centers for Disease Control and Prevention.
and 462,000 during the week ending June 14. Collectively, 30.2% of 12- to 15-year-olds have gotten at least one dose of vaccine so far and 20.7% are now fully vaccinated, the CDC said on its COVID Data Tracker site.
Among children aged 16-17 years, who were able to start the vaccination process earlier, 42.9% have received at least one dose and 34.0% have completed the COVID-19 vaccine regimen. Vaccine initiation – measured as the proportion of all individuals getting a first shot over the previous 2 weeks – has been consistently around 4.8% during the month of June for this age group but has dropped from 17.9% on June 7 to 14.3% on June 28 for those aged 12-15, the CDC data show.
Looking at the same measure for vaccine completion, 16.7% of all those who reached full vaccination status in the 14 days ending June 28 were 12- to 15-years-olds, down from 21.5% on June 21 and 19.6% on June 14. The numbers for those aged 15-16 were, respectively, 4.6%, 4.5%, and 4.2%, the CDC reported.
Fortunately, in the wake of recent vaccination trends, new cases of COVID-19 in children were down to their lowest level – just 8,447 for the week ending June 24 – since May of 2020, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.
New cases had been well over 15,000 the previous week (June 17), following weeks of 14,000 (June 10) and 16,000 (June 3) new cases, so the latest drop down to just four digits represents a 1-week decline of over 46% in the 49 states (excluding New York) that are reporting age distribution, along with the District of Columbia, New York City, Puerto Rico, and Guam.
The cumulative number of child COVID-19 cases in those jurisdictions is about 4.03 million since the beginning of the pandemic, which represents 14.2% of all cases in the United States. At the state level, the cumulative rate of cases in children is highest in Vermont (22.7%) and lowest in Florida (8.9%), which uses an age range of 0-14 years for children, compared with 0-17 or 0-19 for most states, the AAP and CHA said.
Severe illness has been rare in children, which is reflected in the proportion of children among all hospitalizations, 2.2% in 24 jurisdictions, and the proportion of deaths, 0.06% in 46 jurisdictions, since the start of the pandemic, the AAP and CHA said, with a total of 336 COVID-19–related deaths reported.
Even though less than 21% of all children aged 12-15 years are fully vaccinated against COVID-19, the number seeking first vaccinations continues to decline, according to data from the Centers for Disease Control and Prevention.
and 462,000 during the week ending June 14. Collectively, 30.2% of 12- to 15-year-olds have gotten at least one dose of vaccine so far and 20.7% are now fully vaccinated, the CDC said on its COVID Data Tracker site.
Among children aged 16-17 years, who were able to start the vaccination process earlier, 42.9% have received at least one dose and 34.0% have completed the COVID-19 vaccine regimen. Vaccine initiation – measured as the proportion of all individuals getting a first shot over the previous 2 weeks – has been consistently around 4.8% during the month of June for this age group but has dropped from 17.9% on June 7 to 14.3% on June 28 for those aged 12-15, the CDC data show.
Looking at the same measure for vaccine completion, 16.7% of all those who reached full vaccination status in the 14 days ending June 28 were 12- to 15-years-olds, down from 21.5% on June 21 and 19.6% on June 14. The numbers for those aged 15-16 were, respectively, 4.6%, 4.5%, and 4.2%, the CDC reported.
Fortunately, in the wake of recent vaccination trends, new cases of COVID-19 in children were down to their lowest level – just 8,447 for the week ending June 24 – since May of 2020, according to a new report from the American Academy of Pediatrics and the Children’s Hospital Association.
New cases had been well over 15,000 the previous week (June 17), following weeks of 14,000 (June 10) and 16,000 (June 3) new cases, so the latest drop down to just four digits represents a 1-week decline of over 46% in the 49 states (excluding New York) that are reporting age distribution, along with the District of Columbia, New York City, Puerto Rico, and Guam.
The cumulative number of child COVID-19 cases in those jurisdictions is about 4.03 million since the beginning of the pandemic, which represents 14.2% of all cases in the United States. At the state level, the cumulative rate of cases in children is highest in Vermont (22.7%) and lowest in Florida (8.9%), which uses an age range of 0-14 years for children, compared with 0-17 or 0-19 for most states, the AAP and CHA said.
Severe illness has been rare in children, which is reflected in the proportion of children among all hospitalizations, 2.2% in 24 jurisdictions, and the proportion of deaths, 0.06% in 46 jurisdictions, since the start of the pandemic, the AAP and CHA said, with a total of 336 COVID-19–related deaths reported.
Children and COVID: Vaccination trends beginning to diverge
As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.
For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.
Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.
Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.
As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.
For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.
Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.
Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.
As more adolescents became eligible for a second dose of the Pfizer vaccine since it received approval from the Food and Drug Administration in mid-May, the share of 12- to 15-year-olds considered fully vaccinated rose from 11.4% on June 14 to 17.8% on June 28, an increase of 56%, the CDC’s COVID Data Tracker indicated June 22.
For children aged 16-17 years, who have been receiving the vaccine since early April, full vaccination rose by 9.6% in that same week, going from 29.1% on June 14 to 31.9% on June 21. The cumulative numbers for first vaccinations are higher, of course, but are rising more slowly in both age groups: 41.5% of those aged 16-17 had received at least one dose by June 21 (up by 4.3%), with the 12- to 15-year-olds at 28.3% (up by 10.5%), based on the CDC data.
Limiting the time frame to just the last 2 weeks, however, shows the opposite of rising among the younger children. During the 2 weeks ending June 7, 17.9% of those initiating a first dose were 12-15 years old, but that 2-week figure slipped to 17.1% as of June 14 and was down to 16.0% on June 21. The older group was slow but steady over that time: 4.8%, 4.7%, and 4.8%, the CDC said. To give those figures some context, those aged 25-39 years represented 23.7% of past-2-week initiations on June 7 and 24.3% on June 21.
Although no COVID-19 vaccine has been approved for children under 12 years, about 0.4% of that age group – just over 167,000 children – have received a first dose and almost 91,000 are fully vaccinated, according to CDC data.
Why getting a COVID-19 vaccine to children could take time
Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.
So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA).
EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data.
But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard.
Stated another way: Is COVID an emergency for kids?
There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given.
But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.
That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
Vaccine studies different in children?
Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.
But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.
The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.”
In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.
The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.
The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection.
That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.
“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.
“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
Speed vaccines to market, or gather more data?
The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.
In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval.
A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.
Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.
“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.
Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors.
The FDA must decide whether to act based on where we are now or where we could be in a few months.
“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.
She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss.
She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.
That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.
Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.
“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.
“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.
He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.
“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.
Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children. The main value of protecting them is to protect others.
“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.
What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.
“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”
Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.
“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.
Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
Weighing risk over safety
Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.
She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.
“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.”
But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.
“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”
Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.
A version of this article first appeared on Medscape.com.
Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.
So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA).
EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data.
But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard.
Stated another way: Is COVID an emergency for kids?
There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given.
But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.
That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
Vaccine studies different in children?
Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.
But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.
The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.”
In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.
The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.
The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection.
That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.
“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.
“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
Speed vaccines to market, or gather more data?
The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.
In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval.
A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.
Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.
“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.
Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors.
The FDA must decide whether to act based on where we are now or where we could be in a few months.
“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.
She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss.
She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.
That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.
Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.
“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.
“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.
He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.
“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.
Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children. The main value of protecting them is to protect others.
“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.
What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.
“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”
Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.
“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.
Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
Weighing risk over safety
Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.
She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.
“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.”
But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.
“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”
Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.
A version of this article first appeared on Medscape.com.
Testing COVID-19 vaccines in young children is going to be tricky. Deciding how to approve them and who should get them may be even more difficult.
So far, the vaccines available to Americans ages 12 and up have sailed through the U.S. Food and Drug Administration’s regulatory checks, taking advantage of an accelerated clearance process called an Emergency Use Authorization (EUA).
EUAs set a lower bar for effectiveness, saying the vaccines may be safe and effective based on just a few months of data.
But with COVID cases plummeting in the United States and children historically seeing far less serious disease than adults, a panel of expert advisors to the FDA was asked to deliberate on Thursday whether the agency could consider vaccines for this age group under the same standard.
Stated another way: Is COVID an emergency for kids?
There’s another wrinkle in the mix, too – heart inflammation, which appears to be a very rare emerging adverse event tied to vaccination. It seems to happen more often in teens and young adults. To date, cases of myocarditis and pericarditis appear to be happening in 16 to 30 people for every 1 million doses given.
But if it is conclusively linked to the shots, some wonder whether it might tip the balance between benefits and risks for kids.
That left some of the experts who sit on the FDA’s advisory committee for vaccines and related biological products urging the FDA to take its time and more thoroughly study the shots before they’re given to millions of children.
Vaccine studies different in children?
Clinical studies of the vaccines in teens and adults have thus far relied on some straightforward math. You take two groups of similar people. You give half the vaccine and half a placebo. Then you wait and see which group has more symptomatic infections. To date, the vaccines have dramatically cut the risk of getting severely ill with COVID for every age group tested.
But COVID infections are falling rapidly in the U.S., and that may make it more difficult for researchers to conduct a similar kind of experiment in children.
The FDA is considering different approaches to figure out whether a vaccine would be effective in kids, including something called an “immunobridging trial.”
In bridging trials, researchers don’t look for infections; rather, they look for proven signs that someone has developed immunity, like antibody levels. Those biomarkers are then compared to the immune responses of younger adults who have demonstrated good protection against infection.
The main advantage of bridging studies is speed. It’s possible to get a snapshot of how the immune system responds to a vaccine within weeks of the final dose.
The drawback is that researchers don’t know exactly what to look for to judge how well the shots are generating protection.
That’s made even more difficult because kids’ immune systems are still developing, so it may be tough to draw direct parallels to adults.
“We don’t know what the serologic correlate of immunity is now. We don’t know how much antibody you have to get in order to be protected. We don’t know what the role of T cells will be,” said H. Cody Meissner, MD, chief of the division of pediatric infectious disease at Tufts Medical Center, Boston.
“I have so much sympathy for the FDA because these are enormous problems, and you have to make a decision,” said Dr. Meissner, who is a member of the FDA’s vaccines and related biological products advisory committee.
Speed vaccines to market, or gather more data?
The plummeting rate of infections in the United States also means that it may be more difficult for the FDA to justify allowing a vaccine on the market for emergency use for children under age 12.
In its recent advisory committee meeting, the agency asked the panel whether it should consider COVID vaccines for children under an EUA or a biologics license application (BLA), aka full approval.
A BLA typically means the agency considers a year or two of data on a new product, rather than just 2 months’ worth. Emergency use also allows products on the market under a looser standard – they “may be” safe and effective, instead of has been proven to be safe and effective.
Several committee members said they didn’t feel the United States was still in an emergency with COVID and couldn’t see the FDA allowing a vaccine to be used in kids that wasn’t given the agency’s highest level of scrutiny, particularly with reports of adverse events like myocarditis coming to light.
“I just want to be sure the price we pay for vaccinating millions of children justifies the side effects, and I don’t think we know that yet,” Dr. Meissner said.
Others acknowledged that there was little risk to kids now with infections on the decline but said that picture could change as variants spread, schools reopen, and colder temperatures force people indoors.
The FDA must decide whether to act based on where we are now or where we could be in a few months.
“I think it’s the million-dollar question right now,” said Hannah Kirking, MD, a medical epidemiologist with the Centers for Disease Control and Prevention who presented new and unpublished data on COVID’s impact in children to the FDA’s advisory committee.
She said prospective studies tracking the way COVID moves through a household with weekly testing from New York City and Utah had found that children catch and transmit COVID almost as readily as adults. But they don’t usually get as sick as adults do, so their cases are easy to miss.
She also presented the results of blood tests from samples around the country looking for evidence of past infection. In these seroprevalence studies, about 27% of children under age 17 had antibodies to COVID – the most of any age group. So more than 1 in 4 kids already has some natural immunity.
That means the main benefit of vaccinating children might be the protection of others, while they still bear the risks – however tiny.
Some experts felt that wasn’t enough reason to justify mass distribution of the vaccines to kids, and from a regulatory standpoint, it might not be permissible.
“FDA can only approve a medical product in a population if the benefits outweigh the risks in that population,” said Peter Doshi, PhD, assistant professor of pharmaceutical health services research in the University of Maryland’s school of pharmacy, Baltimore.
“If benefits don’t outweigh risks in children, it can’t be indicated for children. Full stop,” said Dr. Doshi, who is also an editor at the BMJ.
He said there’s another way to give children access to vaccines, through an expanded access or compassionate use program. Because most COVID deaths have been in children with underlying health conditions, Dr. Doshi and others said it might make sense to allow expanded access – which would get vaccines to children at high risk for complications – without turning them loose on millions before they are more thoroughly studied.
“It’s not a particularly attractive option for industry, because there’s no money to be made. Your medicine can’t be commercialized under expanded access. The most you can reap is manufacturing cost, which is not a lot,” he said.
Art Caplan, a professor of bioethics at New York University’s Langone medical center, said the argument for vaccinating children for flu falls along the same lines. The benefit-to-risk ratio is finely balanced in children. The main value of protecting them is to protect others.
“Flu rarely kills young folks. But you’re really trying to protect old folks and that’s the classic example,” he said.
What’s more, he said the idea that children would take on some risk with a vaccine for little personal benefit is oversimplified.
“Yes, you might get vaccinated to prevent harm to others, but those others are providing benefits to you. It’s not a one-way street. I think that’s a little morally distorted,” Mr. Caplan said. “Being able to keep society open benefits kids and adults alike.”
Other committee members felt like it was too early to sound the all-clear on COVID and said the FDA should authorize vaccines for children as quickly as it had for other age groups.
“We are still, I believe, in an emergency situation. I think that when this virus goes into our children, which is what it’s going to do, that will give it an incubator to change,” said Oveta Fuller, PhD, associate professor of microbiology and immunology at the University of Michigan, Ann Arbor.
Fuller said that for the good of the world, Americans needed to vaccinate children to prevent the virus from mutating and creating new and potentially more dangerous variants.
Weighing risk over safety
Beth Thielen, MD, PhD, pediatric infectious disease specialist and virologist at the University of Minnesota, Minneapolis, said she had not followed the committee’s discussions, but about once a month she treats kids who are very sick because of the virus – either because of a COVID infection or because of multisystem inflammatory syndrome (MIS-C), an inflammatory reaction that strikes after infection.
She’s worried about how the virus has already changed. She said the kind of disease she’s seeing in kids now is different than what she saw in the early months of the pandemic.
“In the last couple of months, I’ve actually seen a few cases of severe pulmonary disease, more similar to adult disease in children,” Dr. Thielen said. “I see on the horizon that we could start seeing more significant disease in young people, and then the risks of being unvaccinated go up substantially.”
But she also knows nobody has a crystal ball, and right now, everything seems to be trending in the right direction with COVID. That makes the risk-to-benefit consideration murkier.
“The question in my mind is, what is the risk of side effects from the vaccine?” she said. “I think we really need to know what the safety profile of vaccine looks like in children because we do have a decent understanding now what risk from disease looks like, because it’s small, but we are seeing it.”
Dr. Thielen said she’ll be keeping an eye on the next meeting of the CDC’s Advisory Committee on Immunization Practices for more answers.
A version of this article first appeared on Medscape.com.
By the numbers: Children and COVID-19 prevention
Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.
The latest results from the CDC’s COVID Data Tracker show that , with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.
Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.
Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.
People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.
Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.
Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”
Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”
Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.
The latest results from the CDC’s COVID Data Tracker show that , with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.
Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.
Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.
People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.
Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.
Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”
Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”
Over 6.3 million doses of COVID-19 vaccine have been administered to children aged 12-17 years as of June 7, according to data from the Centers for Disease Control and Prevention.
The latest results from the CDC’s COVID Data Tracker show that , with the corresponding figures for vaccine completion coming in at 4.1% and 26.4%. Compared with a week earlier, those numbers are up by 15.4% (one dose) and 486% (completion) for the younger group and by 4.7% and 8.6%, respectively, for the older children.
Children aged 12-15 represented 17.9% of all persons who initiated vaccination in the last 14 days up to June 7, while children aged 16-17 made up 4.8% of vaccine initiation over that period. The 25- to 39-year-olds, at 23.7% of all vaccine initiators, were the only group ahead of those aged 12-15, and the 50- to 64-year-olds were just behind at 17.7%, the CDC data show.
Both groups of children were on the low side, however, when it came to vaccine completion in the last 14 days, with those aged 12-15 at 6.7% of the total and those aged 16-17 years at 4.3%. The only age groups lower than that were ≥75 at 3.5% and <12 at 0.2%, and the highest share of vaccine completion was 26.0% for those aged 25-39, which also happens to be the group with the largest share of the U.S. population (20.5%), the CDC said.
People considered fully vaccinated are those who have received the second dose of a two-dose series or one dose of a single-shot vaccine, but children under age 18 years are eligible only for the Pfizer-BioNTech version, the CDC noted.
Meanwhile, back on the incidence side of the COVID-19 pandemic, the number of new cases in U.S. children for the week ending June 3 was at its lowest point (16,281) since mid-June of 2020, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
Cases among children now total 3.99 million, which represents 14.1% of cases among all ages, a proportion that hasn’t increased since mid-May, which hasn’t happened since the two groups started keeping track in mid-April of 2020 in the 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam that report such data by age.
Less encouraging was the CDC’s report that “COVID-19-associated hospitalization rates among adolescents ages 12-17 years increased during March and April, following declines in January and February 2021.”
Children have been experiencing much lower rates of severe disease than those of adults throughout the pandemic, the CDC pointed out, but “recent increases in COVID-19-associated hospitalization rates and the potential for severe disease in adolescents reinforce the importance of continued prevention strategies, including vaccination and the correct and consistent use of masks in those who are not yet fully vaccinated.”
CDC director cites rise in hospitalizations in urging teen vaccinations
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.
“I am deeply concerned by the numbers of hospitalized adolescents and saddened to see the number of adolescents who required treatment in intensive care units or mechanical ventilation,” CDC Director Rochelle Walensky, MD, said in a statement.
While urging teenagers to wear masks and take precautions around others, she asked “parents, relatives, and close friends to join me and talk with teens about the importance of these prevention strategies and to encourage them to get vaccinated.”
Dr. Walensky referred to the CDC’s Morbidity and Mortality Weekly Report that showed adolescent hospitalizations peaked at 2.1 per 100,000 in early January 2021, then dropped to 0.6 per 100,000 in mid-March.
Alarmingly, hospitalizations rose to 1.3 per 100,000 in April, and a number of teens required serious interventions.
“Among hospitalized adolescents, nearly one-third required intensive care unit admission, and 5% required invasive mechanical ventilation,” the report said. No deaths occurred.
The study looked at 376 adolescents aged 12-17 who were hospitalized and tested positive for coronavirus. Of that group, 204 were hospitalized for COVID-19 and the other 172 were hospitalized for reasons not directly related to COVID-19.
Of the 204 hospitalized for COVID-19, 70.6% had an underlying medical condition such as obesity or chronic lung disease.
The study noted that children and teenagers have lower hospitalization rates and generally show less severe symptoms than do older people.
Possible causes for the rise in adolescent COVID-19 hospitalizations include the arrival of variants, the growing number of children returning to in-person education, and the changes in mask-wearing and other safety precautions, the study said.
The American Academy of Pediatrics said that as of May 27, 4 million children have tested positive for COVID-19 since the pandemic began, with about 34,500 new child cases reported for the week ending May 27.
The AAP said children have represented 14.1% of total cases since the pandemic began, but for the week ending May 27, children represented 24.3% of new reported weekly COVID-19 cases.
On May 10, the FDA granted emergency use authorization for the Pfizer coronavirus vaccine to be given to children aged 12-15 years. Previously, the FDA had authorized the Pfizer vaccine for people aged 16 years and up, whereas the Moderna and Johnson & Johnson vaccines are authorized for people aged 18 years and up.
“Vaccination is our way out of this pandemic,” Dr. Walensky said in her statement. “I continue to see promising signs in CDC data that we are nearing the end of this pandemic in this country; however, we all have to do our part and get vaccinated to cross the finish line.”
A version of this article was first published on WebMD.com.