News from the FDA/CDC

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

A less-than-1% decrease in weekly COVID-19 cases in children demonstrated continued stability in the pandemic situation as the nation heads into the holiday season.

“Over the past 6 weeks, weekly reported child cases have plateaued at an average of about 27,000 cases,” the American Academy of Pediatrics and the Children’s Hospital Association said in the latest edition of their joint COVID report.

New cases for the week of Nov. 11-17 totaled 27,899, down by 0.9% from the previous week and just 4 weeks removed from the lowest total of the year: 22,719 for Oct. 14-20. There have been just under 15 million cases of COVID-19 in children since the pandemic began, and children represent 18.3% of cases in all ages, the AAP and CHA reported.

Conditions look favorable for that plateau to continue, despite the upcoming holidays, White House COVID-19 coordinator Ashish Jha said recently. “We are in a very different place and we will remain in a different place,” Dr. Jha said, according to STAT News. “We are now at a point where I believe if you’re up to date on your vaccines, you have access to treatments ... there really should be no restrictions on people’s activities.”

One possible spoiler, an apparent spike in COVID-related hospitalizations in children we reported last week, seems to have been a false alarm. The rate of new admissions for Nov. 11, which preliminary data suggested was 0.48 per 100,000 population, has now been revised with more solid data to 0.20 per 100,000, according to the Centers for Disease Control and Prevention.

“We continue to monitor the recent increases in admissions among children. Some of these may be admissions with COVID-19, not because of COVID-19. Co-infections are being noted in our surveillance systems for hospitalizations among children; as much as 10% of admissions or higher have viruses codetected (RSV, influenza, enterovirus/rhinovirus, and other respiratory viruses),” a CDC spokesperson told this news organization.

For children aged 0-17 years, the current 7-day (Nov. 13-19) average number of new admissions with confirmed COVID is 129 per day, down from 147 for the previous 7-day average. Emergency department visits with diagnosed COVID, measured as a percentage of all ED visits, are largely holding steady. The latest 7-day averages available (Nov. 18) – 1.0% for children aged 0-11 years, 0.7% for 12- to 15-year-olds, and 0.8% in 16- to 17-year-olds – are the same or within a tenth of a percent of the rates recorded on Oct. 18, CDC data show.

New vaccinations for the week of Nov. 10-16 were down just slightly for children under age 5 years and for those aged 5-11 years, with a larger drop seen among 12- to 17-year-olds, the AAP said in its weekly vaccination report. So far, 7.9% of all children under age 5 have received at least one dose of COVID vaccine, as have 39.1% of 5 to 11-year-olds and 71.5% of those aged 12-17years, the CDC said on its COVID Data Tracker.
 

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

The incidence of new COVID-19 cases in children seems to have stabilized as the national count remained under 30,000 for the fifth consecutive week, but hospitalization data may indicate some possible turbulence.

Just over 28,000 pediatric cases were reported during the week of Nov. 4-10, a drop of 5.4% from the previous week, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report involving data from state and territorial health departments, several of which are no longer updating their websites.

The stability in weekly cases, however, comes in contrast to a very recent and considerable increase in new hospital admissions of children aged 0-17 years with confirmed COVID-19. That rate, which was 0.18 hospitalizations per 100,000 population on Nov. 7 and 0.19 per 100,000 on Nov. 8 and 9, jumped all the way to 0.34 on Nov. 10 and 0.48 on Nov. 11, according to data from the Centers for Disease Control and Prevention. That is the highest rate since the closing days of the Omicron surge in February.

The rate for Nov. 12, the most recent one available, was down slightly to 0.47 admissions per 100,000. There doesn’t seem to be any evidence in the CDC’s data of a similar sudden increase in new hospitalizations among any other age group, and no age group, including children, shows any sign of a recent increase in emergency department visits with diagnosed COVID. (The CDC has not yet responded to our inquiry about this development.)

Centers for Disease Control and Prevention

The two most recent 7-day averages for new admissions in children aged 0-17 show a small increase, but they cover the periods of Oct. 15 to Oct. 31, when there were 126 admissions per day, and Nov. 1 to Nov. 7, when the average went up to 133 per day, the CDC said on its COVID Data Tracker.

The CDC does not publish a weekly count of new COVID cases, but its latest data on the rate of incident cases seem to agree with the AAP/CHA figures: A gradual decline in all age groups, including children, since the beginning of September.

Vaccinations, on the other hand, bucked their recent trend and increased in the last week. About 43,000 children under age 5 years received their initial dose of COVID vaccine during Nov. 3-9, compared with 30,000 and 33,000 the 2 previous weeks, while 5- to 11-year-olds hit their highest weekly mark (31,000) since late August and 12- to 17-year-olds had their biggest week (27,000) since mid-August, the AAP reported based on CDC data.


 

The incidence of new COVID-19 cases in children seems to have stabilized as the national count remained under 30,000 for the fifth consecutive week, but hospitalization data may indicate some possible turbulence.

Just over 28,000 pediatric cases were reported during the week of Nov. 4-10, a drop of 5.4% from the previous week, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report involving data from state and territorial health departments, several of which are no longer updating their websites.

The stability in weekly cases, however, comes in contrast to a very recent and considerable increase in new hospital admissions of children aged 0-17 years with confirmed COVID-19. That rate, which was 0.18 hospitalizations per 100,000 population on Nov. 7 and 0.19 per 100,000 on Nov. 8 and 9, jumped all the way to 0.34 on Nov. 10 and 0.48 on Nov. 11, according to data from the Centers for Disease Control and Prevention. That is the highest rate since the closing days of the Omicron surge in February.

The rate for Nov. 12, the most recent one available, was down slightly to 0.47 admissions per 100,000. There doesn’t seem to be any evidence in the CDC’s data of a similar sudden increase in new hospitalizations among any other age group, and no age group, including children, shows any sign of a recent increase in emergency department visits with diagnosed COVID. (The CDC has not yet responded to our inquiry about this development.)

Centers for Disease Control and Prevention

The two most recent 7-day averages for new admissions in children aged 0-17 show a small increase, but they cover the periods of Oct. 15 to Oct. 31, when there were 126 admissions per day, and Nov. 1 to Nov. 7, when the average went up to 133 per day, the CDC said on its COVID Data Tracker.

The CDC does not publish a weekly count of new COVID cases, but its latest data on the rate of incident cases seem to agree with the AAP/CHA figures: A gradual decline in all age groups, including children, since the beginning of September.

Vaccinations, on the other hand, bucked their recent trend and increased in the last week. About 43,000 children under age 5 years received their initial dose of COVID vaccine during Nov. 3-9, compared with 30,000 and 33,000 the 2 previous weeks, while 5- to 11-year-olds hit their highest weekly mark (31,000) since late August and 12- to 17-year-olds had their biggest week (27,000) since mid-August, the AAP reported based on CDC data.


 

The incidence of new COVID-19 cases in children seems to have stabilized as the national count remained under 30,000 for the fifth consecutive week, but hospitalization data may indicate some possible turbulence.

Just over 28,000 pediatric cases were reported during the week of Nov. 4-10, a drop of 5.4% from the previous week, the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report involving data from state and territorial health departments, several of which are no longer updating their websites.

The stability in weekly cases, however, comes in contrast to a very recent and considerable increase in new hospital admissions of children aged 0-17 years with confirmed COVID-19. That rate, which was 0.18 hospitalizations per 100,000 population on Nov. 7 and 0.19 per 100,000 on Nov. 8 and 9, jumped all the way to 0.34 on Nov. 10 and 0.48 on Nov. 11, according to data from the Centers for Disease Control and Prevention. That is the highest rate since the closing days of the Omicron surge in February.

The rate for Nov. 12, the most recent one available, was down slightly to 0.47 admissions per 100,000. There doesn’t seem to be any evidence in the CDC’s data of a similar sudden increase in new hospitalizations among any other age group, and no age group, including children, shows any sign of a recent increase in emergency department visits with diagnosed COVID. (The CDC has not yet responded to our inquiry about this development.)

Centers for Disease Control and Prevention

The two most recent 7-day averages for new admissions in children aged 0-17 show a small increase, but they cover the periods of Oct. 15 to Oct. 31, when there were 126 admissions per day, and Nov. 1 to Nov. 7, when the average went up to 133 per day, the CDC said on its COVID Data Tracker.

The CDC does not publish a weekly count of new COVID cases, but its latest data on the rate of incident cases seem to agree with the AAP/CHA figures: A gradual decline in all age groups, including children, since the beginning of September.

Vaccinations, on the other hand, bucked their recent trend and increased in the last week. About 43,000 children under age 5 years received their initial dose of COVID vaccine during Nov. 3-9, compared with 30,000 and 33,000 the 2 previous weeks, while 5- to 11-year-olds hit their highest weekly mark (31,000) since late August and 12- to 17-year-olds had their biggest week (27,000) since mid-August, the AAP reported based on CDC data.


 

New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.

The total for new cases reported during the week of Oct. 28 to Nov. 3, while still low at just under 30,000, was 21% higher than the previous week and 31% higher than 2 weeks ago (Oct. 14-20), when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.

The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.

Vaccine initiation continues to slow

During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.

All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.

Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.

New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.

The total for new cases reported during the week of Oct. 28 to Nov. 3, while still low at just under 30,000, was 21% higher than the previous week and 31% higher than 2 weeks ago (Oct. 14-20), when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.

The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.

Vaccine initiation continues to slow

During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.

All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.

Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.

New COVID-19 cases rose among U.S. children for the second consecutive week, while hospitals saw signs of renewed activity on the part of SARS-CoV-2.

The total for new cases reported during the week of Oct. 28 to Nov. 3, while still low at just under 30,000, was 21% higher than the previous week and 31% higher than 2 weeks ago (Oct. 14-20), when the count fell to its lowest level in more than a year, the American Academy of Pediatrics and the Children’s Hospital Association said in their joint report.

The trend is discernible, however, when looking at hospitalizations of children with confirmed COVID. The rate of new admissions of children aged 0-17 years was 0.16 per 100,000 population as late as Oct. 23 but ticked up a notch after that and has been 0.17 per 100,000 since, according to the CDC. As with the ED rate, hospitalizations had been steadily declining since late August.

Vaccine initiation continues to slow

During the week of Oct. 27 to Nov. 2, about 30,000 children under 5 years of age received their initial COVID vaccination. A month earlier (Sept. 29 to Oct. 5), that number was about 40,000. A month before that, about 53,000 children aged 0-5 years received their initial dose, the AAP said in a separate vaccination report based on CDC data.

All of that reduced interest adds up to 7.4% of the age group having received at least one dose and just 3.2% being fully vaccinated as of Nov. 2. Among children aged 5-11 years, the corresponding vaccination rates are 38.9% and 31.8%, while those aged 12-17 years are at 71.3% and 61.1%, the CDC said.

Looking at just the first 20 weeks of the vaccination experience for each age group shows that 1.6 million children under 5 years of age had received at least an initial dose, compared with 8.1 million children aged 5-11 years and 8.1 million children aged 12-15, the AAP said.

To ensure continuity of care for patients taking clozapine, the Food and Drug Administration will temporarily exercise “enforcement discretion” with respect to certain clozapine risk evaluation and mitigation strategy (REMS) program requirements.

In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

To ensure continuity of care for patients taking clozapine, the Food and Drug Administration will temporarily exercise “enforcement discretion” with respect to certain clozapine risk evaluation and mitigation strategy (REMS) program requirements.

In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

To ensure continuity of care for patients taking clozapine, the Food and Drug Administration will temporarily exercise “enforcement discretion” with respect to certain clozapine risk evaluation and mitigation strategy (REMS) program requirements.

In a Nov. 2 notice on its website, the FDA said it is aware that health care professionals and patients continue to experience ongoing difficulties with the clozapine REMS program, including issues with patient access to clozapine following discharge from inpatient care.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

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

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

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

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

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

The Centers for Disease Control and Prevention is warning of an early surge in respiratory disease caused by multiple viruses. As influenza viruses, respiratory syncytial virus (RSV), SARS-CoV-2, and rhinovirus/enterovirus simultaneously circulate, the agency cautioned that this confluence of viral activity could strain the health care system, according to a CDC Health Network Alert advisory issued Nov. 4.

“This early increase in disease incidence highlights the importance of optimizing respiratory virus prevention and treatment measures, including prompt vaccination and antiviral treatment,” the alert stated.

The CDC reports that RSV activity is increasing nationally, but in some areas – such as the South and Mountain West – cases appear to be trending downward.

Influenza cases continue to climb, with the virus activity being the highest in the South, Mid-Atlantic, and the south-central West Coast, according to CDC data. “In fact, we’re seeing the highest influenza hospitalization rates going back a decade,” said José Romero, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, during a press briefing. The agency estimates that there have been 1.6 million illnesses, 13,000 hospitalizations, and 730 deaths from the flu so far this season. As of Nov. 4, there have been two pediatric deaths.

COVID-19 cases appear to have plateaued in the past three weeks, Dr. Romero said; however, the CDC expects that there will be “high-level circulation of SARS-CoV-2 this fall and winter,” the health alert stated.

The CDC advised that all eligible individuals aged 6-months or older should be vaccinated against COVID-19 and influenza. To protect against RSV-hospitalization, high-risk children should receive the monoclonal antibody drug palivizumab (Synagis). High-risk children include infants born before 29 weeks, children younger than age 2 with chronic lung disease or hemodynamically significant congenital heart disease, and children with suppressed immune systems or neuromuscular disorders.

Any patient with confirmed or suspected flu who is hospitalized, at higher risk for influenza complications, or who has a severe or progressive illness should be treated as early as possible with antivirals, such as oral oseltamivir (Tamiflu).

Patients with confirmed SARS-CoV-2 infection with increased risk of complications should also be treated with antivirals, such as nirmatrelvir and ritonavir (Paxlovid) or remdesivir (Veklury).

Patients should also be reminded to wash their hands frequently, cover coughs and sneezes, stay home when sick, and avoid close contact with people who are sick, the CDC advised.

“There’s no doubt that we will face some challenges this winter,” said Dawn O’Connell, HHS Assistant Secretary for Preparedness and Response, “but it’s important to remember that RSV and flu are not new, and we have safe and effective vaccines for COVID-19 and the flu.”

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

Just 3 weeks into the 2022-2023 flu season, the latest data from the Centers for Disease Control and Prevention’s Influenza Division suggest that the flu and respiratory syncytial virus are more than making up for the recent decline in COVID activity.

Outpatient visits for influenzalike illness (ILI), which includes influenza, SARS-CoV-2, and RSV, were higher after 3 weeks than for any of the previous five flu seasons: 3.3% of visits reported through the CDC’s Outpatient Influenza-like Illness Surveillance Network involved ILI as of Oct. 22. The highest comparable rate in the previous 5 years was the 1.9% recorded in late October of 2021, shortly after the definition of ILI was changed to also include illnesses other than influenza.

This season’s higher flu activity is in contrast to the previous two, which were unusually mild. The change, however, is not unexpected, as William Schaffner, MD, an infectious disease expert and professor of preventive medicine at Vanderbilt University, recently told CNN.

“Here we are in the middle of October – not the middle of November – we’re already seeing scattered influenza cases, even hospitalized influenza cases, around the country,” he said. “So we know that this virus is now spreading out in the community already. It’s gathering speed already. It looks to me to be about a month early.”

One indication of the mildness of the previous two flu seasons was the number of deaths, both pediatric and overall. Influenza-associated pediatric deaths had averaged about 110 per season over the previous eight seasons, compared with just 1 for 2020-2021 and 43 in 2021-2022. Overall flu deaths never reached 1% of all weekly deaths for either season, well below baseline levels for the flu, which range from 5.5% to 6.8%, CDC data show.
 

Other indicators of early severity

This season’s early rise in viral activity also can be seen in hospitalizations. The cumulative rate of flu-related admissions was 1.5 per 100,000 population as of Oct. 22, higher than the rate observed in the comparable week of previous seasons going back to 2010-2011, according to the CDC’s Influenza Hospitalization Surveillance Network.

A look at state reports of ILI outpatient visit rates shows that the District of Columbia and South Carolina are already in the very high range of the CDC’s severity scale, while 11 states are in the high range. Again going back to 2010-2011, no jurisdiction has ever been in the very high range this early in the season, based on data from the Outpatient Influenza-like Illness Surveillance Network.

Just 3 weeks into the 2022-2023 flu season, the latest data from the Centers for Disease Control and Prevention’s Influenza Division suggest that the flu and respiratory syncytial virus are more than making up for the recent decline in COVID activity.

Outpatient visits for influenzalike illness (ILI), which includes influenza, SARS-CoV-2, and RSV, were higher after 3 weeks than for any of the previous five flu seasons: 3.3% of visits reported through the CDC’s Outpatient Influenza-like Illness Surveillance Network involved ILI as of Oct. 22. The highest comparable rate in the previous 5 years was the 1.9% recorded in late October of 2021, shortly after the definition of ILI was changed to also include illnesses other than influenza.

This season’s higher flu activity is in contrast to the previous two, which were unusually mild. The change, however, is not unexpected, as William Schaffner, MD, an infectious disease expert and professor of preventive medicine at Vanderbilt University, recently told CNN.

“Here we are in the middle of October – not the middle of November – we’re already seeing scattered influenza cases, even hospitalized influenza cases, around the country,” he said. “So we know that this virus is now spreading out in the community already. It’s gathering speed already. It looks to me to be about a month early.”

One indication of the mildness of the previous two flu seasons was the number of deaths, both pediatric and overall. Influenza-associated pediatric deaths had averaged about 110 per season over the previous eight seasons, compared with just 1 for 2020-2021 and 43 in 2021-2022. Overall flu deaths never reached 1% of all weekly deaths for either season, well below baseline levels for the flu, which range from 5.5% to 6.8%, CDC data show.
 

Other indicators of early severity

This season’s early rise in viral activity also can be seen in hospitalizations. The cumulative rate of flu-related admissions was 1.5 per 100,000 population as of Oct. 22, higher than the rate observed in the comparable week of previous seasons going back to 2010-2011, according to the CDC’s Influenza Hospitalization Surveillance Network.

A look at state reports of ILI outpatient visit rates shows that the District of Columbia and South Carolina are already in the very high range of the CDC’s severity scale, while 11 states are in the high range. Again going back to 2010-2011, no jurisdiction has ever been in the very high range this early in the season, based on data from the Outpatient Influenza-like Illness Surveillance Network.

Just 3 weeks into the 2022-2023 flu season, the latest data from the Centers for Disease Control and Prevention’s Influenza Division suggest that the flu and respiratory syncytial virus are more than making up for the recent decline in COVID activity.

Outpatient visits for influenzalike illness (ILI), which includes influenza, SARS-CoV-2, and RSV, were higher after 3 weeks than for any of the previous five flu seasons: 3.3% of visits reported through the CDC’s Outpatient Influenza-like Illness Surveillance Network involved ILI as of Oct. 22. The highest comparable rate in the previous 5 years was the 1.9% recorded in late October of 2021, shortly after the definition of ILI was changed to also include illnesses other than influenza.

This season’s higher flu activity is in contrast to the previous two, which were unusually mild. The change, however, is not unexpected, as William Schaffner, MD, an infectious disease expert and professor of preventive medicine at Vanderbilt University, recently told CNN.

“Here we are in the middle of October – not the middle of November – we’re already seeing scattered influenza cases, even hospitalized influenza cases, around the country,” he said. “So we know that this virus is now spreading out in the community already. It’s gathering speed already. It looks to me to be about a month early.”

One indication of the mildness of the previous two flu seasons was the number of deaths, both pediatric and overall. Influenza-associated pediatric deaths had averaged about 110 per season over the previous eight seasons, compared with just 1 for 2020-2021 and 43 in 2021-2022. Overall flu deaths never reached 1% of all weekly deaths for either season, well below baseline levels for the flu, which range from 5.5% to 6.8%, CDC data show.
 

Other indicators of early severity

This season’s early rise in viral activity also can be seen in hospitalizations. The cumulative rate of flu-related admissions was 1.5 per 100,000 population as of Oct. 22, higher than the rate observed in the comparable week of previous seasons going back to 2010-2011, according to the CDC’s Influenza Hospitalization Surveillance Network.

A look at state reports of ILI outpatient visit rates shows that the District of Columbia and South Carolina are already in the very high range of the CDC’s severity scale, while 11 states are in the high range. Again going back to 2010-2011, no jurisdiction has ever been in the very high range this early in the season, based on data from the Outpatient Influenza-like Illness Surveillance Network.

New COVID-19 cases in children inched up in late October, just 1 week after dipping to their lowest level in more than a year, and some measures of pediatric emergency visits and hospital admissions rose as well.

There was an 8% increase in the number of cases for the week of Oct. 21-27, compared with the previous week, but this week’s total was still below 25,000, and the overall trend since the beginning of September is still one of decline, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

A similar increase can be seen for hospitalizations with confirmed COVID. The rate for children aged 0-17 years fell from 0.44 admissions per 100,000 population at the end of August to 0.16 per 100,000 on Oct. 23. Hospitalizations have since ticked up to 0.17 per 100,000, according to the Centers for Disease Control and Prevention.

Emergency department visits with diagnosed COVID among children aged 16-17 years, as a percentage of all ED visits, rose from 0.6% on Oct. 21 to 0.8% on Oct. 26. ED visits for 12- to 15-year-olds rose from 0.6% to 0.7% at about the same time, with both increases coming after declines that started in late August. No such increase has occurred yet among children aged 0-11 years, the CDC reported on its COVID Data Tracker.

One small milestone reached in the past week involved the proportion of all COVID cases that have occurred in children. The total number of child cases as of Oct. 27 was almost 14.9 million, which represents 18.3% of cases in all Americans, according to the AAP and CHA. That figure had been sitting at 18.4% since mid-August after reaching as high as 19.0% during the spring.

The CDC puts total COVID-related hospital admissions for children aged 0-17 at 163,588 since Aug. 1, 2020, which is 3.0% of all U.S. admissions. Total pediatric deaths number 1,843, or just about 0.2% of all COVID-related fatalities since the start of the pandemic, the CDC data show.

The latest vaccination figures show that 71.3% of children aged 12-17 years have received at least one dose, as have 38.8% of 5- to 11-year-olds, 8.4% of 2- to 4-year-olds, and 5.5% of those under age 2. Full vaccination by age group looks like this: 60.9% (12-17 years), 31.7% (5-11 years), 3.7% (2-4 years), and 2.1% (<2 years), the CDC reported. Almost 30% of children aged 12-17 have gotten a first booster dose, as have 16% of 5- to 11-year-olds.
 

New COVID-19 cases in children inched up in late October, just 1 week after dipping to their lowest level in more than a year, and some measures of pediatric emergency visits and hospital admissions rose as well.

There was an 8% increase in the number of cases for the week of Oct. 21-27, compared with the previous week, but this week’s total was still below 25,000, and the overall trend since the beginning of September is still one of decline, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

A similar increase can be seen for hospitalizations with confirmed COVID. The rate for children aged 0-17 years fell from 0.44 admissions per 100,000 population at the end of August to 0.16 per 100,000 on Oct. 23. Hospitalizations have since ticked up to 0.17 per 100,000, according to the Centers for Disease Control and Prevention.

Emergency department visits with diagnosed COVID among children aged 16-17 years, as a percentage of all ED visits, rose from 0.6% on Oct. 21 to 0.8% on Oct. 26. ED visits for 12- to 15-year-olds rose from 0.6% to 0.7% at about the same time, with both increases coming after declines that started in late August. No such increase has occurred yet among children aged 0-11 years, the CDC reported on its COVID Data Tracker.

One small milestone reached in the past week involved the proportion of all COVID cases that have occurred in children. The total number of child cases as of Oct. 27 was almost 14.9 million, which represents 18.3% of cases in all Americans, according to the AAP and CHA. That figure had been sitting at 18.4% since mid-August after reaching as high as 19.0% during the spring.

The CDC puts total COVID-related hospital admissions for children aged 0-17 at 163,588 since Aug. 1, 2020, which is 3.0% of all U.S. admissions. Total pediatric deaths number 1,843, or just about 0.2% of all COVID-related fatalities since the start of the pandemic, the CDC data show.

The latest vaccination figures show that 71.3% of children aged 12-17 years have received at least one dose, as have 38.8% of 5- to 11-year-olds, 8.4% of 2- to 4-year-olds, and 5.5% of those under age 2. Full vaccination by age group looks like this: 60.9% (12-17 years), 31.7% (5-11 years), 3.7% (2-4 years), and 2.1% (<2 years), the CDC reported. Almost 30% of children aged 12-17 have gotten a first booster dose, as have 16% of 5- to 11-year-olds.
 

New COVID-19 cases in children inched up in late October, just 1 week after dipping to their lowest level in more than a year, and some measures of pediatric emergency visits and hospital admissions rose as well.

There was an 8% increase in the number of cases for the week of Oct. 21-27, compared with the previous week, but this week’s total was still below 25,000, and the overall trend since the beginning of September is still one of decline, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

A similar increase can be seen for hospitalizations with confirmed COVID. The rate for children aged 0-17 years fell from 0.44 admissions per 100,000 population at the end of August to 0.16 per 100,000 on Oct. 23. Hospitalizations have since ticked up to 0.17 per 100,000, according to the Centers for Disease Control and Prevention.

Emergency department visits with diagnosed COVID among children aged 16-17 years, as a percentage of all ED visits, rose from 0.6% on Oct. 21 to 0.8% on Oct. 26. ED visits for 12- to 15-year-olds rose from 0.6% to 0.7% at about the same time, with both increases coming after declines that started in late August. No such increase has occurred yet among children aged 0-11 years, the CDC reported on its COVID Data Tracker.

One small milestone reached in the past week involved the proportion of all COVID cases that have occurred in children. The total number of child cases as of Oct. 27 was almost 14.9 million, which represents 18.3% of cases in all Americans, according to the AAP and CHA. That figure had been sitting at 18.4% since mid-August after reaching as high as 19.0% during the spring.

The CDC puts total COVID-related hospital admissions for children aged 0-17 at 163,588 since Aug. 1, 2020, which is 3.0% of all U.S. admissions. Total pediatric deaths number 1,843, or just about 0.2% of all COVID-related fatalities since the start of the pandemic, the CDC data show.

The latest vaccination figures show that 71.3% of children aged 12-17 years have received at least one dose, as have 38.8% of 5- to 11-year-olds, 8.4% of 2- to 4-year-olds, and 5.5% of those under age 2. Full vaccination by age group looks like this: 60.9% (12-17 years), 31.7% (5-11 years), 3.7% (2-4 years), and 2.1% (<2 years), the CDC reported. Almost 30% of children aged 12-17 have gotten a first booster dose, as have 16% of 5- to 11-year-olds.
 

With the third autumn of the COVID era now upon us, the discussion has turned again to a possible influenza/COVID twindemic, as well as the new-for-2022 influenza/COVID/respiratory syncytial virus tripledemic. It appears, however, that COVID may have missed the memo.

For the sixth time in the last 7 weeks, the number of new COVID cases in children fell, with just under 23,000 reported during the week of Oct. 14-20, according to the American Academy of Pediatrics and the Children’s Hospital Association. That is the lowest weekly count so far this year, and the lowest since early July of 2021, just as the Delta surge was starting. New pediatric cases had dipped to 8,500, the lowest for any week during the pandemic, a couple of weeks before that, the AAP/CHA data show.

Weekly cases have fallen by almost 75% since over 90,000 were reported for the week of Aug. 26 to Sept. 1, even as children have returned to school and vaccine uptake remains slow in the youngest age groups. Rates of emergency department visits with diagnosed COVID also have continued to drop, as have new admissions, and both are nearing their 2021 lows, according to the Centers for Disease Control and Prevention.

New vaccinations in children under age 5 years were up slightly for the most recent week (Oct. 13-19), but total uptake for that age group is only 7.1% for an initial dose and 2.9% for full vaccination. Among children aged 5-11 years, 38.7% have received at least one dose and 31.6% have completed the primary series, with corresponding figures of 71.2% and 60.9% for those aged 12-17, the CDC said on its COVID Data Tracker.

Despite the low overall numbers, though, the youngest children are, in one respect, punching above their weight when it comes to vaccinations. In the 2 weeks from Oct. 6 to Oct. 19, children under 5 years of age, who represent 5.9% of the U.S. population, received 9.2% of the initial vaccine doses administered. Children aged 5-11 years, who represent 8.7% of the total population, got just 4.2% of all first doses over those same 2 weeks, while 12- to 17-year-olds, who make up 7.6% of the population, got 3.4% of the vaccine doses, the CDC reported.

On the vaccine-approval front, the Food and Drug Administration recently announced that the new bivalent COVID-19 vaccines are now included in the emergency use authorizations for children who have completed primary or booster vaccination. The Moderna vaccine is authorized as a single-dose booster for children as young as 6 years and the Pfizer-BioNTech vaccine can be given as a single booster dose in children as young as 5 years, the FDA said.

“These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages,” the FDA said.


 

With the third autumn of the COVID era now upon us, the discussion has turned again to a possible influenza/COVID twindemic, as well as the new-for-2022 influenza/COVID/respiratory syncytial virus tripledemic. It appears, however, that COVID may have missed the memo.

For the sixth time in the last 7 weeks, the number of new COVID cases in children fell, with just under 23,000 reported during the week of Oct. 14-20, according to the American Academy of Pediatrics and the Children’s Hospital Association. That is the lowest weekly count so far this year, and the lowest since early July of 2021, just as the Delta surge was starting. New pediatric cases had dipped to 8,500, the lowest for any week during the pandemic, a couple of weeks before that, the AAP/CHA data show.

Weekly cases have fallen by almost 75% since over 90,000 were reported for the week of Aug. 26 to Sept. 1, even as children have returned to school and vaccine uptake remains slow in the youngest age groups. Rates of emergency department visits with diagnosed COVID also have continued to drop, as have new admissions, and both are nearing their 2021 lows, according to the Centers for Disease Control and Prevention.

New vaccinations in children under age 5 years were up slightly for the most recent week (Oct. 13-19), but total uptake for that age group is only 7.1% for an initial dose and 2.9% for full vaccination. Among children aged 5-11 years, 38.7% have received at least one dose and 31.6% have completed the primary series, with corresponding figures of 71.2% and 60.9% for those aged 12-17, the CDC said on its COVID Data Tracker.

Despite the low overall numbers, though, the youngest children are, in one respect, punching above their weight when it comes to vaccinations. In the 2 weeks from Oct. 6 to Oct. 19, children under 5 years of age, who represent 5.9% of the U.S. population, received 9.2% of the initial vaccine doses administered. Children aged 5-11 years, who represent 8.7% of the total population, got just 4.2% of all first doses over those same 2 weeks, while 12- to 17-year-olds, who make up 7.6% of the population, got 3.4% of the vaccine doses, the CDC reported.

On the vaccine-approval front, the Food and Drug Administration recently announced that the new bivalent COVID-19 vaccines are now included in the emergency use authorizations for children who have completed primary or booster vaccination. The Moderna vaccine is authorized as a single-dose booster for children as young as 6 years and the Pfizer-BioNTech vaccine can be given as a single booster dose in children as young as 5 years, the FDA said.

“These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages,” the FDA said.


 

With the third autumn of the COVID era now upon us, the discussion has turned again to a possible influenza/COVID twindemic, as well as the new-for-2022 influenza/COVID/respiratory syncytial virus tripledemic. It appears, however, that COVID may have missed the memo.

For the sixth time in the last 7 weeks, the number of new COVID cases in children fell, with just under 23,000 reported during the week of Oct. 14-20, according to the American Academy of Pediatrics and the Children’s Hospital Association. That is the lowest weekly count so far this year, and the lowest since early July of 2021, just as the Delta surge was starting. New pediatric cases had dipped to 8,500, the lowest for any week during the pandemic, a couple of weeks before that, the AAP/CHA data show.

Weekly cases have fallen by almost 75% since over 90,000 were reported for the week of Aug. 26 to Sept. 1, even as children have returned to school and vaccine uptake remains slow in the youngest age groups. Rates of emergency department visits with diagnosed COVID also have continued to drop, as have new admissions, and both are nearing their 2021 lows, according to the Centers for Disease Control and Prevention.

New vaccinations in children under age 5 years were up slightly for the most recent week (Oct. 13-19), but total uptake for that age group is only 7.1% for an initial dose and 2.9% for full vaccination. Among children aged 5-11 years, 38.7% have received at least one dose and 31.6% have completed the primary series, with corresponding figures of 71.2% and 60.9% for those aged 12-17, the CDC said on its COVID Data Tracker.

Despite the low overall numbers, though, the youngest children are, in one respect, punching above their weight when it comes to vaccinations. In the 2 weeks from Oct. 6 to Oct. 19, children under 5 years of age, who represent 5.9% of the U.S. population, received 9.2% of the initial vaccine doses administered. Children aged 5-11 years, who represent 8.7% of the total population, got just 4.2% of all first doses over those same 2 weeks, while 12- to 17-year-olds, who make up 7.6% of the population, got 3.4% of the vaccine doses, the CDC reported.

On the vaccine-approval front, the Food and Drug Administration recently announced that the new bivalent COVID-19 vaccines are now included in the emergency use authorizations for children who have completed primary or booster vaccination. The Moderna vaccine is authorized as a single-dose booster for children as young as 6 years and the Pfizer-BioNTech vaccine can be given as a single booster dose in children as young as 5 years, the FDA said.

“These bivalent COVID-19 vaccines include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages,” the FDA said.