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FDA OKs first condom for anal sex
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
anal sex has gained Food and Drug Administration approval.
specifically designed for use duringAnal intercourse is considered to be much riskier than vaginal sex for the transmission of infections such as HIV and HPV, a risk factor for anal cancer, agency officials said in a statement Feb. 23 announcing the decision. And though the Centers for Disease Control and Prevention has long encouraged the use of a condom during anal intercourse, the FDA had not until now deemed this practice safe.
The latex ONE Male Condom, from prophylactic maker Global Protection Corp. of Boston, has already been available for vaginal sex. The FDA action now allows the company to market the product for anal intercourse.
“This authorization helps us accomplish our priority to advance health equity through the development of safe and effective products that meet the needs of diverse populations,” Courtney Lias, PhD, the director of the FDA’s Office of GastroRenal, ObGyn, General Hospital, and Urology Devices, said in a statement.
The FDA said it relied on an Emory University clinical study of condom safety of more than 500 men. Those who took part in the study were evenly divided between men who have sex with men and men who have sex with women. The condom failure rate, meaning that a condom either broke or slipped, was less than 1% during anal sex. The failure rate was 3 times higher during vaginal intercourse.
The Emory researchers also found that roughly 70% of men who have sex with men would be more likely to use condoms marked as safe for anal sex, according to a survey of 10,000 people.
ONE Male Condoms sell for between $3.48 for a three-pack and $14.48 for a 24-pack, according to Milla Impola, Global Protection’s director of marketing and communications. The FDA said the condom should be used with a condom-compatible lubricant when used during anal sex.
A version of this article first appeared on WebMD.com.
Children and COVID: The Omicron surge has become a retreat
The Omicron decline continued for a fourth consecutive week as new cases of COVID-19 in children fell by 42% from the week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That 42% represents a drop from the 299,000 new cases reported for Feb. 4-10 down to 174,000 for the most recent week, Feb. 11-17.
The overall count of COVID-19 cases in children is 12.5 million over the course of the pandemic, and that represents 19% of cases reported among all ages, the AAP and CHA said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Hospital admissions also continued to fall, with the rate for children aged 0-17 at 0.43 per 100,000 population as of Feb. 20, down by almost 66% from the peak of 1.25 per 100,000 reached on Jan. 16, the Centers for Disease Control and Prevention reported.
A snapshot of the hospitalization situation shows that 1,687 children were occupying inpatient beds on Feb. 16, compared with 4,070 on Jan. 19, which appears to be the peak of the Omicron surge, according to data from the Department of Health & Human Services.
The state with the highest rate – 5.6 per 100,000 children – on Feb. 16 was North Dakota, although the District of Columbia came in at 11.0 per 100,000. They were followed by Oklahoma (5.3), Missouri (5.2), and West Virginia (4.1). There were three states – New Hampshire, Rhode Island, and Utah – with no children in the hospital on that date, the HHS said.
New vaccinations in children aged 5-11 years, which declined in mid- and late January, even as Omicron surged, continued to decline, as did vaccine completions. Vaccinations also fell among children aged 12-17 for the latest reporting week, Feb. 10-16, the AAP said in a separate report.
As more states and school districts drop mask mandates, data from the CDC indicate that 32.5% of 5- to 11-year olds and 67.4% of 12- to 17-year-olds have gotten at least one dose of the COVID-19 vaccine and that 25.1% and 57.3%, respectively, are fully vaccinated. Meanwhile, 20.5% of those fully vaccinated 12- to 17-year-olds have gotten a booster dose, the CDC said.
The Omicron decline continued for a fourth consecutive week as new cases of COVID-19 in children fell by 42% from the week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That 42% represents a drop from the 299,000 new cases reported for Feb. 4-10 down to 174,000 for the most recent week, Feb. 11-17.
The overall count of COVID-19 cases in children is 12.5 million over the course of the pandemic, and that represents 19% of cases reported among all ages, the AAP and CHA said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Hospital admissions also continued to fall, with the rate for children aged 0-17 at 0.43 per 100,000 population as of Feb. 20, down by almost 66% from the peak of 1.25 per 100,000 reached on Jan. 16, the Centers for Disease Control and Prevention reported.
A snapshot of the hospitalization situation shows that 1,687 children were occupying inpatient beds on Feb. 16, compared with 4,070 on Jan. 19, which appears to be the peak of the Omicron surge, according to data from the Department of Health & Human Services.
The state with the highest rate – 5.6 per 100,000 children – on Feb. 16 was North Dakota, although the District of Columbia came in at 11.0 per 100,000. They were followed by Oklahoma (5.3), Missouri (5.2), and West Virginia (4.1). There were three states – New Hampshire, Rhode Island, and Utah – with no children in the hospital on that date, the HHS said.
New vaccinations in children aged 5-11 years, which declined in mid- and late January, even as Omicron surged, continued to decline, as did vaccine completions. Vaccinations also fell among children aged 12-17 for the latest reporting week, Feb. 10-16, the AAP said in a separate report.
As more states and school districts drop mask mandates, data from the CDC indicate that 32.5% of 5- to 11-year olds and 67.4% of 12- to 17-year-olds have gotten at least one dose of the COVID-19 vaccine and that 25.1% and 57.3%, respectively, are fully vaccinated. Meanwhile, 20.5% of those fully vaccinated 12- to 17-year-olds have gotten a booster dose, the CDC said.
The Omicron decline continued for a fourth consecutive week as new cases of COVID-19 in children fell by 42% from the week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That 42% represents a drop from the 299,000 new cases reported for Feb. 4-10 down to 174,000 for the most recent week, Feb. 11-17.
The overall count of COVID-19 cases in children is 12.5 million over the course of the pandemic, and that represents 19% of cases reported among all ages, the AAP and CHA said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
Hospital admissions also continued to fall, with the rate for children aged 0-17 at 0.43 per 100,000 population as of Feb. 20, down by almost 66% from the peak of 1.25 per 100,000 reached on Jan. 16, the Centers for Disease Control and Prevention reported.
A snapshot of the hospitalization situation shows that 1,687 children were occupying inpatient beds on Feb. 16, compared with 4,070 on Jan. 19, which appears to be the peak of the Omicron surge, according to data from the Department of Health & Human Services.
The state with the highest rate – 5.6 per 100,000 children – on Feb. 16 was North Dakota, although the District of Columbia came in at 11.0 per 100,000. They were followed by Oklahoma (5.3), Missouri (5.2), and West Virginia (4.1). There were three states – New Hampshire, Rhode Island, and Utah – with no children in the hospital on that date, the HHS said.
New vaccinations in children aged 5-11 years, which declined in mid- and late January, even as Omicron surged, continued to decline, as did vaccine completions. Vaccinations also fell among children aged 12-17 for the latest reporting week, Feb. 10-16, the AAP said in a separate report.
As more states and school districts drop mask mandates, data from the CDC indicate that 32.5% of 5- to 11-year olds and 67.4% of 12- to 17-year-olds have gotten at least one dose of the COVID-19 vaccine and that 25.1% and 57.3%, respectively, are fully vaccinated. Meanwhile, 20.5% of those fully vaccinated 12- to 17-year-olds have gotten a booster dose, the CDC said.
Babies better protected from COVID if mother vaccinated during pregnancy: study
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
In a first of its kind study, researchers found women who received two mRNA COVID vaccine doses during pregnancy were 61% less likely to have a baby hospitalized for COVID-19 during the first 6 months of life.
In addition, two doses of the Pfizer/BioNTech or Moderna COVID vaccine later in a pregnancy were linked to an even higher level of protection, 80%, compared with 32% when given before 20 weeks’ gestation.
This finding suggests a greater transfer of maternal antibodies closer to birth, but more research is needed, cautioned senior study author Manish Patel, MD, during a Tuesday media telebriefing held by the Centers for Disease Control and Prevention.
Unanswered questions include how the babies got infected or if there is any protection afforded to babies for women vaccinated before pregnancy.
“We cannot be sure about the source of the infection,” said Dr. Patel, a medical epidemiologist with the CDC COVID-19 Emergency Response Team.
Dana Meaney-Delman, MD, MPH, agreed, but added that “perinatal transmission of the virus is very rare” with SARS-CoV-2. She is a practicing obstetrician and gynecologist and chief of the CDC Infant Outcomes Monitoring Research and Prevention Branch.
The study numbers were too small to show if a booster shot during pregnancy or breastfeeding could provide even greater protection for babies, Dr. Patel said.
The early release study was published online Feb. 15 in the CDC’s Morbidity and Mortality Weekly Report (MMWR).
Many previous studies looking at COVID-19 immunization during pregnancy focused on maternal health and “have clearly shown that receiving an mRNA COVID-19 vaccine during pregnancy reduces the risk for severe illness,” Dr. Meaney-Delman said.
Some dual protection suggested
Now there is evidence for a potential benefit to babies as well when a pregnant woman gets vaccinated. The study “provides real-world evidence that getting COVID-19 vaccination during pregnancy might help protect infants less than 6 months [of age],” Dr. Meaney-Delman said.
“These findings continue to emphasize the importance of COVID-19 vaccination during pregnancy to protect people who are pregnant and also to protect their babies,” she said.
Dr. Patel and colleagues studied 379 infants younger than 6 months hospitalized between July 1, 2021 and Jan. 17 of this year. Delta and then the Omicron variant predominated during this time.
The infants were admitted to one of 20 children’s hospitals in 17 states. The researchers compared 176 infants admitted with a positive COVID-19 PCR test to another 203 infants with a negative PCR test who served as controls.
Half as many mothers of infants admitted with COVID-19 were vaccinated during pregnancy, 16%, versus 32% of mothers of the control infants.
Vaccination with two doses of mRNA vaccine during pregnancy was 61% effective (95% confidence interval, 31%-78%) at preventing hospitalization among these infants. Because the study was epidemiological, the lower risk was an association, not a cause-and-effect finding, Dr. Patel said.
Babies admitted to the hospital positive for COVID-19 were more likely to be non-Hispanic Black, 18%, versus 9% of control group babies; and more likely to be Hispanic, 34% versus 28%, respectively.
A total 24% of infants with COVID-19 were admitted to the ICU, including the baby of an unvaccinated mother who required extracorporeal membrane oxygenation (ECMO). Another baby of an unvaccinated mother was the only infant death during the study.
Maternal vaccination trends
A reporter pointed out that COVID-19 vaccination rates tend to be low among pregnant women. “So there is some exciting news,” Dr. Meaney-Delman said, referring to a steady increase in the percentages of pregnant women in the U.S. choosing to get vaccinated, according to the CDC Data Tracker website.
“The numbers are encouraging, [but] they’re not quite where we need them to be, and they do differ by race and ethnicity,” she added.
A version of this article first appeared on Medscape.com.
Children and COVID: Weekly cases down by more than half
A third consecutive week of declines in new COVID-19 cases among children has brought the weekly count down by 74% since the Omicron surge peaked in mid-January, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
weekly COVID report. They also noted that the weekly tally was still higher than anything seen during the Delta surge.
The total number of pediatric cases was over 12.3 million as of Feb. 10, with children representing 18.9% of cases in all ages, according to the AAP/CHA report. The Centers for Disease Control and Prevention puts the two measures at 10.4 million and 17.3% on its COVID Data Tracker, based on availability of age data for 59.6 million total cases as of Feb. 14. The CDC also reported that 1,282 children have died from COVID-19 so far, which is about 0.17% of all deaths with age data available.
The AAP and CHA have been collecting data from state and territorial health departments, which have not always been consistently available over the course of the pandemic. Also, the CDC defines children as those under age 18 years, but that upper boundary varies from 14 to 20 among the states.
The decline of the Omicron variant also can be seen in new admissions of children with confirmed COVID-19, which continued to drop. The 7-day average of 435 admissions per day for the week of Feb. 6-12 was less than half of the peak seen in mid-January, when it reached 914 per day. The daily admission rate on Feb. 12 was 0.60 per 100,000 children aged 0-17 years – again, less than half the peak rate of 1.25 reported on Jan. 16, CDC data show.
The fading threat of Omicron also seems to be reflected in recent vaccination trends. Both initial doses and completions declined for the fourth consecutive week (Feb. 3-9) among children aged 5-11 years, while initiations held steady for 12- to 17-year-olds but completions declined for the third straight week, the AAP said in its separate vaccination report, which is based on data from the CDC.
As of Feb. 14, almost 32% of children aged 5-11 – that’s almost 9.2 million individuals – had received at least one dose of the COVID-19 vaccine and just over 24% (6.9 million) were fully vaccinated, the CDC reported. For children aged 12-17, the corresponding figures are 67% (16.9 million) and 57% (14.4 million). Newly available data from the CDC also indicate that 19.5% (2.8 million) of children aged 12-17 have received a booster dose.
A third consecutive week of declines in new COVID-19 cases among children has brought the weekly count down by 74% since the Omicron surge peaked in mid-January, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
weekly COVID report. They also noted that the weekly tally was still higher than anything seen during the Delta surge.
The total number of pediatric cases was over 12.3 million as of Feb. 10, with children representing 18.9% of cases in all ages, according to the AAP/CHA report. The Centers for Disease Control and Prevention puts the two measures at 10.4 million and 17.3% on its COVID Data Tracker, based on availability of age data for 59.6 million total cases as of Feb. 14. The CDC also reported that 1,282 children have died from COVID-19 so far, which is about 0.17% of all deaths with age data available.
The AAP and CHA have been collecting data from state and territorial health departments, which have not always been consistently available over the course of the pandemic. Also, the CDC defines children as those under age 18 years, but that upper boundary varies from 14 to 20 among the states.
The decline of the Omicron variant also can be seen in new admissions of children with confirmed COVID-19, which continued to drop. The 7-day average of 435 admissions per day for the week of Feb. 6-12 was less than half of the peak seen in mid-January, when it reached 914 per day. The daily admission rate on Feb. 12 was 0.60 per 100,000 children aged 0-17 years – again, less than half the peak rate of 1.25 reported on Jan. 16, CDC data show.
The fading threat of Omicron also seems to be reflected in recent vaccination trends. Both initial doses and completions declined for the fourth consecutive week (Feb. 3-9) among children aged 5-11 years, while initiations held steady for 12- to 17-year-olds but completions declined for the third straight week, the AAP said in its separate vaccination report, which is based on data from the CDC.
As of Feb. 14, almost 32% of children aged 5-11 – that’s almost 9.2 million individuals – had received at least one dose of the COVID-19 vaccine and just over 24% (6.9 million) were fully vaccinated, the CDC reported. For children aged 12-17, the corresponding figures are 67% (16.9 million) and 57% (14.4 million). Newly available data from the CDC also indicate that 19.5% (2.8 million) of children aged 12-17 have received a booster dose.
A third consecutive week of declines in new COVID-19 cases among children has brought the weekly count down by 74% since the Omicron surge peaked in mid-January, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.
weekly COVID report. They also noted that the weekly tally was still higher than anything seen during the Delta surge.
The total number of pediatric cases was over 12.3 million as of Feb. 10, with children representing 18.9% of cases in all ages, according to the AAP/CHA report. The Centers for Disease Control and Prevention puts the two measures at 10.4 million and 17.3% on its COVID Data Tracker, based on availability of age data for 59.6 million total cases as of Feb. 14. The CDC also reported that 1,282 children have died from COVID-19 so far, which is about 0.17% of all deaths with age data available.
The AAP and CHA have been collecting data from state and territorial health departments, which have not always been consistently available over the course of the pandemic. Also, the CDC defines children as those under age 18 years, but that upper boundary varies from 14 to 20 among the states.
The decline of the Omicron variant also can be seen in new admissions of children with confirmed COVID-19, which continued to drop. The 7-day average of 435 admissions per day for the week of Feb. 6-12 was less than half of the peak seen in mid-January, when it reached 914 per day. The daily admission rate on Feb. 12 was 0.60 per 100,000 children aged 0-17 years – again, less than half the peak rate of 1.25 reported on Jan. 16, CDC data show.
The fading threat of Omicron also seems to be reflected in recent vaccination trends. Both initial doses and completions declined for the fourth consecutive week (Feb. 3-9) among children aged 5-11 years, while initiations held steady for 12- to 17-year-olds but completions declined for the third straight week, the AAP said in its separate vaccination report, which is based on data from the CDC.
As of Feb. 14, almost 32% of children aged 5-11 – that’s almost 9.2 million individuals – had received at least one dose of the COVID-19 vaccine and just over 24% (6.9 million) were fully vaccinated, the CDC reported. For children aged 12-17, the corresponding figures are 67% (16.9 million) and 57% (14.4 million). Newly available data from the CDC also indicate that 19.5% (2.8 million) of children aged 12-17 have received a booster dose.
Small group of higher-volume antibiotic prescribers identified
“Higher-volume prescribers prescribed antibiotics to a larger share of their patient panel and their prescribing rate was 60% higher than that of lower-volume prescribers, indicating that their prescribing practices might be independent of the number of beneficiaries under their care,” Katryna A. Gouin, MPH, and associates wrote in the Morbidity and Mortality Weekly Report.
In 2019, 41% of all Part D antibiotics – that’s 24.4 million prescriptions – were prescribed by 69,835 higher-volume prescribers. The other 59% of all antibiotics were prescribed by the 627,000 lower-volume health care providers included in the analysis (those who prescribed fewer than 11 antibiotics were excluded), Ms. Gouin of Chenega in Anchorage, Alaska, and associates noted.
The analysis involved the Medicare Part D Prescribers by Provider data set and defined the highest-volume prescribers “as those in the highest 10th percentile of prescriber-level antibiotic volume (number of antibiotic prescriptions filled) across all Medicare providers nationwide,” the investigators explained.
The antibiotic-prescribing rate for the higher-volume prescribers was 680 prescriptions per 1,000 beneficiaries, which was 60% higher than the 426 prescriptions per 1,000 among the lower 90% of prescribers. Another way to look at it: The top 10% of health care providers “wrote a median of 284 antibiotic prescriptions, compared with a median of 41 among lower-volume prescribers,” the investigators said.
Physicians in internal medicine and family practice, the two largest medical specialties, were the most likely to be 10-percenters, accounting for 24.6% and 27.5%, respectively, of the higher-volume group. They were followed by nurse practitioners (14.1%) and physician assistants (7.4%), who were classified as specialists for the purposes of the study, Ms. Gouin and associates said.
The only other group of physicians among the top six specialties were urologists, who represented 6.8% of high-volume prescribers but only 1% of all prescribers, they noted.
The highest antibiotic prescription rate in the six largest groups of providers occurred among dentists, whose highest-prescribing practitioners wrote 1,271 prescriptions per 1,000 beneficiaries. Even the lower-prescribing 90% of dentists prescribed more antibiotics (1,068 per 1,000) than did the higher-prescribing family physicians (611 per 1,000) and internists (590 per 1,000), the researchers said.
The prescribing rates for all the other specialties that were not included separately also were higher than the family physicians’ and internists’. These rates were 850 per 1,000 beneficiaries for the higher-prescribers and 360 per 1,000 for the lower-prescribers, the researchers wrote.
The considerable differences in prescribing practices between specialties and even among those of the same specialty present “opportunities for improved prescribing through antibiotic stewardship activities focusing on these higher-volume prescribers, independent of specialty,” Ms. Gouin and associates wrote.
“Higher-volume prescribers prescribed antibiotics to a larger share of their patient panel and their prescribing rate was 60% higher than that of lower-volume prescribers, indicating that their prescribing practices might be independent of the number of beneficiaries under their care,” Katryna A. Gouin, MPH, and associates wrote in the Morbidity and Mortality Weekly Report.
In 2019, 41% of all Part D antibiotics – that’s 24.4 million prescriptions – were prescribed by 69,835 higher-volume prescribers. The other 59% of all antibiotics were prescribed by the 627,000 lower-volume health care providers included in the analysis (those who prescribed fewer than 11 antibiotics were excluded), Ms. Gouin of Chenega in Anchorage, Alaska, and associates noted.
The analysis involved the Medicare Part D Prescribers by Provider data set and defined the highest-volume prescribers “as those in the highest 10th percentile of prescriber-level antibiotic volume (number of antibiotic prescriptions filled) across all Medicare providers nationwide,” the investigators explained.
The antibiotic-prescribing rate for the higher-volume prescribers was 680 prescriptions per 1,000 beneficiaries, which was 60% higher than the 426 prescriptions per 1,000 among the lower 90% of prescribers. Another way to look at it: The top 10% of health care providers “wrote a median of 284 antibiotic prescriptions, compared with a median of 41 among lower-volume prescribers,” the investigators said.
Physicians in internal medicine and family practice, the two largest medical specialties, were the most likely to be 10-percenters, accounting for 24.6% and 27.5%, respectively, of the higher-volume group. They were followed by nurse practitioners (14.1%) and physician assistants (7.4%), who were classified as specialists for the purposes of the study, Ms. Gouin and associates said.
The only other group of physicians among the top six specialties were urologists, who represented 6.8% of high-volume prescribers but only 1% of all prescribers, they noted.
The highest antibiotic prescription rate in the six largest groups of providers occurred among dentists, whose highest-prescribing practitioners wrote 1,271 prescriptions per 1,000 beneficiaries. Even the lower-prescribing 90% of dentists prescribed more antibiotics (1,068 per 1,000) than did the higher-prescribing family physicians (611 per 1,000) and internists (590 per 1,000), the researchers said.
The prescribing rates for all the other specialties that were not included separately also were higher than the family physicians’ and internists’. These rates were 850 per 1,000 beneficiaries for the higher-prescribers and 360 per 1,000 for the lower-prescribers, the researchers wrote.
The considerable differences in prescribing practices between specialties and even among those of the same specialty present “opportunities for improved prescribing through antibiotic stewardship activities focusing on these higher-volume prescribers, independent of specialty,” Ms. Gouin and associates wrote.
“Higher-volume prescribers prescribed antibiotics to a larger share of their patient panel and their prescribing rate was 60% higher than that of lower-volume prescribers, indicating that their prescribing practices might be independent of the number of beneficiaries under their care,” Katryna A. Gouin, MPH, and associates wrote in the Morbidity and Mortality Weekly Report.
In 2019, 41% of all Part D antibiotics – that’s 24.4 million prescriptions – were prescribed by 69,835 higher-volume prescribers. The other 59% of all antibiotics were prescribed by the 627,000 lower-volume health care providers included in the analysis (those who prescribed fewer than 11 antibiotics were excluded), Ms. Gouin of Chenega in Anchorage, Alaska, and associates noted.
The analysis involved the Medicare Part D Prescribers by Provider data set and defined the highest-volume prescribers “as those in the highest 10th percentile of prescriber-level antibiotic volume (number of antibiotic prescriptions filled) across all Medicare providers nationwide,” the investigators explained.
The antibiotic-prescribing rate for the higher-volume prescribers was 680 prescriptions per 1,000 beneficiaries, which was 60% higher than the 426 prescriptions per 1,000 among the lower 90% of prescribers. Another way to look at it: The top 10% of health care providers “wrote a median of 284 antibiotic prescriptions, compared with a median of 41 among lower-volume prescribers,” the investigators said.
Physicians in internal medicine and family practice, the two largest medical specialties, were the most likely to be 10-percenters, accounting for 24.6% and 27.5%, respectively, of the higher-volume group. They were followed by nurse practitioners (14.1%) and physician assistants (7.4%), who were classified as specialists for the purposes of the study, Ms. Gouin and associates said.
The only other group of physicians among the top six specialties were urologists, who represented 6.8% of high-volume prescribers but only 1% of all prescribers, they noted.
The highest antibiotic prescription rate in the six largest groups of providers occurred among dentists, whose highest-prescribing practitioners wrote 1,271 prescriptions per 1,000 beneficiaries. Even the lower-prescribing 90% of dentists prescribed more antibiotics (1,068 per 1,000) than did the higher-prescribing family physicians (611 per 1,000) and internists (590 per 1,000), the researchers said.
The prescribing rates for all the other specialties that were not included separately also were higher than the family physicians’ and internists’. These rates were 850 per 1,000 beneficiaries for the higher-prescribers and 360 per 1,000 for the lower-prescribers, the researchers wrote.
The considerable differences in prescribing practices between specialties and even among those of the same specialty present “opportunities for improved prescribing through antibiotic stewardship activities focusing on these higher-volume prescribers, independent of specialty,” Ms. Gouin and associates wrote.
FROM THE MMWR
Children and COVID: New cases down again, but still ‘extremely high’
The indication of an Omicron decline has become a trend: New cases of COVID-19 in children were down for a second consecutive week in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.
To put the effect of the Delta and Omicron variants into some sort of perspective, the total number of COVID-19 cases among children passed 5 million at the beginning of September 2021, about a year and a half into the pandemic. In the last 5 months, the cumulative count has more than doubled and now stands at 12 million, the AAP and CHA said in their weekly COVID report.
Hospital admissions and emergency department visits followed the same downward trend over the last week. The rate of new hospitalizations fell to 0.81 per 100,000 children aged 0-17 years as of Feb. 2 (down from a peak of 1.25 per 100,000 on Jan. 15), and ED visits with diagnosed COVID-19 dropped to 1.8% (peak was 14.1%), 1.9% (peak was 14.3%), and 3.4% (peak was 14%) of all visits for children aged 16-17, 12-15, and 0-11 years, respectively, the Centers for Disease Control and Prevention reported.
The vaccination response
The surge of infections brought about by the Omicron variant, however, did not translate into increased vaccination, at least for the youngest eligible children. Vaccine initiation rose slightly among children aged 5-11 in early and mid-January but, by early February, new vaccinations had declined to their lowest point since approval in early November of 2021, the AAP said in its weekly COVID vaccination report.
As a result, the 5- to 11-year-olds are well behind the pace set by those aged 12-15 for the first 3 months of their vaccination experience. Through the first 13 weeks after the COVID vaccine was approved for children aged 12-15 in early May, 44.5% had received at least one dose and 32.3% were fully vaccinated. Among children aged 5-11, the corresponding figures through 13 weeks were 31% and 22.5%, according to CDC data.
The vaccination reaction to Omicron was somewhat more robust for children aged 12-17, compared with the younger group, but initiations dropped at the same time that new cases began to decline. In terms of total volume, the response among 12- to 17-year-olds was much smaller than that seen in July and August of 2021 as the Delta surge was hitting the United States, the AAP vaccination report shows.
All those vaccinations add up to this: Over 16.8 million children aged 12-17 and almost 9 million aged 5-11 had received at least one dose of vaccine as of Feb. 7, which works out to 66.6% of the older group and 31.2% of the younger cohort. Almost 14.3 million (56.4%) of those aged 12-17 are fully vaccinated, as are 6.6 million (22.9%) of the 5- to 11-year-olds, the CDC said on its COVID Data Tracker.
The indication of an Omicron decline has become a trend: New cases of COVID-19 in children were down for a second consecutive week in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.
To put the effect of the Delta and Omicron variants into some sort of perspective, the total number of COVID-19 cases among children passed 5 million at the beginning of September 2021, about a year and a half into the pandemic. In the last 5 months, the cumulative count has more than doubled and now stands at 12 million, the AAP and CHA said in their weekly COVID report.
Hospital admissions and emergency department visits followed the same downward trend over the last week. The rate of new hospitalizations fell to 0.81 per 100,000 children aged 0-17 years as of Feb. 2 (down from a peak of 1.25 per 100,000 on Jan. 15), and ED visits with diagnosed COVID-19 dropped to 1.8% (peak was 14.1%), 1.9% (peak was 14.3%), and 3.4% (peak was 14%) of all visits for children aged 16-17, 12-15, and 0-11 years, respectively, the Centers for Disease Control and Prevention reported.
The vaccination response
The surge of infections brought about by the Omicron variant, however, did not translate into increased vaccination, at least for the youngest eligible children. Vaccine initiation rose slightly among children aged 5-11 in early and mid-January but, by early February, new vaccinations had declined to their lowest point since approval in early November of 2021, the AAP said in its weekly COVID vaccination report.
As a result, the 5- to 11-year-olds are well behind the pace set by those aged 12-15 for the first 3 months of their vaccination experience. Through the first 13 weeks after the COVID vaccine was approved for children aged 12-15 in early May, 44.5% had received at least one dose and 32.3% were fully vaccinated. Among children aged 5-11, the corresponding figures through 13 weeks were 31% and 22.5%, according to CDC data.
The vaccination reaction to Omicron was somewhat more robust for children aged 12-17, compared with the younger group, but initiations dropped at the same time that new cases began to decline. In terms of total volume, the response among 12- to 17-year-olds was much smaller than that seen in July and August of 2021 as the Delta surge was hitting the United States, the AAP vaccination report shows.
All those vaccinations add up to this: Over 16.8 million children aged 12-17 and almost 9 million aged 5-11 had received at least one dose of vaccine as of Feb. 7, which works out to 66.6% of the older group and 31.2% of the younger cohort. Almost 14.3 million (56.4%) of those aged 12-17 are fully vaccinated, as are 6.6 million (22.9%) of the 5- to 11-year-olds, the CDC said on its COVID Data Tracker.
The indication of an Omicron decline has become a trend: New cases of COVID-19 in children were down for a second consecutive week in the United States, according to the American Academy of Pediatrics and the Children’s Hospital Association.
To put the effect of the Delta and Omicron variants into some sort of perspective, the total number of COVID-19 cases among children passed 5 million at the beginning of September 2021, about a year and a half into the pandemic. In the last 5 months, the cumulative count has more than doubled and now stands at 12 million, the AAP and CHA said in their weekly COVID report.
Hospital admissions and emergency department visits followed the same downward trend over the last week. The rate of new hospitalizations fell to 0.81 per 100,000 children aged 0-17 years as of Feb. 2 (down from a peak of 1.25 per 100,000 on Jan. 15), and ED visits with diagnosed COVID-19 dropped to 1.8% (peak was 14.1%), 1.9% (peak was 14.3%), and 3.4% (peak was 14%) of all visits for children aged 16-17, 12-15, and 0-11 years, respectively, the Centers for Disease Control and Prevention reported.
The vaccination response
The surge of infections brought about by the Omicron variant, however, did not translate into increased vaccination, at least for the youngest eligible children. Vaccine initiation rose slightly among children aged 5-11 in early and mid-January but, by early February, new vaccinations had declined to their lowest point since approval in early November of 2021, the AAP said in its weekly COVID vaccination report.
As a result, the 5- to 11-year-olds are well behind the pace set by those aged 12-15 for the first 3 months of their vaccination experience. Through the first 13 weeks after the COVID vaccine was approved for children aged 12-15 in early May, 44.5% had received at least one dose and 32.3% were fully vaccinated. Among children aged 5-11, the corresponding figures through 13 weeks were 31% and 22.5%, according to CDC data.
The vaccination reaction to Omicron was somewhat more robust for children aged 12-17, compared with the younger group, but initiations dropped at the same time that new cases began to decline. In terms of total volume, the response among 12- to 17-year-olds was much smaller than that seen in July and August of 2021 as the Delta surge was hitting the United States, the AAP vaccination report shows.
All those vaccinations add up to this: Over 16.8 million children aged 12-17 and almost 9 million aged 5-11 had received at least one dose of vaccine as of Feb. 7, which works out to 66.6% of the older group and 31.2% of the younger cohort. Almost 14.3 million (56.4%) of those aged 12-17 are fully vaccinated, as are 6.6 million (22.9%) of the 5- to 11-year-olds, the CDC said on its COVID Data Tracker.
Children and COVID-19: The Omicron tide may have turned
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in theirAs children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in theirAs children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
The Omicron-fueled surge appears to have peaked as new cases of COVID-19 in U.S. children dropped for the first time since late November 2021, dipping back below the 1 million mark for the week, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total number of cases in children was up to 11.4 million as of Jan. 27, with children representing 18.6% of all cases reported since the pandemic started, the AAP and CHA said in theirAs children remain the largest reservoir of unvaccinated Americans, their share of the COVID case load continues to rise quickly. Just 2 weeks ago, children made up 17.8% of the cumulative number of cases, and at the end of December it was 17.4%, the AAP/CHA data show.
The latest data from the Centers for Disease Control and Prevention show that trends for admissions and emergency department visits reflect the decline in new cases. New admissions of children aged 0-17 years with diagnosed COVID-19 peaked at 1.25 per 100,000 population on Jan. 15 and were down to 0.95 per 100,000 on Jan. 29.
Daily ED visits for COVID-19, measured as a percentage of all ED visits, peaked at 13.9% on Jan. 14 for children aged 0-11 years and on Jan. 9 for both 12- to 15-year-olds (14.1%) and 16- to 17-year-olds (13.8%). By Jan. 28, the rates were down to 5.6% (0-11), 3.1% (12-15), and 3.3% (16-17), the CDC reported based on data from the National Syndromic Surveillance Program.
Trends involving more severe illness support observations that Omicron is milder than earlier variants. Children hospitalized with COVID-19 were less likely to be admitted to an intensive care unit over the last 2 months than during the Delta surge in the late summer and early fall or during the winter of 2020-2021, the CDC said based on data from the BD Insights Research Database, which includes 229,000 patients and 267 hospitals.
Those data show that the highest monthly rate occurred early on, in May of 2020, when 27.8% of children with COVID-19 ended up in the ICU. The rates for December 2021 and January 2022, by comparison, were 11.0% and 11.3%, respectively, the CDC said.
Vaccination lags in younger children
As reports surface about Pfizer-BioNTech filing an emergency use request to extend vaccine coverage to children aged 6 months to 5 years, it does appear that prevention efforts could use the proverbial shot in the arm.
As of Jan. 30, just 30.4% of children aged 5-11 have received at least one dose of the COVID-19 vaccine, and only 21.6% are fully vaccinated. At a comparable point in their timeline – just short of 3 months after approval – the respective numbers for children aged 12-15 were about 42% and 31%, CDC data show.
In the younger group, both initial doses and completions rose slightly in the first 2 weeks of January but then dropped in each of the last 2 weeks. There was a more significant surge in interest among the 12- to 17-year-olds in mid-January, but the last full week of the month brought declines of more than 50% in both measures, according to a separate AAP analysis.
CDC issues new pneumococcal vaccine recommendations for adults
The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).
The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.
If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.
As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.
Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.
“As part of that process, ACIP strived to simplify the recommendations,” she said.
The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.
“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.
Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.
While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the
CDC does not recommend one over the other, Dr. Kobayashi noted.
More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.
Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.
“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”
The new approach should help change that, he said.
“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.
Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.
“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”
“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”
According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.
“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”
Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).
The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.
If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.
As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.
Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.
“As part of that process, ACIP strived to simplify the recommendations,” she said.
The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.
“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.
Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.
While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the
CDC does not recommend one over the other, Dr. Kobayashi noted.
More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.
Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.
“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”
The new approach should help change that, he said.
“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.
Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.
“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”
“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”
According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.
“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”
Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The recommendations, voted on by the CDC’s Advisory Committee on Immunization Practices (ACIP) in October and made final in January with publication in the agency’s Morbidity and Mortality Weekly Report (MMWR), call for use of the 15-valent pneumococcal conjugate vaccine (PCV15; Vaxneuvance, Merck Sharp & Dohme) or 20-valent PCV (PREVNAR20; Wyeth Pharmaceuticals).
The recommendations apply to PCV-naive adults in the United States who are either aged 65 years or older, or who are aged 19-64 years and have underlying conditions such as diabetes, chronic heart or liver disease, or HIV, and have not previously received a PCV or whose previous vaccination history is unknown.
If the PCV15 vaccine is used, a subsequent dose of the 23-valent pneumococcal polysaccharide vaccine (PPSV23; Pneumovax23, Merck Sharp & Dohme) should be provided, typically at least 1 year later, under the recommendations.
As reported by this news organization, PCV15 and PREVNAR20 received approval from the Food and Drug Administration last July.
Those approvals provided an impetus for the revised recommendations, “offer[ing] an opportunity to review the existing recommendations and available data,” Miwako Kobayashi, MD, first author of the MMWR report and a medical epidemiologist with the National Center for Immunization and Respiratory Diseases, CDC, in Atlanta, said in an interview.
“As part of that process, ACIP strived to simplify the recommendations,” she said.
The previous recommendations called for the PCV13 vaccine and the PPSV23 and had varying conditions (depending on certain age and risk groups) that added complexity to the process. Under the new approach, the same recommendation applies regardless of specific medical conditions or other risk factors.
“With the simplified recommendation for adults 19 through 64, we expect coverage may increase among this population,” Dr. Kobayashi said.
Compared with the PCV13 vaccine, PREVNAR20 protects against seven additional serotypes involved in cases of invasive pneumococcal disease (IPD) and pneumonia, which are responsible for up to 40% of all cases of pneumococcal disease and related deaths in the United States.
While the PREVNAR20 includes five more pneumococcal serotypes than PCV15, the
CDC does not recommend one over the other, Dr. Kobayashi noted.
More than 90% of cases of adult IPD involve older adults and adults with chronic medical conditions or immunocompromising conditions, cerebrospinal fluid leaks, or cochlear implants, the MMWR report notes.
Commenting on the recommendations, Amit A. Shah, MD, a geriatrician with the Mayo Clinic in Phoenix, Ariz., underscored the need for clinicians to be proactive in recommending the vaccines to those patients.
“Despite only needing one vaccine dose after turning 65 to be considered vaccinated, only about 70% of people in this group have received any pneumococcal vaccination,” he said in an interview. “This percentage has not increased much over the past several years.”
The new approach should help change that, he said.
“These new recommendations are a significant simplification from the prior confusing and challenging-to-implement recommendations from 2019,” Dr. Shah explained.
Among the 2019 recommendations was a stipulation for “shared decision-making” with PCV13, and a conversation that often only complicated matters, he noted.
“Patients and providers alike had confusion about this since it was not a clear-cut ‘yes, give it’ or ‘no, do not give it any longer’ recommendation.”
“Now that this new recommendation will require no extra time for a discussion in the clinic, and just a simple ‘it’s time for your pneumonia shot’ offer, this may become more feasible,” Dr. Shah added. “In addition, removal of the shared decision-making stipulation allows for this immunization to be easily protocolized in the clinic, similar to automatic offers to the flu vaccine for patients each year.”
According to the CDC, pneumococcal pneumonia causes an estimated 150,000 hospitalizations each year in the United States, while pneumococcal meningitis and bacteremia killed approximately 3,250 people in the United States in 2019.
“Clinicians are patients’ most trusted resource when it comes to vaccine recommendations,” Dr. Kobayashi said. “We encourage all clinicians to recommend pneumococcal vaccines when indicated.”
Dr. Kobayashi and Dr. Shah have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE MMWR
Immunocompromised patients should receive fourth COVID shot: CDC
The Centers for Disease Control and Prevention contacted pharmacies on Jan. 26 to reinforce the message that people with moderate to severe immune suppression should receive a fourth COVID-19 vaccine, according to Kaiser Health News.
The conference call came a day after the news outlet reported that immunocompromised people were being turned away by pharmacies. White House officials also emphasized on Jan. 26 that immunocompromised people should receive an additional shot.
During the call, the CDC “reiterated the recommendations, running through case examples,” Mitchel Rothholz, RPh, MBA, chief of governance and state affiliates for the American Pharmacists Association, told KHN.
While on the call, Mr. Rothholz asked for a “prepared document” with the CDC’s recommendations “so we can clearly and consistently communicate the message.” The CDC officials on the call said they would create a document but “don’t know how long that will take,” Mr. Rothholz told KHN.
The CDC recommends an additional shot -– or a fourth shot – for those who have weak immune systems, which makes them more at risk for severe COVID-19 and death. About 7 million American adults are considered immunocompromised, KHN reported, which includes people who have certain medical conditions that impair their immune response or who take immune-suppressing drugs because of organ transplants, cancer, or autoimmune diseases.
The CDC first recommended fourth shots for immunocompromised people in October. This month, the CDC shortened the time for booster shots from 6 months to 5 months, and some immunocompromised people who are due for another shot have begun to seek them. The agency has been educating pharmacists and other health providers since then, a CDC spokesperson told KHN.
While patients don’t need to provide proof that they are immunocompromised, according to the CDC, some have been turned away, KHN reported.
To improve communication with the public, large pharmacies could issue news releases and update their websites “explicitly stating that they are offering fourth doses” to immunocompromised people, Ameet Kini, MD, a professor of pathology and laboratory medicine at Loyola University Medical Center in Chicago, told KHN.
Pharmacies should also update their patient portals and provide “clear guidance for their pharmacists,” he said.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention contacted pharmacies on Jan. 26 to reinforce the message that people with moderate to severe immune suppression should receive a fourth COVID-19 vaccine, according to Kaiser Health News.
The conference call came a day after the news outlet reported that immunocompromised people were being turned away by pharmacies. White House officials also emphasized on Jan. 26 that immunocompromised people should receive an additional shot.
During the call, the CDC “reiterated the recommendations, running through case examples,” Mitchel Rothholz, RPh, MBA, chief of governance and state affiliates for the American Pharmacists Association, told KHN.
While on the call, Mr. Rothholz asked for a “prepared document” with the CDC’s recommendations “so we can clearly and consistently communicate the message.” The CDC officials on the call said they would create a document but “don’t know how long that will take,” Mr. Rothholz told KHN.
The CDC recommends an additional shot -– or a fourth shot – for those who have weak immune systems, which makes them more at risk for severe COVID-19 and death. About 7 million American adults are considered immunocompromised, KHN reported, which includes people who have certain medical conditions that impair their immune response or who take immune-suppressing drugs because of organ transplants, cancer, or autoimmune diseases.
The CDC first recommended fourth shots for immunocompromised people in October. This month, the CDC shortened the time for booster shots from 6 months to 5 months, and some immunocompromised people who are due for another shot have begun to seek them. The agency has been educating pharmacists and other health providers since then, a CDC spokesperson told KHN.
While patients don’t need to provide proof that they are immunocompromised, according to the CDC, some have been turned away, KHN reported.
To improve communication with the public, large pharmacies could issue news releases and update their websites “explicitly stating that they are offering fourth doses” to immunocompromised people, Ameet Kini, MD, a professor of pathology and laboratory medicine at Loyola University Medical Center in Chicago, told KHN.
Pharmacies should also update their patient portals and provide “clear guidance for their pharmacists,” he said.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention contacted pharmacies on Jan. 26 to reinforce the message that people with moderate to severe immune suppression should receive a fourth COVID-19 vaccine, according to Kaiser Health News.
The conference call came a day after the news outlet reported that immunocompromised people were being turned away by pharmacies. White House officials also emphasized on Jan. 26 that immunocompromised people should receive an additional shot.
During the call, the CDC “reiterated the recommendations, running through case examples,” Mitchel Rothholz, RPh, MBA, chief of governance and state affiliates for the American Pharmacists Association, told KHN.
While on the call, Mr. Rothholz asked for a “prepared document” with the CDC’s recommendations “so we can clearly and consistently communicate the message.” The CDC officials on the call said they would create a document but “don’t know how long that will take,” Mr. Rothholz told KHN.
The CDC recommends an additional shot -– or a fourth shot – for those who have weak immune systems, which makes them more at risk for severe COVID-19 and death. About 7 million American adults are considered immunocompromised, KHN reported, which includes people who have certain medical conditions that impair their immune response or who take immune-suppressing drugs because of organ transplants, cancer, or autoimmune diseases.
The CDC first recommended fourth shots for immunocompromised people in October. This month, the CDC shortened the time for booster shots from 6 months to 5 months, and some immunocompromised people who are due for another shot have begun to seek them. The agency has been educating pharmacists and other health providers since then, a CDC spokesperson told KHN.
While patients don’t need to provide proof that they are immunocompromised, according to the CDC, some have been turned away, KHN reported.
To improve communication with the public, large pharmacies could issue news releases and update their websites “explicitly stating that they are offering fourth doses” to immunocompromised people, Ameet Kini, MD, a professor of pathology and laboratory medicine at Loyola University Medical Center in Chicago, told KHN.
Pharmacies should also update their patient portals and provide “clear guidance for their pharmacists,” he said.
A version of this article first appeared on WebMD.com.
FDA approves risankizumab (Skyrizi) for psoriatic arthritis
The Food and Drug Administration on Jan. 21 approved risankizumab-rzaa (Skyrizi) for a second indication – treating adults with active psoriatic arthritis (PsA) – making it the second anti–interleukin-23 monoclonal antibody available to treat PsA, according to an announcement from manufacturer AbbVie.
The agency previously approved risankizumab in April 2019 for adults with moderate to severe plaque psoriasis.
The dosing regimen for PsA is the same as it is for patients with moderate to severe plaque psoriasis: a single 150-mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4), and it can be administered alone or in combination with disease-modifying antirheumatic drugs (DMARDs).
Two phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, were the basis for the approval. These two trials tested the biologic agent in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or nonbiologic DMARDs. Fulfillment of the trials’ primary endpoint of at least a 20% improvement in American College of Rheumatology response criteria at 24 weeks occurred in 51.3%-57.3% of patients, compared with 26.5%-33.5% of placebo-treated patients.
Those on risankizumab also achieved significantly higher rates of ACR50 and ACR70 responses than those on placebo. In addition, patients with preexisting dactylitis and enthesitis experienced improvements in these PsA manifestations. Risankizumab was also associated with an improvement in physical function at 24 weeks on the Health Assessment Questionnaire–Disability Index, bettering placebo by a mean difference of 0.16-0.20 points in the two trials. A significantly higher percentage of patients who had psoriatic skin lesions experienced at least 90% improvement with risankizumab on the Psoriasis Area and Severity Index, compared with placebo.
AbbVie said that the safety profile of risankizumab in patients with PsA has been generally consistent with its effects in patients with plaque psoriasis.
The KEEPsAKE 1 and KEEPsAKE 2 studies are ongoing, and patients in the long-term extensions of the trials remain blinded to the original randomized allocation for the duration of the studies.
Phase 3 trials of risankizumab are also ongoing in patients with Crohn’s disease and ulcerative colitis.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Jan. 21 approved risankizumab-rzaa (Skyrizi) for a second indication – treating adults with active psoriatic arthritis (PsA) – making it the second anti–interleukin-23 monoclonal antibody available to treat PsA, according to an announcement from manufacturer AbbVie.
The agency previously approved risankizumab in April 2019 for adults with moderate to severe plaque psoriasis.
The dosing regimen for PsA is the same as it is for patients with moderate to severe plaque psoriasis: a single 150-mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4), and it can be administered alone or in combination with disease-modifying antirheumatic drugs (DMARDs).
Two phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, were the basis for the approval. These two trials tested the biologic agent in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or nonbiologic DMARDs. Fulfillment of the trials’ primary endpoint of at least a 20% improvement in American College of Rheumatology response criteria at 24 weeks occurred in 51.3%-57.3% of patients, compared with 26.5%-33.5% of placebo-treated patients.
Those on risankizumab also achieved significantly higher rates of ACR50 and ACR70 responses than those on placebo. In addition, patients with preexisting dactylitis and enthesitis experienced improvements in these PsA manifestations. Risankizumab was also associated with an improvement in physical function at 24 weeks on the Health Assessment Questionnaire–Disability Index, bettering placebo by a mean difference of 0.16-0.20 points in the two trials. A significantly higher percentage of patients who had psoriatic skin lesions experienced at least 90% improvement with risankizumab on the Psoriasis Area and Severity Index, compared with placebo.
AbbVie said that the safety profile of risankizumab in patients with PsA has been generally consistent with its effects in patients with plaque psoriasis.
The KEEPsAKE 1 and KEEPsAKE 2 studies are ongoing, and patients in the long-term extensions of the trials remain blinded to the original randomized allocation for the duration of the studies.
Phase 3 trials of risankizumab are also ongoing in patients with Crohn’s disease and ulcerative colitis.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration on Jan. 21 approved risankizumab-rzaa (Skyrizi) for a second indication – treating adults with active psoriatic arthritis (PsA) – making it the second anti–interleukin-23 monoclonal antibody available to treat PsA, according to an announcement from manufacturer AbbVie.
The agency previously approved risankizumab in April 2019 for adults with moderate to severe plaque psoriasis.
The dosing regimen for PsA is the same as it is for patients with moderate to severe plaque psoriasis: a single 150-mg subcutaneous injection four times a year (after two starter doses at weeks 0 and 4), and it can be administered alone or in combination with disease-modifying antirheumatic drugs (DMARDs).
Two phase 3 trials, KEEPsAKE 1 and KEEPsAKE 2, were the basis for the approval. These two trials tested the biologic agent in adults with active PsA, including those who had responded inadequately or were intolerant to biologic therapy and/or nonbiologic DMARDs. Fulfillment of the trials’ primary endpoint of at least a 20% improvement in American College of Rheumatology response criteria at 24 weeks occurred in 51.3%-57.3% of patients, compared with 26.5%-33.5% of placebo-treated patients.
Those on risankizumab also achieved significantly higher rates of ACR50 and ACR70 responses than those on placebo. In addition, patients with preexisting dactylitis and enthesitis experienced improvements in these PsA manifestations. Risankizumab was also associated with an improvement in physical function at 24 weeks on the Health Assessment Questionnaire–Disability Index, bettering placebo by a mean difference of 0.16-0.20 points in the two trials. A significantly higher percentage of patients who had psoriatic skin lesions experienced at least 90% improvement with risankizumab on the Psoriasis Area and Severity Index, compared with placebo.
AbbVie said that the safety profile of risankizumab in patients with PsA has been generally consistent with its effects in patients with plaque psoriasis.
The KEEPsAKE 1 and KEEPsAKE 2 studies are ongoing, and patients in the long-term extensions of the trials remain blinded to the original randomized allocation for the duration of the studies.
Phase 3 trials of risankizumab are also ongoing in patients with Crohn’s disease and ulcerative colitis.
A version of this article first appeared on Medscape.com.