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FDA approves two JAK-1 inhibitors for moderate to severe atopic dermatitis
The available for this indication in the United States.
“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.
“The only oral approved drug for AD up to now was oral prednisone, which has terrible safety concerns. This is basically the first oral medication that we can provide our patients for long-term use.”
Upadacitinib
The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.
Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.
“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”
She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”
Abrocitinib
Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.
The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.
The available for this indication in the United States.
“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.
“The only oral approved drug for AD up to now was oral prednisone, which has terrible safety concerns. This is basically the first oral medication that we can provide our patients for long-term use.”
Upadacitinib
The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.
Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.
“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”
She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”
Abrocitinib
Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.
The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.
The available for this indication in the United States.
“It’s big news because a few years ago we didn’t have any systemic treatments that are safer than the classical immunosuppressants like cyclosporine and methotrexate,” Emma Guttman-Yassky, MD, PhD, Waldman professor and system chair of dermatology at the Icahn School of Medicine at Mount Sinai in New York, told this news organization commenting on upadacitinib’s approval.
“The only oral approved drug for AD up to now was oral prednisone, which has terrible safety concerns. This is basically the first oral medication that we can provide our patients for long-term use.”
Upadacitinib
The approval of upadacitinib (Rinvoq), marketed by AbbVie, for moderate to severe AD in patients ages 12 and older, comes on the heels of findings from three pivotal phase 3 studies involving more than 2,500 adults and children 12 years of age and older with moderate to severe AD: Measure Up 1 and 2, led by Dr. Guttman-Yassky, which evaluated upadacitinib compared with placebo, and AD UP, which compared upadacitinib along with topical corticosteroids, compared with placebo.
Across the three studies, upadacitinib – both 15 mg and 30 mg once daily monotherapy – met all primary and secondary endpoints at week 16, with some patients achieving higher levels of skin clearance based on the Eczema Area and Severity Index 90 (EASI-90) and EASI-100.
“I always say that patients with AD need options,” Dr. Guttman-Yassky said. “We need biologics. We need oral medications. Not everybody likes an injectable. The plus of the class of JAK inhibitors in general is the quick onset of action.” Many patients in her clinic are maintained on upadacitinib more than two years later “and are super happy,” she said. “Many of them failed cyclosporine and other immunosuppressants such as methotrexate and prednisone.”
She predicted that health insurance companies will find coverage cost-effective “because it sets a new bar for efficacy, and because many patients have failed other treatments.”
Abrocitinib
Abrocitinib (Cibinqo), marketed by Pfizer, was approved for adults with moderate to severe AD. The approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The recommended doses are 100 mg and 200 mg, with the 200 mg dose recommended for patients who are not responding to the 100 mg dose.
The labeling of abrocitinib and upadacitinib include a boxed warning for JAK inhibitors, regarding the risk of serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Dr. Guttman-Yassky has served as a principal investigator for AbbVie and has received consulting fees from the company.
ACIP releases new dengue vaccine recommendations
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The vaccine is only to be used for children aged 9-16 who live in endemic areas and who have evidence with a specific diagnostic test of prior dengue infection.
Dengue is a mosquito-borne virus found throughout the world, primarily in tropical or subtropical climates. Cases had steadily been increasing to 5.2 million in 2019, and the geographic distribution of cases is broadening with climate change and urbanization. About half of the world’s population is now at risk.
The dengue virus has four serotypes. The first infection may be mild or asymptomatic, but the second one can be life-threatening because of a phenomenon called antibody-dependent enhancement.
The lead author of the new recommendations is Gabriela Paz-Bailey, MD, PhD, division of vector-borne diseases, dengue branch, CDC. She told this news organization that, during the second infection, when there are “low levels of antibodies from that first infection, the antibodies help the virus get inside the cells. There the virus is not killed, and that results in increased viral load, and then that can result in more severe disease and the plasma leakage” syndrome, which can lead to shock, severe bleeding, and organ failure. The death rate for severe dengue is up to 13%.
Previous infection with Zika virus, common in the same areas where dengue is endemic, can also increase the risk for symptomatic and severe dengue for subsequent infections.
In the United States, Puerto Rico is the main focus of control efforts because 95% of domestic dengue cases originate there – almost 30,000 cases between 2010 and 2020, with 11,000 cases and 4,000 hospitalizations occurring in children between the ages of 10 and 19.
Because Aedes aegypti, the primary mosquito vector transmitting dengue, is resistant to all commonly used insecticides in Puerto Rico, preventive efforts have shifted from insecticides to vaccination.
Antibody tests prevaccination
The main concern with the Sanofi’s dengue vaccine is that it could act as an asymptomatic primary dengue infection, in effect priming the body for a severe reaction from antibody-dependent enhancement with a subsequent infection. That is why it’s critical that the vaccine only be given to children with evidence of prior disease.
Dr. Paz-Bailey said: “The CDC came up with recommendations of what the performance of the test used for prevaccination screening should be. And it was 98% specificity and 75% sensitivity. ... But no test by itself was found to have a specificity of 98%, and this is why we’re recommending the two-test algorithm,” in which two different assays are run off the same blood sample, drawn at a prevaccination visit.
If the child has evidence of prior dengue, they can proceed with vaccination to protect against recurrent infection. Dengvaxia is given as a series of three shots over 6 months. Vaccine efficacy is 82% – so not everyone is protected, and additionally, that protection declines over time.
There is concern that it will be difficult to achieve compliance with such a complex regimen. Dr. Paz-Bailey said, “But I think that the trust in vaccines that is highly prevalent for [Puerto] Rico and trusting the health care system, and sort of the importance that is assigned to dengue by providers and by parents because of previous outbreaks and previous experiences is going to help us.” She added, “I think that the COVID experience has been very revealing. And what we have learned is that Puerto Rico has a very strong health care system, a very strong network of vaccine providers. ... Coverage for COVID vaccine is higher than in other parts of the U.S.”
One of the interesting things about dengue is that the first infection can range from asymptomatic to life-threatening. The second infection is generally worse because of this antibody-dependent enhancement phenomenon. Eng Eong Ooi, MD, PhD, professor of microbiology and immunology, National University of Singapore, told this news organization, “After you have two infections, you seem to be protected quite well against the remaining two [serotypes]. The vaccine serves as another episode of infection in those who had prior dengue, so then any natural infections after the vaccination in the seropositive become like the outcome of a third or fourth infection.”
Vaccination alone will not solve dengue. Dr. Ooi said, “There’s not one method that would fully control dengue. You need both vaccines as well as control measures, whether it’s Wolbachia or something else. At the same time, I think we need antiviral drugs, because hitting this virus in just one part of its life cycle wouldn’t make a huge, lasting impact.” Dr. Ooi added that as “the spread of the virus and the population immunity drops, you’re actually now more vulnerable to dengue outbreaks when they do get introduced. So, suppressing transmission alone isn’t the answer. You also have to keep herd immunity levels high. So if we can reduce the virus transmission by controlling either mosquito population or transmission and at the same time vaccinate to keep the immunity levels high, then I think we have a chance of controlling dengue.”
Dr. Paz-Bailey concluded: “I do want to emphasize that we are excited about having these tools, because for years and years, we have had really limited options to prevent and control dengue. It’s an important addition to have the vaccine be approved to be used within the U.S., and it’s going to pave the road for future vaccines.”
Dr. Paz-Bailey and Dr. Ooi reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM MMWR RECOMMENDATIONS AND REPORTS
CDC to update mask recommendations as Omicron spreads
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Children and COVID: New cases and hospital admissions skyrocket
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.
“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.
The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.
The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.
For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.
Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.
“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.
The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.
The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.
For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.
Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The total for the week of Dec. 31 to Jan. 6 – the highest since the pandemic began – was an increase of 78% over the previous week (325,000) and 192% higher than just 2 weeks before (199,000), the AAP and CHA said in their weekly COVID-19 report. No region of the country was spared, as all four saw at least 50,000 more cases than the week before, but the increase was largest in the West and smallest in the Midwest.
“Nearly 8.5 million children have tested positive for COVID-19 since the onset of the pandemic; nearly 11% of these cases have been added in the past 2 weeks,” the AAP said.
The situation is the same for hospitalizations. On Dec. 15, the daily rate of new admissions for children aged 0-17 years was 0.26 per 100,000, and by Jan. 7 it had more than quadrupled to 1.15 per 100,000, the Centers for Disease Control and Prevention reported. Before Omicron, the highest rate was 0.47 per 100,000 on Sept. 4, 2021.
The number of children occupying inpatient beds who had laboratory-confirmed COVID-19 went from 2,343 on Jan. 2 to 3,476 on Jan. 9, a jump of more than 48% in just 1 week. Texas had more hospitalized children (392) than any other state on Jan. 9, with California (339) and New York (313) the only other states over 300, according to data from the Department of Health & Human Services.
For vaccinations. however, the situation is definitely not the same. The number of children added to the ranks of those with at least one dose of COVID-19 vaccine was down in early 2022 (Jan. 3-9) for both 5- to 11-year-olds (–8.2%) and 16- to 17-year-olds (–12.2%) but higher among those aged 12-15 (12.2%), compared with the previous week (Dec. 27 to Jan. 2), the CDC said on its COVID Data Tracker.
Cumulative figures show that 26.3% of all children aged 5-11 had received at least one dose of vaccine and 17.2% were fully vaccinated as of Jan. 10, compared with 62.2% and 52.0% of 12- to 15-year-olds and 68.5% and 58.1% of those aged 16-17. Altogether, over 23.8 million children in those three age groups have received at least one dose and almost 18.6 million are fully vaccinated, the CDC said.
FDA OKs new adult insomnia med
The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.
The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.
Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.
“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.
The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
Favorable safety profile
Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.
As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.
The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.
Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.
Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.
“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020.
In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.
The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.
Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.
“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.
The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
Favorable safety profile
Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.
As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.
The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.
Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.
Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.
“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020.
In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the dual orexin receptor antagonist daridorexant (Quviviq) for the treatment of insomnia in adults, the drug’s manufacturer, Idorsia, has announced.
The FDA’s decision was based partly on a phase 3 trial of adults with moderate to severe insomnia who were randomly assigned to receive 25 or 50 mg of daridorexant or matching placebo. Daridorexant was associated with dose-dependent improvements in wake after sleep onset, total sleep time, and latency to persistent sleep.
Whereas the overall results are very positive, the improvements in daytime functioning are especially “exciting,” Thomas Roth, PhD, director of the Sleep Disorders and Research Center at Henry Ford Hospital in Detroit, said in an interview.
“That’s sort of a big deal. For me, that’s the biggest deal there is,” said Dr. Roth, who was a consultant on the design of the phase 3 trial and on the interpretation of the data.
The drug will be available in doses of 25 mg and 50 mg, and the FDA has recommended that it be classified as a controlled substance. After it is scheduled by the Drug Enforcement Administration, daridorexant is expected to be made available in May.
Favorable safety profile
Insomnia is a common disorder characterized by difficulty falling asleep or staying asleep and by early-morning awakenings. Patients with insomnia often report fatigue, irritability, and difficulty with concentration. The condition can also result in significant problems with work and social activities, thus contributing to anxiety or depression.
As with other dual orexin receptor antagonists, daridorexant competitively binds with both orexin receptors in the lateral hypothalamus to block the activity of orexin in a reversible way. This approach decreases the downstream action of the wake-promoting neurotransmitters that are overactive in patients with insomnia.
The phase 3 trial measured daytime functioning using the new Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ), a patient-reported outcome instrument. Daridorexant was associated with significant improvements in daytime function, particularly in sleepiness and mood.
Previous trials of other dual orexin receptor antagonists did not use the IDSIQ as an outcome, so it is not possible to compare daridorexant with those drugs in this respect, Dr. Roth noted. Researchers also have not conducted head-to-head trials of the drug with other dual orexin receptor antagonists.
Daridorexant also had a favorable safety profile and was not associated with rebound insomnia or withdrawal effects. The most common adverse events were headache and somnolence or fatigue.
“They had no effect on sleep stage distribution [and] they had no significant effects on sleep and breathing in people with mild to moderate sleep apnea,” said Dr. Roth, who presented the phase 3 findings at SLEEP 2020.
In addition to serving as a consultant for Idorsia on the trial design and interpretation of results, Dr. Roth has also served as a consultant for other companies that develop sleep agents.
A version of this article first appeared on Medscape.com.
CDC defends new COVID guidance as doctors raise concerns
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
, Director Rochelle Walenksy, MD, said during a White House briefing Jan. 5.
Health officials recently shortened the recommended COVID-19 isolation and quarantine period from 10 days to 5, creating confusion amid an outbreak of the highly transmissible Omicron variant, which now accounts for 95% of cases in the United States.
Then, in slightly updated guidance, the CDC recommended using an at-home antigen test after 5 days of isolation if possible, even though these tests having aren’t as sensitive to the Omicron variant, according to the FDA.
“After we released our recs early last week, it became very clear people were interested in using the rapid test, though not authorized for this purpose after the end of their isolation period,” Dr. Walensky said. “We then provided guidance on how they should be used.”
“If that test is negative, people really do need to understand they must continue to wear their mask for those 5 days,” Dr. Walensky said.
But for many, the CDC guidelines are murky and seem to always change.
“Nearly 2 years into this pandemic, with Omicron cases surging across the country, the American people should be able to count on the Centers for Disease Control and Prevention for timely, accurate, clear guidance to protect themselves, their loved ones, and their communities,” American Medical Association president Gerald Harmon, MD, said in a statement. “Instead, the new recommendations on quarantine and isolation are not only confusing, but are risking further spread of the virus.”
About 31% of people remain infectious 5 days after a positive COVID-19 test, Dr. Harmon said, quoting the CDC’s own rationale for changing its guidance.
“With hundreds of thousands of new cases daily and more than a million positive reported cases on January 3, tens of thousands – potentially hundreds of thousands of people – could return to work and school infectious if they follow the CDC’s new guidance on ending isolation after 5 days without a negative test,” he said. “Physicians are concerned that these recommendations put our patients at risk and could further overwhelm our health care system.”
Instead, Dr. Harmon said a negative test should be required for ending isolation.
“Reemerging without knowing one’s status unnecessarily risks further transmission of the virus,” he said.
Meanwhile, also during the White House briefing, officials said that early data continue to show that Omicron infections are less severe than those from other variants, but skyrocketing cases will still put a strain on the health care system.
“The big caveat is we should not be complacent,” presidential Chief Medical Adviser Anthony Fauci, MD, said a White House briefing Jan. 5.
He added that Omicron “could still stress our hospital system because a certain proportion of a large volume of cases, no matter what, are going to be severe.”
Cases continue to increase greatly. This week’s 7-day daily average of infections is 491,700 -- an increase of 98% over last week, Dr. Walensky said. Hospitalizations, while lagging behind case numbers, are still rising significantly: The daily average is 14,800 admissions, up 63% from last week. Daily deaths this week are 1,200, an increase of only 5%.
Dr. Walensky continues to encourage vaccinations, boosters, and other precautions.
“Vaccines and boosters are protecting people from the severe and tragic outcomes that can occur from COVID-19 infection,” she said. “Get vaccinated and get boosted if eligible, wear a mask, stay home when you’re sick, and take a test if you have symptoms or are looking for greater reassurance before you gather with others.”
A version of this article first appeared on WebMD.com.
Children and COVID: New cases, admissions are higher than ever
Weekly COVID-19 cases in children passed 300,000 for the first time since the pandemic started, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The rate of new COVID-related hospital admissions also reached a new high of 0.74 per 100,000 children as of Dec. 31. The highest rate seen before the current Omicron-fueled surge was 0.47 per 100,000 in early September, data from the Centers for Disease Control and Prevention show.
and exceeding the previous week’s count by almost 64%, the AAP and CHA said in their weekly COVID report.
New cases were up in all four regions of the United States, with the Northeast adding the most newly infected children while setting a new high for the fifth consecutive week. The South was just behind for the week but still well off the record it reached in September, the Midwest was third but recorded its busiest week ever, and the West was fourth and nowhere near its previous high, the AAP/CHA report indicated.
The total number of child cases since the pandemic began is almost 7.9 million, they said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. That figure represents 17.4% of all cases reported in the United States, and the cumulative rate of COVID infection is up to almost 10,500 per 100,000 children, meaning that 1 in 10 children have been infected.
Children are still less likely to be hospitalized than adults, but the gap appears to be closing. On Jan. 2 there were 2,343 children and 87,690 adults in the hospital with confirmed COVID, a ratio of 37 adults for each child, but on Sept. 5, at the height of the previous surge, the ratio of hospitalized adults (93,647) to children (1,632) was 57:1, according to data from the Department of Health & Human Services.
New admissions show a similar pattern: The 0.74 admissions per 100,000 children recorded on Dec. 31 was lower than, for example, adults aged 30-39 years (2.7 per 100,000) or 50-59 years (4.25 per 100,000), but on Sept. 5 the corresponding figures were 0.46 (children), 2.74 (ages 30-39), and 5.03 (aged 50-59), based on the HHS data.
A look at vaccinations
The vaccination response to Omicron, however, has been more subdued and somewhat inconsistent. Vaccine initiation, not surprisingly, was down among eligible children for the week of Dec. 23-29. Before that, both the 5- to 11-year-olds and 12- to 15-year-olds were down for the second week of December and then up a bit (5.6% and 14.3%, respectively) during the third week, while the 16- to 17-year-olds, increased initiation by 63.2%, CDC’s COVID Data Tracker shows.
Less than a quarter (23.5%) of children aged 5-11 received at least one dose of the vaccine in the first 2 months of their eligibility, and only 14.7% are fully vaccinated. Among the older children, coverage looks like this: at least one dose for 61.2% of 12- to 15-year-olds and 67.4% of 16- to 17-year-olds and full vaccination for 51.3% and 57.6%, respectively, the CDC said.
At the state level, Massachusetts and Hawaii have the highest rates for children aged 12-17 years, with 86% having received a least one dose, and Vermont is highest for children aged 5-11 at 56%. The lowest rates can be found in Wyoming (38%) for 12- to 17-year-olds and in Mississippi (6%) for 5- to 11-year-olds, the AAP said in a separate report.
Weekly COVID-19 cases in children passed 300,000 for the first time since the pandemic started, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The rate of new COVID-related hospital admissions also reached a new high of 0.74 per 100,000 children as of Dec. 31. The highest rate seen before the current Omicron-fueled surge was 0.47 per 100,000 in early September, data from the Centers for Disease Control and Prevention show.
and exceeding the previous week’s count by almost 64%, the AAP and CHA said in their weekly COVID report.
New cases were up in all four regions of the United States, with the Northeast adding the most newly infected children while setting a new high for the fifth consecutive week. The South was just behind for the week but still well off the record it reached in September, the Midwest was third but recorded its busiest week ever, and the West was fourth and nowhere near its previous high, the AAP/CHA report indicated.
The total number of child cases since the pandemic began is almost 7.9 million, they said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. That figure represents 17.4% of all cases reported in the United States, and the cumulative rate of COVID infection is up to almost 10,500 per 100,000 children, meaning that 1 in 10 children have been infected.
Children are still less likely to be hospitalized than adults, but the gap appears to be closing. On Jan. 2 there were 2,343 children and 87,690 adults in the hospital with confirmed COVID, a ratio of 37 adults for each child, but on Sept. 5, at the height of the previous surge, the ratio of hospitalized adults (93,647) to children (1,632) was 57:1, according to data from the Department of Health & Human Services.
New admissions show a similar pattern: The 0.74 admissions per 100,000 children recorded on Dec. 31 was lower than, for example, adults aged 30-39 years (2.7 per 100,000) or 50-59 years (4.25 per 100,000), but on Sept. 5 the corresponding figures were 0.46 (children), 2.74 (ages 30-39), and 5.03 (aged 50-59), based on the HHS data.
A look at vaccinations
The vaccination response to Omicron, however, has been more subdued and somewhat inconsistent. Vaccine initiation, not surprisingly, was down among eligible children for the week of Dec. 23-29. Before that, both the 5- to 11-year-olds and 12- to 15-year-olds were down for the second week of December and then up a bit (5.6% and 14.3%, respectively) during the third week, while the 16- to 17-year-olds, increased initiation by 63.2%, CDC’s COVID Data Tracker shows.
Less than a quarter (23.5%) of children aged 5-11 received at least one dose of the vaccine in the first 2 months of their eligibility, and only 14.7% are fully vaccinated. Among the older children, coverage looks like this: at least one dose for 61.2% of 12- to 15-year-olds and 67.4% of 16- to 17-year-olds and full vaccination for 51.3% and 57.6%, respectively, the CDC said.
At the state level, Massachusetts and Hawaii have the highest rates for children aged 12-17 years, with 86% having received a least one dose, and Vermont is highest for children aged 5-11 at 56%. The lowest rates can be found in Wyoming (38%) for 12- to 17-year-olds and in Mississippi (6%) for 5- to 11-year-olds, the AAP said in a separate report.
Weekly COVID-19 cases in children passed 300,000 for the first time since the pandemic started, according to the American Academy of Pediatrics and the Children’s Hospital Association.
The rate of new COVID-related hospital admissions also reached a new high of 0.74 per 100,000 children as of Dec. 31. The highest rate seen before the current Omicron-fueled surge was 0.47 per 100,000 in early September, data from the Centers for Disease Control and Prevention show.
and exceeding the previous week’s count by almost 64%, the AAP and CHA said in their weekly COVID report.
New cases were up in all four regions of the United States, with the Northeast adding the most newly infected children while setting a new high for the fifth consecutive week. The South was just behind for the week but still well off the record it reached in September, the Midwest was third but recorded its busiest week ever, and the West was fourth and nowhere near its previous high, the AAP/CHA report indicated.
The total number of child cases since the pandemic began is almost 7.9 million, they said based on data collected from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. That figure represents 17.4% of all cases reported in the United States, and the cumulative rate of COVID infection is up to almost 10,500 per 100,000 children, meaning that 1 in 10 children have been infected.
Children are still less likely to be hospitalized than adults, but the gap appears to be closing. On Jan. 2 there were 2,343 children and 87,690 adults in the hospital with confirmed COVID, a ratio of 37 adults for each child, but on Sept. 5, at the height of the previous surge, the ratio of hospitalized adults (93,647) to children (1,632) was 57:1, according to data from the Department of Health & Human Services.
New admissions show a similar pattern: The 0.74 admissions per 100,000 children recorded on Dec. 31 was lower than, for example, adults aged 30-39 years (2.7 per 100,000) or 50-59 years (4.25 per 100,000), but on Sept. 5 the corresponding figures were 0.46 (children), 2.74 (ages 30-39), and 5.03 (aged 50-59), based on the HHS data.
A look at vaccinations
The vaccination response to Omicron, however, has been more subdued and somewhat inconsistent. Vaccine initiation, not surprisingly, was down among eligible children for the week of Dec. 23-29. Before that, both the 5- to 11-year-olds and 12- to 15-year-olds were down for the second week of December and then up a bit (5.6% and 14.3%, respectively) during the third week, while the 16- to 17-year-olds, increased initiation by 63.2%, CDC’s COVID Data Tracker shows.
Less than a quarter (23.5%) of children aged 5-11 received at least one dose of the vaccine in the first 2 months of their eligibility, and only 14.7% are fully vaccinated. Among the older children, coverage looks like this: at least one dose for 61.2% of 12- to 15-year-olds and 67.4% of 16- to 17-year-olds and full vaccination for 51.3% and 57.6%, respectively, the CDC said.
At the state level, Massachusetts and Hawaii have the highest rates for children aged 12-17 years, with 86% having received a least one dose, and Vermont is highest for children aged 5-11 at 56%. The lowest rates can be found in Wyoming (38%) for 12- to 17-year-olds and in Mississippi (6%) for 5- to 11-year-olds, the AAP said in a separate report.
COVID-19–positive or exposed? What to do next
With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?
New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.
This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
If you have tested positive for COVID-19, what do you do next?
“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)
Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.
Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5 days.
Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.
According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
If you have been exposed to someone with COVID-19, what do you do next?
“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.
For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.
On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.
But if someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
When should the person who has been exposed get tested?
After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”
Testing should be done by those exposed at least once, Dr. Adalja said.
“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
At what point can the infected person mingle safely with others?
“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”
A version of this article first appeared on WebMD.com.
With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?
New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.
This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
If you have tested positive for COVID-19, what do you do next?
“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)
Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.
Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5 days.
Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.
According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
If you have been exposed to someone with COVID-19, what do you do next?
“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.
For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.
On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.
But if someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
When should the person who has been exposed get tested?
After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”
Testing should be done by those exposed at least once, Dr. Adalja said.
“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
At what point can the infected person mingle safely with others?
“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”
A version of this article first appeared on WebMD.com.
With new cases of COVID-19 skyrocketing to more than 240,000 a day recently in the U.S., many people are facing the same situation: A family member or friend tests positive or was exposed to someone who did, and the holiday gathering, visit, or return to work is just days or hours away. Now what?
New guidance issued Dec. 27 by the Centers for Disease Control and Prevention shortens the recommended isolation and quarantine period for the general population, coming after the agency shortened the isolation period for health care workers.
This news organization reached out to two infectious disease specialists to get answers to questions that are frequently asked in these situations.
If you have tested positive for COVID-19, what do you do next?
“If you have tested positive, you are infected. At the moment, you are [either] symptomatically affected or presymptomatically infected,’’ said Paul A. Offit, MD, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia. At that point, you need to isolate for 5 days, according to the new CDC guidance. (That period has been shortened from 10 days.)
Isolation means separating the infected person from others. Quarantine refers to things you should do if you’re exposed to the virus or you have a close contact infected with COVID-19.
Under the new CDC guidelines, after the 5-day isolation, if the infected person then has no symptoms, he or she can leave isolation and then wear a mask for 5 days.
Those who test positive also need to tell their close contacts they are positive, said Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security.
According to the CDC, the change to a shortened quarantine time is motivated by science ‘’demonstrating that the majority of SARS-CoV-2 transmission occurs early in the course of the illness, generally in the 1-2 days prior to onset of symptoms and the 2-3 days after.”
If you have been exposed to someone with COVID-19, what do you do next?
“If they are vaccinated and boosted, the guidance says there is no need to quarantine,” Dr. Adalja said. But the CDC guidance does recommend these people wear a well-fitting mask at all times when around others for 10 days after exposure.
For everyone else, including the unvaccinated and those who are more than 6 months out from their second Pfizer or Moderna vaccine dose, or more than 2 months from their J&J dose, the CDC recommends a quarantine for 5 days – and wearing a mask for the 5 days after that.
On a practical level, Dr. Adalja said he thinks those who are vaccinated but not boosted could also skip the quarantine and wear a mask for 10 days. Dr. Offit agrees. Because many people exposed have trouble quarantining, Dr. Offit advises those exposed who can’t follow that guidance to be sure to wear a mask for 10 days when indoors. The CDC guidance also offers that as another strategy – that if a 5-day quarantine is not feasible, the exposed person should wear a mask for 10 days when around others.
But if someone who was exposed gets symptoms, that person then enters the infected category and follows that guidance, Dr. Offit said.
When should the person who has been exposed get tested?
After the exposure, ‘’you should probably wait 2-3 days,” Dr. Offit said. “The virus has to reproduce itself.”
Testing should be done by those exposed at least once, Dr. Adalja said.
“But there’s data to support daily testing to guide their activities, but this is not CDC guidance. Home tests are sufficient for this purpose.”
At what point can the infected person mingle safely with others?
“Technically, if asymptomatic, 10 days without a mask, 5 days with a mask,” said Dr. Adalja. “I think this could also be guided with home test negativity being a gauge [as to whether to mingle].”
A version of this article first appeared on WebMD.com.
COVID-19 antigen tests may be less sensitive to Omicron: FDA
Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.
Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.
The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.
The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.
Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.
“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
Testing still important
The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.
They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.
The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.
An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.
The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.
The agency said that it will provide updated information and any needed recommendations when appropriate.
A version of this article first appeared on Medscape.com.
Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.
Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.
The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.
The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.
Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.
“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
Testing still important
The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.
They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.
The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.
An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.
The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.
The agency said that it will provide updated information and any needed recommendations when appropriate.
A version of this article first appeared on Medscape.com.
Rapid antigen tests for COVID-19 might be less effective at detecting the Omicron variant that is spreading rapidly across the United States, according to the Food and Drug Administration.
Early data suggest that COVID-19 antigen tests “do detect the Omicron variant but may have reduced sensitivity,” the FDA said in a statement posted Dec. 28 on its website.
The FDA is working with the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) initiative to assess the performance of antigen tests with patient samples that have the Omicron variant.
The potential for antigen tests to be less sensitive for the Omicron variant emerged in tests using patient samples containing live virus, “which represents the best way to evaluate true test performance in the short term,” the FDA said.
Initial laboratory tests using heat-activated (killed) virus samples found that antigen tests were able to detect the Omicron variant.
“It is important to note that these laboratory data are not a replacement for clinical study evaluations using patient samples with live virus, which are ongoing. The FDA and RADx are continuing to further evaluate the performance of antigen tests using patient samples with live virus,” the FDA said.
Testing still important
The agency continues to recommend use of antigen tests as directed in the authorized labeling and in accordance with the instructions included with the tests.
They note that antigen tests are generally less sensitive and less likely to pick up very early infections, compared with molecular tests.
The FDA continues to recommend that an individual with a negative antigen test who has symptoms or a high likelihood of infection because of exposure follow-up with a molecular test to determine if they have COVID-19.
An individual with a positive antigen test should self-isolate and seek follow-up care with a health care provider to determine the next steps.
The FDA, with partners and test developers, are continuing to evaluate test sensitivity, as well as the best timing and frequency of antigen testing.
The agency said that it will provide updated information and any needed recommendations when appropriate.
A version of this article first appeared on Medscape.com.
Children and COVID: Nearly 200,000 new cases reported in 1 week
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Available state data show that 198,551 child COVID cases were added during the week of Dec. 17-23 – up by 16.8% from the nearly 170,000 new cases reported the previous week and the highest 7-day figure since Sept. 17-23, when 207,000 cases were reported, the AAP and the CHA said in their weekly COVID report. Since Oct. 22-28, when the weekly count dropped to a seasonal low, the weekly count has nearly doubled.
The largest shares of the nearly 199,000 new cases were divided pretty equally between the Northeast and the South, while the West had just a small bump in cases and the Midwest was in the middle. The largest statewide percent increases came in the New England states, along with New Jersey, the District of Columbia, and Puerto Rico. New York State does not report age ranges for COVID cases, the AAP/CHA report noted.
Emergency department visits and hospital admissions are following a similar trend, as both have risen considerably over the last 2 months, data from the Centers for Disease Control and Prevention show.
COVID-related ED visits for children aged 0-11 years – measured as a proportion of all ED visits – are nearing the pandemic high of 4.1% set in late August, while visits in 12- to 15-year-olds have risen from 1.4% in early November to 5.6% on Dec. 24 and 16- to 17-year-olds have gone from 1.5% to 6% over the same period of time, the CDC reported on its COVID Data Tracker.
As for hospital admissions in children aged 0-17 years, the rate was down to 0.19 per 100,000 population on Nov. 11 but had risen to 0.38 per 100,000 as of Dec. 24. The highest point reached in children during the pandemic was 0.46 per 100,000 in early September, the CDC said.
On Dec. 23, 367 children were admitted to hospitals in the United States, the highest number since Sept. 7, when 374 were hospitalized. The highest 1-day total over the course of the pandemic, 394, came just a week before that, Aug. 31, according to the Department of Health & Human Services.
A look at the most recent HHS data shows that 1,161 children were being hospitalized in pediatric inpatient beds with confirmed COVID-19 on Dec. 26. The highest number by state was in New York (136), followed by Texas (90) and Illinois and Ohio, both with 83. There were four states – Alaska, New Hampshire, Utah, and Wyoming – with no hospitalized children, the HHS said. Puerto Rico, meanwhile, had 28 children in the hospital with COVID, more than 38 states.
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Available state data show that 198,551 child COVID cases were added during the week of Dec. 17-23 – up by 16.8% from the nearly 170,000 new cases reported the previous week and the highest 7-day figure since Sept. 17-23, when 207,000 cases were reported, the AAP and the CHA said in their weekly COVID report. Since Oct. 22-28, when the weekly count dropped to a seasonal low, the weekly count has nearly doubled.
The largest shares of the nearly 199,000 new cases were divided pretty equally between the Northeast and the South, while the West had just a small bump in cases and the Midwest was in the middle. The largest statewide percent increases came in the New England states, along with New Jersey, the District of Columbia, and Puerto Rico. New York State does not report age ranges for COVID cases, the AAP/CHA report noted.
Emergency department visits and hospital admissions are following a similar trend, as both have risen considerably over the last 2 months, data from the Centers for Disease Control and Prevention show.
COVID-related ED visits for children aged 0-11 years – measured as a proportion of all ED visits – are nearing the pandemic high of 4.1% set in late August, while visits in 12- to 15-year-olds have risen from 1.4% in early November to 5.6% on Dec. 24 and 16- to 17-year-olds have gone from 1.5% to 6% over the same period of time, the CDC reported on its COVID Data Tracker.
As for hospital admissions in children aged 0-17 years, the rate was down to 0.19 per 100,000 population on Nov. 11 but had risen to 0.38 per 100,000 as of Dec. 24. The highest point reached in children during the pandemic was 0.46 per 100,000 in early September, the CDC said.
On Dec. 23, 367 children were admitted to hospitals in the United States, the highest number since Sept. 7, when 374 were hospitalized. The highest 1-day total over the course of the pandemic, 394, came just a week before that, Aug. 31, according to the Department of Health & Human Services.
A look at the most recent HHS data shows that 1,161 children were being hospitalized in pediatric inpatient beds with confirmed COVID-19 on Dec. 26. The highest number by state was in New York (136), followed by Texas (90) and Illinois and Ohio, both with 83. There were four states – Alaska, New Hampshire, Utah, and Wyoming – with no hospitalized children, the HHS said. Puerto Rico, meanwhile, had 28 children in the hospital with COVID, more than 38 states.
, according to the American Academy of Pediatrics and the Children’s Hospital Association.
Available state data show that 198,551 child COVID cases were added during the week of Dec. 17-23 – up by 16.8% from the nearly 170,000 new cases reported the previous week and the highest 7-day figure since Sept. 17-23, when 207,000 cases were reported, the AAP and the CHA said in their weekly COVID report. Since Oct. 22-28, when the weekly count dropped to a seasonal low, the weekly count has nearly doubled.
The largest shares of the nearly 199,000 new cases were divided pretty equally between the Northeast and the South, while the West had just a small bump in cases and the Midwest was in the middle. The largest statewide percent increases came in the New England states, along with New Jersey, the District of Columbia, and Puerto Rico. New York State does not report age ranges for COVID cases, the AAP/CHA report noted.
Emergency department visits and hospital admissions are following a similar trend, as both have risen considerably over the last 2 months, data from the Centers for Disease Control and Prevention show.
COVID-related ED visits for children aged 0-11 years – measured as a proportion of all ED visits – are nearing the pandemic high of 4.1% set in late August, while visits in 12- to 15-year-olds have risen from 1.4% in early November to 5.6% on Dec. 24 and 16- to 17-year-olds have gone from 1.5% to 6% over the same period of time, the CDC reported on its COVID Data Tracker.
As for hospital admissions in children aged 0-17 years, the rate was down to 0.19 per 100,000 population on Nov. 11 but had risen to 0.38 per 100,000 as of Dec. 24. The highest point reached in children during the pandemic was 0.46 per 100,000 in early September, the CDC said.
On Dec. 23, 367 children were admitted to hospitals in the United States, the highest number since Sept. 7, when 374 were hospitalized. The highest 1-day total over the course of the pandemic, 394, came just a week before that, Aug. 31, according to the Department of Health & Human Services.
A look at the most recent HHS data shows that 1,161 children were being hospitalized in pediatric inpatient beds with confirmed COVID-19 on Dec. 26. The highest number by state was in New York (136), followed by Texas (90) and Illinois and Ohio, both with 83. There were four states – Alaska, New Hampshire, Utah, and Wyoming – with no hospitalized children, the HHS said. Puerto Rico, meanwhile, had 28 children in the hospital with COVID, more than 38 states.