Covid ICYMI

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Earlier this year, hospitals in India were dealing not only with the coronavirus pandemic but also with a surge in a potentially lethal fungal infection in patients previously treated for COVID-19. Mucormycosis, also known as black fungus, is typically a rare infection, but India had recorded more than 45,000 cases as of July 2021.

Now, a recent report suggests that patients with COVID-19–associated rhino-orbital cerebral mucormycosis (CAM) may have a higher mortality rate than previously estimated. At highest risk, CAM patients with severe COVID-19 or orbital disease are more likely to die within 10 days of admission. The study was published Dec. 9 in JAMA Ophthalmology.

“The mortality indicators we observed, such as assisted ventilation and presence of severe orbital manifestations, can help physicians triage patients for emergency procedures, such as functional endoscopic sinus surgery (FESS), and administer systemic antifungal agents when in short supply,” the study authors wrote.

Mucormycosis usually infects immunocompromised patients. Previous research has found that poorly controlled diabetes – an epidemic in India – and use of high-dose systemic corticosteroids are two main risk factors for developing CAM. Even before COVID-19, India had a high incidence of mucormycosis compared to other countries, but cases exist around the world. In fact, on Dec. 17, the Centers for Disease Control and Prevention reported 10 isolated cases of COVID-19–associated mucormycosis identified in Arkansas hospitals between July and September 2021.

The disease can cause blurred vision, black lesions on the nose or inside of the mouth, and facial swelling. In rhino-orbital cerebral mucormycosis, extensive infection can necessitate orbital exenteration surgery, a disfiguring procedure that typically involves removal of the entire contents of the bony eye socket, as well as removal of the sinuses. Estimates for the mortality rate for this disease range from 14% to nearly 80%.

To better understand the cumulative morality rates for CAM and to identify additional risk factors, researchers reviewed the medical records of patients diagnosed and treated for CAM at a tertiary care multispecialty government hospital in Maharashtra, a state in the west-central region of India. The analysis included patients who died after admission or who had at minimum 30 days of documented follow-up. All diagnoses occurred between March 1 and May 30, 2021. All patients underwent comprehensive ophthalmic exams and routine blood workups.

Seventy-three patients were included in the study, with the average age of 53.5 years; 66% of the patients were male, and 74% of all patients had diabetes. Of the 47 individuals with available COVID-19 vaccination information, 89% had not had either shot of the vaccine, and 11% had the first dose. No patients in the cohort had received both doses of the vaccine; 87% of the patients were previously hospitalized for COVID-19, with 43 needing supplemental oxygen, 14 receiving noninvasive ventilation and ventilator support (NIV), and three requiring mechanical ventilation.

Patients developed CAM a median of 28 days after being discharged from the hospital for COVID-19 treatment; 26 patients died, 18 patients underwent FESS, and five underwent orbital exenteration. While 36% of patients died overall, the researchers found the cumulative probability of death from CAM rose from 26% at day 7 to 53% at day 21. They also found that the patients who died had more severe COVID-19, indicated by more days spent on supplemental oxygen (P = .003) and increased need for NIV or mechanical ventilation (P = .02) compared to patients who survived CAM. Those who died also had poorer visual acuity, with 35% of the group having no light perception during examination compared to 6% of surviving CAM patients (P = .02).

These findings are largely “confirmatory to what we previously knew, which is that [CAM] is a very bad disease with high morbidity and high mortality,” Ilan Schwartz, MD, PHD, an infectious disease physician at the University of Alberta, Edmonton, who researches emerging fungal infections, said in an interview. He was not involved with the research.

While larger studies looking at similar questions have been published, the new report has longer patient follow-up and is “better positioned to be able to estimate the mortality rate,” Dr. Schwartz noted. Even with 30 days of follow-up, “patients can have ongoing problems for many months, and so it’s possible that the true mortality rate is even higher, once you get beyond that period,” he added.

But Santosh G. Honavar, MD, the director of medical services at the Centre for Sight Eye Hospital in Hyderabad, India, also unaffiliated with the study, noted that the subset of patients included in the latest report may have had much more severe infection – and subsequently higher mortality rates – than a more generalized study in a broader patient population.

For example, a study by Mrittika Sen, PhD, Dr. Honavar, and their coauthors, published in the Indian Journal of Ophthalmology earlier this year, found a mortality rate of 14% when they examined the records of more than 2,800 patients across 102 treatment centers.

Taking that into account, “we believe that the actual mortality may be somewhere between the 14% reported by Sen et al. from the large Indian series and the 53% that we report at 3 weeks,” the JAMA Ophthalmology authors wrote.

Dr. Honavar also noted that the new report of severe infection outcomes identifies subgroups at higher risk of death due to CAM: those with severe COVID-19 infection or orbital disease. These groups “would need higher surveillance for mucormycosis, thus enabling early diagnosis and prompt initiation of amphotericin B upon diagnosis of mucormycosis,” he said in an interview. “These measures can possibly minimize the risk of death.”

Ongoing research on CAM cases will continue to inform knowledge and treatment of the disease, but there are still unanswered questions. “We still have a fairly unsatisfactory understanding of exactly why this [CAM] epidemic occurred and why it was so bad,” Dr. Schwartz noted. And while mucormycosis cases have seemed to drop off since the surge earlier this year, “I don’t think we’re out of the woods,” he added. “There’s a lot more awareness in India and around the world about this disease now, but we’re still quite vulnerable to seeing it again.”

Dr. Honavar is the editor-in-chief of the Indian Journal of Ophthalmology. Dr. Schwartz reports no relevant financial relationships.

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

Around the world, people with HIV show variations in COVID-19 vaccination rates similar to those seen in the general population, raising concerns because of their increased risk for morbidity and mortality from COVID-19 infection.

“To our knowledge, this analysis presents the first and largest investigation of vaccination rates among people with HIV,” reported the authors in research published in the Journal of Infectious Diseases.

The findings reflect data on nearly 7,000 people with HIV participating in the REPRIEVE clinical trial. As of July, COVID-19 vaccination rates ranged from a high of 71% in higher income regions to just 18% in sub-Saharan Africa and bottomed out at 0% in Haiti.

“This disparity in COVID-19 vaccination rates among people with HIV across income regions may increase morbidity from COVID-19 in the most vulnerable HIV populations,” the authors noted.

In general, people with HIV have been shown in recent research to have as much as 29% higher odds of morality from COVID-19 than the general population, and a 20% higher odds of hospitalization, hence their need for vaccination is especially pressing.

To understand the vaccination rates, the authors looked at data from the ongoing REPRIEVE trial, designed to investigate primary cardiovascular prevention worldwide among people with HIV. The trial includes data on COVID-19 vaccination status, providing a unique opportunity to capture those rates.

The study specifically included 6,952 people with HIV aged 40-75 years and on stable antiretroviral therapy (ART), without known cardiovascular disease, and a low to moderate atherosclerotic cardiovascular disease (ASCVD) risk.

The diverse participants with HIV were from 12 countries, including 66% who were people of color, as well as 32% women. Countries represented include Brazil (n = 1,042), Botswana (n = 273), Canada (n = 123), Haiti (n = 136), India (n = 469), Peru (n = 142), South Africa (n = 527), Spain (n = 198), Thailand (n = 582), Uganda (n = 175), United States (n = 3,162), and Zimbabwe (n = 123).

With vaccination defined as having received at least one vaccine shot, the overall cumulative COVID-19 vaccination rate in the study was 55% through July 2021.

By region, the highest cumulative rates were in the high-income countries of the United States and Canada (71%), followed by Latin America and the Caribbean (59%) – all consistent with the general population in these areas

Lower cumulative vaccination rates were observed in South Asia (49%), Southeast/East Asia (41%), and sub-Saharan Africa (18%), also reflecting the regional vaccination rates.

The United States had the highest country-specific COVID-19 vaccination rate of 72%, followed by Peru (69%) and Brazil (63%). Countries with the lowest vaccination rates were South Africa (18%), Uganda (3%), and Haiti (0%).

Of note, South Africa and Botswana have the largest share of deaths from HIV/AIDS, and both had very low COVID-19 vaccination rates in general, compared with high-income countries.

Overall, factors linked to the likelihood of being vaccinated included residing in the high-income U.S./Canada Global Burden of Disease superregion, as well as being White, male, older, having a higher body mass index (BMI), a higher ASCVD risk score, and longer duration of ART.

Participants’ decisions regarding COVID-19 vaccination in the study were made individually and were not based on any study-related recommendations or requirements, the authors noted.

Vaccination rates were higher among men than women in most regions, with the exception of sub-Saharan Africa. Vaccination rates were higher among Whites than Blacks in the U.S./Canada high-income region, with a high proportion of participants from the United States.

“It was surprising to us – and unfortunate – that in the high-income superregion vaccination rates were higher among individuals who identified as White than those who identified as Black and among men,” senior author Steven K. Grinspoon, MD, said in an interview.

“Given data for higher morbidity from COVID-19 among people of color with HIV, this disparity is likely to have significant public health implications,” said Dr. Grinspoon, a professor of medicine at Harvard Medical School and chief of the metabolism unit at Massachusetts General Hospital, both in Boston.

Newer data from the REPRIEVE study through October has shown continued steady increases in the cumulative vaccination rates in all regions, Dr. Grinspoon noted, with the largest increases in the Southeast/East Asia, South Asia, and sub-Saharan Africa, whereas a leveling off of rates was observed in the high-income regions.

Overall, “it is encouraging that rates among people with HIV are similar to and, in many regions, higher than the general population,” Dr. Grinspoon said.

However, with the data showing a higher risk for COVID-19 death in people with HIV, “it is critical that people with HIV, representing a vulnerable and immunocompromised population, be vaccinated for COVID-19,” Dr. Grinspoon said.

Commenting on the study, Monica Gandhi, MD, MPH, director of the Gladstone Center for AIDS Research at the University of California, San Francisco, agreed that “it is encouraging that these rates are as high as the general population, showing that there is not excess hesitancy among those living with HIV.”

Unlike other immunocompromised groups, people with HIV were not necessarily prioritized for vaccination, since antiretroviral therapy can reconstitute the immune system, “so I am not surprised the [vaccination] rates aren’t higher,” Dr. Gandhi, who was not involved with the study, said in an interview.

Nevertheless, “it is important that those with risk factors for more severe disease, such as higher BMI and higher cardiovascular disease, are prioritized for COVID-19 vaccination, [as] these are important groups in which to increase rates,” she said.

“The take-home message is that we have to increase our rates of vaccination in this critically important population,” Dr. Gandhi emphasized. “Global vaccine equity is paramount given that the burden of HIV infections remains in sub-Saharan Africa.”

The study received support from the National Institutes of Health and funding from Kowa Pharmaceuticals and Gilead Sciences. The authors and Dr. Gandhi disclosed no relevant financial relationships.

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

Around the world, people with HIV show variations in COVID-19 vaccination rates similar to those seen in the general population, raising concerns because of their increased risk for morbidity and mortality from COVID-19 infection.

“To our knowledge, this analysis presents the first and largest investigation of vaccination rates among people with HIV,” reported the authors in research published in the Journal of Infectious Diseases.

The findings reflect data on nearly 7,000 people with HIV participating in the REPRIEVE clinical trial. As of July, COVID-19 vaccination rates ranged from a high of 71% in higher income regions to just 18% in sub-Saharan Africa and bottomed out at 0% in Haiti.

“This disparity in COVID-19 vaccination rates among people with HIV across income regions may increase morbidity from COVID-19 in the most vulnerable HIV populations,” the authors noted.

In general, people with HIV have been shown in recent research to have as much as 29% higher odds of morality from COVID-19 than the general population, and a 20% higher odds of hospitalization, hence their need for vaccination is especially pressing.

To understand the vaccination rates, the authors looked at data from the ongoing REPRIEVE trial, designed to investigate primary cardiovascular prevention worldwide among people with HIV. The trial includes data on COVID-19 vaccination status, providing a unique opportunity to capture those rates.

The study specifically included 6,952 people with HIV aged 40-75 years and on stable antiretroviral therapy (ART), without known cardiovascular disease, and a low to moderate atherosclerotic cardiovascular disease (ASCVD) risk.

The diverse participants with HIV were from 12 countries, including 66% who were people of color, as well as 32% women. Countries represented include Brazil (n = 1,042), Botswana (n = 273), Canada (n = 123), Haiti (n = 136), India (n = 469), Peru (n = 142), South Africa (n = 527), Spain (n = 198), Thailand (n = 582), Uganda (n = 175), United States (n = 3,162), and Zimbabwe (n = 123).

With vaccination defined as having received at least one vaccine shot, the overall cumulative COVID-19 vaccination rate in the study was 55% through July 2021.

By region, the highest cumulative rates were in the high-income countries of the United States and Canada (71%), followed by Latin America and the Caribbean (59%) – all consistent with the general population in these areas

Lower cumulative vaccination rates were observed in South Asia (49%), Southeast/East Asia (41%), and sub-Saharan Africa (18%), also reflecting the regional vaccination rates.

The United States had the highest country-specific COVID-19 vaccination rate of 72%, followed by Peru (69%) and Brazil (63%). Countries with the lowest vaccination rates were South Africa (18%), Uganda (3%), and Haiti (0%).

Of note, South Africa and Botswana have the largest share of deaths from HIV/AIDS, and both had very low COVID-19 vaccination rates in general, compared with high-income countries.

Overall, factors linked to the likelihood of being vaccinated included residing in the high-income U.S./Canada Global Burden of Disease superregion, as well as being White, male, older, having a higher body mass index (BMI), a higher ASCVD risk score, and longer duration of ART.

Participants’ decisions regarding COVID-19 vaccination in the study were made individually and were not based on any study-related recommendations or requirements, the authors noted.

Vaccination rates were higher among men than women in most regions, with the exception of sub-Saharan Africa. Vaccination rates were higher among Whites than Blacks in the U.S./Canada high-income region, with a high proportion of participants from the United States.

“It was surprising to us – and unfortunate – that in the high-income superregion vaccination rates were higher among individuals who identified as White than those who identified as Black and among men,” senior author Steven K. Grinspoon, MD, said in an interview.

“Given data for higher morbidity from COVID-19 among people of color with HIV, this disparity is likely to have significant public health implications,” said Dr. Grinspoon, a professor of medicine at Harvard Medical School and chief of the metabolism unit at Massachusetts General Hospital, both in Boston.

Newer data from the REPRIEVE study through October has shown continued steady increases in the cumulative vaccination rates in all regions, Dr. Grinspoon noted, with the largest increases in the Southeast/East Asia, South Asia, and sub-Saharan Africa, whereas a leveling off of rates was observed in the high-income regions.

Overall, “it is encouraging that rates among people with HIV are similar to and, in many regions, higher than the general population,” Dr. Grinspoon said.

However, with the data showing a higher risk for COVID-19 death in people with HIV, “it is critical that people with HIV, representing a vulnerable and immunocompromised population, be vaccinated for COVID-19,” Dr. Grinspoon said.

Commenting on the study, Monica Gandhi, MD, MPH, director of the Gladstone Center for AIDS Research at the University of California, San Francisco, agreed that “it is encouraging that these rates are as high as the general population, showing that there is not excess hesitancy among those living with HIV.”

Unlike other immunocompromised groups, people with HIV were not necessarily prioritized for vaccination, since antiretroviral therapy can reconstitute the immune system, “so I am not surprised the [vaccination] rates aren’t higher,” Dr. Gandhi, who was not involved with the study, said in an interview.

Nevertheless, “it is important that those with risk factors for more severe disease, such as higher BMI and higher cardiovascular disease, are prioritized for COVID-19 vaccination, [as] these are important groups in which to increase rates,” she said.

“The take-home message is that we have to increase our rates of vaccination in this critically important population,” Dr. Gandhi emphasized. “Global vaccine equity is paramount given that the burden of HIV infections remains in sub-Saharan Africa.”

The study received support from the National Institutes of Health and funding from Kowa Pharmaceuticals and Gilead Sciences. The authors and Dr. Gandhi disclosed no relevant financial relationships.

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

Around the world, people with HIV show variations in COVID-19 vaccination rates similar to those seen in the general population, raising concerns because of their increased risk for morbidity and mortality from COVID-19 infection.

“To our knowledge, this analysis presents the first and largest investigation of vaccination rates among people with HIV,” reported the authors in research published in the Journal of Infectious Diseases.

The findings reflect data on nearly 7,000 people with HIV participating in the REPRIEVE clinical trial. As of July, COVID-19 vaccination rates ranged from a high of 71% in higher income regions to just 18% in sub-Saharan Africa and bottomed out at 0% in Haiti.

“This disparity in COVID-19 vaccination rates among people with HIV across income regions may increase morbidity from COVID-19 in the most vulnerable HIV populations,” the authors noted.

In general, people with HIV have been shown in recent research to have as much as 29% higher odds of morality from COVID-19 than the general population, and a 20% higher odds of hospitalization, hence their need for vaccination is especially pressing.

To understand the vaccination rates, the authors looked at data from the ongoing REPRIEVE trial, designed to investigate primary cardiovascular prevention worldwide among people with HIV. The trial includes data on COVID-19 vaccination status, providing a unique opportunity to capture those rates.

The study specifically included 6,952 people with HIV aged 40-75 years and on stable antiretroviral therapy (ART), without known cardiovascular disease, and a low to moderate atherosclerotic cardiovascular disease (ASCVD) risk.

The diverse participants with HIV were from 12 countries, including 66% who were people of color, as well as 32% women. Countries represented include Brazil (n = 1,042), Botswana (n = 273), Canada (n = 123), Haiti (n = 136), India (n = 469), Peru (n = 142), South Africa (n = 527), Spain (n = 198), Thailand (n = 582), Uganda (n = 175), United States (n = 3,162), and Zimbabwe (n = 123).

With vaccination defined as having received at least one vaccine shot, the overall cumulative COVID-19 vaccination rate in the study was 55% through July 2021.

By region, the highest cumulative rates were in the high-income countries of the United States and Canada (71%), followed by Latin America and the Caribbean (59%) – all consistent with the general population in these areas

Lower cumulative vaccination rates were observed in South Asia (49%), Southeast/East Asia (41%), and sub-Saharan Africa (18%), also reflecting the regional vaccination rates.

The United States had the highest country-specific COVID-19 vaccination rate of 72%, followed by Peru (69%) and Brazil (63%). Countries with the lowest vaccination rates were South Africa (18%), Uganda (3%), and Haiti (0%).

Of note, South Africa and Botswana have the largest share of deaths from HIV/AIDS, and both had very low COVID-19 vaccination rates in general, compared with high-income countries.

Overall, factors linked to the likelihood of being vaccinated included residing in the high-income U.S./Canada Global Burden of Disease superregion, as well as being White, male, older, having a higher body mass index (BMI), a higher ASCVD risk score, and longer duration of ART.

Participants’ decisions regarding COVID-19 vaccination in the study were made individually and were not based on any study-related recommendations or requirements, the authors noted.

Vaccination rates were higher among men than women in most regions, with the exception of sub-Saharan Africa. Vaccination rates were higher among Whites than Blacks in the U.S./Canada high-income region, with a high proportion of participants from the United States.

“It was surprising to us – and unfortunate – that in the high-income superregion vaccination rates were higher among individuals who identified as White than those who identified as Black and among men,” senior author Steven K. Grinspoon, MD, said in an interview.

“Given data for higher morbidity from COVID-19 among people of color with HIV, this disparity is likely to have significant public health implications,” said Dr. Grinspoon, a professor of medicine at Harvard Medical School and chief of the metabolism unit at Massachusetts General Hospital, both in Boston.

Newer data from the REPRIEVE study through October has shown continued steady increases in the cumulative vaccination rates in all regions, Dr. Grinspoon noted, with the largest increases in the Southeast/East Asia, South Asia, and sub-Saharan Africa, whereas a leveling off of rates was observed in the high-income regions.

Overall, “it is encouraging that rates among people with HIV are similar to and, in many regions, higher than the general population,” Dr. Grinspoon said.

However, with the data showing a higher risk for COVID-19 death in people with HIV, “it is critical that people with HIV, representing a vulnerable and immunocompromised population, be vaccinated for COVID-19,” Dr. Grinspoon said.

Commenting on the study, Monica Gandhi, MD, MPH, director of the Gladstone Center for AIDS Research at the University of California, San Francisco, agreed that “it is encouraging that these rates are as high as the general population, showing that there is not excess hesitancy among those living with HIV.”

Unlike other immunocompromised groups, people with HIV were not necessarily prioritized for vaccination, since antiretroviral therapy can reconstitute the immune system, “so I am not surprised the [vaccination] rates aren’t higher,” Dr. Gandhi, who was not involved with the study, said in an interview.

Nevertheless, “it is important that those with risk factors for more severe disease, such as higher BMI and higher cardiovascular disease, are prioritized for COVID-19 vaccination, [as] these are important groups in which to increase rates,” she said.

“The take-home message is that we have to increase our rates of vaccination in this critically important population,” Dr. Gandhi emphasized. “Global vaccine equity is paramount given that the burden of HIV infections remains in sub-Saharan Africa.”

The study received support from the National Institutes of Health and funding from Kowa Pharmaceuticals and Gilead Sciences. The authors and Dr. Gandhi disclosed no relevant financial relationships.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

Booster shot protection against symptomatic COVID-19 caused by the Omicron variant appears to fade in about 10 weeks, according to new data from Britain.

U.K. health officials shared the data just before Christmas and noted that there haven’t been enough severe cases of the Omicron variant to calculate how well boosters protect against severe disease. But they believe the extra shots provide significant protection against hospitalization and death.

“It will be a few weeks before effectiveness against severe disease with Omicron can be estimated,” U.K. Health Security Agency officials wrote in the report. “However, based on experience with previous variants, this is likely to be substantially higher than the estimates against symptomatic disease.”

Since countries began reporting Omicron cases in November, multiple studies have suggested the variant is better at escaping antibodies from vaccination and previous infection, according to the New York Times. The U.K. report adds to that, noting that both the initial vaccine series and booster doses were less effective and faded faster against the Omicron variant than the Delta variant.

Among those who received two doses of the AstraZeneca vaccine, a booster of the Pfizer or Moderna vaccine was 60% effective at preventing symptomatic disease 2 to 4 weeks after the shot. But after 10 weeks, the Pfizer booster was 35% effective, and the Moderna booster was 45% effective. (The AstraZeneca vaccine is not authorized in the United States, but the Johnson & Johnson shot uses a similar technology, the New York Times reported.)

Among those who received three Pfizer doses, vaccine effectiveness was 70% about a week after the booster but dropped to 45% after 10 weeks. At the same time, those who received an initial two-dose series of the Pfizer vaccine and then a Moderna booster seemed to have 75% effectiveness up to 9 weeks.

The report was based on an analysis of 148,000 Delta cases and 68,000 Omicron cases in the United Kingdom through Dec. 20. So far, the U.K. health officials wrote, Omicron infections appear to be less severe and less likely to lead to hospitalization than Delta infections. At that time, 132 people with lab-confirmed Omicron had been admitted to hospitals, and 14 deaths had been reported among ages 52-96.

“This analysis is preliminary because of the small numbers of Omicron cases currently in hospital and the limited spread of Omicron into older age groups as yet,” the report said.

The reinfection rate has also increased for the Omicron variant, the report found. Among the 116,000 people who had an Omicron infection, about 11,000 -- or 9.5% -- were linked to a previously confirmed infection, which is likely an undercount of reinfections. In the data analyzed, 69 Omicron cases were a third episode of COVID-19 infection, and 290 cases occurred 60-89 days after a first infection.

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

The antiviral remdesivir, an intravenous drug given mostly to seriously ill COVID-19 patients in hospitals, could keep unvaccinated people who become infected out of the hospital if given on an outpatient basis, a new study says.

Researchers studied 562 unvaccinated people from September 2020 to April 2021, according to the study published in the New England Journal of Medicine. The study determined the risk of hospitalization or death was 87% lower in study participants who were given remdesivir than participants who received a placebo.

All participants were at high risk of developing severe COVID-19 because of their age – they were over 60 – or because they had an underlying medical condition such as diabetes or obesity.

An important caveat: The findings are based on data collected before the Delta variant surged in the summer of 2021 or the Omicron variant surged late in the year, the Washington Post reported.

The new study says the drug could be helpful in keeping vaccinated as well as unvaccinated people out of the hospital – an important factor as the Omicron surge threatens to overwhelm health systems around the world.

Remdesivir could be a boon for COVID-19 patients in parts of the world that don’t have vaccines or for patients with immunocompromised systems.

“These data provide evidence that a 3-day course of remdesivir could play a critical role in helping COVID-19 patients stay out of the hospital,” Robert L. Gottlieb, MD, PhD, the therapeutic lead for COVID-19 research at Baylor Scott & White Health in Dallas, said in a news release from Gilead Pharmaceuticals. “While our hospitals are ready to assist patients in need, prevention and early intervention are preferable to reduce the risk of disease progression and allow patients not requiring oxygen to recover from home when appropriate.”

Remdesivir was the first antiviral for COVID-19 authorized by the Food and Drug Administration. It was given to then-President Donald Trump when he was hospitalized with COVID-19 in October 2020.

Gilead released the study findings in September.

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

The antiviral remdesivir, an intravenous drug given mostly to seriously ill COVID-19 patients in hospitals, could keep unvaccinated people who become infected out of the hospital if given on an outpatient basis, a new study says.

Researchers studied 562 unvaccinated people from September 2020 to April 2021, according to the study published in the New England Journal of Medicine. The study determined the risk of hospitalization or death was 87% lower in study participants who were given remdesivir than participants who received a placebo.

All participants were at high risk of developing severe COVID-19 because of their age – they were over 60 – or because they had an underlying medical condition such as diabetes or obesity.

An important caveat: The findings are based on data collected before the Delta variant surged in the summer of 2021 or the Omicron variant surged late in the year, the Washington Post reported.

The new study says the drug could be helpful in keeping vaccinated as well as unvaccinated people out of the hospital – an important factor as the Omicron surge threatens to overwhelm health systems around the world.

Remdesivir could be a boon for COVID-19 patients in parts of the world that don’t have vaccines or for patients with immunocompromised systems.

“These data provide evidence that a 3-day course of remdesivir could play a critical role in helping COVID-19 patients stay out of the hospital,” Robert L. Gottlieb, MD, PhD, the therapeutic lead for COVID-19 research at Baylor Scott & White Health in Dallas, said in a news release from Gilead Pharmaceuticals. “While our hospitals are ready to assist patients in need, prevention and early intervention are preferable to reduce the risk of disease progression and allow patients not requiring oxygen to recover from home when appropriate.”

Remdesivir was the first antiviral for COVID-19 authorized by the Food and Drug Administration. It was given to then-President Donald Trump when he was hospitalized with COVID-19 in October 2020.

Gilead released the study findings in September.

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

The antiviral remdesivir, an intravenous drug given mostly to seriously ill COVID-19 patients in hospitals, could keep unvaccinated people who become infected out of the hospital if given on an outpatient basis, a new study says.

Researchers studied 562 unvaccinated people from September 2020 to April 2021, according to the study published in the New England Journal of Medicine. The study determined the risk of hospitalization or death was 87% lower in study participants who were given remdesivir than participants who received a placebo.

All participants were at high risk of developing severe COVID-19 because of their age – they were over 60 – or because they had an underlying medical condition such as diabetes or obesity.

An important caveat: The findings are based on data collected before the Delta variant surged in the summer of 2021 or the Omicron variant surged late in the year, the Washington Post reported.

The new study says the drug could be helpful in keeping vaccinated as well as unvaccinated people out of the hospital – an important factor as the Omicron surge threatens to overwhelm health systems around the world.

Remdesivir could be a boon for COVID-19 patients in parts of the world that don’t have vaccines or for patients with immunocompromised systems.

“These data provide evidence that a 3-day course of remdesivir could play a critical role in helping COVID-19 patients stay out of the hospital,” Robert L. Gottlieb, MD, PhD, the therapeutic lead for COVID-19 research at Baylor Scott & White Health in Dallas, said in a news release from Gilead Pharmaceuticals. “While our hospitals are ready to assist patients in need, prevention and early intervention are preferable to reduce the risk of disease progression and allow patients not requiring oxygen to recover from home when appropriate.”

Remdesivir was the first antiviral for COVID-19 authorized by the Food and Drug Administration. It was given to then-President Donald Trump when he was hospitalized with COVID-19 in October 2020.

Gilead released the study findings in September.

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

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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

The Food and Drug Administration has granted emergency use authorization to Merck’s antiviral drug to treat adults with mild to moderate COVID-19 who are at risk for severe disease.

Similar to FDA authorization of another antiviral pill regimen – ritonavir plus nirmatrelvir, or Paxlovid – granted to Pfizer on Wednesday, molnupiravir (brand name Lagevrio) should be taken early in the course of COVID-19 illness.

Pfizer’s drug is authorized for anyone aged 12 and up. But Merck’s is only for adults aged 18 and older.

Merck filed an application for emergency use authorization with the FDA in October. The company included results of its phase 3 study showing the treatment could lead to a 50% reduction in COVID-19 hospitalizations. Data later showed this efficacy at closer to a 30% reduction. In November, an FDA advisory panel narrowly recommended the agency grant authorization by a 13-10 vote.

Animal studies found the drug may harm a fetus, so it is not recommended for pregnant people, the FDA says. It may be prescribed to a pregnant person only after their doctor determines the benefits outweigh the risks and the patient is told of those risks.

Women who may get pregnant should use a reliable method of birth control if being treated with molnupiravir and for 4 days after the final dose.

Two weapons against COVID

Two antiviral pills could be better than one, at least in terms of making more COVID-19 treatments available in early 2022. It is yet to be seen if the drugmakers will be able to keep up with demand, which could substantially increase with an expected surge in Omicron variant cases.

Ritonavir and molnupiravir join remdesivir (brand name Veklury) as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is given only through an IV to people in the hospital.

Officials point out that COVID-19 treatments in tablet form are more convenient for patients in the United States and across the globe, particularly where IV infusion services may be limited.

In March 2021, experts accurately predicted that the molnupiravir pill would be available by year’s end.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of SARS-CoV-2 because the agent does not target the virus’s spike protein.

Perhaps in part because of early promising results, the U.S. government announced in November intentions to purchase $1 billion worth of molnupiravir. That new order came on top of $1.2 billion worth of the pills the U.S. ordered in June.

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

People who get COVID-19 infections caused by the Omicron variant are less likely to need hospital care, compared with those infected by the Delta variant, according to two large new studies from the U.K. and South Africa.

The findings, which were released ahead of peer review, add to previous glimmers of evidence suggesting that Omicron – while extremely contagious -– may result in less severe symptoms than its predecessors.

“This is helping us quantify how much less severe Omicron is than Delta, and it appears to be between 40 to 75% reduced risk of hospitalizations, adjusted for many factors, which is very good,” said Eric Topol, MD, the editor-in-chief of Medscape and a cardiologist at Scripps Research Translational Institute in La Jolla, CA.

The first analysis, which was done by the World Health Organization Collaborating Centre for Infectious Disease Modelling and Imperial College London, found that overall, people infected by Omicron had about a 20% reduced risk of needing any hospital care for their infections and a 40% lower risk of an overnight hospital stay, compared to those infected with Delta.

Meanwhile, people who were re-infected – meaning they caught Omicron after recovering from a previous COVID-19 infection – had a 50%-60% lower risk of needing hospital care, likely reflecting the benefits of having some prior immunity against the same family of viruses.

The study included everyone with polymerase chain reaction-confirmed COVID-19 in the U.K. during the first 2 weeks of December – roughly 56,000 Omicron cases and 269,000 Delta infections.

The second study, from researchers at the National Institute for Communicable Diseases in South Africa, included more than 29,000 COVID-19 cases that had lab results highly suggestive of Omicron infections. Compared to people infected with the Delta variant, those with presumed Omicron infections were about 70% less likely to have severe disease.

While the news is hopeful for individuals, on a population level, health care systems may still be stressed, the study authors warned.

“Given the high transmissibility of the Omicron virus, there remains the potential for health services to face increasing demand if Omicron cases continue to grow at the rate that has been seen in recent weeks,” said study author Neil Ferguson, PhD, who studies how infectious diseases spread at Imperial College London.

The study authors say their findings are specific to the U.K. and South Africa, where substantial portions of the population have some immune protection from past infection. In other words, they may not apply to countries where fewer people have been vaccinated or recovered from a bout with COVID-19.

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

People who get COVID-19 infections caused by the Omicron variant are less likely to need hospital care, compared with those infected by the Delta variant, according to two large new studies from the U.K. and South Africa.

The findings, which were released ahead of peer review, add to previous glimmers of evidence suggesting that Omicron – while extremely contagious -– may result in less severe symptoms than its predecessors.

“This is helping us quantify how much less severe Omicron is than Delta, and it appears to be between 40 to 75% reduced risk of hospitalizations, adjusted for many factors, which is very good,” said Eric Topol, MD, the editor-in-chief of Medscape and a cardiologist at Scripps Research Translational Institute in La Jolla, CA.

The first analysis, which was done by the World Health Organization Collaborating Centre for Infectious Disease Modelling and Imperial College London, found that overall, people infected by Omicron had about a 20% reduced risk of needing any hospital care for their infections and a 40% lower risk of an overnight hospital stay, compared to those infected with Delta.

Meanwhile, people who were re-infected – meaning they caught Omicron after recovering from a previous COVID-19 infection – had a 50%-60% lower risk of needing hospital care, likely reflecting the benefits of having some prior immunity against the same family of viruses.

The study included everyone with polymerase chain reaction-confirmed COVID-19 in the U.K. during the first 2 weeks of December – roughly 56,000 Omicron cases and 269,000 Delta infections.

The second study, from researchers at the National Institute for Communicable Diseases in South Africa, included more than 29,000 COVID-19 cases that had lab results highly suggestive of Omicron infections. Compared to people infected with the Delta variant, those with presumed Omicron infections were about 70% less likely to have severe disease.

While the news is hopeful for individuals, on a population level, health care systems may still be stressed, the study authors warned.

“Given the high transmissibility of the Omicron virus, there remains the potential for health services to face increasing demand if Omicron cases continue to grow at the rate that has been seen in recent weeks,” said study author Neil Ferguson, PhD, who studies how infectious diseases spread at Imperial College London.

The study authors say their findings are specific to the U.K. and South Africa, where substantial portions of the population have some immune protection from past infection. In other words, they may not apply to countries where fewer people have been vaccinated or recovered from a bout with COVID-19.

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

People who get COVID-19 infections caused by the Omicron variant are less likely to need hospital care, compared with those infected by the Delta variant, according to two large new studies from the U.K. and South Africa.

The findings, which were released ahead of peer review, add to previous glimmers of evidence suggesting that Omicron – while extremely contagious -– may result in less severe symptoms than its predecessors.

“This is helping us quantify how much less severe Omicron is than Delta, and it appears to be between 40 to 75% reduced risk of hospitalizations, adjusted for many factors, which is very good,” said Eric Topol, MD, the editor-in-chief of Medscape and a cardiologist at Scripps Research Translational Institute in La Jolla, CA.

The first analysis, which was done by the World Health Organization Collaborating Centre for Infectious Disease Modelling and Imperial College London, found that overall, people infected by Omicron had about a 20% reduced risk of needing any hospital care for their infections and a 40% lower risk of an overnight hospital stay, compared to those infected with Delta.

Meanwhile, people who were re-infected – meaning they caught Omicron after recovering from a previous COVID-19 infection – had a 50%-60% lower risk of needing hospital care, likely reflecting the benefits of having some prior immunity against the same family of viruses.

The study included everyone with polymerase chain reaction-confirmed COVID-19 in the U.K. during the first 2 weeks of December – roughly 56,000 Omicron cases and 269,000 Delta infections.

The second study, from researchers at the National Institute for Communicable Diseases in South Africa, included more than 29,000 COVID-19 cases that had lab results highly suggestive of Omicron infections. Compared to people infected with the Delta variant, those with presumed Omicron infections were about 70% less likely to have severe disease.

While the news is hopeful for individuals, on a population level, health care systems may still be stressed, the study authors warned.

“Given the high transmissibility of the Omicron virus, there remains the potential for health services to face increasing demand if Omicron cases continue to grow at the rate that has been seen in recent weeks,” said study author Neil Ferguson, PhD, who studies how infectious diseases spread at Imperial College London.

The study authors say their findings are specific to the U.K. and South Africa, where substantial portions of the population have some immune protection from past infection. In other words, they may not apply to countries where fewer people have been vaccinated or recovered from a bout with COVID-19.

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

The Food and Drug Administration on Dec. 22, 2021, granted emergency use authorization (EUA) for a new antiviral pill to treat people with symptomatic COVID-19.

Pfizer’s ritonavir, name brand Paxlovid, can now be taken by patients ages 12 and up who weigh at least 88 pounds.

The antiviral is only for people who test positive for the coronavirus and who are at high risk for severe COVID-19, including hospitalization or death. It is available by prescription only and should be taken as soon as possible after diagnosis and within 5 days of the start of symptoms.

Paxlovid is taken as three tablets together orally twice a day for 5 days, for a total of 30 tablets.

Possible side effects include a reduced sense of taste, diarrhea, high blood pressure, and muscle aches.

The authorization arrives as U.S. cases of the Omicron variant are surging, some monoclonal antibody treatments are becoming less effective, and Americans struggle to maintain some sense of tradition and normalcy around the holidays.

Paxlovid joins remdesivir as an available antiviral to treat COVID-19. Remdesivir is fully approved by the FDA but is given only intravenously in a hospital.  

The COVID-19 antiviral pills come with some obvious advantages, including greater convenience for consumers – such as home use – and the potential to expand treatment for people in low- and middle-income countries.

‘An exciting step forward’

The EUA for Pfizer’s new drug has been highly anticipated, and news of its impending authorization circulated on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward.” Dr. Topol is editor in chief of Medscape, the parent company of MDedge.

He and many others also expected the FDA to grant emergency use authorization for an antiviral from Merck. But there was no immediate word Wednesday if that was still going to happen.

An accelerated authorization?

The FDA’s authorization for Pfizer’s antiviral comes about 5 weeks after the company submitted an application to the agency. In its submission, the company said a study showed the pill reduced by 89% the rate of hospitalization and death for people with mild to moderate COVID-19 illness.

In April 2021, Pfizer announced its antiviral pill for COVID-19 could be available by year’s end. In September, an official at the National Institutes of Allergy and Infectious Diseases seconded the prediction.

Merck filed its EUA application with the FDA in October. The company included results of its phase 3 study showing the treatment was linked to a 50% reduction in COVID-19 hospitalizations.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of the coronavirus because the agent does not target the virus’s spike protein. At the time, Delta was the dominant variant in the United States.

Faith-based purchasing

The U.S. government has already recognized the potential of these oral therapies, at least in terms of preorders.

Last month, it announced intentions to purchase $1 billion worth of Merck’s molnupiravir, adding to the $1.2 billion worth of the pills the U.S. ordered in June 2021. Also in November, the government announced it would purchase 10 million courses of the Pfizer pill at an estimated cost of $5.3 billion.

The government preorders of the antiviral pills for COVID-19 are separate from the orders for COVID-19 vaccines. Most recently, the Biden administration announced it will make 500 million tests for coronavirus infection available to Americans for free in early 2022.

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

The Food and Drug Administration on Dec. 22, 2021, granted emergency use authorization (EUA) for a new antiviral pill to treat people with symptomatic COVID-19.

Pfizer’s ritonavir, name brand Paxlovid, can now be taken by patients ages 12 and up who weigh at least 88 pounds.

The antiviral is only for people who test positive for the coronavirus and who are at high risk for severe COVID-19, including hospitalization or death. It is available by prescription only and should be taken as soon as possible after diagnosis and within 5 days of the start of symptoms.

Paxlovid is taken as three tablets together orally twice a day for 5 days, for a total of 30 tablets.

Possible side effects include a reduced sense of taste, diarrhea, high blood pressure, and muscle aches.

The authorization arrives as U.S. cases of the Omicron variant are surging, some monoclonal antibody treatments are becoming less effective, and Americans struggle to maintain some sense of tradition and normalcy around the holidays.

Paxlovid joins remdesivir as an available antiviral to treat COVID-19. Remdesivir is fully approved by the FDA but is given only intravenously in a hospital.  

The COVID-19 antiviral pills come with some obvious advantages, including greater convenience for consumers – such as home use – and the potential to expand treatment for people in low- and middle-income countries.

‘An exciting step forward’

The EUA for Pfizer’s new drug has been highly anticipated, and news of its impending authorization circulated on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward.” Dr. Topol is editor in chief of Medscape, the parent company of MDedge.

He and many others also expected the FDA to grant emergency use authorization for an antiviral from Merck. But there was no immediate word Wednesday if that was still going to happen.

An accelerated authorization?

The FDA’s authorization for Pfizer’s antiviral comes about 5 weeks after the company submitted an application to the agency. In its submission, the company said a study showed the pill reduced by 89% the rate of hospitalization and death for people with mild to moderate COVID-19 illness.

In April 2021, Pfizer announced its antiviral pill for COVID-19 could be available by year’s end. In September, an official at the National Institutes of Allergy and Infectious Diseases seconded the prediction.

Merck filed its EUA application with the FDA in October. The company included results of its phase 3 study showing the treatment was linked to a 50% reduction in COVID-19 hospitalizations.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of the coronavirus because the agent does not target the virus’s spike protein. At the time, Delta was the dominant variant in the United States.

Faith-based purchasing

The U.S. government has already recognized the potential of these oral therapies, at least in terms of preorders.

Last month, it announced intentions to purchase $1 billion worth of Merck’s molnupiravir, adding to the $1.2 billion worth of the pills the U.S. ordered in June 2021. Also in November, the government announced it would purchase 10 million courses of the Pfizer pill at an estimated cost of $5.3 billion.

The government preorders of the antiviral pills for COVID-19 are separate from the orders for COVID-19 vaccines. Most recently, the Biden administration announced it will make 500 million tests for coronavirus infection available to Americans for free in early 2022.

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

The Food and Drug Administration on Dec. 22, 2021, granted emergency use authorization (EUA) for a new antiviral pill to treat people with symptomatic COVID-19.

Pfizer’s ritonavir, name brand Paxlovid, can now be taken by patients ages 12 and up who weigh at least 88 pounds.

The antiviral is only for people who test positive for the coronavirus and who are at high risk for severe COVID-19, including hospitalization or death. It is available by prescription only and should be taken as soon as possible after diagnosis and within 5 days of the start of symptoms.

Paxlovid is taken as three tablets together orally twice a day for 5 days, for a total of 30 tablets.

Possible side effects include a reduced sense of taste, diarrhea, high blood pressure, and muscle aches.

The authorization arrives as U.S. cases of the Omicron variant are surging, some monoclonal antibody treatments are becoming less effective, and Americans struggle to maintain some sense of tradition and normalcy around the holidays.

Paxlovid joins remdesivir as an available antiviral to treat COVID-19. Remdesivir is fully approved by the FDA but is given only intravenously in a hospital.  

The COVID-19 antiviral pills come with some obvious advantages, including greater convenience for consumers – such as home use – and the potential to expand treatment for people in low- and middle-income countries.

‘An exciting step forward’

The EUA for Pfizer’s new drug has been highly anticipated, and news of its impending authorization circulated on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward.” Dr. Topol is editor in chief of Medscape, the parent company of MDedge.

He and many others also expected the FDA to grant emergency use authorization for an antiviral from Merck. But there was no immediate word Wednesday if that was still going to happen.

An accelerated authorization?

The FDA’s authorization for Pfizer’s antiviral comes about 5 weeks after the company submitted an application to the agency. In its submission, the company said a study showed the pill reduced by 89% the rate of hospitalization and death for people with mild to moderate COVID-19 illness.

In April 2021, Pfizer announced its antiviral pill for COVID-19 could be available by year’s end. In September, an official at the National Institutes of Allergy and Infectious Diseases seconded the prediction.

Merck filed its EUA application with the FDA in October. The company included results of its phase 3 study showing the treatment was linked to a 50% reduction in COVID-19 hospitalizations.

Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of the coronavirus because the agent does not target the virus’s spike protein. At the time, Delta was the dominant variant in the United States.

Faith-based purchasing

The U.S. government has already recognized the potential of these oral therapies, at least in terms of preorders.

Last month, it announced intentions to purchase $1 billion worth of Merck’s molnupiravir, adding to the $1.2 billion worth of the pills the U.S. ordered in June 2021. Also in November, the government announced it would purchase 10 million courses of the Pfizer pill at an estimated cost of $5.3 billion.

The government preorders of the antiviral pills for COVID-19 are separate from the orders for COVID-19 vaccines. Most recently, the Biden administration announced it will make 500 million tests for coronavirus infection available to Americans for free in early 2022.

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

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The pandemic has created a hostile environment for pregnant people and their babies.

Stress levels among expectant mothers have soared. Pregnant women with COVID are 5 times as likely as uninfected pregnant people to require intensive care and 22 times as likely to die. Infected moms are four times as likely to have a stillborn child.

Yet some of the pandemic’s greatest threats to infants’ health may not be apparent for years or even decades.

That’s because babies of COVID-infected moms are 60% more likely to be born very prematurely, which increases the danger of infant mortality and long-term disabilities such as cerebral palsy, asthma, and hearing loss, as well as a child’s risk of adult disease, including depression, anxiety, heart disease, and kidney disease.

Studies have linked fever and infection during pregnancy to developmental and psychiatric conditions such as autism, depression, and schizophrenia.

“Some of these conditions do not show up until middle childhood or early adult life, but they have their origins in fetal life,” said Evdokia Anagnostou, MD, a child neurologist at Holland Bloorview Kids Rehabilitation Hospital and a pediatrics professor at the University of Toronto.

For fetuses exposed to COVID, the greatest danger is usually not the coronavirus itself, but the mother’s immune system.

Both severe COVID infections and the strain of the pandemic can expose fetuses to harmful inflammation, which can occur when a mother’s immune system is fighting a virus or when stress hormones send nonstop alarm signals.

Prenatal inflammation “changes the way the brain develops and, depending on the timing of the infection, it can change the way the heart or kidneys develop,” Dr. Anagnostou said.

Although health officials have strongly recommended COVID vaccines for pregnant people, only 35% are fully vaccinated.

At least 150,000 pregnant women have been diagnosed with COVID; more than 25,000 of them have been hospitalized, and 249 have died, according to the Centers for Disease Control and Prevention.

Although most babies will be fine, even a small increase in the percentage of children with special medical or educational needs could have a large effect on the population, given the huge number of COVID infections, Dr. Anagnostou said.

“If someone has a baby who is doing well, that is what they should focus on,” Dr. Anagnostou said. “But from a public health point of view, we need to follow women who experienced severe COVID and their babies to understand the impact.”

Learning from history

Researchers in the United States and other countries are already studying “the COVID generation” to see whether these children have more health issues than those conceived or born before 2020.

Previous crises have shown that the challenges fetuses face in the womb – such as maternal infections, hunger, stress, and hormone-disrupting chemicals – can leave a lasting imprint on their health, as well as that of their children and grandchildren, said Frederick Kaskel, MD, director of pediatric nephrology at the Children’s Hospital at Montefiore, New York.

People whose mothers were pregnant during surges in the 1918 influenza pandemic, for example, had poorer health throughout their lives, compared with Americans born at other times, said John McCarthy, who is a medical student at Albert Einstein College of Medicine, New York, and cowrote a recent review in JAMA Pediatrics with Dr. Kaskel.

Researchers don’t know exactly which moms were infected with pandemic flu, Mr. McCarthy said. But women who were pregnant during major surges – when infection was widespread – had children with higher rates of heart disease or diabetes. These children were also less successful in school, less economically productive, and more likely to live with a disability.

Because organ systems develop during different periods of pregnancy, fetuses exposed during the first trimester may face different risks than those exposed toward the end of pregnancy, Mr. McCarthy said. For example, people born in the fall of 1918 were 50% more likely than others to develop kidney disease; that may reflect an exposure to the pandemic in the third trimester, while the kidneys were still developing.

Nearly 2 years into the COVID pandemic, researchers have begun to publish preliminary observations of infants exposed to COVID infections and stress before birth.

Although Dr. Anagnostou noted that it’s too early to reach definitive conclusions, “there is evidence that babies born to moms with severe COVID infections have changes to their immune system,” she said. “It’s enough to make us worry a little bit.”

Damaging a fetal security system

The good news about the coronavirus is that it seldom crosses the placenta, the organ tasked with protecting a developing fetus from infections and providing it with oxygen. So moms with COVID rarely give the virus to their children before birth.

That’s important, because some viruses that directly infect the fetus – such as Zika – can cause devastating birth defects, said Karin Nielsen-Saines, MD, a specialist in pediatric infectious diseases at University of California, Los Angeles.

But studies also suggest that inflammation from a mother’s COVID infection can injure the placenta, said Jeffery Goldstein, MD, an assistant professor of pathology at Northwestern University, Chicago. In a study published in American Journal of Clinical Pathology , Dr. Goldstein and his coauthors found that placentas from COVID-infected moms had more abnormal blood vessels than placentas from patients without COVID, making it harder for them to deliver sufficient oxygen to the fetus.

Placental damage can also lead to preeclampsia, a serious complication of pregnancy that can cause a mother’s blood pressure to spike.

Preeclampsia occurs when blood vessels in the placenta don’t develop or function properly, forcing the mother’s heart to work harder to get blood to the fetus, which may not receive enough oxygen and nutrients. Preeclampsia also predisposes women to heart attacks and strokes later in life.

Rewiring the immune system

In some cases, COVID also appears to rewire a baby’s immune response, Dr. Nielsen-Saines said.

In an October study in the journal Cell Reports Medicine, Dr. Nielsen-Saines and her coauthors found that infants born to people with severe COVID infections had a different mix of immune cells and proteins than other babies. None of the newborns tested positive for the coronavirus.

The immune changes are concerning, Dr. Nielsen-Saines said, because this pattern of immune cells and proteins has previously been found in infants with respiratory problems and in some cases poor neurodevelopment.

Notably, all the babies in her study appear healthy, said Dr. Nielsen-Saines, who plans to follow them for 3 years to see whether these early signals translate into developmental delays, such as problems talking, walking, or interacting with others.

“How big of a difference does any of this make in the baby?” asked Dr. Anagnostou. “We won’t know for a few years. All we can do is try to be as prepared as possible.”

Increasing the risk for boys

Boys could face higher risks from COVID, even before birth.

Males are generally more vulnerable than females as fetuses and newborns; they’re more likely to be born prematurely and to die as infants. Preterm boys also have a higher risk of disability and death.

But coronavirus infection poses special dangers, said Sabra Klein, PhD, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, Baltimore.

That’s because boys are disproportionately affected by conditions linked to maternal infections. Boys are four times as likely as girls to be diagnosed with autism or attention-deficit/hyperactivity disorder, for example, while men are 75% more likely than women to develop schizophrenia.

Scientists don’t fully understand why boys appear more fragile in the womb, although testosterone – which can dampen immune response – may play a role, said Kristina Adams Waldorf, MD, a professor of obstetrics and gynecology at the University of Washington.

Men generally mount weaker immune responses than women and more often develop severe COVID infections. Recent research suggests boys with COVID are more likely than girls to become seriously ill or develop a rare inflammatory condition called multisystem inflammatory syndrome.

New research on COVID could help illuminate this vulnerability.

In a study published in October, researchers found that the sex of a fetus influences the way its placenta responds to COVID, as well as how its mother’s immune system responds.

Pregnant people infected with COVID made fewer antibodies against the coronavirus if they were carrying male fetuses than if they were carrying females. Mothers also transferred fewer antibodies to boys than to girls, said Andrea Edlow, MD, senior author of the study and a maternal-fetal medicine specialist at Massachusetts General Hospital, Boston.

When examining the placentas of male fetuses after delivery, researchers found changes that could leave boys less protected against damaging inflammation.

The sex of a fetus can influence its mother’s response to other illnesses, as well.

For example, research shows that pregnant women with asthma have worse symptoms if they’re carrying a female. Women carrying males are slightly more likely to develop gestational diabetes.

Dr. Edlow said her findings raise questions about the “cross talk” between mother and baby. “The mom’s immune system is sensing there is a male fetus,” Dr. Edlow said. “And the fetus is actively communicating with the mom’s immune system.”

Boosting toxic stress

Rates of depression and stress among pregnant women have increased dramatically during the pandemic.

That’s concerning because chronic stress can lead to inflammation, affecting the babies of both infected and uninfected women, Dr. Anagnostou said.

Studies consistently show that infants born to mothers who experience significant stress during pregnancy have higher rates of short- and long-term health damage – including heart defects and obesity – than babies born to women with less stress.

“We know that inflammation directly influences the way a baby’s brain develops,” said Elinor Sullivan, PhD, an associate professor in psychiatry at Oregon Health & Science University, Portland.

Lockdowns, travel restrictions and physical distancing left many pregnant women without the support of family and friends. The stress of losing a loved one, a job, or a home further heightens the risks to moms and babies, said Dr. Sullivan, who is following children born during the pandemic for 5 years.

In research that has not yet been published, Dr. Sullivan found that babies of women who were pregnant during the pandemic showed more sadness and negative emotions in the first year of life, compared with infants of women who were pregnant before the pandemic.

The findings show the importance of helping and protecting pregnant people before and after delivery, said Dr. Sullivan, who conducted a separate study that found women who received more social support were less depressed.

Italian researchers are also studying the effect of maternal stress on infants’ behavior, as well as the way their genes are regulated.

Although stress-related inflammation doesn’t alter the structure of a baby’s genes, it can influence whether they’re turned on and off, said Livio Provenzi, PhD, a psychologist at the C. Mondino National Institute of Neurology Foundation in Pavia, Italy.

In Dr. Provenzi’s study of 163 mother-baby pairs he found differences in how genes that regulate the stress response were activated. Genes that help people respond to stress were more likely to be turned off in babies whose moms reported the most stress during pregnancy. The same moms also reported that their babies cried more and were fussier when they were 3 months old.

Researchers usually prefer to make in-person observations of babies as they interact with their mothers, Dr. Provenzi said. But because of the pandemic, Dr. Provenzi asked mothers to fill out questionnaires about infant behavior. He plans to observe mothers and babies in person when the children are 12 months old.

While vaccinating pregnant people is the best way to protect them and their fetuses from the virus, Dr. Anagnostou said, society needs to do more to preserve expectant mothers’ mental health.

“We can’t escape the fact that we’ve lived through 2 years of a pandemic,” Dr. Anagnostou said. “But we can think about opportunities for reducing the risk.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

The clinical value of bamlanivimab for hospitalized COVID-19 patients depends on whether patients have endogenous neutralizing antibodies at the time of treatment, according to new research.

In the randomized controlled trial, in both the group who received bamlanivimab and the group who received placebo, higher antigen and viral RNA levels were associated with a lower proportion of patients achieving recovery.

Other studies have shown that the use of monoclonal antibodies reduces hospitalization risk in outpatients with early COVID-19, and appears to promote viral load decline in the nasopharynx, wrote Jens D. Lundgren, MD, of the University of Copenhagen and colleagues in their article published in the Annals of Internal Medicine. What had been missing prior to this new research was final results from hospitalized patients, the authors said.

In the new study, the researchers randomized 314 adults hospitalized with COVID-19 but without end-organ failure to receive 7,000 mg bamlanivimab (163 patients) or a placebo (151 patients). All patients received study-supplied remdesivir unless contraindicated. The researchers compared the efficacy of bamlanivimab versus placebo, but considered remdesivir the standard of care in this study.

At baseline, 50% of patients overall had antispike endogenous neutralizing antibodies (nAbs), and 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1,000 ng/L.

The median time to sustained recovery, 19 days, was not significantly different between the bamlanivimab and placebo groups (subhazard ratio, 0.99).

“As hypothesized, among those who were negative for nAb, the difference between bamlanivimab and placebo was more evident if levels of plasma antigen or nasal-swab viral RNA were above the median entry levels,” with subhazard ratios of 1.48 and 1.89, respectively, the researchers explained.

However, the hazard ratio for death for bamlanivimab vs. placebo was 0.45 for patients negative for nAb vs. 3.53 for those positive for nAb. These differences with respect to nAb status were similar across all 90 elements of a composite safety outcome, the researchers said.

Potential benefits remain unclear

The use of neutralizing monoclonal antibodies has been extensively documented as an effective treatment for COVID-19 among ambulatory patients, corresponding author Dr. Lundgren said in an interview.

“Conversely, among admitted patients with COVID-19 pneumonia, the benefit has been questionable,” he said.

The researchers examined a hypothesis that the null finding in hospitalized patients may stem from differences in underlying mechanisms, “either from uncontrolled viral replication – which would be predicted to occur in particular among those not yet been able to mount an endogenous immune response – or from hyperinflammation among those that have mounted such a response,” Dr. Lundgren said.

 The study findings supported the stated hypothesis, said Dr. Lundgren. “However, it was surprising that not only was the neutralizing antibody without any benefit among those that had mounted an endogenous immune response, but it actually may have been harmful,” he said.

Bamlanivimab was effective against the viral strain that circulated at the time of enrollment in the study, but subsequent viral strains have appeared to be unaffected by the neutralizing activity of the antibody, said Dr. Lundgren.

From a practical standpoint, “the findings would suggest that use of neutralizing monoclonal antibodies for patients admitted to a hospital with COVID pneumonia should be restricted to those that have not yet mounted an endogenous immune response, as determined by lack of detectable neutralizing antibodies at the time of admission,” Dr. Lundgren said.

Looking ahead, studies are currently underway to examine how the findings translate to vaccinated patients, he added. Other questions to be addressed include whether the benefits and harms apply to some or all neutralizing antibody products, he said.

In addition, “our research consortium is currently doing field testing of several point-of-care test candidates to examine their reliability and functionality,” for how quickly they might identify an endogenous neutralizing antibody response in an admitted COVID pneumonia patient,” Dr. Lundgren noted.

Findings show bamlanivimab’s limits

“Based on the findings of the current study, no clear subgroup of patients could be identified who would benefit from bamlanivimab when hospitalized with COVID-19,” said Suman Pal, MD, of the University of New Mexico, Albuquerque, in an interview.

“The study findings also show possible harm of using bamlanivimab in hospitalized COVID-19 patients who were seropositive for neutralizing antibodies prior to receiving therapy,” Dr. Pal emphasized. “Moreover, the study did not include participants with COVID-19 from variant strains, such as delta and omicron, which currently account for a large number of cases.” “Therefore, the results of this study do not support the use of bamlanivimab in the clinical setting until further evidence is available to guide the selection of patients who may benefit from therapy,” he explained.

“The possible benefit of bamlanivimab does not outweigh the risks in patients hospitalized with COVID-19,” he concluded.

Dr. Pal emphasized the need for larger prospective studies to establish whether bamlanivimab may have benefits in a subgroup of patients, but “well-validated point-of-care tests to identify such patients need to be readily available before this therapy can be considered by clinicians at the bedside,” he concluded.

Diligent screening required before use

Monoclonal antibody treatment has been administered to individuals with diagnosis of COVID-19 infection as outpatients as well as for hospitalized inpatients, said Noel Deep, MD, an internist in Antigo, Wisc., in an interview. “This study is important because it helps physicians and health care institutions to evaluate whether continued use of the monoclonal antibodies would be beneficial and, if so, in what patient populations,” he said.

The findings present interesting implications for the care of COVID-19 patients, said Dr. Deep. “This study indicates that bamlanivimab does not provide the benefit that was initially envisioned when the monoclonal antibody infusions were initially initiated in the treatment of COVID-19 infections. “Serological screening of the patients would help to identify that subgroup of individuals who could benefit from this monoclonal antibody rather than administering it to every COVID-19–positive individual,” he explained.

However, “it is important to note that the emergency use authorization (EUA) for single-agent bamlanivimab has been revoked,” Dr. Deep said.

“The potential benefits of bamlanivimab can be realized only if adequate attention is paid to identifying the appropriate candidates based on serological screening, and administering bamlanivimab to those who are already producing endogenous antibodies could lead to increased risk to those individuals,” he said. Dr. Deep added that he would favor administration of bamlanivimab “in those appropriately screened and eligible candidates, and it is my opinion that the benefits outweigh the risks in those individuals.”

Although the EUA for single-agent bamlanivimab has been revoked, “alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab administered together, for the same uses as previously authorized for bamlanivimab alone,” Dr. Deep said. “The FDA believes that these alternative monoclonal antibody therapies remain appropriate to treat patients with COVID-19, and I would like to see some data about the benefits and risks of these agents,” he noted.

Limitations, funding, and disclosures

The main limitation of the study was the small size and the fact that it was a subgroup analysis of a trial that ended early because of futility, the researchers wrote. However, the Therapeutics for Inpatients With COVID-19 (TICO) platform will proceed with clinical evaluation of additional COVID-19 treatments, they said.

The study was supported primarily by the U.S. government Operation Warp Speed and the National Institute of Allergy and Infectious Diseases. Other funding sources included the Division of Clinical Research and Leidos Biomedical Research for the INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) Network, as well as an agreement between the National Heart, Lung, and Blood Institute and the Research Triangle Institute for the PETAL (Prevention & Early Treatment of Acute Lung Injury) Network and CTSN (Cardiothoracic Surgical Trials Network). Other support came from the U.S. Department of Veterans Affairs and the governments of Denmark (National Research Foundation), Australia (National Health and Medical Research Council), and the United Kingdom (Medical Research Council).

The medications used in the study were donated by Gilead Sciences and Eli Lilly.

The researchers had no financial conflicts do disclose. Dr. Deep and Dr. Pal had no relevant financial conflicts to disclose.

The clinical value of bamlanivimab for hospitalized COVID-19 patients depends on whether patients have endogenous neutralizing antibodies at the time of treatment, according to new research.

In the randomized controlled trial, in both the group who received bamlanivimab and the group who received placebo, higher antigen and viral RNA levels were associated with a lower proportion of patients achieving recovery.

Other studies have shown that the use of monoclonal antibodies reduces hospitalization risk in outpatients with early COVID-19, and appears to promote viral load decline in the nasopharynx, wrote Jens D. Lundgren, MD, of the University of Copenhagen and colleagues in their article published in the Annals of Internal Medicine. What had been missing prior to this new research was final results from hospitalized patients, the authors said.

In the new study, the researchers randomized 314 adults hospitalized with COVID-19 but without end-organ failure to receive 7,000 mg bamlanivimab (163 patients) or a placebo (151 patients). All patients received study-supplied remdesivir unless contraindicated. The researchers compared the efficacy of bamlanivimab versus placebo, but considered remdesivir the standard of care in this study.

At baseline, 50% of patients overall had antispike endogenous neutralizing antibodies (nAbs), and 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1,000 ng/L.

The median time to sustained recovery, 19 days, was not significantly different between the bamlanivimab and placebo groups (subhazard ratio, 0.99).

“As hypothesized, among those who were negative for nAb, the difference between bamlanivimab and placebo was more evident if levels of plasma antigen or nasal-swab viral RNA were above the median entry levels,” with subhazard ratios of 1.48 and 1.89, respectively, the researchers explained.

However, the hazard ratio for death for bamlanivimab vs. placebo was 0.45 for patients negative for nAb vs. 3.53 for those positive for nAb. These differences with respect to nAb status were similar across all 90 elements of a composite safety outcome, the researchers said.

Potential benefits remain unclear

The use of neutralizing monoclonal antibodies has been extensively documented as an effective treatment for COVID-19 among ambulatory patients, corresponding author Dr. Lundgren said in an interview.

“Conversely, among admitted patients with COVID-19 pneumonia, the benefit has been questionable,” he said.

The researchers examined a hypothesis that the null finding in hospitalized patients may stem from differences in underlying mechanisms, “either from uncontrolled viral replication – which would be predicted to occur in particular among those not yet been able to mount an endogenous immune response – or from hyperinflammation among those that have mounted such a response,” Dr. Lundgren said.

 The study findings supported the stated hypothesis, said Dr. Lundgren. “However, it was surprising that not only was the neutralizing antibody without any benefit among those that had mounted an endogenous immune response, but it actually may have been harmful,” he said.

Bamlanivimab was effective against the viral strain that circulated at the time of enrollment in the study, but subsequent viral strains have appeared to be unaffected by the neutralizing activity of the antibody, said Dr. Lundgren.

From a practical standpoint, “the findings would suggest that use of neutralizing monoclonal antibodies for patients admitted to a hospital with COVID pneumonia should be restricted to those that have not yet mounted an endogenous immune response, as determined by lack of detectable neutralizing antibodies at the time of admission,” Dr. Lundgren said.

Looking ahead, studies are currently underway to examine how the findings translate to vaccinated patients, he added. Other questions to be addressed include whether the benefits and harms apply to some or all neutralizing antibody products, he said.

In addition, “our research consortium is currently doing field testing of several point-of-care test candidates to examine their reliability and functionality,” for how quickly they might identify an endogenous neutralizing antibody response in an admitted COVID pneumonia patient,” Dr. Lundgren noted.

Findings show bamlanivimab’s limits

“Based on the findings of the current study, no clear subgroup of patients could be identified who would benefit from bamlanivimab when hospitalized with COVID-19,” said Suman Pal, MD, of the University of New Mexico, Albuquerque, in an interview.

“The study findings also show possible harm of using bamlanivimab in hospitalized COVID-19 patients who were seropositive for neutralizing antibodies prior to receiving therapy,” Dr. Pal emphasized. “Moreover, the study did not include participants with COVID-19 from variant strains, such as delta and omicron, which currently account for a large number of cases.” “Therefore, the results of this study do not support the use of bamlanivimab in the clinical setting until further evidence is available to guide the selection of patients who may benefit from therapy,” he explained.

“The possible benefit of bamlanivimab does not outweigh the risks in patients hospitalized with COVID-19,” he concluded.

Dr. Pal emphasized the need for larger prospective studies to establish whether bamlanivimab may have benefits in a subgroup of patients, but “well-validated point-of-care tests to identify such patients need to be readily available before this therapy can be considered by clinicians at the bedside,” he concluded.

Diligent screening required before use

Monoclonal antibody treatment has been administered to individuals with diagnosis of COVID-19 infection as outpatients as well as for hospitalized inpatients, said Noel Deep, MD, an internist in Antigo, Wisc., in an interview. “This study is important because it helps physicians and health care institutions to evaluate whether continued use of the monoclonal antibodies would be beneficial and, if so, in what patient populations,” he said.

The findings present interesting implications for the care of COVID-19 patients, said Dr. Deep. “This study indicates that bamlanivimab does not provide the benefit that was initially envisioned when the monoclonal antibody infusions were initially initiated in the treatment of COVID-19 infections. “Serological screening of the patients would help to identify that subgroup of individuals who could benefit from this monoclonal antibody rather than administering it to every COVID-19–positive individual,” he explained.

However, “it is important to note that the emergency use authorization (EUA) for single-agent bamlanivimab has been revoked,” Dr. Deep said.

“The potential benefits of bamlanivimab can be realized only if adequate attention is paid to identifying the appropriate candidates based on serological screening, and administering bamlanivimab to those who are already producing endogenous antibodies could lead to increased risk to those individuals,” he said. Dr. Deep added that he would favor administration of bamlanivimab “in those appropriately screened and eligible candidates, and it is my opinion that the benefits outweigh the risks in those individuals.”

Although the EUA for single-agent bamlanivimab has been revoked, “alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab administered together, for the same uses as previously authorized for bamlanivimab alone,” Dr. Deep said. “The FDA believes that these alternative monoclonal antibody therapies remain appropriate to treat patients with COVID-19, and I would like to see some data about the benefits and risks of these agents,” he noted.

Limitations, funding, and disclosures

The main limitation of the study was the small size and the fact that it was a subgroup analysis of a trial that ended early because of futility, the researchers wrote. However, the Therapeutics for Inpatients With COVID-19 (TICO) platform will proceed with clinical evaluation of additional COVID-19 treatments, they said.

The study was supported primarily by the U.S. government Operation Warp Speed and the National Institute of Allergy and Infectious Diseases. Other funding sources included the Division of Clinical Research and Leidos Biomedical Research for the INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) Network, as well as an agreement between the National Heart, Lung, and Blood Institute and the Research Triangle Institute for the PETAL (Prevention & Early Treatment of Acute Lung Injury) Network and CTSN (Cardiothoracic Surgical Trials Network). Other support came from the U.S. Department of Veterans Affairs and the governments of Denmark (National Research Foundation), Australia (National Health and Medical Research Council), and the United Kingdom (Medical Research Council).

The medications used in the study were donated by Gilead Sciences and Eli Lilly.

The researchers had no financial conflicts do disclose. Dr. Deep and Dr. Pal had no relevant financial conflicts to disclose.

The clinical value of bamlanivimab for hospitalized COVID-19 patients depends on whether patients have endogenous neutralizing antibodies at the time of treatment, according to new research.

In the randomized controlled trial, in both the group who received bamlanivimab and the group who received placebo, higher antigen and viral RNA levels were associated with a lower proportion of patients achieving recovery.

Other studies have shown that the use of monoclonal antibodies reduces hospitalization risk in outpatients with early COVID-19, and appears to promote viral load decline in the nasopharynx, wrote Jens D. Lundgren, MD, of the University of Copenhagen and colleagues in their article published in the Annals of Internal Medicine. What had been missing prior to this new research was final results from hospitalized patients, the authors said.

In the new study, the researchers randomized 314 adults hospitalized with COVID-19 but without end-organ failure to receive 7,000 mg bamlanivimab (163 patients) or a placebo (151 patients). All patients received study-supplied remdesivir unless contraindicated. The researchers compared the efficacy of bamlanivimab versus placebo, but considered remdesivir the standard of care in this study.

At baseline, 50% of patients overall had antispike endogenous neutralizing antibodies (nAbs), and 50% had SARS-CoV-2 nucleocapsid plasma antigen levels of at least 1,000 ng/L.

The median time to sustained recovery, 19 days, was not significantly different between the bamlanivimab and placebo groups (subhazard ratio, 0.99).

“As hypothesized, among those who were negative for nAb, the difference between bamlanivimab and placebo was more evident if levels of plasma antigen or nasal-swab viral RNA were above the median entry levels,” with subhazard ratios of 1.48 and 1.89, respectively, the researchers explained.

However, the hazard ratio for death for bamlanivimab vs. placebo was 0.45 for patients negative for nAb vs. 3.53 for those positive for nAb. These differences with respect to nAb status were similar across all 90 elements of a composite safety outcome, the researchers said.

Potential benefits remain unclear

The use of neutralizing monoclonal antibodies has been extensively documented as an effective treatment for COVID-19 among ambulatory patients, corresponding author Dr. Lundgren said in an interview.

“Conversely, among admitted patients with COVID-19 pneumonia, the benefit has been questionable,” he said.

The researchers examined a hypothesis that the null finding in hospitalized patients may stem from differences in underlying mechanisms, “either from uncontrolled viral replication – which would be predicted to occur in particular among those not yet been able to mount an endogenous immune response – or from hyperinflammation among those that have mounted such a response,” Dr. Lundgren said.

 The study findings supported the stated hypothesis, said Dr. Lundgren. “However, it was surprising that not only was the neutralizing antibody without any benefit among those that had mounted an endogenous immune response, but it actually may have been harmful,” he said.

Bamlanivimab was effective against the viral strain that circulated at the time of enrollment in the study, but subsequent viral strains have appeared to be unaffected by the neutralizing activity of the antibody, said Dr. Lundgren.

From a practical standpoint, “the findings would suggest that use of neutralizing monoclonal antibodies for patients admitted to a hospital with COVID pneumonia should be restricted to those that have not yet mounted an endogenous immune response, as determined by lack of detectable neutralizing antibodies at the time of admission,” Dr. Lundgren said.

Looking ahead, studies are currently underway to examine how the findings translate to vaccinated patients, he added. Other questions to be addressed include whether the benefits and harms apply to some or all neutralizing antibody products, he said.

In addition, “our research consortium is currently doing field testing of several point-of-care test candidates to examine their reliability and functionality,” for how quickly they might identify an endogenous neutralizing antibody response in an admitted COVID pneumonia patient,” Dr. Lundgren noted.

Findings show bamlanivimab’s limits

“Based on the findings of the current study, no clear subgroup of patients could be identified who would benefit from bamlanivimab when hospitalized with COVID-19,” said Suman Pal, MD, of the University of New Mexico, Albuquerque, in an interview.

“The study findings also show possible harm of using bamlanivimab in hospitalized COVID-19 patients who were seropositive for neutralizing antibodies prior to receiving therapy,” Dr. Pal emphasized. “Moreover, the study did not include participants with COVID-19 from variant strains, such as delta and omicron, which currently account for a large number of cases.” “Therefore, the results of this study do not support the use of bamlanivimab in the clinical setting until further evidence is available to guide the selection of patients who may benefit from therapy,” he explained.

“The possible benefit of bamlanivimab does not outweigh the risks in patients hospitalized with COVID-19,” he concluded.

Dr. Pal emphasized the need for larger prospective studies to establish whether bamlanivimab may have benefits in a subgroup of patients, but “well-validated point-of-care tests to identify such patients need to be readily available before this therapy can be considered by clinicians at the bedside,” he concluded.

Diligent screening required before use

Monoclonal antibody treatment has been administered to individuals with diagnosis of COVID-19 infection as outpatients as well as for hospitalized inpatients, said Noel Deep, MD, an internist in Antigo, Wisc., in an interview. “This study is important because it helps physicians and health care institutions to evaluate whether continued use of the monoclonal antibodies would be beneficial and, if so, in what patient populations,” he said.

The findings present interesting implications for the care of COVID-19 patients, said Dr. Deep. “This study indicates that bamlanivimab does not provide the benefit that was initially envisioned when the monoclonal antibody infusions were initially initiated in the treatment of COVID-19 infections. “Serological screening of the patients would help to identify that subgroup of individuals who could benefit from this monoclonal antibody rather than administering it to every COVID-19–positive individual,” he explained.

However, “it is important to note that the emergency use authorization (EUA) for single-agent bamlanivimab has been revoked,” Dr. Deep said.

“The potential benefits of bamlanivimab can be realized only if adequate attention is paid to identifying the appropriate candidates based on serological screening, and administering bamlanivimab to those who are already producing endogenous antibodies could lead to increased risk to those individuals,” he said. Dr. Deep added that he would favor administration of bamlanivimab “in those appropriately screened and eligible candidates, and it is my opinion that the benefits outweigh the risks in those individuals.”

Although the EUA for single-agent bamlanivimab has been revoked, “alternative monoclonal antibody therapies remain available under EUA, including REGEN-COV (casirivimab and imdevimab, administered together), and bamlanivimab and etesevimab administered together, for the same uses as previously authorized for bamlanivimab alone,” Dr. Deep said. “The FDA believes that these alternative monoclonal antibody therapies remain appropriate to treat patients with COVID-19, and I would like to see some data about the benefits and risks of these agents,” he noted.

Limitations, funding, and disclosures

The main limitation of the study was the small size and the fact that it was a subgroup analysis of a trial that ended early because of futility, the researchers wrote. However, the Therapeutics for Inpatients With COVID-19 (TICO) platform will proceed with clinical evaluation of additional COVID-19 treatments, they said.

The study was supported primarily by the U.S. government Operation Warp Speed and the National Institute of Allergy and Infectious Diseases. Other funding sources included the Division of Clinical Research and Leidos Biomedical Research for the INSIGHT (International Network for Strategic Initiatives in Global HIV Trials) Network, as well as an agreement between the National Heart, Lung, and Blood Institute and the Research Triangle Institute for the PETAL (Prevention & Early Treatment of Acute Lung Injury) Network and CTSN (Cardiothoracic Surgical Trials Network). Other support came from the U.S. Department of Veterans Affairs and the governments of Denmark (National Research Foundation), Australia (National Health and Medical Research Council), and the United Kingdom (Medical Research Council).

The medications used in the study were donated by Gilead Sciences and Eli Lilly.

The researchers had no financial conflicts do disclose. Dr. Deep and Dr. Pal had no relevant financial conflicts to disclose.

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]

New COVID-19 vaccinations in children were down by almost 24% in the last week as new cases rose by just 3.5%, based on new data.

That fairly low number suggests the latest case count from the American Academy of Pediatrics and the Children’s Hospital Association has not caught up yet to the reality of the Omicron variant, which has sent new cases climbing among all ages and now represents the majority of COVID-19 infections nationwide, the Centers for Disease Control and Prevention said.

Meanwhile, in the midst of the latest surge, the United States just passed yet another sobering COVID milestone: 1,000 deaths in children aged 17 and under. The total as of Dec. 20 was 1,015, according to the CDC, with the largest share, almost 32%, occurring in children less than 5 years of age.

The 3.5% increase in child cases brought the total to nearly 170,000 for the week of Dec. 10-16, the fifth such rise in the last 6 weeks and the 19th consecutive week with a count of over 100,000 dating back to mid-August. Regionally, the majority of that increase came in the Northeast, with a small rise in the South and decreases in the Midwest and West, the AAP and CHA said in their weekly COVID report.

At the state level, the largest percent increases in cases over the past 2 weeks were seen in Maine and New Hampshire, as well as Vermont, which has the nation’s highest vaccination rates for children aged 5-11 (51%) and 12-17 (84%), the AAP said in its vaccination trends report.

Nationally, new COVID vaccinations in children continue to trend downward. The number of children aged 5-17 years who had received at least one dose increased by about 498,000 for the week of Dec. 13-19, down from 654,000 (–23.9%) the previous week. Children aged 5-11 years still represented the largest share (22.7%) of all vaccine initiators in the last 2 weeks, but that proportion was 42.8% just before Thanksgiving, according to data from the CDC.

On a more positive note, children aged 5-11 made up 51% of all Americans who completed the vaccine regimen during the 2 weeks ending Dec. 20. The cumulative completion count is 3.6 million in that age group, along with almost 13.4 million children aged 12-17, and the CDC data show that 6.1 million children aged 5-11 and 15.9 million children aged 12-17 have received at least one dose.

On a less positive note, however, that means almost half (47%) of 12- to 17-year-olds still are not fully vaccinated and that over a third (37%) have received no vaccine at all, according to the COVID Data Tracker.

[email protected]