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TB prevention in people with HIV: How short can we go?

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Fri, 08/27/2021 - 14:29

 

A 3-month, 12-dose regimen of rifapentine and isoniazid (INH) was less toxic, had better compliance, and showed similar efficacy as 6 months of INH alone in preventing tuberculosis (TB) in people with HIV, according to the results of a clinical trial reported in Annals of Internal Medicine.

The study, a randomized pragmatic trial in South Africa, Ethiopia, and Mozambique, was called WHIP3TB (Weekly High Dose Isoniazid and Rifapentine [P] Periodic Prophylaxis for TB).

Investigators randomized patients to three groups, comparing a 3-month course of weekly rifapentine-INH, given either once or repeated in a year, with daily isoniazid for 6 months. At 1 year, 90% of the rifapentine-INH group (3HP) were still on therapy, compared with only 50.5% in the INH group.

In the study, patients were initially assessed for TB using the World Health Organization four-symptom screen, but the sensitivity in HIV patients on antiretrovirals (ARVs) was only 53%. In addition to symptoms, screening at 12 months included a chest x-ray and sputum culture.

Of the 30 patients at month 12 with confirmed TB, 26 were asymptomatic, suggesting physicians should do further evaluation prior to initiating preventive TB treatment (which was not part of the WHO recommendation when the study was initiated).

Another unexpected finding was that 10.2% of the TB cases detected in the combined 3HP groups in South Africa, along with 18% of the cases in Mozambique, had rifampin resistance.

Investigator Gavin Churchyard, MBBCh, PhD, CEO of the Aurum Institute in Johannesburg, South Africa, said in an interview: “It appeared that taking this potent short course regimen – they’re just taking a single course – provided the same level of protection as taking repeat courses of the antibiotics. So that’s good news.” He noted, too, that TB transmission rates have been declining in sub-Saharan Africa because of ARV, and “so it may just be that a single course is now adequate because the risk of exposure and reinfection” is decreasing.

But Madhu Pai, MD, PhD, associate director, McGill International TB Centre, Montreal, who was not involved in the study, shared a more cautious interpretation. He said in an interview that the 2020 WHO Consolidated Guidelines on Tuberculosis state: “In settings with high TB transmission, adults and adolescents living with HIV ... should receive at least 36 months of daily isoniazid preventive therapy (IPT) ... whether or not the person is on ART.” The problem is that almost no one can tolerate prolonged therapy with INH because of side effects, as has been shown in numerous studies.

For successful TB treatment, Dr. Pai said, “Even 3HP is not going to cut it; they’re going to get reinfected again. So that shortening of that 36 months is what this trial is really all about, in terms of new information ... and they were not successful.” But because this is still the most practical course, Dr. Pai suggests that follow-up monitoring for reinfection will be the most likely path forward.

Dr. Churchyard concluded: “If we wanted to end the global TB epidemic, we need to continue to find ways to further reduce the risk of TB overall at a population level, and then amongst high-risk groups such as people with HIV, including those on ARVs, and who have had a course of preventive therapy. ... We need to look for other strategies to further reduce that risk. Part of those strategies may be doing a more intensive screen. But also, it may be adding another intervention, particularly TB vaccines. ... No single intervention by itself will adequately address the risk of TB in people with HIV in these high TB transmission settings.”

Dr. Pai reported no relevant financial relationships. Dr. Churchyard has reported participation in a Sanofi advisory committee on the prevention of TB. Judy Stone, MD, is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research.”

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

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A 3-month, 12-dose regimen of rifapentine and isoniazid (INH) was less toxic, had better compliance, and showed similar efficacy as 6 months of INH alone in preventing tuberculosis (TB) in people with HIV, according to the results of a clinical trial reported in Annals of Internal Medicine.

The study, a randomized pragmatic trial in South Africa, Ethiopia, and Mozambique, was called WHIP3TB (Weekly High Dose Isoniazid and Rifapentine [P] Periodic Prophylaxis for TB).

Investigators randomized patients to three groups, comparing a 3-month course of weekly rifapentine-INH, given either once or repeated in a year, with daily isoniazid for 6 months. At 1 year, 90% of the rifapentine-INH group (3HP) were still on therapy, compared with only 50.5% in the INH group.

In the study, patients were initially assessed for TB using the World Health Organization four-symptom screen, but the sensitivity in HIV patients on antiretrovirals (ARVs) was only 53%. In addition to symptoms, screening at 12 months included a chest x-ray and sputum culture.

Of the 30 patients at month 12 with confirmed TB, 26 were asymptomatic, suggesting physicians should do further evaluation prior to initiating preventive TB treatment (which was not part of the WHO recommendation when the study was initiated).

Another unexpected finding was that 10.2% of the TB cases detected in the combined 3HP groups in South Africa, along with 18% of the cases in Mozambique, had rifampin resistance.

Investigator Gavin Churchyard, MBBCh, PhD, CEO of the Aurum Institute in Johannesburg, South Africa, said in an interview: “It appeared that taking this potent short course regimen – they’re just taking a single course – provided the same level of protection as taking repeat courses of the antibiotics. So that’s good news.” He noted, too, that TB transmission rates have been declining in sub-Saharan Africa because of ARV, and “so it may just be that a single course is now adequate because the risk of exposure and reinfection” is decreasing.

But Madhu Pai, MD, PhD, associate director, McGill International TB Centre, Montreal, who was not involved in the study, shared a more cautious interpretation. He said in an interview that the 2020 WHO Consolidated Guidelines on Tuberculosis state: “In settings with high TB transmission, adults and adolescents living with HIV ... should receive at least 36 months of daily isoniazid preventive therapy (IPT) ... whether or not the person is on ART.” The problem is that almost no one can tolerate prolonged therapy with INH because of side effects, as has been shown in numerous studies.

For successful TB treatment, Dr. Pai said, “Even 3HP is not going to cut it; they’re going to get reinfected again. So that shortening of that 36 months is what this trial is really all about, in terms of new information ... and they were not successful.” But because this is still the most practical course, Dr. Pai suggests that follow-up monitoring for reinfection will be the most likely path forward.

Dr. Churchyard concluded: “If we wanted to end the global TB epidemic, we need to continue to find ways to further reduce the risk of TB overall at a population level, and then amongst high-risk groups such as people with HIV, including those on ARVs, and who have had a course of preventive therapy. ... We need to look for other strategies to further reduce that risk. Part of those strategies may be doing a more intensive screen. But also, it may be adding another intervention, particularly TB vaccines. ... No single intervention by itself will adequately address the risk of TB in people with HIV in these high TB transmission settings.”

Dr. Pai reported no relevant financial relationships. Dr. Churchyard has reported participation in a Sanofi advisory committee on the prevention of TB. Judy Stone, MD, is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research.”

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

 

A 3-month, 12-dose regimen of rifapentine and isoniazid (INH) was less toxic, had better compliance, and showed similar efficacy as 6 months of INH alone in preventing tuberculosis (TB) in people with HIV, according to the results of a clinical trial reported in Annals of Internal Medicine.

The study, a randomized pragmatic trial in South Africa, Ethiopia, and Mozambique, was called WHIP3TB (Weekly High Dose Isoniazid and Rifapentine [P] Periodic Prophylaxis for TB).

Investigators randomized patients to three groups, comparing a 3-month course of weekly rifapentine-INH, given either once or repeated in a year, with daily isoniazid for 6 months. At 1 year, 90% of the rifapentine-INH group (3HP) were still on therapy, compared with only 50.5% in the INH group.

In the study, patients were initially assessed for TB using the World Health Organization four-symptom screen, but the sensitivity in HIV patients on antiretrovirals (ARVs) was only 53%. In addition to symptoms, screening at 12 months included a chest x-ray and sputum culture.

Of the 30 patients at month 12 with confirmed TB, 26 were asymptomatic, suggesting physicians should do further evaluation prior to initiating preventive TB treatment (which was not part of the WHO recommendation when the study was initiated).

Another unexpected finding was that 10.2% of the TB cases detected in the combined 3HP groups in South Africa, along with 18% of the cases in Mozambique, had rifampin resistance.

Investigator Gavin Churchyard, MBBCh, PhD, CEO of the Aurum Institute in Johannesburg, South Africa, said in an interview: “It appeared that taking this potent short course regimen – they’re just taking a single course – provided the same level of protection as taking repeat courses of the antibiotics. So that’s good news.” He noted, too, that TB transmission rates have been declining in sub-Saharan Africa because of ARV, and “so it may just be that a single course is now adequate because the risk of exposure and reinfection” is decreasing.

But Madhu Pai, MD, PhD, associate director, McGill International TB Centre, Montreal, who was not involved in the study, shared a more cautious interpretation. He said in an interview that the 2020 WHO Consolidated Guidelines on Tuberculosis state: “In settings with high TB transmission, adults and adolescents living with HIV ... should receive at least 36 months of daily isoniazid preventive therapy (IPT) ... whether or not the person is on ART.” The problem is that almost no one can tolerate prolonged therapy with INH because of side effects, as has been shown in numerous studies.

For successful TB treatment, Dr. Pai said, “Even 3HP is not going to cut it; they’re going to get reinfected again. So that shortening of that 36 months is what this trial is really all about, in terms of new information ... and they were not successful.” But because this is still the most practical course, Dr. Pai suggests that follow-up monitoring for reinfection will be the most likely path forward.

Dr. Churchyard concluded: “If we wanted to end the global TB epidemic, we need to continue to find ways to further reduce the risk of TB overall at a population level, and then amongst high-risk groups such as people with HIV, including those on ARVs, and who have had a course of preventive therapy. ... We need to look for other strategies to further reduce that risk. Part of those strategies may be doing a more intensive screen. But also, it may be adding another intervention, particularly TB vaccines. ... No single intervention by itself will adequately address the risk of TB in people with HIV in these high TB transmission settings.”

Dr. Pai reported no relevant financial relationships. Dr. Churchyard has reported participation in a Sanofi advisory committee on the prevention of TB. Judy Stone, MD, is an infectious disease specialist and author of “Resilience: One Family’s Story of Hope and Triumph Over Evil” and of “Conducting Clinical Research.”

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

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Vax campaign averted nearly 140,000 U.S. deaths through early May: Study

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Thu, 08/26/2021 - 15:43

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

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From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

From mid-December 2020 through early May 2021, there were 139,393 fewer deaths from COVID-19 and about 3.1 million fewer confirmed cases in the United States than would have been expected without the COVID-19 vaccination campaign, finds a new report published online in Health Affairs.

New York had 11.7 fewer COVID-19 deaths per 10,000 adults, and Hawaii had 1.1 fewer deaths per 10,000 than would have occurred without vaccinations, the study shows. The rest of the states fell somewhere in between, with the average state experiencing five fewer COVID-19 deaths per 10,000 adults.

At a national level, this means that instead of the 550,000 COVID-19 deaths that occurred by early May, there would have been 709,000 deaths in the absence of a vaccination campaign, according to the study.

Researchers from RAND and Indiana University created models to estimate the number of COVID-19 deaths that would have happened without vaccinations. The difference between the actual number of deaths and those estimates provides a measure of the number of COVID-19 deaths averted by the vaccination campaign.

Information about vaccine doses administered in each state came from the Bloomberg COVID-19 Vaccine Tracker, and data on COVID-19 deaths for each state came from The New York Times’ Coronavirus (COVID-19) Data in the United States database.

The study spanned the period from Dec. 21, 2020 to May 9, 2021. The U.S. Food and Drug Administration issued its first emergency use authorization (EUA) for a COVID-19 vaccine to Pfizer/BioNTech on December 11, followed by an EUA for the Moderna vaccine on December 18 and one for Johnson & Johnson’s vaccine on Feb. 27, 2021.
 

Varied by state

There were wide variations in the speed and extent of the vaccination campaigns in various states, the researchers found. For example, West Virginia was the first state to reach 10 doses per 100 adults, reaching that goal on Jan. 16, 2021, and Idaho was the last state to hit that mark, on Feb. 4, 2021. Alaska was the first to reach 20 doses per 100 adults, on January 29, and Alabama was the last to do it, on February 21.

On May 6, California was the first state to administer 120 doses per 100 adults, but many states have still not reached that milestone.

The median number of days between the milestones of 10 and 20 doses per 100 adults was 19 days, and the median number of days between 20 and 40 doses per 100 adults was 24 days.
 

Hard to establish causality

The researchers emphasized that “establishment of causality is challenging” in comparing individual states’ vaccination levels with their COVID-19 mortality rates.

Aside from the study being observational, they pointed out, the analysis “relied on variation in the administration of COVID-19 vaccines across states … Vaccine administration patterns may be associated with declining mortality because of vaccine prevention of deaths and severe complications as state-level vaccine campaigns allocated initial doses to the highest-risk populations with the aim of immediately reducing COVID-19 deaths.”

Nevertheless, the authors note, “clinical trial evidence has shown that COVID-19 vaccines have high efficacy. Our study provides support for policies that further expand vaccine administration, which will enable larger populations to benefit.”
 

 

 

Study confirms vaccine benefit

Aaron Glatt, MD, chair of medicine at Mount Sinai South Nassau in Oceanside, New York, and a spokesman for the Infectious Disease Society of America, said in an interview that the study is important because it confirms the benefit of COVID-19 vaccination.

Regardless of whether the study’s results are statistically valid, he said, “I don’t think anyone can argue the benefit isn’t there. It’s a question of how important the benefit is.”

Dr. Glatt is not surprised that there are variations across states in the number of COVID-19 deaths averted through vaccination. “Clearly, in states where there was a lot of disease, a significant amount of vaccination is going to impact that tremendously.”

The authors note that their paper has some limitations. For one thing, they couldn’t determine what share of the estimated reduction in COVID-19 deaths was a result of the proportion of the population that was vaccinated or had antibodies and what share was a result of lower population-level risk for COVID-19 transmission.
 

Vaccination versus natural immunity

In addition, the researchers weren’t able to identify the roles of vaccination, natural immunity, and changes in mobility in the numbers of COVID-19 deaths.

Dr. Glatt says that’s understandable, since this was a retrospective study, and the researchers didn’t know how many people had been infected with COVID-19 at some point. Moreover, he adds, scientists don’t know how strong natural immunity from prior infection is, how long it endures, or how robust it is against new variants.

“It’s clear to me that there’s a benefit in preventing the second episode of COVID in people who had a first episode of COVID,” he said. “What we don’t know is how much that benefit is and how long it will last.”

The researchers also didn’t know how many people had gotten both doses of the Pfizer or the Moderna vaccine and how many of them had received only one. This is an important piece of information, Dr. Glatt said, but the lack of it doesn’t impair the study’s overall finding.

“Every vaccine potentially prevents death,” he stressed. “The more we vaccinate, the more deaths we’ll prevent. We’re starting to see increased vaccinations again. There were a million of them yesterday. So people are recognizing that COVID hasn’t gone away, and we need to vaccinate more people. The benefit from the vaccination hasn’t decreased. The more we vaccinate, the more the benefit will be.”

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

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COVID-19 mitigation measures led to shifts in typical annual respiratory virus patterns

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Thu, 08/26/2021 - 15:43

Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

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

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Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

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

Nonpharmaceutical interventions, such as masking, staying home, limiting travel, and social distancing, have been doing more than reducing the risk for COVID-19. They’re also having an impact on infection rates and the timing of seasonal surges of other common respiratory diseases, according to an article published July 23 in Morbidity and Mortality Weekly Report.

Typically, respiratory pathogens such as respiratory syncytial virus (RSV), common cold coronaviruses, parainfluenza viruses, and respiratory adenoviruses increase in the fall and remain high throughout winter, following the same basic patterns as influenza. Although the historically low rates of influenza remained low into spring 2021, that’s not the case for several other common respiratory viruses.

“Clinicians should be aware of increases in some respiratory virus activity and remain vigilant for off-season increases,” wrote Sonja J. Olsen, PhD, and her colleagues at the Centers for Disease Control and Prevention. She told this news organization that clinicians should use multipathogen testing to help guide treatment.

The authors also underscore the importance of fall influenza vaccination campaigns for anyone aged 6 months or older.

Timothy Brewer, MD, MPH, a professor of medicine in the Division of Infectious Diseases at the University of California, Los Angeles (UCLA), and of epidemiology at the UCLA Fielding School of Public Health, agreed that it’s important for health care professionals to consider off-season illnesses in their patients.

“Practitioners should be aware that if they see a sick child in the summer, outside of what normally might be influenza season, but they look like they have influenza, consider potentially influenza and test for it, because it might be possible that we may have disrupted that natural pattern,” Dr. Brewer told this news organization. Dr. Brewer, who was not involved in the CDC research, said it’s also “critically important” to encourage influenza vaccination as the season approaches.

The CDC researchers used the U.S. World Health Organization Collaborating Laboratories System and the CDC’s National Respiratory and Enteric Virus Surveillance System to analyze virologic data from Oct. 3, 2020, to May 22, 2021, for influenza and Jan. 4, 2020, to May 22, 2021, for other respiratory viruses. The authors compared virus circulation during these periods to circulation during the same dates from four previous years.

Data to calculate influenza and RSV hospitalization rates came from the Influenza Hospitalization Surveillance Network and RSV Hospitalization Surveillance Network.

The authors report that flu activity dropped dramatically in March 2020 to its lowest levels since 1997, the earliest season for which data are available. Only 0.2% of more than 1 million specimens tested positive for influenza; the rate of hospitalizations for lab-confirmed flu was 0.8 per 100,000 people. Flu levels remained low through the summer, fall, and on to May 2021.

A potential drawback to this low activity, however, is a more prevalent and severe upcoming flu season, the authors write. The repeated exposure to flu viruses every year often “does not lead to illness, but it does serve to boost our immune response to influenza viruses,” Dr. Olsen said in an interview. “The absence of influenza viruses in the community over the last year means that we are not getting these regular boosts to our immune system. When we finally get exposed, our body may mount a weak response, and this could mean we develop a more clinically severe illness.”

Children are most susceptible to that phenomenon because they haven’t had a lifetime of exposure to flu viruses, Dr. Olsen said.

“An immunologically naive child may be more likely to develop a severe illness than someone who has lived through several influenza seasons,” she said. “This is why it is especially important for everyone 6 months and older to get vaccinated against influenza this season.”

Rhinovirus and enterovirus infections rebounded fairly quickly after their decline in March 2020 and started increasing in May 2020 until they reached “near prepandemic seasonal levels,” the authors write.

RSV infections dropped from 15.3% of weekly positive results in January 2020 to 1.4% by April and then stayed below 1% through the end of 2020. In past years, weekly positive results climbed to 3% in October and peaked at 12.5% to 16.7% in late December. Instead, RSV weekly positive results began increasing in April 2021, rising from 1.1% to 2.8% in May.

The “unusually timed” late spring increase in RSV “is probably associated with various nonpharmaceutical measures that have been in place but are now relaxing,” Dr. Olsen stated.

The RSV hospitalization rate was 0.3 per 100,000 people from October 2020 to April 2021, compared to 27.1 and 33.4 per 100,000 people in the previous 2 years. Of all RSV hospitalizations in the past year, 76.5% occurred in April-May 2021.

Rates of illness caused by the four common human coronaviruses (OC43, NL63, 229E, and HKU1) dropped from 7.5% of weekly positive results in January 2020 to 1.3% in April 2020 and stayed below 1% through February 2021. Then they climbed to 6.6% by May 2021. Infection rates of parainfluenza viruses types 1-4 similarly dropped from 2.6% in January 2020 to 1% in March 2020 and stayed below 1% until April 2021. Since then, rates of the common coronaviruses increased to 6.6% and parainfluenza viruses to 10.9% in May 2021.

Normally, parainfluenza viruses peak in October-November and May-June, so “the current increase could represent a return to prepandemic seasonality,” the authors write.

Human pneumoviruses’ weekly positive results initially increased from 4.2% in January 2020 to 7% in March and then fell to 1.9% the second week of April and remained below 1% through May 2021. In typical years, these viruses peak from 6.2% to 7.7% in March-April. Respiratory adenovirus activity similarly dropped to historically low levels in April 2021 and then began increasing to reach 3% by May 2021, the usual level for that month.

“The different circulation patterns observed across respiratory viruses probably also reflect differences in the virus transmission routes and how effective various nonpharmaceutical measures are at stopping transmission,” Dr. Olsen said in an interview. “As pandemic mitigation measures continue to be adjusted, we expect to see more changes in the circulation of these viruses, including a return to prepandemic circulation, as seen for rhinoviruses and enteroviruses.”

Rhinovirus and enterovirus rates dropped from 14.9% in March 2020 to 3.2% in May – lower than typical – and then climbed to a peak in October 2020. The peak (21.7% weekly positive results) was, however, still lower than the usual median of 32.8%. After dropping to 9.9% in January 2021, it then rose 19.1% in May, potentially reflecting “the usual spring peak that has occurred in previous years,” the authors write.

The authors note that it’s not yet clear how the COVID-19 pandemic and related mitigation measures will continue to affect respiratory virus circulation.

The authors hypothesize that the reasons for a seeming return to seasonal activity of respiratory adenoviruses, rhinoviruses, and enteroviruses could involve “different transmission mechanisms, the role of asymptomatic transmission, and prolonged survival of these nonenveloped viruses on surfaces, all of which might make these viruses less susceptible to nonpharmaceutical interventions.”

Dr. Brewer, of UCLA, agreed.

All the viruses basically “flatline except for adenoviruses and enteroviruses, and they behave a little differently in terms of how they spread,” he said. “Enteroviruses are much more likely to be fecal-oral spread than the other viruses [in the study].”

The delayed circulation of parainfluenza and human coronaviruses may have resulted from suspension of in-person classes through late winter 2020, they write, but that doesn’t explain the relative absence of pneumovirus activity, which usually affects the same young pediatric populations as RSV.

Dr. Brewer said California is seeing a surge of RSV right now, as are many states, especially throughout in the South. He’s not surprised by RSV’s deferred season, because those most affected – children younger than 2 years – are less likely to wear masks now and were “not going to daycare, not being out in public” in 2020. “As people are doing more activities, that’s probably why RSV has been starting to go up since April,” he said.

Despite the fact that, unlike many East Asian cultures, the United States has not traditionally been a mask-wearing culture, Dr. Brewer wouldn’t be surprised if more Americans begin wearing masks during flu season. “Hopefully another thing that will come out of this is better hand hygiene, with people just getting used to washing their hands more, particularly after they come home from being out,” he added.

Dr. Brewer similarly emphasized the importance of flu vaccination for the upcoming season, especially for younger children who may have poorer natural immunity to influenza, owing to its low circulation rates in 2020-2021.

The study was funded by the CDC. Dr. Brewer and Dr. Olsen have disclosed no relevant financial relationships.

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

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Exposure to marijuana smoke linked to increased risk of respiratory infections in children

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Tue, 08/10/2021 - 08:16

Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

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Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

Exposure to secondhand marijuana smoke is more strongly associated with viral respiratory infections in children, compared with children who were exposed to tobacco smoke and those with no smoke exposure, new research shows.

“The findings of this study are interesting and pleasantly raise further questions,” said Kristen Miller, MD, attending physician in the division of pulmonary and sleep medicine at Children’s Hospital of Philadelphia, who was not involved in the study. “Given the robust literature regarding secondhand smoke exposure and the current landscape surrounding marijuana, this is a timely study to evaluate the prevalence of marijuana use and the associated effects of marijuana exposure among children.”

Prior research has linked primary marijuana use with respiratory effects. A 2020 study associated cannabis use with an increased risk of severe bronchitis, lung hyperinflation, and increased central airway resistance. However, according to the Centers for Disease Control and Prevention, there are still a lot of unanswered questions surrounding secondhand marijuana smoke exposure and its effects.

“If kids are exposed to enough secondhand smoke, regardless of what the substance is, they’re going to have some negative health outcomes with it,” study author Adam Johnson, MD, of Wake Forest University, Winston-Salem, N.C., said in an interview.

The study, published in Pediatric Research, looked at rates of reported ED and urgent care visits and specific illnesses – such as otitis media, viral respiratory infections, and asthma exacerbations – among children with marijuana exposure and tobacco exposure.

For the study, Dr. Johnson and colleagues surveyed 1,500 parents and caregivers who went to an academic children’s hospital between Dec. 1, 2015, and July 30, 2017. Researchers found that children exposed to marijuana smoke had higher rates of ED visits at 2.21 within the past 12 months, compared with those exposed to tobacco smoke (2.14 within the past 12 months) and those with no smoke exposure (1.94 within the past 12 months). However, the difference in these visits were not statistically significant.

Researchers saw that children exposed to secondhand marijuana smoke saw a 30% increase in viral respiratory infections, compared with those who were not exposed to tobacco or marijuana smoke, Dr. Johnson said. Caregivers who smoked marijuana reported a rate of 1.31 viral infections in their children within the last year. Meanwhile those who smoked tobacco reported a rate of 1.00 infections within the last 12 months and caregivers who did not smoke reported 1.04 infections within the year.

“It suggests that components in marijuana smoke may depress the body’s immune responses to viral infections in children,” Dr. Miller said in an interview.

When it came to otitis media episodes, children exposed to marijuana had a rate of 0.96 episodes within the past 12 months. Children experiencing secondhand tobacco smoke had a rate of 0.83 episodes and those with no smoke exposure had 0.75 episodes within the past 12 months. Researchers did not note this difference as statistically significant.

When it came to asthma exacerbations, children exposed to marijuana smoke also had statistically insignificantly higher rates of exacerbations, compared with those exposed to tobacco smoke and those not exposed to smoke.

“I think it was surprising that the survey results found that marijuana seemed to be more strongly associated with the viral respiratory infections than tobacco,” Dr. Johnson said. “We know that secondhand tobacco smoke exposure in kids does lead to things like otitis media or ear infections, asthma attacks, and other processes, including colds. It was interesting that we didn’t find that association [in the new study], but we found that with marijuana.”

Dr. Johnson said the findings are especially concerning with increases in the acceptance and accessibility of marijuana as it becomes legalized in many states.

A 2015 study examined the effect of secondhand marijuana smoke exposure. Researchers found that exposure to secondhand marijuana smoke can increase heart rate, have mild to moderate sedative effects and can produce detectable cannabinoid levels in blood and urine. However, another study published in 2012 found that low to moderate primary marijuana use is less harmful to users’ lungs than tobacco exposure.

Dr. Miller added that little is known about how exposure to marijuana smoke can affect the innate responses to pathogens and there is a need to “study this in more detail” to figure out if secondhand marijuana smoke is a risk factor for either an increase in respiratory virus infections or their severity.

“These questions could have considerable implications for the health of our children and public health measures regarding marijuana use,” she explained. “As documented marijuana use increases, health care providers need to be aware of the effects of marijuana use and exposure.”

Neither Dr. Johnson nor Dr. Miller has any relevant financial disclosures.

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Injectable monoclonal antibodies prevent COVID-19 in trial

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Thu, 08/26/2021 - 15:43

 

A combination of two monoclonal antibodies given as a subcutaneous injection prevented COVID-19 in patients at a high risk of infection due to household exposure, according to results of a randomized, double-blind, placebo-controlled clinical trial published online August 4, 2021, in the New England Journal of Medicine.

The cocktail of the monoclonal antibodies casirivimab and imdevimab (REGEN-COV, Regeneron Pharmaceuticals) reduced participants’ relative risk of infection by 72%, compared with placebo within the first week. After the first week, risk reduction increased to 93%.

“Long after you would be exposed by your household, there is an enduring effect that prevents you from community spread,” said David Wohl, MD, professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill, who was a site investigator for the trial but not a study author.

Participants were enrolled within 96 hours after someone in their household tested positive for SARS-CoV-2. Participants were randomly assigned to receive 1,200 mg of REGEN-COV subcutaneously or a placebo. Based on serologic testing, study participants showed no evidence of current or previous SARS-CoV-2 infection. The median age of participants was 42.9, but 45% were male teenagers (ages 12-17).

In the group that received REGEN-COV, 11 out of 753 participants developed symptomatic COVID-19, compared with 59 out of 752 participants who received placebo. The relative risk reduction for the study’s 4-week period was 81.4% (P < .001). Of the participants that did develop a SARS-CoV-2 infection, those that received REGEN-COV were less likely to be symptomatic. Asymptomatic infections developed in 25 participants who received REGEN-COV versus 48 in the placebo group. The relative risk of developing any SARS-CoV-2 infection, symptomatic or asymptomatic, was reduced by 66.4% with REGEN-COV (P < .001).

Among the patients who were symptomatic, symptoms subsided within a median of 1.2 weeks for the group that received REGEN-COV, 2 weeks earlier than the placebo group. These patients also had a shorter duration of a high viral load (>104 copies/mL). Few adverse events were reported in the treatment or placebo groups. Monoclonal antibodies “seem to be incredibly safe,” Dr. Wohl said.

“These monoclonal antibodies have proven they can reduce the viral replication in the nose,” said study author Myron Cohen, MD, an infectious disease specialist and professor of epidemiology at the University of North Carolina.

The Food and Drug Administration first granted REGEN-COV emergency use authorization (EUA) in November 2020 for use in patients with mild or moderate COVID-19 who were also at high risk for progressing to severe COVID-19. At that time, the cocktail of monoclonal antibodies was delivered by a single intravenous infusion.

In January, Regeneron first announced the success of this trial of the subcutaneous injection for exposed household contacts based on early results, and in June of 2021, the FDA expanded the EUA to include a subcutaneous delivery when IV is not feasible. On July 30, the EUA was expanded again to include prophylactic use in exposed patients based on these trial results.

The U.S. government has purchased approximately 1.5 million doses of REGEN-COV from Regeneron and has agreed to make the treatments free of charge to patients.

But despite being free, available, and backed by promising data, monoclonal antibodies as a therapeutic answer to COVID-19 still hasn’t really taken off. “The problem is, it first requires knowledge and awareness,” Dr. Wohl said. “A lot [of people] don’t know this exists. To be honest, vaccination has taken up all the oxygen in the room.”

Dr. Cohen agreed. One reason for the slow uptake may be because the drug supply is owned by the government and not a pharmaceutical company. There hasn’t been a typical marketing push to make physicians and consumers aware. Additionally, “the logistics are daunting,” Dr. Cohen said. The office spaces where many physicians care for patients “often aren’t appropriate for patients who think they have SARS-CoV-2.”

“Right now, there’s not a mechanism” to administer the drug to people who could benefit from it, Dr. Wohl said. Eligible patients are either immunocompromised and unlikely to mount a sufficient immune response with vaccination, or not fully vaccinated. They should have been exposed to an infected individual or have a high likelihood of exposure due to where they live, such as in a prison or nursing home. Local doctors are unlikely to be the primary administrators of the drug, Dr. Wohl added. “How do we operationalize this for people who fit the criteria?”

There’s also an issue of timing. REGEN-COV is most effective when given early, Dr. Cohen said. “[Monoclonal antibodies] really only work well in the replication phase.” Many patients who would be eligible delay care until they’ve had symptoms for several days, when REGEN-COV would no longer have the desired effect.

Eventually, Dr. Wohl suspects demand will increase when people realize REGEN-COV can help those with COVID-19 and those who have been exposed. But before then, “we do have to think about how to integrate this into a workflow people can access without being confused.”

The trial was done before there was widespread vaccination, so it’s unclear what the results mean for people who have been vaccinated. Dr. Cohen and Dr. Wohl said there are ongoing conversations about whether monoclonal antibodies could be complementary to vaccination and if there’s potential for continued monthly use of these therapies.

Cohen and Wohl reported no relevant financial relationships. The trial was supported by Regeneron Pharmaceuticals, F. Hoffmann–La Roche, the National Institute of Allergy and Infectious Diseases, NIH, and the COVID-19 Prevention Network.

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

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A combination of two monoclonal antibodies given as a subcutaneous injection prevented COVID-19 in patients at a high risk of infection due to household exposure, according to results of a randomized, double-blind, placebo-controlled clinical trial published online August 4, 2021, in the New England Journal of Medicine.

The cocktail of the monoclonal antibodies casirivimab and imdevimab (REGEN-COV, Regeneron Pharmaceuticals) reduced participants’ relative risk of infection by 72%, compared with placebo within the first week. After the first week, risk reduction increased to 93%.

“Long after you would be exposed by your household, there is an enduring effect that prevents you from community spread,” said David Wohl, MD, professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill, who was a site investigator for the trial but not a study author.

Participants were enrolled within 96 hours after someone in their household tested positive for SARS-CoV-2. Participants were randomly assigned to receive 1,200 mg of REGEN-COV subcutaneously or a placebo. Based on serologic testing, study participants showed no evidence of current or previous SARS-CoV-2 infection. The median age of participants was 42.9, but 45% were male teenagers (ages 12-17).

In the group that received REGEN-COV, 11 out of 753 participants developed symptomatic COVID-19, compared with 59 out of 752 participants who received placebo. The relative risk reduction for the study’s 4-week period was 81.4% (P < .001). Of the participants that did develop a SARS-CoV-2 infection, those that received REGEN-COV were less likely to be symptomatic. Asymptomatic infections developed in 25 participants who received REGEN-COV versus 48 in the placebo group. The relative risk of developing any SARS-CoV-2 infection, symptomatic or asymptomatic, was reduced by 66.4% with REGEN-COV (P < .001).

Among the patients who were symptomatic, symptoms subsided within a median of 1.2 weeks for the group that received REGEN-COV, 2 weeks earlier than the placebo group. These patients also had a shorter duration of a high viral load (>104 copies/mL). Few adverse events were reported in the treatment or placebo groups. Monoclonal antibodies “seem to be incredibly safe,” Dr. Wohl said.

“These monoclonal antibodies have proven they can reduce the viral replication in the nose,” said study author Myron Cohen, MD, an infectious disease specialist and professor of epidemiology at the University of North Carolina.

The Food and Drug Administration first granted REGEN-COV emergency use authorization (EUA) in November 2020 for use in patients with mild or moderate COVID-19 who were also at high risk for progressing to severe COVID-19. At that time, the cocktail of monoclonal antibodies was delivered by a single intravenous infusion.

In January, Regeneron first announced the success of this trial of the subcutaneous injection for exposed household contacts based on early results, and in June of 2021, the FDA expanded the EUA to include a subcutaneous delivery when IV is not feasible. On July 30, the EUA was expanded again to include prophylactic use in exposed patients based on these trial results.

The U.S. government has purchased approximately 1.5 million doses of REGEN-COV from Regeneron and has agreed to make the treatments free of charge to patients.

But despite being free, available, and backed by promising data, monoclonal antibodies as a therapeutic answer to COVID-19 still hasn’t really taken off. “The problem is, it first requires knowledge and awareness,” Dr. Wohl said. “A lot [of people] don’t know this exists. To be honest, vaccination has taken up all the oxygen in the room.”

Dr. Cohen agreed. One reason for the slow uptake may be because the drug supply is owned by the government and not a pharmaceutical company. There hasn’t been a typical marketing push to make physicians and consumers aware. Additionally, “the logistics are daunting,” Dr. Cohen said. The office spaces where many physicians care for patients “often aren’t appropriate for patients who think they have SARS-CoV-2.”

“Right now, there’s not a mechanism” to administer the drug to people who could benefit from it, Dr. Wohl said. Eligible patients are either immunocompromised and unlikely to mount a sufficient immune response with vaccination, or not fully vaccinated. They should have been exposed to an infected individual or have a high likelihood of exposure due to where they live, such as in a prison or nursing home. Local doctors are unlikely to be the primary administrators of the drug, Dr. Wohl added. “How do we operationalize this for people who fit the criteria?”

There’s also an issue of timing. REGEN-COV is most effective when given early, Dr. Cohen said. “[Monoclonal antibodies] really only work well in the replication phase.” Many patients who would be eligible delay care until they’ve had symptoms for several days, when REGEN-COV would no longer have the desired effect.

Eventually, Dr. Wohl suspects demand will increase when people realize REGEN-COV can help those with COVID-19 and those who have been exposed. But before then, “we do have to think about how to integrate this into a workflow people can access without being confused.”

The trial was done before there was widespread vaccination, so it’s unclear what the results mean for people who have been vaccinated. Dr. Cohen and Dr. Wohl said there are ongoing conversations about whether monoclonal antibodies could be complementary to vaccination and if there’s potential for continued monthly use of these therapies.

Cohen and Wohl reported no relevant financial relationships. The trial was supported by Regeneron Pharmaceuticals, F. Hoffmann–La Roche, the National Institute of Allergy and Infectious Diseases, NIH, and the COVID-19 Prevention Network.

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

 

A combination of two monoclonal antibodies given as a subcutaneous injection prevented COVID-19 in patients at a high risk of infection due to household exposure, according to results of a randomized, double-blind, placebo-controlled clinical trial published online August 4, 2021, in the New England Journal of Medicine.

The cocktail of the monoclonal antibodies casirivimab and imdevimab (REGEN-COV, Regeneron Pharmaceuticals) reduced participants’ relative risk of infection by 72%, compared with placebo within the first week. After the first week, risk reduction increased to 93%.

“Long after you would be exposed by your household, there is an enduring effect that prevents you from community spread,” said David Wohl, MD, professor of medicine in the division of infectious diseases at the University of North Carolina at Chapel Hill, who was a site investigator for the trial but not a study author.

Participants were enrolled within 96 hours after someone in their household tested positive for SARS-CoV-2. Participants were randomly assigned to receive 1,200 mg of REGEN-COV subcutaneously or a placebo. Based on serologic testing, study participants showed no evidence of current or previous SARS-CoV-2 infection. The median age of participants was 42.9, but 45% were male teenagers (ages 12-17).

In the group that received REGEN-COV, 11 out of 753 participants developed symptomatic COVID-19, compared with 59 out of 752 participants who received placebo. The relative risk reduction for the study’s 4-week period was 81.4% (P < .001). Of the participants that did develop a SARS-CoV-2 infection, those that received REGEN-COV were less likely to be symptomatic. Asymptomatic infections developed in 25 participants who received REGEN-COV versus 48 in the placebo group. The relative risk of developing any SARS-CoV-2 infection, symptomatic or asymptomatic, was reduced by 66.4% with REGEN-COV (P < .001).

Among the patients who were symptomatic, symptoms subsided within a median of 1.2 weeks for the group that received REGEN-COV, 2 weeks earlier than the placebo group. These patients also had a shorter duration of a high viral load (>104 copies/mL). Few adverse events were reported in the treatment or placebo groups. Monoclonal antibodies “seem to be incredibly safe,” Dr. Wohl said.

“These monoclonal antibodies have proven they can reduce the viral replication in the nose,” said study author Myron Cohen, MD, an infectious disease specialist and professor of epidemiology at the University of North Carolina.

The Food and Drug Administration first granted REGEN-COV emergency use authorization (EUA) in November 2020 for use in patients with mild or moderate COVID-19 who were also at high risk for progressing to severe COVID-19. At that time, the cocktail of monoclonal antibodies was delivered by a single intravenous infusion.

In January, Regeneron first announced the success of this trial of the subcutaneous injection for exposed household contacts based on early results, and in June of 2021, the FDA expanded the EUA to include a subcutaneous delivery when IV is not feasible. On July 30, the EUA was expanded again to include prophylactic use in exposed patients based on these trial results.

The U.S. government has purchased approximately 1.5 million doses of REGEN-COV from Regeneron and has agreed to make the treatments free of charge to patients.

But despite being free, available, and backed by promising data, monoclonal antibodies as a therapeutic answer to COVID-19 still hasn’t really taken off. “The problem is, it first requires knowledge and awareness,” Dr. Wohl said. “A lot [of people] don’t know this exists. To be honest, vaccination has taken up all the oxygen in the room.”

Dr. Cohen agreed. One reason for the slow uptake may be because the drug supply is owned by the government and not a pharmaceutical company. There hasn’t been a typical marketing push to make physicians and consumers aware. Additionally, “the logistics are daunting,” Dr. Cohen said. The office spaces where many physicians care for patients “often aren’t appropriate for patients who think they have SARS-CoV-2.”

“Right now, there’s not a mechanism” to administer the drug to people who could benefit from it, Dr. Wohl said. Eligible patients are either immunocompromised and unlikely to mount a sufficient immune response with vaccination, or not fully vaccinated. They should have been exposed to an infected individual or have a high likelihood of exposure due to where they live, such as in a prison or nursing home. Local doctors are unlikely to be the primary administrators of the drug, Dr. Wohl added. “How do we operationalize this for people who fit the criteria?”

There’s also an issue of timing. REGEN-COV is most effective when given early, Dr. Cohen said. “[Monoclonal antibodies] really only work well in the replication phase.” Many patients who would be eligible delay care until they’ve had symptoms for several days, when REGEN-COV would no longer have the desired effect.

Eventually, Dr. Wohl suspects demand will increase when people realize REGEN-COV can help those with COVID-19 and those who have been exposed. But before then, “we do have to think about how to integrate this into a workflow people can access without being confused.”

The trial was done before there was widespread vaccination, so it’s unclear what the results mean for people who have been vaccinated. Dr. Cohen and Dr. Wohl said there are ongoing conversations about whether monoclonal antibodies could be complementary to vaccination and if there’s potential for continued monthly use of these therapies.

Cohen and Wohl reported no relevant financial relationships. The trial was supported by Regeneron Pharmaceuticals, F. Hoffmann–La Roche, the National Institute of Allergy and Infectious Diseases, NIH, and the COVID-19 Prevention Network.

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

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Standard medical mask can protect wearer from aerosols

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Changed
Tue, 07/13/2021 - 09:08

 

A standard medical face mask is more effective at preventing the wearer from inhaling aerosols without causing substantial breathing resistance than various cloth, medical, or respirator masks, new research shows.

“Medical face masks with good filtration efficacies can provide even better protective effects than KN95 respirators,” Christian Sterr, MD, from Philipps University of Marburg (Germany), and colleagues wrote. “FFP2 respirators, on the other hand, could be useful in high-risk situations but require greater breathing effort and therefore physical stress for users.”

Extensive evidence has shown that face masks are an excellent form of source control, preventing infectious people from spreading the SARS-CoV-2 virus into the environment. But evidence has been less clear about how well masks protect the wearer from inhaling particles containing the virus.

The researchers conducted three experiments to test 32 different face masks. The findings were presented at the 31st European Congress of Clinical Microbiology & Infectious Diseases and published online in PLOS One .

First they tested pressure drop, which “relates to how easily air can pass through the material,” said Chris Cappa, PhD, professor of civil and environmental engineering at the University of California, Davis, who was not involved with the study.

“Higher pressure drops mean that there is greater resistance to the air passing through. A higher pressure drop will typically mean breathing through the material will be slightly more challenging, compared to a low pressure drop. There is no relationship between pressure drop and the mask effectiveness,” he said in an interview.

Pressure drop was lowest with type II medical face masks, the typical three-ply surgical masks designed to stop large particles expelled by the wearer from entering the environment, was highest with respirators, including KN95 and FFP2 masks, and varied with the different cloth masks tested.

Next the researchers compared filtration efficacy, which “refers to how well the material removes particles from the air that passes through the mask material,” Dr. Cappa explained. They did this by placing each mask over the opening to an air collector that measured how many particles got through. “A mask that has 100% filtration efficacy will remove all particles from the air that passes through it and 0% means that no particles are removed.”

Cloth masks had the lowest filtration efficacy, at 28%. Certified face masks that met European Standards had a relatively high efficacy, at 70%; for uncertified face masks, filtration efficacy was 63%. As expected, KN95 and FFP2 masks had the highest filtration efficacy, at 94% and 98%, respectively.Finally, the researchers tested as-worn filtration efficacies. They placed each mask on a dummy head with an artificial airway that collected airborne particles. They then pumped a mixture of aerosol particles – ranging in size from 0.3 to 2.0 mcm – and particle-free pressurized air into the air-proof acrylic chamber in which the head was placed.

In this experiment, cloth masks and noncertified face masks were least effective, filtering less than 20% of aerosols. Interestingly, the cloth face mask with the highest filtration on its own (84%) had the lowest filtration efficacy (9%), apparently because of its very high pressure drop (breathing resistance). When more effort is required to breathe through a mask, more air can bypass the filtration system.

 

 



Type II medical face masks, however, filtered 47% of aerosols, KN95 masks filtered 41%, and FFP2 masks filtered 65%. Face shields did not prevent the inhalation of any aerosols.

“We know that face shields will only be effective in stopping very large droplets, essentially visible spittle,” Dr. Cappa explained. “Most of the particles that we exhale will travel right around a face shield.”

The “optimal mask effect is a combination of high filter performance and low filter resistance,” which applies to most of the FFP2 and medical type II face masks tested, Dr. Sterr and colleagues wrote. “The type II medical masks in our random sample showed very good as-worn filtration performances with a low additional work of breathing at the same time.”

Although this study showed how well different masks filtered out particles, it could not assess how well different masks prevent actual infection.

“Like any virus, SARS-CoV-2 can only infect people as long as it is viable,” the researchers wrote. “Moreover, a certain number of viable virus particles need to be inhaled to trigger an infection. Thus, the assessed filtration efficacy may differ from the provided protection rate against SARS-CoV-2.”

In addition, particles containing the virus could dry out while going through the mask and become less infectious. “Even a small reduction in inhaled particles might prevent infection or at least lead to a less severe infection,” they noted.

In fact, filtration efficacy does not necessarily indicate how well the mask filters out particles while being worn. “This might be due to the combined effects of mask fit and pressure drop of the mask material and therefore tendency for mask leakage,” the team wrote. “High pressure drop results in higher breathing resistance and therefore supports leakage, especially if combined to a loosely fitting mask.”

These findings are “in line with what we already knew,” Dr. Cappa explained. “Even if the mask material filters out nearly all particles that pass through it, as is the case for high-efficiency masks such as N95 and FFP2, if the mask does not fit well, then it will only provide moderate protection for the wearer.”

Although the findings reaffirm the different levels of filtration provided by various cloth masks, they do not “provide any guidance on which types of cloth masks are better or worse,” he said. But they do show that “medical face masks will generally provide more protection to the wearer.”

It’s not surprising that face shields offer little protection from aerosols, Dr. Cappa said, but they can provide added protection when worn with a mask.

“A face shield could prevent large droplets that might shoot out when a person coughs or sneezes from depositing on a person’s eye,” he pointed out. And it can help “redirect the plume of particles that an infected person exhales, which could be useful in close quarters. However, even then those particles will keep moving around and could be inhaled. A mask can really help to decrease the amount inhaled.”

The study did not use external funding. The authors and Dr. Cappa disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.
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A standard medical face mask is more effective at preventing the wearer from inhaling aerosols without causing substantial breathing resistance than various cloth, medical, or respirator masks, new research shows.

“Medical face masks with good filtration efficacies can provide even better protective effects than KN95 respirators,” Christian Sterr, MD, from Philipps University of Marburg (Germany), and colleagues wrote. “FFP2 respirators, on the other hand, could be useful in high-risk situations but require greater breathing effort and therefore physical stress for users.”

Extensive evidence has shown that face masks are an excellent form of source control, preventing infectious people from spreading the SARS-CoV-2 virus into the environment. But evidence has been less clear about how well masks protect the wearer from inhaling particles containing the virus.

The researchers conducted three experiments to test 32 different face masks. The findings were presented at the 31st European Congress of Clinical Microbiology & Infectious Diseases and published online in PLOS One .

First they tested pressure drop, which “relates to how easily air can pass through the material,” said Chris Cappa, PhD, professor of civil and environmental engineering at the University of California, Davis, who was not involved with the study.

“Higher pressure drops mean that there is greater resistance to the air passing through. A higher pressure drop will typically mean breathing through the material will be slightly more challenging, compared to a low pressure drop. There is no relationship between pressure drop and the mask effectiveness,” he said in an interview.

Pressure drop was lowest with type II medical face masks, the typical three-ply surgical masks designed to stop large particles expelled by the wearer from entering the environment, was highest with respirators, including KN95 and FFP2 masks, and varied with the different cloth masks tested.

Next the researchers compared filtration efficacy, which “refers to how well the material removes particles from the air that passes through the mask material,” Dr. Cappa explained. They did this by placing each mask over the opening to an air collector that measured how many particles got through. “A mask that has 100% filtration efficacy will remove all particles from the air that passes through it and 0% means that no particles are removed.”

Cloth masks had the lowest filtration efficacy, at 28%. Certified face masks that met European Standards had a relatively high efficacy, at 70%; for uncertified face masks, filtration efficacy was 63%. As expected, KN95 and FFP2 masks had the highest filtration efficacy, at 94% and 98%, respectively.Finally, the researchers tested as-worn filtration efficacies. They placed each mask on a dummy head with an artificial airway that collected airborne particles. They then pumped a mixture of aerosol particles – ranging in size from 0.3 to 2.0 mcm – and particle-free pressurized air into the air-proof acrylic chamber in which the head was placed.

In this experiment, cloth masks and noncertified face masks were least effective, filtering less than 20% of aerosols. Interestingly, the cloth face mask with the highest filtration on its own (84%) had the lowest filtration efficacy (9%), apparently because of its very high pressure drop (breathing resistance). When more effort is required to breathe through a mask, more air can bypass the filtration system.

 

 



Type II medical face masks, however, filtered 47% of aerosols, KN95 masks filtered 41%, and FFP2 masks filtered 65%. Face shields did not prevent the inhalation of any aerosols.

“We know that face shields will only be effective in stopping very large droplets, essentially visible spittle,” Dr. Cappa explained. “Most of the particles that we exhale will travel right around a face shield.”

The “optimal mask effect is a combination of high filter performance and low filter resistance,” which applies to most of the FFP2 and medical type II face masks tested, Dr. Sterr and colleagues wrote. “The type II medical masks in our random sample showed very good as-worn filtration performances with a low additional work of breathing at the same time.”

Although this study showed how well different masks filtered out particles, it could not assess how well different masks prevent actual infection.

“Like any virus, SARS-CoV-2 can only infect people as long as it is viable,” the researchers wrote. “Moreover, a certain number of viable virus particles need to be inhaled to trigger an infection. Thus, the assessed filtration efficacy may differ from the provided protection rate against SARS-CoV-2.”

In addition, particles containing the virus could dry out while going through the mask and become less infectious. “Even a small reduction in inhaled particles might prevent infection or at least lead to a less severe infection,” they noted.

In fact, filtration efficacy does not necessarily indicate how well the mask filters out particles while being worn. “This might be due to the combined effects of mask fit and pressure drop of the mask material and therefore tendency for mask leakage,” the team wrote. “High pressure drop results in higher breathing resistance and therefore supports leakage, especially if combined to a loosely fitting mask.”

These findings are “in line with what we already knew,” Dr. Cappa explained. “Even if the mask material filters out nearly all particles that pass through it, as is the case for high-efficiency masks such as N95 and FFP2, if the mask does not fit well, then it will only provide moderate protection for the wearer.”

Although the findings reaffirm the different levels of filtration provided by various cloth masks, they do not “provide any guidance on which types of cloth masks are better or worse,” he said. But they do show that “medical face masks will generally provide more protection to the wearer.”

It’s not surprising that face shields offer little protection from aerosols, Dr. Cappa said, but they can provide added protection when worn with a mask.

“A face shield could prevent large droplets that might shoot out when a person coughs or sneezes from depositing on a person’s eye,” he pointed out. And it can help “redirect the plume of particles that an infected person exhales, which could be useful in close quarters. However, even then those particles will keep moving around and could be inhaled. A mask can really help to decrease the amount inhaled.”

The study did not use external funding. The authors and Dr. Cappa disclosed no relevant financial relationships.

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

 

A standard medical face mask is more effective at preventing the wearer from inhaling aerosols without causing substantial breathing resistance than various cloth, medical, or respirator masks, new research shows.

“Medical face masks with good filtration efficacies can provide even better protective effects than KN95 respirators,” Christian Sterr, MD, from Philipps University of Marburg (Germany), and colleagues wrote. “FFP2 respirators, on the other hand, could be useful in high-risk situations but require greater breathing effort and therefore physical stress for users.”

Extensive evidence has shown that face masks are an excellent form of source control, preventing infectious people from spreading the SARS-CoV-2 virus into the environment. But evidence has been less clear about how well masks protect the wearer from inhaling particles containing the virus.

The researchers conducted three experiments to test 32 different face masks. The findings were presented at the 31st European Congress of Clinical Microbiology & Infectious Diseases and published online in PLOS One .

First they tested pressure drop, which “relates to how easily air can pass through the material,” said Chris Cappa, PhD, professor of civil and environmental engineering at the University of California, Davis, who was not involved with the study.

“Higher pressure drops mean that there is greater resistance to the air passing through. A higher pressure drop will typically mean breathing through the material will be slightly more challenging, compared to a low pressure drop. There is no relationship between pressure drop and the mask effectiveness,” he said in an interview.

Pressure drop was lowest with type II medical face masks, the typical three-ply surgical masks designed to stop large particles expelled by the wearer from entering the environment, was highest with respirators, including KN95 and FFP2 masks, and varied with the different cloth masks tested.

Next the researchers compared filtration efficacy, which “refers to how well the material removes particles from the air that passes through the mask material,” Dr. Cappa explained. They did this by placing each mask over the opening to an air collector that measured how many particles got through. “A mask that has 100% filtration efficacy will remove all particles from the air that passes through it and 0% means that no particles are removed.”

Cloth masks had the lowest filtration efficacy, at 28%. Certified face masks that met European Standards had a relatively high efficacy, at 70%; for uncertified face masks, filtration efficacy was 63%. As expected, KN95 and FFP2 masks had the highest filtration efficacy, at 94% and 98%, respectively.Finally, the researchers tested as-worn filtration efficacies. They placed each mask on a dummy head with an artificial airway that collected airborne particles. They then pumped a mixture of aerosol particles – ranging in size from 0.3 to 2.0 mcm – and particle-free pressurized air into the air-proof acrylic chamber in which the head was placed.

In this experiment, cloth masks and noncertified face masks were least effective, filtering less than 20% of aerosols. Interestingly, the cloth face mask with the highest filtration on its own (84%) had the lowest filtration efficacy (9%), apparently because of its very high pressure drop (breathing resistance). When more effort is required to breathe through a mask, more air can bypass the filtration system.

 

 



Type II medical face masks, however, filtered 47% of aerosols, KN95 masks filtered 41%, and FFP2 masks filtered 65%. Face shields did not prevent the inhalation of any aerosols.

“We know that face shields will only be effective in stopping very large droplets, essentially visible spittle,” Dr. Cappa explained. “Most of the particles that we exhale will travel right around a face shield.”

The “optimal mask effect is a combination of high filter performance and low filter resistance,” which applies to most of the FFP2 and medical type II face masks tested, Dr. Sterr and colleagues wrote. “The type II medical masks in our random sample showed very good as-worn filtration performances with a low additional work of breathing at the same time.”

Although this study showed how well different masks filtered out particles, it could not assess how well different masks prevent actual infection.

“Like any virus, SARS-CoV-2 can only infect people as long as it is viable,” the researchers wrote. “Moreover, a certain number of viable virus particles need to be inhaled to trigger an infection. Thus, the assessed filtration efficacy may differ from the provided protection rate against SARS-CoV-2.”

In addition, particles containing the virus could dry out while going through the mask and become less infectious. “Even a small reduction in inhaled particles might prevent infection or at least lead to a less severe infection,” they noted.

In fact, filtration efficacy does not necessarily indicate how well the mask filters out particles while being worn. “This might be due to the combined effects of mask fit and pressure drop of the mask material and therefore tendency for mask leakage,” the team wrote. “High pressure drop results in higher breathing resistance and therefore supports leakage, especially if combined to a loosely fitting mask.”

These findings are “in line with what we already knew,” Dr. Cappa explained. “Even if the mask material filters out nearly all particles that pass through it, as is the case for high-efficiency masks such as N95 and FFP2, if the mask does not fit well, then it will only provide moderate protection for the wearer.”

Although the findings reaffirm the different levels of filtration provided by various cloth masks, they do not “provide any guidance on which types of cloth masks are better or worse,” he said. But they do show that “medical face masks will generally provide more protection to the wearer.”

It’s not surprising that face shields offer little protection from aerosols, Dr. Cappa said, but they can provide added protection when worn with a mask.

“A face shield could prevent large droplets that might shoot out when a person coughs or sneezes from depositing on a person’s eye,” he pointed out. And it can help “redirect the plume of particles that an infected person exhales, which could be useful in close quarters. However, even then those particles will keep moving around and could be inhaled. A mask can really help to decrease the amount inhaled.”

The study did not use external funding. The authors and Dr. Cappa disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.
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Texas doctor accused of vaccine theft faces grand jury

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Thu, 08/26/2021 - 15:45

A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

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

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A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

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

A Texas grand jury has declined to indict a former health department doctor who was accused of theft because he took nine doses of Moderna COVID-19 vaccine that were about to expire and gave them to acquaintances and friends.

Hasan Gokal, MD, was fired from his job and charged with theft by a public servant. A judge dismissed the theft charge in January 2021, saying there was no probable cause, but prosecutors took the accusation to the Harris County Grand Jury, which on June 30 decided no prosecution was warranted, the Associated Press reported.

“I came as a practicing ER doctor into public health and as an ER doctor, I err on the side of life and that’s how I chose to make my decision,” Dr. Gokal told the Associated Press. “It was the right thing to do and it meant saving more lives.”

Dr. Gokal, 48, was supervising a COVID-19 vaccination clinic Dec. 29, 2020, in Humble, Tex., when the clinic closed for the day with an open vial containing nine doses of Moderna vaccine, the New York Times reported.

Since the vaccine would expire in 6 hours, Dr. Gokal scrambled to find people with medical conditions who needed vaccinating, he said. He gave the last dose to his wife, who has a lung condition, pulmonary sarcoidosis.

Dr. Gokal said he contacted his supervisor before acting and provided documentation the next day. He was fired for breaking protocol and then charged with theft.

“He abused his position to place his friends and family in line in front of people who had gone through the lawful process to be there,” Harris County District Attorney Kim Ogg said in a January statement. “What he did was illegal and he’ll be held accountable under the law.”

The AP reported that on June 30 the DA’s office issued a statement saying: “We respect the decision of the grand jury in this and every case. Evidence, not public opinion, is the guiding principle of our work.”

The AP said numerous doctors voiced support for Dr. Gokal and that the Texas Medical Board dismissed an investigation against him.

Dr. Gokal told the AP he’d still like to work in public health. Since being fired by the health department, he’s worked part time in the emergency departments at two Houston hospitals.

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

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Antimicrobial resistance threat continues during COVID-19

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The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

 

 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

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The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

 

 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

 

The stark realities of antimicrobial resistance – including rising rates of difficult-to-treat infections, lack of a robust pipeline of future antimicrobials, and COVID-19 treatments that leave people more vulnerable to infections – remain urgent priorities, experts say.

For some patients, the pandemic and antimicrobial resistance (AMR) are intertwined.

“One patient I’m seeing now in service really underscores how the two interact,” Vance Fowler, MD, said during a June 30 media briefing sponsored by the Infectious Diseases Society of America (IDSA). A man in his mid-40s, married with a small child, developed COVID-19 in early January 2021. He was intubated, spent about 1 month in the ICU, and managed to survive.

“But since then he has been struck with a series of progressively more drug resistant bacteria,” said Dr. Fowler, professor of medicine at Duke University, Durham, N.C., and chair of the IDSA Antimicrobial Resistance Committee.

The patient acquired Pseudomonas ventilator-associated pneumonia. Although the infection initially responded to standard antibiotics, he has experienced relapses over the past few months. Through these multiple infections the Pseudomonas grew increasingly pan-resistant to treatment.

The only remaining antimicrobial agent for this patient, Dr. Fowler said, is “a case study in what we are describing ... a drug that is used relatively infrequently, that is fairly expensive, but for that particular patient is absolutely vital.”
 

A ‘terrifying’ personal experience

Tori Kinamon, a Duke University medical student and Food and Drug Administration antibacterial drug resistance fellow, joined Dr. Fowler at the IDSA briefing. She shared her personal journey of surviving a methicillin-resistant Staphylococcus aureus (MRSA) infection, one that sparked her interest in becoming a physician.

“I had a very frightening and unexpected confrontation with antimicrobial resistance when I was a freshman in college,” Ms. Kinamon said.

A few days after competing in a Division One gymnastics championship, she felt a gradual onset of pain in her left hamstring. The pain grew acutely worse and, within days, her leg become red, swollen, and painful to the touch.

Ms. Kinamon was admitted to the hospital for suspected cellulitis and put on intravenous antibiotics.

“However, my clinical condition continued to decline,” she recalled. “Imaging studies revealed a 15-cm abscess deep in my hamstring.”

The limb- and life-threatening infection left her wondering if she would come out of surgery with both legs.

“Ultimately, I had eight surgeries in 2 weeks,” she said.

“As a 19-year-old collegiate athlete, that’s terrifying. And I never imagined that something like that would happen to me – until it did,” said Ms. Kinamon, who is an NCAA infection prevention advocate.

When Ms. Kinamon’s kidneys could no longer tolerate vancomycin, she was switched to daptomycin.

“I reflect quite frequently on how having that one extra drug in the stockpile had a significant impact on my outcome,” she said.
 

 

 

Incentivizing new antimicrobial agents

A lack of new antimicrobials in development is not a new story.

“There’s been a chill that’s been sustained on the antibiotic development field. Most large pharmaceutical companies have left the area of anti-infectants and the bulk of research and development is now in small pharmaceutical companies,” Dr. Fowler said. “And they’re struggling.”

One potential solution is the Pasteur Act, a bipartisan bill reintroduced in Congress and supported by IDSA. The bill encourages pharmaceutical companies to develop new antimicrobial agents with funding not linked to sales or use of the drugs.

Furthermore, the bill emphasizes appropriate use of these agents through effective stewardship programs.

Although some institutions shifted resources away from AMR out of necessity when COVID-19 struck, “I can say certainly from our experience at Duke that at least stewardship was alive and well. It was not relegated to the side,” Dr. Fowler said.

“In fact,” he added, “if anything, COVID really emphasized the importance of stewardship” by helping clinicians with guidance on the use of remdesivir and other antivirals during the pandemic.

Also, in some instances, treatments used to keep people with COVID-19 alive can paradoxically place them at higher risk for other infections, Dr. Fowler said, citing corticosteroids as an example.
 

Everyone’s concern

AMR isn’t just an issue in hospital settings, either. Ms. Kinamon reiterated that she picked up the infection in an athletic environment.

“Antimicrobial resistance is not just a problem for ICU patients in the hospital. I was the healthiest I had ever been and just very nearly escaped death due to one of these infections,” she said. ”As rates of resistance rise as these pathogens become more virulent, AMR is becoming more and more of a community threat,” she added.

Furthermore, consumers are partially to blame as well, Dr. Fowler noted.

“It’s interesting when you look at the surveys of the numbers of patients that have used someone else’s antibiotics” or leftover antimicrobial agents from a prior infection.

“It’s really startling ... that’s the sort of antibiotic overuse that directly contributes to antibacterial resistance,” he said.
 

Reasons for optimism

Promising advances in diagnostics, treatment, and prevention of AMRs are underway, Dr. Fowler said.

“It always gets me really excited to talk about it. It’s amazing what technology and scientific discovery can bring to this discussion and to this threat,” he said.

For example, there is a “silent revolution” in diagnostics with the aim to rapidly provide life-saving actionable data on a real patient in nearly real time.

Traditionally, “you start off by treating what should be there” while awaiting results of tests to narrow down therapy, Dr. Fowler said. However, a whole host of new platforms are in development to reduce the time to susceptibility results. This kind of technology has “the potential to transform our ability to take care of patients, giving them the right drug at the right time and no more,” he said.

Another promising avenue of research involves bacteriophages. Dr. Fowler is principal investigator on a clinical trial underway to evaluate bacteriophages as adjunct therapy for MRSA bacteremia.

When it comes to prevention on AMR infections in the future, “I continue to be optimistic about the possibility of vaccines to prevent many of these infections,” Dr. Fowler said, adding that companies are working on vaccines against these kinds of infections caused by MRSA or Escherichia coli, for example.
 

Patient outcomes

The man in his 40s with the multidrug resistant Pseudomonas infections “is now to the point where he’s walking in the halls and I think he’ll get out of the hospital eventually,” Dr. Fowler said.

“But his life is forever changed,” he added.

Ms. Kinamon’s recovery from MRSA included time in the ICU, 1 month in a regular hospital setting, and 5 months at home.

“It sparked my interest in antibiotic research and development because I see myself as a direct beneficiary of the stockpile of antibiotics that were available to treat my infection,” Ms. Kinamon said. “Now as a medical student working with patients who have similar infections, I feel a deep empathy and connectedness to them because they ask the same questions that I did.”

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

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Tofacitinib shows mortality benefit in patients with COVID-19 pneumonia

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The Janus kinase inhibitor tofacitinib reduces the risk of both death and respiratory failure in hospitalized adults with COVID-19 pneumonia, a new Brazilian study has found.

“Whether the use of JAK inhibitors is superior or additive to other specific immunomodulatory therapies in patients hospitalized with COVID-19 remains to be determined,” Patrícia O. Guimarães, MD, PhD, of the Hospital Israelita Albert Einstein in São Paulo, and coauthors wrote. The study was published in the New England Journal of Medicine.

The results of previous trials that tested JAK inhibitors as therapies for COVID-19 have been mixed. The second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2) found that a combination treatment of baricitinib and the Food and Drug Administration–authorized remdesivir was superior to remdesivir alone, but ACTT-4 – which compared baricitinib plus remdesivir with dexamethasone plus remdesivir – was stopped for futility in April 2021.

To assess the efficacy and safety of tofacitinib as a potential treatment for COVID-19, the researchers launched a randomized, double-blind trial made up of 289 patients from 15 sites in Brazil. The Study of Tofacitinib in Hospitalized Patients with COVID-19 Pneumonia (STOP-COVID) split its participants into two groups: one (n = 144) received 10 mg of oral tofacitinib twice daily and the other (n = 145) received placebo. Treatment was to be administered for up to 14 days or until hospital discharge. The participants’ mean age was 56 years, and 34.9% were women.

Over 89% of participants received glucocorticoids during hospitalization, a significant increase, compared with ACTT-2’s 12%. Through 28 days, death or respiratory failure occurred in 18.1% of the tofacitinib group and in 29.0% of the placebo group (risk ratio, 0.63; 95% confidence interval, 0.41-0.97; P = .04). Death from any cause occurred in 2.8% of the tofacitinib group and 5.5% of the placebo group (hazard ratio, 0.49; 95% CI, 0.15-1.63). The median number of days that treatment was administered was 5 in the tofacitinib group and 6 in the placebo group, and the median duration of hospital and ICU stays were similar across groups.

On the eight-level National Institute of Allergy and Infectious Diseases ordinal scale of disease severity, the proportional odds of having a worse score with tofacitinib, compared with placebo, was 0.6 (95% CI, 0.36-1.00) at day 14 and 0.54 (95% CI, 0.27-1.06) at day 28. Adverse events occurred in 26.1% of the tofacitinib group and 22.5% of the placebo group, with serious adverse events occurring in 20 patients (14.1%) on tofacitinib and 17 patients (12%) on placebo. Patients on tofacitinib suffered from events like deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis, each of which affected one person, while one placebo patient each suffered from hemorrhagic stroke and cardiogenic shock. The incidence of serious infection was 3.5% in the tofacitinib group and 4.2% in the placebo group.
 

Timing may be everything

“There is a lot of interest in repurposing a variety of disease-modifying antirheumatic drugs for the treatment of COVID-19, which includes JAK inhibitors,” Zachary S. Wallace, MD, of the rheumatology unit at Massachusetts General Hospital, Boston, said in an interview. “The ACTT-2 data was compelling; it did suggest perhaps a benefit associated with baricitinib for COVID. This study certainly is more compelling.”

Dr. Zachary Wallace

“For many people, there is this hyperinflammatory response in COVID-19 that seems to drive a lot of the morbidity and mortality that we see,” he added. “I think we all hypothesize that some of our treatments may be beneficial there. The challenge that we face is figuring out when the best time is to administer these medicines, and whether they need to be administered as part of a cocktail of therapy.”

Along those lines, Dr. Wallace cited a recent study he coauthored in which rheumatoid arthritis patients who were on JAK inhibitors at baseline had worse COVID-19 severity. But he emphasized that, despite their differing findings, the two studies are not irreconcilable.

“What this might speak to is, the timing of your exposure may be really important,” he said. “At the time of your initial infection, you may need certain aspects of your immune system that a JAK inhibitor may interfere with. But when you initiate a JAK inhibitor, once that phase is complete and you’re in this hyperinflammatory phase, you may have more benefit to target and treat the intense inflammation that we observe in patients who have COVID.”

He also offered up another variable potentially in play: different JAK inhibitors having different targets among the JAK receptors. “It may be that targeting specific JAKs is more beneficial when it comes to treating the hyperinflammatory response of COVID-19.”

The trial was sponsored by Pfizer. Several authors acknowledged potential conflicts of interest, including receiving grants and personal fees from Pfizer and various other pharmaceutical companies.

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The Janus kinase inhibitor tofacitinib reduces the risk of both death and respiratory failure in hospitalized adults with COVID-19 pneumonia, a new Brazilian study has found.

“Whether the use of JAK inhibitors is superior or additive to other specific immunomodulatory therapies in patients hospitalized with COVID-19 remains to be determined,” Patrícia O. Guimarães, MD, PhD, of the Hospital Israelita Albert Einstein in São Paulo, and coauthors wrote. The study was published in the New England Journal of Medicine.

The results of previous trials that tested JAK inhibitors as therapies for COVID-19 have been mixed. The second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2) found that a combination treatment of baricitinib and the Food and Drug Administration–authorized remdesivir was superior to remdesivir alone, but ACTT-4 – which compared baricitinib plus remdesivir with dexamethasone plus remdesivir – was stopped for futility in April 2021.

To assess the efficacy and safety of tofacitinib as a potential treatment for COVID-19, the researchers launched a randomized, double-blind trial made up of 289 patients from 15 sites in Brazil. The Study of Tofacitinib in Hospitalized Patients with COVID-19 Pneumonia (STOP-COVID) split its participants into two groups: one (n = 144) received 10 mg of oral tofacitinib twice daily and the other (n = 145) received placebo. Treatment was to be administered for up to 14 days or until hospital discharge. The participants’ mean age was 56 years, and 34.9% were women.

Over 89% of participants received glucocorticoids during hospitalization, a significant increase, compared with ACTT-2’s 12%. Through 28 days, death or respiratory failure occurred in 18.1% of the tofacitinib group and in 29.0% of the placebo group (risk ratio, 0.63; 95% confidence interval, 0.41-0.97; P = .04). Death from any cause occurred in 2.8% of the tofacitinib group and 5.5% of the placebo group (hazard ratio, 0.49; 95% CI, 0.15-1.63). The median number of days that treatment was administered was 5 in the tofacitinib group and 6 in the placebo group, and the median duration of hospital and ICU stays were similar across groups.

On the eight-level National Institute of Allergy and Infectious Diseases ordinal scale of disease severity, the proportional odds of having a worse score with tofacitinib, compared with placebo, was 0.6 (95% CI, 0.36-1.00) at day 14 and 0.54 (95% CI, 0.27-1.06) at day 28. Adverse events occurred in 26.1% of the tofacitinib group and 22.5% of the placebo group, with serious adverse events occurring in 20 patients (14.1%) on tofacitinib and 17 patients (12%) on placebo. Patients on tofacitinib suffered from events like deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis, each of which affected one person, while one placebo patient each suffered from hemorrhagic stroke and cardiogenic shock. The incidence of serious infection was 3.5% in the tofacitinib group and 4.2% in the placebo group.
 

Timing may be everything

“There is a lot of interest in repurposing a variety of disease-modifying antirheumatic drugs for the treatment of COVID-19, which includes JAK inhibitors,” Zachary S. Wallace, MD, of the rheumatology unit at Massachusetts General Hospital, Boston, said in an interview. “The ACTT-2 data was compelling; it did suggest perhaps a benefit associated with baricitinib for COVID. This study certainly is more compelling.”

Dr. Zachary Wallace

“For many people, there is this hyperinflammatory response in COVID-19 that seems to drive a lot of the morbidity and mortality that we see,” he added. “I think we all hypothesize that some of our treatments may be beneficial there. The challenge that we face is figuring out when the best time is to administer these medicines, and whether they need to be administered as part of a cocktail of therapy.”

Along those lines, Dr. Wallace cited a recent study he coauthored in which rheumatoid arthritis patients who were on JAK inhibitors at baseline had worse COVID-19 severity. But he emphasized that, despite their differing findings, the two studies are not irreconcilable.

“What this might speak to is, the timing of your exposure may be really important,” he said. “At the time of your initial infection, you may need certain aspects of your immune system that a JAK inhibitor may interfere with. But when you initiate a JAK inhibitor, once that phase is complete and you’re in this hyperinflammatory phase, you may have more benefit to target and treat the intense inflammation that we observe in patients who have COVID.”

He also offered up another variable potentially in play: different JAK inhibitors having different targets among the JAK receptors. “It may be that targeting specific JAKs is more beneficial when it comes to treating the hyperinflammatory response of COVID-19.”

The trial was sponsored by Pfizer. Several authors acknowledged potential conflicts of interest, including receiving grants and personal fees from Pfizer and various other pharmaceutical companies.

 

The Janus kinase inhibitor tofacitinib reduces the risk of both death and respiratory failure in hospitalized adults with COVID-19 pneumonia, a new Brazilian study has found.

“Whether the use of JAK inhibitors is superior or additive to other specific immunomodulatory therapies in patients hospitalized with COVID-19 remains to be determined,” Patrícia O. Guimarães, MD, PhD, of the Hospital Israelita Albert Einstein in São Paulo, and coauthors wrote. The study was published in the New England Journal of Medicine.

The results of previous trials that tested JAK inhibitors as therapies for COVID-19 have been mixed. The second iteration of the Adaptive COVID-19 Treatment Trial (ACTT-2) found that a combination treatment of baricitinib and the Food and Drug Administration–authorized remdesivir was superior to remdesivir alone, but ACTT-4 – which compared baricitinib plus remdesivir with dexamethasone plus remdesivir – was stopped for futility in April 2021.

To assess the efficacy and safety of tofacitinib as a potential treatment for COVID-19, the researchers launched a randomized, double-blind trial made up of 289 patients from 15 sites in Brazil. The Study of Tofacitinib in Hospitalized Patients with COVID-19 Pneumonia (STOP-COVID) split its participants into two groups: one (n = 144) received 10 mg of oral tofacitinib twice daily and the other (n = 145) received placebo. Treatment was to be administered for up to 14 days or until hospital discharge. The participants’ mean age was 56 years, and 34.9% were women.

Over 89% of participants received glucocorticoids during hospitalization, a significant increase, compared with ACTT-2’s 12%. Through 28 days, death or respiratory failure occurred in 18.1% of the tofacitinib group and in 29.0% of the placebo group (risk ratio, 0.63; 95% confidence interval, 0.41-0.97; P = .04). Death from any cause occurred in 2.8% of the tofacitinib group and 5.5% of the placebo group (hazard ratio, 0.49; 95% CI, 0.15-1.63). The median number of days that treatment was administered was 5 in the tofacitinib group and 6 in the placebo group, and the median duration of hospital and ICU stays were similar across groups.

On the eight-level National Institute of Allergy and Infectious Diseases ordinal scale of disease severity, the proportional odds of having a worse score with tofacitinib, compared with placebo, was 0.6 (95% CI, 0.36-1.00) at day 14 and 0.54 (95% CI, 0.27-1.06) at day 28. Adverse events occurred in 26.1% of the tofacitinib group and 22.5% of the placebo group, with serious adverse events occurring in 20 patients (14.1%) on tofacitinib and 17 patients (12%) on placebo. Patients on tofacitinib suffered from events like deep vein thrombosis, acute myocardial infarction, ventricular tachycardia, and myocarditis, each of which affected one person, while one placebo patient each suffered from hemorrhagic stroke and cardiogenic shock. The incidence of serious infection was 3.5% in the tofacitinib group and 4.2% in the placebo group.
 

Timing may be everything

“There is a lot of interest in repurposing a variety of disease-modifying antirheumatic drugs for the treatment of COVID-19, which includes JAK inhibitors,” Zachary S. Wallace, MD, of the rheumatology unit at Massachusetts General Hospital, Boston, said in an interview. “The ACTT-2 data was compelling; it did suggest perhaps a benefit associated with baricitinib for COVID. This study certainly is more compelling.”

Dr. Zachary Wallace

“For many people, there is this hyperinflammatory response in COVID-19 that seems to drive a lot of the morbidity and mortality that we see,” he added. “I think we all hypothesize that some of our treatments may be beneficial there. The challenge that we face is figuring out when the best time is to administer these medicines, and whether they need to be administered as part of a cocktail of therapy.”

Along those lines, Dr. Wallace cited a recent study he coauthored in which rheumatoid arthritis patients who were on JAK inhibitors at baseline had worse COVID-19 severity. But he emphasized that, despite their differing findings, the two studies are not irreconcilable.

“What this might speak to is, the timing of your exposure may be really important,” he said. “At the time of your initial infection, you may need certain aspects of your immune system that a JAK inhibitor may interfere with. But when you initiate a JAK inhibitor, once that phase is complete and you’re in this hyperinflammatory phase, you may have more benefit to target and treat the intense inflammation that we observe in patients who have COVID.”

He also offered up another variable potentially in play: different JAK inhibitors having different targets among the JAK receptors. “It may be that targeting specific JAKs is more beneficial when it comes to treating the hyperinflammatory response of COVID-19.”

The trial was sponsored by Pfizer. Several authors acknowledged potential conflicts of interest, including receiving grants and personal fees from Pfizer and various other pharmaceutical companies.

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Clean indoor air is vital for infection control

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Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

 

 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

 

 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

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Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

 

 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

 

 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

 

Health workers already know that indoor air quality can be as important to human health as clean water and uncontaminated food. But before the COVID-19 pandemic, its importance in the prevention of respiratory illnesses outside of health circles was only whispered about.

Now, a team of nearly 40 scientists from 14 countries is calling for “a paradigm shift,” so that improvements in indoor air quality are viewed as essential to curb respiratory infections.

Most countries do not have indoor air-quality standards, the scientists point out in their recent report, and those that do often fall short in scope and enforcement.

“We expect everywhere in the world to have clean water flowing from our taps. In most parts of the developed world, it is happening and we take it completely for granted,” said lead investigator Lidia Morawska, PhD, of the International Laboratory for Air Quality and Health at the Queensland University of Technology in Brisbane, Australia.

But bacteria and viruses can circulate freely in the air, and “no one thinks about this, whatsoever, apart from health care facilities,” she said.

A first step is to recognize the risk posed by airborne pathogens, something not yet universally acknowledged. The investigators also want the World Health Organization to extend its guidelines to cover airborne pathogens, and for ventilation standards to include higher airflow and filtration rates.

Germany has been at the forefront of air-quality measures, Dr. Morawska said. Years ago, she observed a monitor showing the carbon dioxide level and relative humidity in the room where she was attending a meeting. The screen was accompanied by red, yellow, and green signals to communicate risk. Such indicators are also commonly displayed in German schools so teachers know when to open the windows or adjust the ventilation.
 

Monitors show carbon dioxide levels

But this is not yet being done in most other countries, Dr. Morawska said. Levels of carbon dioxide are one measure of indoor air quality, but they serve as a proxy for ventilation, she pointed out. Although the technology is available, sensors that can test a variety of components in a building in real time are not yet affordable.

Dr. Morawska envisions a future where the air quality numbers of the places people frequent are displayed so they know the risk for airborne transmission of respiratory illnesses. And people can begin to expect clean indoor air when they enter a business, office, or entertainment space and request changes when the air quality dips and improvement is needed, she said.

It is a daunting challenge to clean indoor air for several reasons. Air is not containable in the same way water is, which makes it difficult to trace contaminants. And infections transmitted through dirty water and food are usually evident immediately, whereas infections transmitted through airborne pathogens can take days to develop. Plus, the necessary infrastructure changes will be expensive.

However, the initial cost required to change the flow and quality of indoor air might be less than the cost of infections, the scientists pointed out. It is estimated that the global harm caused by COVID-19 alone costs $1 trillion each month.

“In the United States, the yearly cost – direct and indirect – of influenza has been calculated at $11.2 billion. For respiratory infections other than influenza, the yearly cost stood at $40 billion,” the team noted.

“If even half of this was caused by inhalation, we are still talking about massive costs,” said Dr. Morawska.
 

 

 

Bigger is not always better

It is tempting to see the solution as increased ventilation, said Ehsan Mousavi, PhD, assistant professor of construction science and management at Clemson (S.C.) University, who studies indoor air quality and ventilation in hospitals.

“We are ventilating the heck out of hospitals,” he said in an interview. But there is much debate about how much ventilation is the right amount. Too much and “you can blow pathogens into an open wound,” he explained. “Bigger is not always better.”

And there is still debate about the best mix of outside and recirculated air. An increase in the intake of outdoor air can refresh indoor air if it is clean, but that depends on where you live, he pointed out.

The mix used in most standard office buildings is 15% outside air and 85% recirculated air, Dr. Mousavi said. Boosting the percentage of outside air increases costs and energy use.

In fact, it can take five times more energy to ventilate hospital spaces than office spaces, he reported.

Engineers searching for clean-air solutions need to know what particulates are in the air and whether they are harmful to humans, but the sensors currently available can’t identify whether a virus is present in real time.

Samples have to be taken to a lab and, “by the time you know a virus was in the space, the moment is gone,” Dr. Mousavi explained.

More research is needed. “We need a reasonable answer that looks at the problem holistically, not just from the infectious disease perspective,” he said.
 

Hydrating indoor air

Research is making it clear that health care environments can play a significant role in patient recovery, according to Stephanie Taylor, MD. Dr. Taylor is president of Building4Health, which she founded to help businesses assess the quality of air in their buildings and find solutions. The company uses an algorithm to arrive at a health assessment score.

Air hydration is the most important aspect to target, she said.

Since the 1980s, research has shown that a relative humidity of 40%-60% is healthy for humans, she said. Currently, in an office building in a winter climate, the humidity level is more like 20%.

Canada is the first country to officially recommend the 40%-60% range for senior citizen centers and residential homes.

“Properly hydrated air supports our immune system and prevents skin problems and respiratory problems. It also inactivates many bacteria and viruses,” Dr. Taylor explained. Inhaling dry air compromises the ability of the body to restrict influenza virus infection, researchers showed in a 2019 study.

In the case of COVID-19, as virus particles attach to water molecules, they get bigger and heavier and eventually drop out of the breathing zone and onto surfaces where they can be wiped away, she explained.

But when the particles “are very small – like 5 microns in diameter – and you inhale them, they can lodge deep in the lungs,” she said.

In properly hydrated air, particles will be larger – about 10-20 microns when they attach to the water vapor – so they will get stuck in the nose or the back of the throat, where they can be washed away by mucous and not travel to the lungs.

“Indoor air metrics” can support our health or contribute to disease, “not just over time, but quickly, within minutes or hours,” she said.

No one expects the world’s building stock to suddenly upgrade to the ideal air quality. “But that doesn’t mean we shouldn’t move in that direction,” Dr. Taylor said. Changes can start small and gradually increase.
 

 

 

New research targets indoor air

Humidity is one of the key areas for current research, said Karl Rockne, PhD, director of the environmental engineering program at the National Science Foundation.

“When a virus comes out, it’s not just a naked virus, which is exceptionally small. It’s a virus encapsulated in liquid. And that’s why the humidity is so key. The degree of humidity can determine how fast the water evaporates from the particle,” he said in an interview.

In the wake of COVID-19, his institution is funding more cross-disciplinary research in biology, building science, architecture, and physics, he pointed out.

One such effort involved the development of a sensor that can capture live COVID-19 virus. This so-called “smoking gun,” which proved that the virus can spread through the air, took the combined expertise of professionals in medicine, engineering, and several other disciplines.

Currently, investigators are examining indoor air quality and water supplies in offices that have been left empty during the pandemic, and the effect they will have on human health. And others are looking at the way outside air quality affects indoor air quality, particularly where outdoor air quality is poor, such as in areas experiencing wildfires.

So will COVID-19 be the catalyst that finally drives changes to building design, regulation, and public expectations of air quality in the spaces where we spend close to 90% of our time?

“If not COVID, what else? It affected every country, every sector,” Dr. Morawska said. “There’s enough momentum now to do something about this. And enough realization there is a problem.”
 

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

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