Covid ICYMI

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

Individuals with substance use disorders (SUDs) have a twofold increased risk for COVID-related hospitalization and death even after vaccination, new research shows.

Investigators analyzed data on over 10,000 vaccinated individuals with various SUDs and almost 600,000 vaccinated individuals without an SUD. They found about twice as many individuals with an SUD had a breakthrough COVID-19 infection as their counterparts without an SUD, at 7% versus 3.6%, respectively.

Worrisome phase

SUDs are “often associated with multiple comorbid conditions that are known risk factors for severe outcome of COVID-19 infection,” the investigators note.

Research published early in the pandemic showed patients with SUDs, including alcohol, cannabis, cocaine, opioid, and tobacco use disorders, were “at increased risk for COVID-19 infection and associated severe outcomes, especially among African Americans,” they add.

To date, no research has focused on the potential risk for COVID in individuals with SUDs following vaccination. In addition, although vaccines are “very effective,” breakthrough infections have been recorded, “highlighting the need to identify populations that might be most vulnerable, as we have entered a worrisome new phase of the pandemic,” the authors write.

For the study, researchers used a data analytics platform that included de-identified information from 63 health care organizations across the U.S. to estimate the risk for breakthrough COVID-19 among vaccinated patients with SUD (n = 30,183; mean age 59.3, 51.4% male, 63.2% White, 26.2% African American), compared with vaccinated individuals without SUDs (n = 549,189; mean age 54.7, 43.2% male, 63.4% White, 14.3% African American) between December 2020 and August 2021.

They also conducted statistical analyses to examine how the rate of breakthrough cases changed over that timeframe.

The cohorts were matched by demographics, adverse socioeconomic determinants of health, lifetime medical and psychiatric comorbidities, and vaccine type.

Among vaccinated SUD patients, three-quarters received the Pfizer-BioNTech vaccine, one-fifth received the Moderna vaccine, and 3.3% received the Johnson & Johnson vaccine.

In contrast, among the vaccinated non-SUD population, almost all (88.2%) received the Pfizer-BioNTech vaccine, 10% received Moderna, and only 1.2% received the Johnson & Johnson vaccine.
 

Underlying drivers

The prevalence of adverse socioeconomic determinants of health was higher in vaccinated individuals with SUDs compared to those without (7.9% vs. 1.2%, respectively). Moreover, vaccinated patients with SUD had a higher lifetime prevalence of all comorbidities as well as transplants (all Ps < .001).

The risk for breakthrough infection was significantly higher in vaccinated individuals with SUDs compared to those without (all Ps < .001).

After controlling for adverse socioeconomic determinants of health and comorbid medical conditions, the risk for breakthrough infection “no longer differed in SUD compared to non-SUD cohorts, except for patients with cannabis use disorder, who remained at significantly increased risk,” the authors report.

In both populations, the rate of breakthrough infections “steadily increased” between January and August 2021.

The risk for hospitalization and death was higher among those with breakthrough infections, compared with those in the matched cohort without breakthrough infections, but the risk for hospitalization and death were higher in the SUD compared with the non-SUD population.

In the SUD patients, after matching an array of demographic, socioeconomic, and medical factors as well as vaccine type, only cannabis use disorder was associated with a higher risk in African Americans, compared with matched Caucasians (HR = 1.63; 95% confidence interval, 1.06-2.51).

“When we adjusted the data to account for comorbidities and for socioeconomic background, we no longer saw a difference between those with substance use disorders and those without – the only exception to this was for people with cannabis use disorder,” said Dr. Volkow.

“This suggests that these factors, which are often associated with substance use disorders, are likely the underlying drivers for the increased risk,” she continued.

She added that it is important for other studies to investigate why individuals with cannabis use disorder had a higher risk for breakthrough infections.
 

Good news, bad news

Commenting for this news organization, Anna Lembke, MD, professor of psychiatry and behavioral sciences, Stanford (Calif.) University, said the study is important and contains good news and bad news.

The good news, she said, “is that, after controlling for comorbidities and socioeconomic variables, patients with SUDs are no more likely than patients without SUDs to get COVID after getting vaccinated, and the bad news is that if vaccinated patients with SUDs do get COVID, they’re more likely to end up hospitalized or die from it,” said Dr. Lembke, who was not involved with the study.

“The take-home message for clinicians is that if your vaccinated patient with an SUD gets COVID, be on the alert for a more complicated medical outcome and a higher risk of death,” warned Dr. Lembke.

This study was supported by the U.S. National Institute on Drug Abuse, the U.S. National Institute of Aging, and the Clinical and Translational Science Collaborative (CTSC) of Cleveland. No disclosures were listed on the original study. Dr. Lembke has disclosed no relevant financial relationships.

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

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

COVID-19 has killed Native Americans at twice the rate of White Americans, underscoring the health inequities and deep-rooted distrust tribal nations have of federal government entities.

And yet, Native Americans have the highest vaccination rates of any major racial or ethnic group in the United States. Like many other tribal nations, the Navajo had to embrace Western science to reclaim its social customs and ceremonies. “We’re a very social culture, so having to isolate really impacted our mental health,” said Mary Hasbah Roessel, MD, DLFAPA, a Navajo psychiatrist who is affiliated with Santa Fe Indian Hospital in New Mexico.

The Navajo nation occupies the largest Native American reservation in the United States, spanning New Mexico, Arizona, and Utah. As of mid-October, the nation had reported more than 34,000 COVID-19 cases and 1,400 deaths in its jurisdiction.

In an interview with this news organization, Dr. Roessel described the partnerships that mobilized a nation of more than 250,000 individuals to get vaccinated.

Question: Why has the death rate been so high in the Navajo nation?

Answer: A lot of health disparities before the pandemic were blatantly revealed during COVID. Only 40% of people on the reservation had running water. Having to stay home and isolate led to food insecurity. Further insecurity issues affected our ability to stay healthy, such as having good sanitation. There’s a lot of poverty, a high unemployment rate. Some people had to go to work off reservation and were potentially bringing the virus home. A lot of generations live in the same household. Elders were vulnerable to getting the infection, and there was little ability to isolate if someone wasn’t having symptoms. Hospitals nearby didn’t have ICUs.

Therefore, the rate of cases skyrocketed early on. We were disproportionately affected. The Navajo nation per capita had the highest rate of cases in any state.
 

Q: What changes took place within the Navajo nation to get people vaccinated? What role did the federal Indian Health Service have in promoting this?

A: There had to be a shift in acceptance of the vaccinations. I think what particularly helped the Navajo nation was seeing the IHS rise up and provide access for treatments and vaccinations early on.

With the IHS, we went into a disaster response mode with all-hands-on deck meetings. We had to figure out how we could access mass vaccination clinics. Partnering with the Navajo Department of Health, we did that right away with hospitals and small clinics across the Navajo nation. Casinos owned by tribal entities that closed during COVID reopened and were used as vaccination clinics.

Vaccinations were sent to us fairly quickly. I ended up getting vaccinated in December 2020, when it was first rolled out.

Native and Navajo individuals have been reluctant to rely on government services. Because IHS came through with the vaccines, COVID reduced that stigma to access its services. Even the Navajo Department of Health partnered with the Indian Health Service to provide culturally relevant campaigns that explain why the vaccine is valuable.

I think because people were so impacted, they saw something valuable with the vaccine. Given the education and access, people were ready to get vaccinated. They realized if a whole household got vaccinated, they could see early on that they could be social again.
 

Q: What cultural factors have been contributing to this positive development?

A: In our Navajo culture, we’ve dealt with monsters before. We talk about that in terms of how we teach our young people to be strong and resilient. We talked about this virus as being another monster we had to tackle and control. The teaching was along those lines. We’ve dealt with this before, and we can handle it. We’re resilient. Our culture is very strong in that way. So how do we do it? We have to partner; we have to embrace Western medicine to return back to the ceremonies we want to have again and be social again. We focus on positive things, so if we see something as potentially positive, such as the vaccine, we see that and know that’s something to help us come into our life again.

Q: I would expect that protecting elders in the tribe would be a big incentive in taking the vaccine.

A: Yes, we didn’t want to lose our language and culture, and we wanted to protect our elders. Having a way to do that was very important as well. They were among the first to get vaccinated.

Q: What is the current vaccination rate in the Navajo nation?

A: I think it’s in the upper 80th percentile. It’s very high.

Q: What have been the biggest takeaways so far, and what are your hopes for the future?

A: Even though the Navajo Nation has been impacted and devastated with the loss of elders and knowledge keepers, we still have our culture and ceremonies intact to the point that we know we can be resilient get through this difficult time.

Through collaborations with the federal and state governments and the clinics, we see that things are different now. Going forward, my hope is these partnerships will continue, that we’ll build those relationships and not be so siloed in our care. When the New Mexico Department of Health rolled out its first vaccination clinic, for example, we jumped on and saw how they did it. We were then able to do our own, collaborating with the state.

We also saw how important our culture was, how it helped our Navajo people through these difficult times.

Dr. Roessel, a distinguished fellow of the American Psychiatric Association, has special expertise in cultural psychiatry. Her childhood was spent growing up in the Navajo nation with her grandfather, who was a Navajo medicine man. Her psychiatric practice focuses on integrating Indigenous knowledge and principles.

References

American Public Media Research Lab. “The Color of Coronavirus: COVID-19 Deaths by Race and Ethnicity in the U.S.” 2021 Mar 5.

Centers for Disease Control and Prevention. “Demographic Characteristics of People Receiving COVID-19 Vaccinations in the United States.” Data as of 2021 Oct 14.

Navajo Nation. Indian Health Service. U.S. Department of Health & Human Services.

The Navajo Nation’s Office of the President and Vice President. “11 New Cases, 32,735 Recoveries, and Six Recent Deaths Related to COVID-19.” 2021 Oct 13.

Navajo Nation Government web page.

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

A new U.S. government study shows it isn’t risky and may even be a good idea to mix, rather than match, COVID-19 vaccines when getting a booster dose.

The study also shows mixing different kinds of vaccines appears to spur the body to make higher levels of virus-blocking antibodies than they would have gotten by boosting with a dose of the vaccine the person already had.

If regulators endorse the study findings, it should make getting a COVID-19 booster as easy as getting a yearly influenza vaccine.

“Currently when you go to do your flu shot nobody asks you what kind you had last year. Nobody cares what you had last year. And we were hoping that that was the same — that we would be able to boost regardless of what you had [previously],” said the study’s senior author, John Beigel, MD, who is associate director for clinical research in the division of microbiology and infectious diseases at the National Institutes of Health.

“But we needed to have the data,” he said.

Studies have suggested that higher antibody levels translate into better protection against disease, though the exact level that confers protection is not yet known.

“The antibody responses are so much higher [with mix and match], it’s really impressive,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville, who was not involved in the study.

Dr. Shaffner said if the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) sign off on the approach, he would especially recommend that people who got the Johnson & Johnson vaccine follow up with a dose of an mRNA vaccine from Pfizer or Moderna.

“It is a broader stimulation of the immune system, and I think that broader stimulation is advantageous,” he said.

Minimal side effects

The preprint study was published late Oct. 13 in medRxiv ahead of peer review, just before a slate of meetings involving vaccine experts that advise the FDA and CDC. 

These experts are tasked with trying to figure out whether additional shots of Moderna and Johnson & Johnson vaccines are safe and effective for boosting immunity against COVID-19.

The FDA’s panel is the Vaccines and Related Biological Products Advisory Committee (VRBPAC), and the CDC’s panel is the Advisory Committee on Immunization Practices (ACIP). 

During the pandemic, they have been meeting almost in lock step to tackle important vaccine-related questions.

“We got this data out because we knew VRBPAC was coming and we knew ACIP was going to grapple with these issues,” Dr. Beigel said.

He noted that these are just the first results. The study will continue for a year, and the researchers aim to deeply characterize the breadth and depth of the immune response to all nine of the different vaccine combinations included in the study.

The study included 458 participants at 10 study sites around the country who had been fully vaccinated with one of the three COVID-19 vaccines authorized for use in the United States: Moderna, Johnson & Johnson, or Pfizer-BioNTech. 

About 150 study participants were recruited from each group. Everyone in the study had finished their primary series at least 12 weeks before starting the study. None had a prior SARS-CoV-2 infection.

About 50 participants from each vaccine group were randomly assigned to get a third (booster) dose of either the same vaccine as the one they had already received, or a different vaccine, creating nine possible combinations of shots.

About half of study participants reported mild side effects — including pain at the injection site, fatigue, headache, and muscle aches.

Two study participants had serious medical problems during the study, but they were judged to be unrelated to vaccination. One study participant experienced kidney failure after their muscles broke down following a fall. The other experienced cholecystitis, or an inflamed gallbladder. 

Up to 1 month after the booster shots, no other serious adverse events were seen.

The study didn’t look at whether people got COVID-19, so it’s not possible to say that they were better protected against disease after their boosters.

Increase in antibodies

But all the groups saw substantial increases in their antibody levels, which is thought to indicate that they were better protected.

Overall, groups that got the same vaccine as their primary series saw 4 to 20-fold increases in their antibody levels. Groups that got different shots than the ones in their primary series got 6 to 76 fold increases in their antibody levels.

People who had originally gotten a Johnson & Johnson vaccine saw far bigger increases in antibodies, and were more likely to see a protective rise in antibodies if they got a second dose of an mRNA vaccine.

Dr. Schaffner noted that European countries had already been mixing the vaccine doses this way, giving people who had received the AstraZeneca vaccine, which is similar to the Johnson & Johnson shot, another dose of an mRNA vaccine.

German Chancellor Angela Merkel received a Moderna vaccine for her second dose after an initial shot of the Oxford-AstraZeneca vaccines, for example.

No safety signals related to mixing vaccines has been seen in countries that routinely use the approach for their initial series.

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

Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

Many pediatric patients with headache experienced increased headache frequency, increased anxiety, and worsening mood through the first year of the COVID-19 pandemic, a newly released survey finds. But some actually found the pandemic era to be less stressful since they were tightly wound and could more easily control their home environments, a researcher said.

“We need to be very mindful of the connections between school and home environments – and social situations – and how they impact headache frequency,” said Marc DiSabella, DO, a pediatric neurologist at Children’s National Hospital/George Washington University, Washington. He is coauthor of a poster presented at the 50th annual meeting of the Child Neurology Society.

Dr. DiSabella and colleagues launched the survey to understand what headache patients were experiencing during the pandemic. They expected that “things were going to go really terrible in terms of headaches – or things would go great, and then things would crash when we had to reintegrate into society,” he said in an interview.

The team surveyed 113 pediatric patients who were evaluated at the hospital’s headache clinic between summer 2020 and winter 2021. Most of the patients were female (60%) and were aged 12-17 years (63%). Twenty-one percent were younger than 12 and 16% were older than 17. Chronic migraine (37%) was the most common diagnosis, followed by migraine with aura (22%), migraine without aura (19%), and new daily persistent headache (15%).

Nearly half (46%) of patients said their headaches had worsened during the pandemic. Many also reported more anxiety (55%), worsened mood (48%) and more stress (55%).

Dr. DiSabella said it’s especially notable that nearly two-thirds of those surveyed reported they were exercising less during the pandemic. Research has suggested that exercise and proper diet/sleep are crucial to improving headaches in kids, he said, and the survey findings suggest that exercise may be especially important. “Engaging in physical activity changes their pain threshold,” he said.

The researchers also reported that 60% of those surveyed said they looked at screens more than 6 hours per day. According to Dr. DiSabella, high screen use may not be worrisome from a headache perspective. “We have another study in publication that shows there’s not a clear association between frequency of screen use and headache intensity,” he said.

The survey doesn’t examine what has happened in recent weeks as schools have reopened. Anecdotally, Dr. DiSabella said some patients with migraine are feeling the stress of returning to normal routines. “They tend to be type A perfectionists and do well when they’re in control of their environment,” he said. “Now they’ve lost the control they had at home and are being put back into a stressful environment.”
 

Pandemic effects mixed

Commenting on the study, child neurologist Andrew D. Hershey, MD, PhD, of Cincinnati Children’s Hospital Medical Center, questioned the finding that many children suffered from more headaches during the pandemic. In his experience, “headaches were overall better when [children] were doing virtual learning,” he said in an interview. “We had fewer admissions, ED visits declined, and patients were maintaining better healthy habits. Some did express anxiety about not seeing friends, but were accommodating by doing this remotely.”

He added: “Since their return, kids are back to the same sleep deprivation issue since schools start too early, and they have more difficulty treating headaches acutely since they have to go to the nurse’s office [to do so]. They self-report a higher degree of stress and anxiety.”

On the other hand, Jack Gladstein, MD, a child neurologist at the University of Maryland, Baltimore, said in an interview that most of his patients suffered more headaches during the pandemic, although a small number with social anxiety thrived because they got to stay at home.

He agreed with Dr. DiSabella about the value of exercise. “At every visit we remind our youngsters with migraine to eat breakfast, exercise, get regular sleep, and drink fluids,” he said.

No study funding was reported. The study authors, Dr. Hershey, and Dr. Gladstein reported no disclosures.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

The proportion of children caught up on vaccinations is lower than 2019 levels, despite an increase in weekly vaccine administration among children from summer to fall 2020.

The finding, published in JAMA Pediatrics, joins a growing collection of studies examining the COVID-19 pandemic’s effect on routine pediatric vaccine delivery. A 2021 survey from the Urban Institute that found that nearly one in five parents delayed or did not get care for their children in the past 12 months because of fear of exposure to the virus.

“We need to think about what additional interventions are needed to promote catch-up vaccination, especially for those at-risk populations that we saw were undervaccinated even prior to the pandemic,” study author Malini B. DeSilva, MD, MPH, said in an interview. “[That means] working creatively to ensure that all children would have the opportunity to receive these recommended vaccines.”

While examining data on pediatric vaccination of 1.4 million children between Jan. 5, 2020, and Oct. 3, 2020, across eight health systems in California, Oregon, Washington, Colorado, Minnesota, and Wisconsin, Dr. DeSilva and colleagues saw vaccination administration rates return to near prepandemic levels after an initial decline, particularly after the Centers for Disease Control and Prevention and American Academy of Pediatrics guidelines specified that in-person visits for children younger than 2 years should be prioritized.

“I think we’ve all been concerned and aware that people just weren’t bringing their children to their pediatricians as frequently [caused by] the fear of being in medical settings during the heat of the pandemic,” said James Schneider, MD, who was not involved with the study. “So it’s not surprising that we saw lower rates of overall vaccinations in all age groups.”

The current study found that lower vaccination rates persisted among most age groups from March to September 2020. However, during the period of expanded primary care, which took place between May and October 2020, vaccination administration rates in infants younger than 2 years old and children aged 4-6 years approached or were equal to 2019 rates. However, these rebounds were not enough to make up for the missed vaccines.

Still, only 74% of infants reaching 7 months old in September 2020 were caught up on their vaccinations, compared with 81% of infants turning the same age in 2019. Researchers also found that, compared with 61% of infants reaching 18 months in September 2019, only 57% of 18-month-olds were up to date with vaccinations in September 2020. However, the proportion of 6-, 13-, and 18-year-olds up to date on vaccinations were about the same in 2020 and 2019.

Racial disparities also persisted during this time, with Black children having the lowest proportion of up-to-date vaccinations for most ages from January to September 2020. Although these disparities were evident prior to the pandemic, these differences became more pronounced for the 18-month-old age group, where just 41% of Black infants were up to date in vaccinations, compared with 76% of Asian infants, 54% of Hispanics infants, and 56% of White infants.

Dr. Schneider believes Dr. DeSilva’s study is a “robust” one and paints an accurate picture of the pandemic’s effect on pediatric vaccinations, despite examining data from just eight health systems.

“I think it’s a fairly reasonable representation of what we already have been recognizing during the pandemic,” he explained. “Which is that people are really reluctant to go to their physicians’ offices for routine care because of the fear of getting sick. I think the study emphasized the importance of catching these children up to keep them safe in the future.”

The Advisory Committee on Immunization Practices recommends a childhood immunization schedule that protects children against 14 infectious diseases before their second birthday. Since the on-time administration of these vaccines is essential for preventing communicable diseases, many pediatric offices are trying to ensure a safe environment for patients and families, said Dr. Schneider, chief of pediatric critical care at Cohen Children’s Medical Center, New York.

There’s also some concern that COVID-19 vaccine hesitancy my spillover into routine childhood vaccinations, especially for families who were already hesitant toward the routine well-established vaccine schedule for children.

The CDC and AAP recommend that children continue to receive recommended vaccinations during the COVID-19 pandemic.

To boost the number of children caught up on vaccinations, health system and community-level interventions are needed, especially in underserved communities, the researchers wrote. Additionally, enforcing mandates that require vaccination prior to school entry could also increase vaccine administration across populations and reduce disparities.

The study emphasizes the “immediate and lagging” disruptions in the delivery of pediatric health care caused by the pandemic, which will likely have long-term consequences for pediatric health, Brian P. Jenssen, MD, MSHP, who was not involved in the study, wrote in a solicited commentary.

However, interventions tailored to specific age groups could help remedy this. These include increasing the frequency of well-child care during the next year of life for infants younger than 24 months and prioritizing visits with 13-year-old adolescents who are behind on vaccinations.

“Although there is no evidence base for this approach, such a change could create not only catch-up opportunities for vaccination for children delayed at age 7 and 18 months, but also provide opportunities to attend to developmental concerns and social needs that have emerged during COVID-19,” wrote Dr. Jenssen, a researcher and primary care pediatrician at Children’s Hospital of Philadelphia.

Other practices such as reaching out to patients and families directly via text message, email, or phone to “notify them of needed vaccinations,” vaccine mandates, and having pediatric health systems partner with alternative settings to promote vaccination could also get kids back on track, health wise. Furthermore, financial incentives from insurers or primary care practices also may help.

“The COVID-19 pandemic’s lost care may have long-term consequences unless pediatric health care systems and child health advocates are proactive in engaging families to take advantage of every opportunity to catch up,” Dr. Jenssen wrote.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

A panel of experts that advises the Food and Drug Administration on vaccine decisions voted unanimously Oct. 14 to approve booster doses of Moderna’s COVID-19 vaccine.

The 19 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted to authorize a 50-milligram dose -- half the dose used in the primary series of shots -- to boost immunity against COVID-19 at least 6 months after the second dose. Those who might need a booster are the same groups who’ve gotten a green light for third Pfizer doses. They include people:

• Over age 65
• Ages 18 to 64 who are at higher risk for severe COVID
• Who are at higher risk of catching COVID because they live in group settings like nursing homes or prisons, or because they are frequently exposed at work, as health care workers are

The agency is not bound by the committee’s vote but usually follows its recommendations.

Some members of the committee said they weren’t satisfied with the data Moderna submitted to support its application but, for practical reasons, said it wouldn’t be fair to take booster doses off the table for Moderna recipients when Pfizer’s boosters were already available.

“The data are not perfect, but these are extraordinary times and we have to work with data that are not perfect,” said Eric Rubin, MD, editor-in-chief of TheNew England Journal of Medicine and a temporary voting member on the committee.

Patrick Moore, MD, a professor at the University of Pittsburgh Cancer Institute who is also a temporary voting member, said he voted to approve the Moderna boosters based “more on a gut feeling than on truly serious data.”

“I’ve got some real issues with this vote,” he said.

“We need to see good solid data, and it needs to be explained well,” Dr. Moore said, challenging companies making future applications to do better.

Next, the FDA will have to formally sign off on the emergency use authorization, which it is expected to do. Then, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to make formal recommendations on use of the Moderna boosters. That group is scheduled to meet Oct. 21 to take up questions of exactly how these boosters should be used.

Peter Marks, MD, head of the FDA’s Center for Biologics Evaluation and Research, cautioned that the CDC is more constrained in making recommendations under an emergency use authorization than it would be if the boosters had gotten full approval. So it will likely align its vote with the conditions of the emergency use authorization from the FDA.

After the advisory committee votes, the director of the CDC has to approve its recommendation.

Overall, data show that two doses of the Moderna vaccine remains highly effective at preventing hospitalization and death. But over time, levels of the body’s first line of defense against a virus -- its neutralizing antibodies -- fall somewhat. This drop seems to correspond with an increased risk for breakthrough cases of COVID-19.

Data presented by Moderna Oct. 14 showed the risk of breakthrough infections increased by 36% in study participants who received the vaccine in their clinical trials, compared to people in the same study who received a placebo first, and got the vaccine later, when the trial was unblended. Their protection was more recent, and they had fewer breakthrough infections.

In considering booster doses, the FDA has asked drugmakers to do studies that look at the immune responses of small groups of study participants and compare them to the immune responses seen in study participants after their first two vaccine doses.

To be considered effective, boosters have to clear two bars. The first looks at the concentration of antibodies generated in the blood of boosted study volunteers. The second looks at how many boosted study participants saw a four-fold increase in their blood antibody levels a month after the booster minus the number of people who saw the same increase after their original two doses.

Moderna presented data that its boosters met the first criteria, but failed to meet the second, perhaps because so many people in the study had good responses after their first two doses of the vaccines.

The FDA’s advisory committee will reconvene Oct. 15 to hear evidence supporting the emergency use authorization of a booster dose of the Johnson & Johnson vaccine.

This article was updated Oct. 15 and first appeared on WebMD.com.

Most vaccines are given with hypodermic needle injections. But shots aren’t necessarily the most efficient or effective way to deliver a vaccine. Scientists have been experimenting with microneedle patches to painlessly deliver a vaccine into the outermost layer of the skin with dozens of extremely tiny needles coated in the vaccine solution.

Now, researchers have found a three-dimensional printing method that lets them customize microneedle shapes in the patches for different pathogens, such as flu, measles, hepatitis, or COVID-19. In tests using mice, the patches led to stronger and longer-lasting immune responses than traditional shots under the skin. The research team described their findings in the Proceedings of the National Academy of Sciences.
 

Tiny needles, big advantages

Previous research has shown delivering vaccines into the skin can cause a stronger immune response because the skin has a high concentration of immune cells. But shots can be painful and require skilled medical providers.

Microneedles painlessly deliver the vaccine into the skin without the need for a trained clinician. In fact, a person can even give the vaccine to themselves.

The needles – made of metal, silicon, or plastic – are so tiny that they puncture only the tough outermost layer of skin. The prospect of a painless vaccination without a hypodermic needle may ease anxiety in people who fear needles.

Scientists also can store dried patches after coating them with the vaccine solution, so there’s no preparation needed before giving the vaccine and the patches may not even require cold storage. This latest study suggests that the patches generate a stronger immune response than standard shots, allowing for a smaller dose than traditional vaccine delivery methods and possibly fewer side effects.
 

Breaking the mold

Past methods of making microneedle patches often used molds, but that approach limited the ability to customize patches for different diseases. Repeatedly using same mold also can blunt the tiny needles.

For the three-dimensional–printed patches, Cassie Caudill at the University of North Carolina at Chapel Hill and colleagues used a printing technique that allows greater control over and consistency in the shape of the microneedles. The investigators printed two shapes: a slender pyramid microneedle that is similar to previous versions, and one with serrated grooves that resembles a pine tree.

The increased surface area from the grooves let researchers add 36% more of the ingredient that causes an immune response, compared with using only the pyramid shape, yet still less than a conventional shot. At only 1 cm by 1 cm, each patch contains 100 microneedles that are just over 1 mm long. The researchers found that in mice the patch drew a stronger immune response than a conventional shot, despite carrying a much smaller dose of vaccine ingredient.

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

Most vaccines are given with hypodermic needle injections. But shots aren’t necessarily the most efficient or effective way to deliver a vaccine. Scientists have been experimenting with microneedle patches to painlessly deliver a vaccine into the outermost layer of the skin with dozens of extremely tiny needles coated in the vaccine solution.

Now, researchers have found a three-dimensional printing method that lets them customize microneedle shapes in the patches for different pathogens, such as flu, measles, hepatitis, or COVID-19. In tests using mice, the patches led to stronger and longer-lasting immune responses than traditional shots under the skin. The research team described their findings in the Proceedings of the National Academy of Sciences.
 

Tiny needles, big advantages

Previous research has shown delivering vaccines into the skin can cause a stronger immune response because the skin has a high concentration of immune cells. But shots can be painful and require skilled medical providers.

Microneedles painlessly deliver the vaccine into the skin without the need for a trained clinician. In fact, a person can even give the vaccine to themselves.

The needles – made of metal, silicon, or plastic – are so tiny that they puncture only the tough outermost layer of skin. The prospect of a painless vaccination without a hypodermic needle may ease anxiety in people who fear needles.

Scientists also can store dried patches after coating them with the vaccine solution, so there’s no preparation needed before giving the vaccine and the patches may not even require cold storage. This latest study suggests that the patches generate a stronger immune response than standard shots, allowing for a smaller dose than traditional vaccine delivery methods and possibly fewer side effects.
 

Breaking the mold

Past methods of making microneedle patches often used molds, but that approach limited the ability to customize patches for different diseases. Repeatedly using same mold also can blunt the tiny needles.

For the three-dimensional–printed patches, Cassie Caudill at the University of North Carolina at Chapel Hill and colleagues used a printing technique that allows greater control over and consistency in the shape of the microneedles. The investigators printed two shapes: a slender pyramid microneedle that is similar to previous versions, and one with serrated grooves that resembles a pine tree.

The increased surface area from the grooves let researchers add 36% more of the ingredient that causes an immune response, compared with using only the pyramid shape, yet still less than a conventional shot. At only 1 cm by 1 cm, each patch contains 100 microneedles that are just over 1 mm long. The researchers found that in mice the patch drew a stronger immune response than a conventional shot, despite carrying a much smaller dose of vaccine ingredient.

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

Most vaccines are given with hypodermic needle injections. But shots aren’t necessarily the most efficient or effective way to deliver a vaccine. Scientists have been experimenting with microneedle patches to painlessly deliver a vaccine into the outermost layer of the skin with dozens of extremely tiny needles coated in the vaccine solution.

Now, researchers have found a three-dimensional printing method that lets them customize microneedle shapes in the patches for different pathogens, such as flu, measles, hepatitis, or COVID-19. In tests using mice, the patches led to stronger and longer-lasting immune responses than traditional shots under the skin. The research team described their findings in the Proceedings of the National Academy of Sciences.
 

Tiny needles, big advantages

Previous research has shown delivering vaccines into the skin can cause a stronger immune response because the skin has a high concentration of immune cells. But shots can be painful and require skilled medical providers.

Microneedles painlessly deliver the vaccine into the skin without the need for a trained clinician. In fact, a person can even give the vaccine to themselves.

The needles – made of metal, silicon, or plastic – are so tiny that they puncture only the tough outermost layer of skin. The prospect of a painless vaccination without a hypodermic needle may ease anxiety in people who fear needles.

Scientists also can store dried patches after coating them with the vaccine solution, so there’s no preparation needed before giving the vaccine and the patches may not even require cold storage. This latest study suggests that the patches generate a stronger immune response than standard shots, allowing for a smaller dose than traditional vaccine delivery methods and possibly fewer side effects.
 

Breaking the mold

Past methods of making microneedle patches often used molds, but that approach limited the ability to customize patches for different diseases. Repeatedly using same mold also can blunt the tiny needles.

For the three-dimensional–printed patches, Cassie Caudill at the University of North Carolina at Chapel Hill and colleagues used a printing technique that allows greater control over and consistency in the shape of the microneedles. The investigators printed two shapes: a slender pyramid microneedle that is similar to previous versions, and one with serrated grooves that resembles a pine tree.

The increased surface area from the grooves let researchers add 36% more of the ingredient that causes an immune response, compared with using only the pyramid shape, yet still less than a conventional shot. At only 1 cm by 1 cm, each patch contains 100 microneedles that are just over 1 mm long. The researchers found that in mice the patch drew a stronger immune response than a conventional shot, despite carrying a much smaller dose of vaccine ingredient.

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

The plasma D-dimer assay has been used, along with clinical prediction scores, to rule out pulmonary embolism (PE) in critically ill patients for decades, but a new study suggests it may not be the right test to use in hospitalized COVID-19 patients.

The results showed that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater, the cutoff point for the diagnosis.

“If using D-dimer to exclude patients with PE, the increased values we found among 92.3% of patients suggest that this assay would be less useful than in the populations in which it was originally validated, among which a minority of patients had increased D-dimer values,” the authors write. “Setting higher D-dimer thresholds was associated with improved specificity at the cost of an increased false-negative rate that could be associated with an unacceptable patient safety risk.”

The inclusion of patients with D-dimer and computed tomography pulmonary angiography (CTPA) was necessary to estimate diagnostic performance, they note, but “this may have introduced selection bias by excluding patients unable to undergo CTPA.”

“Nonetheless, given the high pretest probability of PE and low specificity observed in this and other studies, these results suggest that use of D-dimer levels to exclude PE among patients hospitalized with COVID-19 may be inappropriate and have limited clinical utility,” they conclude.

Led by Constantine N. Logothetis, MD, from Morsani College of Medicine, University of South Florida, Tampa, the study was published online Oct. 8 as a Research Letter in JAMA Network Open.
 

Uncertain utility

The authors note that the availability of D-dimer samples routinely collected from hospitalized COVID-19 patients – as well as the heterogeneity of early, smaller studies – generated uncertainty about the utility of this assay.

This uncertainty prompted them to test the diagnostic accuracy of the D-dimer assay among a sample of 1,541 patients who were hospitalized with COVID-19 at their institution between January 2020 and February 2021 for a possible PE.

They compared plasma D-dimer concentrations with CTPA, the criterion standard for diagnosing PE, in 287 of those patients.

Overall, 118 patients (41.1%) required care in the ICU, and 27 patients (9.4%) died during hospitalization.

The investigators looked at the ability of plasma D-dimer levels collected on the same day as CTPA to diagnose PE.

Thirty-seven patients (12.9%) had radiographic evidence of PE, and 250 patients (87.1%) did not.

Overall, the vast majority of patients (92.3%; n = 265 patients) had plasma D-dimer levels of 0.05 mcg/mL or more, including all patients with PE and 225 of 250 patients without PE (91.2%).

The median D-dimer values were 1.0 mcg/mL for 250 patients without PE and 6.1 mcg/mL for 37 patients with PE.

D-dimer values ranged from 0.2 mcg/mL to 128 mcg/mL among patients without PE, and from 0.5 mcg/mL to more than 10,000 mcg/mL among patients with PE. Patients without PE had statistically significantly decreased mean D-dimer values (8.7 mcg/mL vs. 1.2 mcg/mL; P < .001).

A D-dimer concentration of 0.05 mcg/mL was associated with a sensitivity of 100%, specificity of 8.8%, negative predictive value (NPV) of 100%, positive predictive value (PPV) of 13.9%, and a negative likelihood ratio (NLR) of less than 0.1.

The age-adjusted threshold was associated with a sensitivity of 94.6%, specificity of 22.8%, NPV of 96.6%, PPV of 13.9%, and NLR of 0.24.

The authors note that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater.
 

D-dimer in VTE may not extrapolate to COVID-19

“The D-dimer test, which is a measure of circulating byproducts of blood clot dissolution, has long been incorporated into diagnostic algorithms for venous thromboembolic [VTE] disease, including deep vein thrombosis and pulmonary embolism. It is uncertain whether this diagnostic use of D-dimer testing can be extrapolated to the context of COVID-19 – an illness we now understand to be associated itself with intravascular thrombosis and fibrinolysis,” Matthew Tomey, MD, a cardiologist at Mount Sinai Morningside, New York, said in an interview.

“The authors of this study sought to evaluate the test characteristics of the D-dimer assay for diagnosis of pulmonary embolism in a consecutive series of 287 hospitalized patients with COVID-19 who underwent computed tomography pulmonary angiography (CTPA). This was a selected group of patients representing less than 20% of the 1,541 patients screened. Exclusion of data on the more than 80% of screened patients who did not undergo CTPA is a significant limitation of the study,” Dr. Tomey said.

“In the highly selected, small cohort studied, representing a group of patients at high pretest probability of pulmonary embolism, there was no patient with pulmonary embolism who had a D-dimer value less than 0.5 mcg/mL. Yet broad ranges of D-dimer values were observed in COVID-19 patients with (0.5 to >10,000 mcg/mL) and without (0.2 to 128 mcg/mL) pulmonary embolism,” he added.

Based on the presented data, it is likely true that very low levels of D-dimer decrease the likelihood of finding a pulmonary embolus on a CTPA, if it is performed, Dr. Tomey noted.

“Yet the data confirm that a wide range of D-dimer values can be observed in COVID-19 patients with or without pulmonary embolism. It is not clear at this time that D-dimer levels should be used as gatekeepers to diagnostic imaging studies such as CTPA when pretest suspicion of pulmonary embolism is high,” he said.

“This issue becomes relevant as we consider evolving data on use of anticoagulation in treatment of hospitalized patients with COVID-19. We learned this year that in critically ill patients hospitalized with COVID-19, routine therapeutic anticoagulation (with heparin) was not beneficial and potentially harmful when compared with usual thromboprophylaxis,” he concluded.

“As we strive to balance competing risks of bleeding and thrombosis, accurate diagnosis of pulmonary embolism is important to guide decision-making about therapeutic anticoagulation, including in COVID-19.”

Dr. Logothetis and Dr. Tomey have disclosed no relevant financial relationships.

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

The plasma D-dimer assay has been used, along with clinical prediction scores, to rule out pulmonary embolism (PE) in critically ill patients for decades, but a new study suggests it may not be the right test to use in hospitalized COVID-19 patients.

The results showed that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater, the cutoff point for the diagnosis.

“If using D-dimer to exclude patients with PE, the increased values we found among 92.3% of patients suggest that this assay would be less useful than in the populations in which it was originally validated, among which a minority of patients had increased D-dimer values,” the authors write. “Setting higher D-dimer thresholds was associated with improved specificity at the cost of an increased false-negative rate that could be associated with an unacceptable patient safety risk.”

The inclusion of patients with D-dimer and computed tomography pulmonary angiography (CTPA) was necessary to estimate diagnostic performance, they note, but “this may have introduced selection bias by excluding patients unable to undergo CTPA.”

“Nonetheless, given the high pretest probability of PE and low specificity observed in this and other studies, these results suggest that use of D-dimer levels to exclude PE among patients hospitalized with COVID-19 may be inappropriate and have limited clinical utility,” they conclude.

Led by Constantine N. Logothetis, MD, from Morsani College of Medicine, University of South Florida, Tampa, the study was published online Oct. 8 as a Research Letter in JAMA Network Open.
 

Uncertain utility

The authors note that the availability of D-dimer samples routinely collected from hospitalized COVID-19 patients – as well as the heterogeneity of early, smaller studies – generated uncertainty about the utility of this assay.

This uncertainty prompted them to test the diagnostic accuracy of the D-dimer assay among a sample of 1,541 patients who were hospitalized with COVID-19 at their institution between January 2020 and February 2021 for a possible PE.

They compared plasma D-dimer concentrations with CTPA, the criterion standard for diagnosing PE, in 287 of those patients.

Overall, 118 patients (41.1%) required care in the ICU, and 27 patients (9.4%) died during hospitalization.

The investigators looked at the ability of plasma D-dimer levels collected on the same day as CTPA to diagnose PE.

Thirty-seven patients (12.9%) had radiographic evidence of PE, and 250 patients (87.1%) did not.

Overall, the vast majority of patients (92.3%; n = 265 patients) had plasma D-dimer levels of 0.05 mcg/mL or more, including all patients with PE and 225 of 250 patients without PE (91.2%).

The median D-dimer values were 1.0 mcg/mL for 250 patients without PE and 6.1 mcg/mL for 37 patients with PE.

D-dimer values ranged from 0.2 mcg/mL to 128 mcg/mL among patients without PE, and from 0.5 mcg/mL to more than 10,000 mcg/mL among patients with PE. Patients without PE had statistically significantly decreased mean D-dimer values (8.7 mcg/mL vs. 1.2 mcg/mL; P < .001).

A D-dimer concentration of 0.05 mcg/mL was associated with a sensitivity of 100%, specificity of 8.8%, negative predictive value (NPV) of 100%, positive predictive value (PPV) of 13.9%, and a negative likelihood ratio (NLR) of less than 0.1.

The age-adjusted threshold was associated with a sensitivity of 94.6%, specificity of 22.8%, NPV of 96.6%, PPV of 13.9%, and NLR of 0.24.

The authors note that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater.
 

D-dimer in VTE may not extrapolate to COVID-19

“The D-dimer test, which is a measure of circulating byproducts of blood clot dissolution, has long been incorporated into diagnostic algorithms for venous thromboembolic [VTE] disease, including deep vein thrombosis and pulmonary embolism. It is uncertain whether this diagnostic use of D-dimer testing can be extrapolated to the context of COVID-19 – an illness we now understand to be associated itself with intravascular thrombosis and fibrinolysis,” Matthew Tomey, MD, a cardiologist at Mount Sinai Morningside, New York, said in an interview.

“The authors of this study sought to evaluate the test characteristics of the D-dimer assay for diagnosis of pulmonary embolism in a consecutive series of 287 hospitalized patients with COVID-19 who underwent computed tomography pulmonary angiography (CTPA). This was a selected group of patients representing less than 20% of the 1,541 patients screened. Exclusion of data on the more than 80% of screened patients who did not undergo CTPA is a significant limitation of the study,” Dr. Tomey said.

“In the highly selected, small cohort studied, representing a group of patients at high pretest probability of pulmonary embolism, there was no patient with pulmonary embolism who had a D-dimer value less than 0.5 mcg/mL. Yet broad ranges of D-dimer values were observed in COVID-19 patients with (0.5 to >10,000 mcg/mL) and without (0.2 to 128 mcg/mL) pulmonary embolism,” he added.

Based on the presented data, it is likely true that very low levels of D-dimer decrease the likelihood of finding a pulmonary embolus on a CTPA, if it is performed, Dr. Tomey noted.

“Yet the data confirm that a wide range of D-dimer values can be observed in COVID-19 patients with or without pulmonary embolism. It is not clear at this time that D-dimer levels should be used as gatekeepers to diagnostic imaging studies such as CTPA when pretest suspicion of pulmonary embolism is high,” he said.

“This issue becomes relevant as we consider evolving data on use of anticoagulation in treatment of hospitalized patients with COVID-19. We learned this year that in critically ill patients hospitalized with COVID-19, routine therapeutic anticoagulation (with heparin) was not beneficial and potentially harmful when compared with usual thromboprophylaxis,” he concluded.

“As we strive to balance competing risks of bleeding and thrombosis, accurate diagnosis of pulmonary embolism is important to guide decision-making about therapeutic anticoagulation, including in COVID-19.”

Dr. Logothetis and Dr. Tomey have disclosed no relevant financial relationships.

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

The plasma D-dimer assay has been used, along with clinical prediction scores, to rule out pulmonary embolism (PE) in critically ill patients for decades, but a new study suggests it may not be the right test to use in hospitalized COVID-19 patients.

The results showed that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater, the cutoff point for the diagnosis.

“If using D-dimer to exclude patients with PE, the increased values we found among 92.3% of patients suggest that this assay would be less useful than in the populations in which it was originally validated, among which a minority of patients had increased D-dimer values,” the authors write. “Setting higher D-dimer thresholds was associated with improved specificity at the cost of an increased false-negative rate that could be associated with an unacceptable patient safety risk.”

The inclusion of patients with D-dimer and computed tomography pulmonary angiography (CTPA) was necessary to estimate diagnostic performance, they note, but “this may have introduced selection bias by excluding patients unable to undergo CTPA.”

“Nonetheless, given the high pretest probability of PE and low specificity observed in this and other studies, these results suggest that use of D-dimer levels to exclude PE among patients hospitalized with COVID-19 may be inappropriate and have limited clinical utility,” they conclude.

Led by Constantine N. Logothetis, MD, from Morsani College of Medicine, University of South Florida, Tampa, the study was published online Oct. 8 as a Research Letter in JAMA Network Open.
 

Uncertain utility

The authors note that the availability of D-dimer samples routinely collected from hospitalized COVID-19 patients – as well as the heterogeneity of early, smaller studies – generated uncertainty about the utility of this assay.

This uncertainty prompted them to test the diagnostic accuracy of the D-dimer assay among a sample of 1,541 patients who were hospitalized with COVID-19 at their institution between January 2020 and February 2021 for a possible PE.

They compared plasma D-dimer concentrations with CTPA, the criterion standard for diagnosing PE, in 287 of those patients.

Overall, 118 patients (41.1%) required care in the ICU, and 27 patients (9.4%) died during hospitalization.

The investigators looked at the ability of plasma D-dimer levels collected on the same day as CTPA to diagnose PE.

Thirty-seven patients (12.9%) had radiographic evidence of PE, and 250 patients (87.1%) did not.

Overall, the vast majority of patients (92.3%; n = 265 patients) had plasma D-dimer levels of 0.05 mcg/mL or more, including all patients with PE and 225 of 250 patients without PE (91.2%).

The median D-dimer values were 1.0 mcg/mL for 250 patients without PE and 6.1 mcg/mL for 37 patients with PE.

D-dimer values ranged from 0.2 mcg/mL to 128 mcg/mL among patients without PE, and from 0.5 mcg/mL to more than 10,000 mcg/mL among patients with PE. Patients without PE had statistically significantly decreased mean D-dimer values (8.7 mcg/mL vs. 1.2 mcg/mL; P < .001).

A D-dimer concentration of 0.05 mcg/mL was associated with a sensitivity of 100%, specificity of 8.8%, negative predictive value (NPV) of 100%, positive predictive value (PPV) of 13.9%, and a negative likelihood ratio (NLR) of less than 0.1.

The age-adjusted threshold was associated with a sensitivity of 94.6%, specificity of 22.8%, NPV of 96.6%, PPV of 13.9%, and NLR of 0.24.

The authors note that all hospitalized patients with COVID-19 and radiographic evidence of PE had plasma D-dimer levels of 0.05 mcg/mL or greater.
 

D-dimer in VTE may not extrapolate to COVID-19

“The D-dimer test, which is a measure of circulating byproducts of blood clot dissolution, has long been incorporated into diagnostic algorithms for venous thromboembolic [VTE] disease, including deep vein thrombosis and pulmonary embolism. It is uncertain whether this diagnostic use of D-dimer testing can be extrapolated to the context of COVID-19 – an illness we now understand to be associated itself with intravascular thrombosis and fibrinolysis,” Matthew Tomey, MD, a cardiologist at Mount Sinai Morningside, New York, said in an interview.

“The authors of this study sought to evaluate the test characteristics of the D-dimer assay for diagnosis of pulmonary embolism in a consecutive series of 287 hospitalized patients with COVID-19 who underwent computed tomography pulmonary angiography (CTPA). This was a selected group of patients representing less than 20% of the 1,541 patients screened. Exclusion of data on the more than 80% of screened patients who did not undergo CTPA is a significant limitation of the study,” Dr. Tomey said.

“In the highly selected, small cohort studied, representing a group of patients at high pretest probability of pulmonary embolism, there was no patient with pulmonary embolism who had a D-dimer value less than 0.5 mcg/mL. Yet broad ranges of D-dimer values were observed in COVID-19 patients with (0.5 to >10,000 mcg/mL) and without (0.2 to 128 mcg/mL) pulmonary embolism,” he added.

Based on the presented data, it is likely true that very low levels of D-dimer decrease the likelihood of finding a pulmonary embolus on a CTPA, if it is performed, Dr. Tomey noted.

“Yet the data confirm that a wide range of D-dimer values can be observed in COVID-19 patients with or without pulmonary embolism. It is not clear at this time that D-dimer levels should be used as gatekeepers to diagnostic imaging studies such as CTPA when pretest suspicion of pulmonary embolism is high,” he said.

“This issue becomes relevant as we consider evolving data on use of anticoagulation in treatment of hospitalized patients with COVID-19. We learned this year that in critically ill patients hospitalized with COVID-19, routine therapeutic anticoagulation (with heparin) was not beneficial and potentially harmful when compared with usual thromboprophylaxis,” he concluded.

“As we strive to balance competing risks of bleeding and thrombosis, accurate diagnosis of pulmonary embolism is important to guide decision-making about therapeutic anticoagulation, including in COVID-19.”

Dr. Logothetis and Dr. Tomey have disclosed no relevant financial relationships.

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

New data on COVID vaccination in patients with multiple sclerosis (MS) has shown a reduced humoral response in patients treated with the anti-CD20 antibodies ocrelizumab or rituximab, but not in those receiving the similar product, ofatumumab.

The results also show a reduced response to COVID vaccination in some patients on fingolimod.

The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”

“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
 

Assessing postvaccination antibody response

For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.

Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.

Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.

Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.

Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.

Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.

However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.

Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.

“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.

She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.

The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.

Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”

Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.

Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
 

Cellular response also impaired with fingolimod

These data are consistent with those from another cohort from Israel reported previously.

In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.

Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.

For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.

They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm³), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm³, no humoral response was detected.

At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.

The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.

While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.

Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.

But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.

“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”

Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.

“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.

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

New data on COVID vaccination in patients with multiple sclerosis (MS) has shown a reduced humoral response in patients treated with the anti-CD20 antibodies ocrelizumab or rituximab, but not in those receiving the similar product, ofatumumab.

The results also show a reduced response to COVID vaccination in some patients on fingolimod.

The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”

“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
 

Assessing postvaccination antibody response

For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.

Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.

Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.

Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.

Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.

Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.

However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.

Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.

“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.

She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.

The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.

Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”

Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.

Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
 

Cellular response also impaired with fingolimod

These data are consistent with those from another cohort from Israel reported previously.

In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.

Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.

For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.

They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm³), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm³, no humoral response was detected.

At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.

The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.

While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.

Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.

But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.

“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”

Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.

“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.

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

New data on COVID vaccination in patients with multiple sclerosis (MS) has shown a reduced humoral response in patients treated with the anti-CD20 antibodies ocrelizumab or rituximab, but not in those receiving the similar product, ofatumumab.

The results also show a reduced response to COVID vaccination in some patients on fingolimod.

The data come from a new series of vaccinated patients with MS from Madrid, which was presented at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Presenting the data, Celia Oreja-Guevara, MD, Hospital Clínico San Carlos, Madrid, concluded that “currently approved COVID-19 vaccines appear safe in MS patients and are effective in most patients. However, vaccine strategy in patients treated with anti-CD20 and S1P inhibitors [such as fingolimod] need further study.”

“We showed that patients on ocrelizumab or rituximab had a very low or no antibody response to COVID vaccination,” she added. “However, some previous studies have shown some T-cell response to vaccination in these patients, and we are looking at that now.”
 

Assessing postvaccination antibody response

For the current study, the researchers analyzed the antibody response to COVID-19 vaccination at week 3, week 6, and month 3 after the first dose in 165 patients with MS and 200 healthy controls.

Of the patients with MS, 120 received both doses of mRNA vaccine and 42 received the AstraZeneca vaccine. The mean age of the MS patients was 45 years and 46 years in the healthy controls.

Adverse events were similar in the two groups, and no increase in relapse activity was seen in the patients with MS.

Mean antibody titers were slightly lower in the patients with MS versus the healthy controls. At 3 weeks, mean titers were 7,910 AU/mL in the patients with MS and 9,397 in the healthy controls. At 6 weeks, mean levels were 16,347 AU/mL in the patients with MS and 18,120 in the healthy controls.

Patients with MS treated with interferon-beta, glatiramer acetate, teriflunomide, dimethyl fumarate, cladribine, and natalizumab who received mRNA vaccines developed a similar postvaccination humoral response as the healthy controls at each of 3, 6, and 12 weeks after the first dose.

Patients with MS receiving the AstraZeneca vaccine mounted a lower humoral response than those receiving the mRNA vaccine, but this same effect was also seen in the healthy controls.

However, patients on the anti-CD20 drugs ocrelizumab or rituximab showed a lower humoral response to COVID vaccination. Only 3 of 20 patients who had been treated with ocrelizumab developed antibodies, but these patients had longer washout periods (at least 6 months) between receiving ocrelizumab and the COVID vaccine. All six patients treated with rituximab had no antibody response to the COVID vaccination.

Dr. Oreja-Guevara suggested that ocrelizumab-treated patients may have a worse outcome after COVID-19 infection. “In the first wave of infection in Madrid, we recorded five patients on ocrelizumab with COVID-19, four of whom were hospitalized,” she noted.

“In patients on ocrelizumab we need to try and have a long interval between giving this drug and giving the COVID vaccine. The longer the washout period, the more antibodies are seen,” she said.

She noted that two patients in the study received the COVID vaccine 1 year after ocrelizumab administration and had a normal humoral response, similar to the healthy controls.

The new anti-CD20 drug, ofatumumab, did not seem to affect the COVID vaccine antibody response as much as ocrelizumab or rituximab. In the current study, four of five patients treated with ofatumumab had an antibody response.

Dr. Oreja-Guevara suggested that this was probably because the depletion of B cells is not so strong with ofatumumab. “This drug is dosed every 4 weeks and it doesn’t deplete all the B cells and they are replaced quite quickly.”

Fingolimod is another MS drug that seems to affect the antibody response to COVID-19 vaccination.

Dr. Oreja-Guevara described the response to COVID vaccination in patients on fingolimod as “very variable.” Of 16 patients treated with fingolimod, 4 failed to develop a humoral response, 7 had a low antibody response, and 5 had a similar response to that seen in the healthy controls (three of these patients had also had a previous COVID-19 infection). The response to vaccination in fingolimod-treated patients did not appear to be related to lymphopenia.
 

Cellular response also impaired with fingolimod

These data are consistent with those from another cohort from Israel reported previously.

In that study, which was published earlier in 2021, a team led by Anat Achiron, MD, Sheba Medical Center, Tel Aviv, analyzed humoral immunity in 125 patients with MS 1 month after the second dose of the Pfizer COVID vaccine. A group of healthy people similarly vaccinated served as control.

Results showed that protective humoral immunity occurred in 97.9% of the control group after vaccination, compared with 100% in untreated patients and 100% in patients treated with cladribine but in just 22.7% of those treated with ocrelizumab and only 3.8% of those taking fingolimod.

For ocrelizumab-treated patients, the failure to mount appropriate IgG immune response was regardless of the absolute lymphocyte counts that were in the normal range or to the time interval from the last ocrelizumab treatment dose that ranged from 3.1 to 8.9 months, “suggesting the need to postpone the next dosing to enable an effective postvaccination humoral response,” the authors said.

They noted that the majority of the fingolimod-treated patients in the study had a low lymphocyte count (<1,000 cells/mm³), which may be the cause for failing to mount an immune response. But even in the small group of fingolimod-treated MS patients with an absolute lymphocyte count above 1,000 cells/mm³, no humoral response was detected.

At the ECTRIMS meeting, Dr. Achiron presented further results from this study on memory B-cell and T-cell responses to the COVID vaccine in these patients.

The results showed that COVID-specific B- and T-cell responses were only present in about half of healthy subjects, untreated patients with MS, and those treated with cladribine.

While the B-cell response was almost completely impaired in the ocrelizumab-treated patients, the T-cell response was present to the same extent as in the control group. But fingolimod patients showed no B- or T-cell responses.

Dr. Achiron concluded that patients on ocrelizumab should wait at least 9 months following the last dose before receiving COVID vaccination, and that patients taking fingolimod should consider a switch to a different medication.

But she pointed out that, despite the lack of humoral cellular responses in the fingolimod group, in this study there does not seem to have been an increase in COVID infection in patients taking fingolimod in a large registry study.

“This leads us to the idea that maybe lymphopenia is not the only story, and maybe innate immunity is playing a role. We still don’t really know the answer for that.”

Dr. Achiron said she was also surprised to see that even untreated and healthy subjects did not develop complete B-cell and T-cell responses after double COVID vaccination. And similar results have been seen in patients who have recovered from natural COVID infection, where the B-cell response is “not 100%,” she added.

“This points to the suggestion that everyone might need a third vaccination, MS patients or not,” she concluded.

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

Scientists who speak about COVID-19 to the media or comment about the pandemic on social media often meet with harassment and abuse, according to a survey published in Nature.

The survey of 321 scientists, largely from the United States, the United Kingdom, and Germany, found that 22% were threatened with physical or sexual violence and that 15% received death threats.

More than one quarter of scientists surveyed said they “always” or “usually” received comments from trolls or were personally attacked after speaking out about COVID-19. More than 40% suffered emotional or psychological distress as a result.

Some scientists said the experience of being trolled online or receiving personal attacks had a chilling effect on their willingness to speak to the media in the future.

Even scientists who had a high profile before the COVID-19 pandemic said in the Nature article that the abuse was a “new and unwelcome phenomenon tied to the pandemic.”

Some scientists reported anonymously that they were hesitant to speak about some topics after witnessing the abuse received by others.
 

“Shocking” results require action

An editorial in Nature calls the results of the survey “shocking” and says institutions at all levels must do more to “protect and defend scientists, and to condemn intimidation.

“Intimidation is unacceptable on any scale, and the findings should be of concern to all those who care about scientists’ well-being. Such behavior also risks discouraging researchers from contributing to public discussion — which would be a huge loss, given their expertise, during the pandemic,” the editorial states.

“Scientists and health officials should expect their research to be questioned and challenged, and should welcome critical feedback that is given in good faith. But threats of violence and extreme online abuse do nothing to encourage debate — and risk undermining science communication at a time when it has never mattered more,” the editorial concludes.

A number of scientists weighed in on the survey in a statement from the U.K. nonprofit organization, Science Media Center.

“Undoubtedly there is a danger that scientists who have themselves been, or had colleagues who have been attacked in ways that disturb one’s equilibrium, may decide to disengage from the media. This will be sad and result in overall harm,” warned Stephen Evans, MSc, with the London School of Hygiene and Tropical Medicine.

Simon Clarke, PhD, with the University of Reading, who responded to the Nature survey, said he is “glad to see so many fellow scientists took the time to reflect on their experiences.”

Dr. Clarke said he is “shocked and saddened to hear that so many fellow scientists have experienced death threats or threats of physical or sexual violence, simply for doing their job trying to communicate the scientific facts that are so important for society in understanding and responding to this global health emergency.”

Dr. Clarke said he too has had some “bad experiences after appearing in the media, particularly after calling out conspiracy theorists and some politicians, who seem to dislike having their pet theories debunked. I have on occasion been threatened with various forms of death, violence and lifelong imprisonment. I am fortunate to have felt able to ignore the threats I’ve received, but I know that some colleagues have had far worse experiences.”

Michael Head, PhD, with the University of Southampton, said there’s been “a huge amount of abuse aimed at everyone contributing to the pandemic response. This has included NHS frontline staff, and also scientists and academics providing thoughts and explanatory comments to the public.

“I myself have received plenty of abuse throughout the pandemic. For those of us who have been pulling apart anti-vaccine misinformation from pre-pandemic times, the presence of these attempts at intimidation is very wearying, but not surprising,” said Dr. Head.

“As a white, male academic, I would imagine I’m far less likely to receive abuse than a scientist making similar points but from a different demographic,” he said.

Susan Michie, FMedSci, with the University College London, said the findings of harassment and abuse of scientists during the pandemic align closely with what she and many U.K. women colleagues who have been prominent in speaking to the media have endured.

“The online abuse occurs most intensively after media engagements and especially after those that address restrictions to social mixing, the wearing of face masks or vaccination,” Dr. Michie said.

“This abuse has not put off many women colleagues I know from speaking to the media,” she said. “I think this is because they are well established in their careers and/or brave and very committed to communicating scientific understanding.

“They have also set up a variety of networks to support each other. However, I am concerned that it discourages early career scientists, especially young women and young women from minoritized ethnic backgrounds, from engaging with the media,” she said.

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

Scientists who speak about COVID-19 to the media or comment about the pandemic on social media often meet with harassment and abuse, according to a survey published in Nature.

The survey of 321 scientists, largely from the United States, the United Kingdom, and Germany, found that 22% were threatened with physical or sexual violence and that 15% received death threats.

More than one quarter of scientists surveyed said they “always” or “usually” received comments from trolls or were personally attacked after speaking out about COVID-19. More than 40% suffered emotional or psychological distress as a result.

Some scientists said the experience of being trolled online or receiving personal attacks had a chilling effect on their willingness to speak to the media in the future.

Even scientists who had a high profile before the COVID-19 pandemic said in the Nature article that the abuse was a “new and unwelcome phenomenon tied to the pandemic.”

Some scientists reported anonymously that they were hesitant to speak about some topics after witnessing the abuse received by others.
 

“Shocking” results require action

An editorial in Nature calls the results of the survey “shocking” and says institutions at all levels must do more to “protect and defend scientists, and to condemn intimidation.

“Intimidation is unacceptable on any scale, and the findings should be of concern to all those who care about scientists’ well-being. Such behavior also risks discouraging researchers from contributing to public discussion — which would be a huge loss, given their expertise, during the pandemic,” the editorial states.

“Scientists and health officials should expect their research to be questioned and challenged, and should welcome critical feedback that is given in good faith. But threats of violence and extreme online abuse do nothing to encourage debate — and risk undermining science communication at a time when it has never mattered more,” the editorial concludes.

A number of scientists weighed in on the survey in a statement from the U.K. nonprofit organization, Science Media Center.

“Undoubtedly there is a danger that scientists who have themselves been, or had colleagues who have been attacked in ways that disturb one’s equilibrium, may decide to disengage from the media. This will be sad and result in overall harm,” warned Stephen Evans, MSc, with the London School of Hygiene and Tropical Medicine.

Simon Clarke, PhD, with the University of Reading, who responded to the Nature survey, said he is “glad to see so many fellow scientists took the time to reflect on their experiences.”

Dr. Clarke said he is “shocked and saddened to hear that so many fellow scientists have experienced death threats or threats of physical or sexual violence, simply for doing their job trying to communicate the scientific facts that are so important for society in understanding and responding to this global health emergency.”

Dr. Clarke said he too has had some “bad experiences after appearing in the media, particularly after calling out conspiracy theorists and some politicians, who seem to dislike having their pet theories debunked. I have on occasion been threatened with various forms of death, violence and lifelong imprisonment. I am fortunate to have felt able to ignore the threats I’ve received, but I know that some colleagues have had far worse experiences.”

Michael Head, PhD, with the University of Southampton, said there’s been “a huge amount of abuse aimed at everyone contributing to the pandemic response. This has included NHS frontline staff, and also scientists and academics providing thoughts and explanatory comments to the public.

“I myself have received plenty of abuse throughout the pandemic. For those of us who have been pulling apart anti-vaccine misinformation from pre-pandemic times, the presence of these attempts at intimidation is very wearying, but not surprising,” said Dr. Head.

“As a white, male academic, I would imagine I’m far less likely to receive abuse than a scientist making similar points but from a different demographic,” he said.

Susan Michie, FMedSci, with the University College London, said the findings of harassment and abuse of scientists during the pandemic align closely with what she and many U.K. women colleagues who have been prominent in speaking to the media have endured.

“The online abuse occurs most intensively after media engagements and especially after those that address restrictions to social mixing, the wearing of face masks or vaccination,” Dr. Michie said.

“This abuse has not put off many women colleagues I know from speaking to the media,” she said. “I think this is because they are well established in their careers and/or brave and very committed to communicating scientific understanding.

“They have also set up a variety of networks to support each other. However, I am concerned that it discourages early career scientists, especially young women and young women from minoritized ethnic backgrounds, from engaging with the media,” she said.

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

Scientists who speak about COVID-19 to the media or comment about the pandemic on social media often meet with harassment and abuse, according to a survey published in Nature.

The survey of 321 scientists, largely from the United States, the United Kingdom, and Germany, found that 22% were threatened with physical or sexual violence and that 15% received death threats.

More than one quarter of scientists surveyed said they “always” or “usually” received comments from trolls or were personally attacked after speaking out about COVID-19. More than 40% suffered emotional or psychological distress as a result.

Some scientists said the experience of being trolled online or receiving personal attacks had a chilling effect on their willingness to speak to the media in the future.

Even scientists who had a high profile before the COVID-19 pandemic said in the Nature article that the abuse was a “new and unwelcome phenomenon tied to the pandemic.”

Some scientists reported anonymously that they were hesitant to speak about some topics after witnessing the abuse received by others.
 

“Shocking” results require action

An editorial in Nature calls the results of the survey “shocking” and says institutions at all levels must do more to “protect and defend scientists, and to condemn intimidation.

“Intimidation is unacceptable on any scale, and the findings should be of concern to all those who care about scientists’ well-being. Such behavior also risks discouraging researchers from contributing to public discussion — which would be a huge loss, given their expertise, during the pandemic,” the editorial states.

“Scientists and health officials should expect their research to be questioned and challenged, and should welcome critical feedback that is given in good faith. But threats of violence and extreme online abuse do nothing to encourage debate — and risk undermining science communication at a time when it has never mattered more,” the editorial concludes.

A number of scientists weighed in on the survey in a statement from the U.K. nonprofit organization, Science Media Center.

“Undoubtedly there is a danger that scientists who have themselves been, or had colleagues who have been attacked in ways that disturb one’s equilibrium, may decide to disengage from the media. This will be sad and result in overall harm,” warned Stephen Evans, MSc, with the London School of Hygiene and Tropical Medicine.

Simon Clarke, PhD, with the University of Reading, who responded to the Nature survey, said he is “glad to see so many fellow scientists took the time to reflect on their experiences.”

Dr. Clarke said he is “shocked and saddened to hear that so many fellow scientists have experienced death threats or threats of physical or sexual violence, simply for doing their job trying to communicate the scientific facts that are so important for society in understanding and responding to this global health emergency.”

Dr. Clarke said he too has had some “bad experiences after appearing in the media, particularly after calling out conspiracy theorists and some politicians, who seem to dislike having their pet theories debunked. I have on occasion been threatened with various forms of death, violence and lifelong imprisonment. I am fortunate to have felt able to ignore the threats I’ve received, but I know that some colleagues have had far worse experiences.”

Michael Head, PhD, with the University of Southampton, said there’s been “a huge amount of abuse aimed at everyone contributing to the pandemic response. This has included NHS frontline staff, and also scientists and academics providing thoughts and explanatory comments to the public.

“I myself have received plenty of abuse throughout the pandemic. For those of us who have been pulling apart anti-vaccine misinformation from pre-pandemic times, the presence of these attempts at intimidation is very wearying, but not surprising,” said Dr. Head.

“As a white, male academic, I would imagine I’m far less likely to receive abuse than a scientist making similar points but from a different demographic,” he said.

Susan Michie, FMedSci, with the University College London, said the findings of harassment and abuse of scientists during the pandemic align closely with what she and many U.K. women colleagues who have been prominent in speaking to the media have endured.

“The online abuse occurs most intensively after media engagements and especially after those that address restrictions to social mixing, the wearing of face masks or vaccination,” Dr. Michie said.

“This abuse has not put off many women colleagues I know from speaking to the media,” she said. “I think this is because they are well established in their careers and/or brave and very committed to communicating scientific understanding.

“They have also set up a variety of networks to support each other. However, I am concerned that it discourages early career scientists, especially young women and young women from minoritized ethnic backgrounds, from engaging with the media,” she said.

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