The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

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

USE OUR CONTENT

This story can be republished for free (details).

Subscribe to KHN's free Morning Briefing.

The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

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

USE OUR CONTENT

This story can be republished for free (details).

Subscribe to KHN's free Morning Briefing.

The lungs Bill Thompson was born with told a gruesome, harrowing and unmistakable tale to Dr. Anthony Szema when he analyzed them and found the black spots, scarring, partially combusted jet fuel and metal inside.

The retired Army staff sergeant had suffered catastrophic lung damage from breathing incinerated waste burned in massive open-air pits and probably other irritants during his tour of duty in Iraq.

“There’s black spots that are burns, particles all over; there’s metal. It was all scarred,” said Szema, a pulmonologist and professor who studies toxic exposures and examined Thompson’s preserved lung tissue. “There was no gas exchange anywhere in that lung.”

Thompson is still alive, surviving on his second transplanted set of lungs. Yet the story burned into the veteran’s internal organs is not one that has been entirely convincing to the U.S. government.

The military has not linked the burn pits to illness. That means many who were exposed to burn pits and are sick do not qualify for benefits under any existing program.

Retirement and health benefits for members of the military depend on factors like length of service, active or reserve status, deployments to combat zones and whether the military considers specific injuries or illnesses to be service-related. Thompson has been able to get care through the Department of Veterans Affairs for his lung disease but has not been able to secure other benefits, like early retirement pay.

“I was denied my Army retirement because if it was not a combat action, then I don’t receive that retirement,” Thompson said at a Senate Veterans’ Affairs Committee hearing last week on service members’ exposures to toxic substances.

Thompson is one of at least 3.5 million veterans since 2001 who have served in war zones where the U.S. military decided to dispose of its trash by burning it, according to VA estimates.

It’s not clear how many people within that population have gotten sick from exposure. Only a small fraction — 234,000 — have enrolled in the VA’s online burn pit registry. Veterans’ advocacy groups have said the majority of claims to the agency stemming from toxic exposures are denied, even as most former service members report contacts with toxins in their deployments.

Soldiers returning from tours in the global war on terror have reported debilitating illnesses almost from its beginning, but got little traction with the military. This year, though, the likelihood of congressional action is high, with Democrats expressing interest and a president who suspects burn pits are to blame for his son’s death.

President Joe Biden’s son Beau died of brain cancer in 2015 at age 46. He had deployed to Iraq in two sites with burn pits — at Baghdad and Balad — around the same time Thompson was at Camp Striker, near the Baghdad airport.

“Because of exposure to burn pits — in my view, I can’t prove it yet — he came back with stage 4 glioblastoma,” Biden said in a 2019 speech.

In testimony at the March 10 hearing, Shane Liermann, who works for the group Disabled American Veterans, told the committee that 78% of burn pit claims are denied. “Part of the problem is VA is not recognizing that exposure as being toxic exposures,” Liermann said.

Aleks Morosky, with the Wounded Warrior Project, said that in his group’s survey of 28,000 veterans last year, 71% said they had “definitely” been exposed to toxic substances or hazardous chemicals, and 18% said they had “probably” been exposed. Half of those people rated their health as poor or fair. Only about 16% of the service members who believed they had suffered exposure said they got treatment from the VA, and 11% said they were denied treatment.

Thompson, who is 49, said care for his lung disease is often slow and sometimes denied. It took the VA three years to approve an air purifier for his home to filter out allergens, and the VA refused to help pay for the removal of dust-trapping carpets, he said.

Thompson’s presence at the hearing, though, was not just meant to put the spotlight on the VA. The military’s entire approach to toxic exposure is a morass that leaves ill soldiers and veterans like Thompson trying to navigate a bureaucracy more labyrinthine than the Pentagon’s corridors.

After Thompson was shipped back to Fort Stewart in Georgia, his medical ordeal was at first addressed within the military system, including a year at Walter Reed National Military Medical Center in Bethesda, Maryland, where doctors found his lungs filled with titanium, magnesium, iron and silica.

Yet he said he didn’t qualify for the Army’s traumatic-injury insurance program, which might have helped him pay to retrofit his home in West Virginia. And he can’t get his military retirement pay until he’s 60.

“I may not live to be age 60. I turn 50 this year,” Thompson said.

Illustrating the problem, several officials at the hearing with the Department of Defense, the Army and the National Guard were unable to explain why Thompson — with 23 years of service between the Guard and Army — might have such a hard time qualifying for retirement benefits when the evidence of his lungs and the findings of the Army’s own doctors are so vivid and extreme.

For advocates who have been working on the problem for decades, it reminds them all too vividly of Agent Orange, which the military is still coming to grips with.

“It’s already been, since the first Persian Gulf [War] — we’re talking 30 years — and since burn pits were again active, since 2001,” said Liermann. “We’re way behind the curve here.”

Although Congress has done relatively little to deal with burn pits, many members seem to at least be thinking along the same lines. The Senate Veterans’ Affairs hearing promised to be something of a kickoff to a year when lawmakers are poised to offer a slew of bills designed to confront the military’s inability to care for service members poisoned during their deployments.

“Make no mistake about it,” said the committee chairman, Sen. Jon Tester (D-Mont.). “We hold these hearings for two reasons: to gather information for the committee members and to help educate the VA that they might take action before Congress does.”

Republicans have also shown growing interest in the problem, offering targeted bills to ensure a handful of toxin-related diseases are covered by the VA.

At the hearing, conservative freshman Sen. Tommy Tuberville (R-Ala.) seemed especially moved.

“We got to do a better job of taking care of our young people,” Tuberville said. “If we’re going to go to war, we got to understand we got to pay the price for it on both ends.”

There is also likely to be high-profile support and attention when revised legislation starts rolling out this spring.

The broadest bill likely to be offered was first introduced by Sen. Kirsten Gillibrand (D-N.Y.) in the Senate and Rep. Raul Ruiz (D-Calif.) in the House in late 2019, with a boost from former “Daily Show” host Jon Stewart and a cadre of 9/11 responders who are turning their attention to toxic exposures.

Indeed, Ruiz and Gillibrand’s legislation is modeled in part on the 9/11 health act that passed in 2015. The burn pit bill would remove the burden of proving a service-related connection.

It would vastly simplify the lives of people like Thompson.

“I am a warrior of the United States of America. I gave my lungs for my country,” Thompson said.

He was cut off before he could finish, but his prepared remarks concluded, “Hopefully, after hearing my story, it will bring awareness for not only me but others who are battling the same or similar injuries related to burn pit exposures from Iraq or Afghanistan.”

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

USE OUR CONTENT

This story can be republished for free (details).

Subscribe to KHN's free Morning Briefing.

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

The first large study of its kind reveals that SARS-CoV-2 reinfections remain rare, although people older than 65 are at higher risk.

When researchers analyzed test results of 4 million people in Denmark, they found that less than 1% of those who tested positive experienced reinfection.

Initial infection was associated with about 80% protection overall against getting SARS-CoV-2 again. However, among those older than 65, the protection plummeted to 47%.

“Not everybody is protected against reinfection after a first infection. Older people are at higher risk of catching it again,” co–lead author Daniela Michlmayr, PhD, said in an interview. “Our findings emphasize the importance of policies to protect the elderly and of adhering to infection control measures and restrictions, even if previously infected with COVID-19.”
 

Verifying the need for vaccination

“The findings also highlight the need to vaccinate people who had COVID-19 before, as natural immunity to infection – especially among the elderly 65 and older – cannot be relied upon,” added Dr. Michlmayr, a researcher in the department of bacteria, parasites, and fungi at the Staten Serums Institut, Copenhagen.

The population-based observational study was published online March 17 in The Lancet.

“The findings make sense, as patients who are immunocompromised or of advanced age may not mount an immune response that is as long-lasting,” David Hirschwerk, MD, said in an interview. “It does underscore the importance of vaccination for people of more advanced age, even if they previously were infected with COVID.

“For those who were infected last spring and have not yet been vaccinated, this helps to support the value of still pursuing the vaccine,” added Dr. Hirschwerk, an infectious disease specialist at Northwell Health in Manhasset, N.Y.

Evidence on reinfection risk was limited prior to this study. “Little is known about protection against SARS-CoV-2 repeat infections, but two studies in the UK have found that immunity could last at least 5 to 6 months after infection,” the authors noted.

Along with co–lead author Christian Holm Hansen, PhD, Dr. Michlmayr and colleagues found that 2.11% of 525,339 individuals tested positive for SARS-CoV-2 during the first surge in Denmark from March to May 2020. Within this group, 0.65% tested positive during a second surge from September to December.

By the end of 2020, more than 10 million people had undergone free polymerase chain reaction testing by the Danish government or through the national TestDenmark program.

“My overall take is that it is great to have such a big dataset looking at this question,” E. John Wherry, PhD, said in an interview. The findings support “what we’ve seen in previous, smaller studies.”

Natural protection against reinfection of approximately 80% “is not as good as the vaccines, but not bad,” added Dr. Wherry, director of the Institute for Immunology at the University of Pennsylvania, Philadelphia.
 

Age alters immunity?

“Our finding that older people were more likely than younger people to test positive again if they had already tested positive could be explained by natural age-related changes in the immune system of older adults, also referred to as immune senescence,” the authors noted.

The investigators found no significant differences in reinfection rates between women and men.

As with the previous research, this study also indicates that an initial bout with SARS-CoV-2 infection appears to confer protection for at least 6 months. The researchers found no significant differences between people who were followed for 3-6 months and those followed for 7 months or longer.
 

Variants not included

To account for possible bias among people who got tested repeatedly, Dr. Michlmayr and colleagues performed a sensitivity analysis in a subgroup. They assessed reinfection rates among people who underwent testing frequently and routinely – nurses, doctors, social workers, and health care assistants – and found that 1.2% tested positive a second time during the second surge.

A limitation of the study was the inability to correlate symptoms with risk for reinfection. Also, the researchers did not account for SARS-CoV-2 variants, noting that “during the study period, such variants were not yet established in Denmark; although into 2021 this pattern is changing.”

Asked to speculate whether the results would be different had the study accounted for variants, Dr. Hirschwerk said, “It depends upon the variant, but certainly for the B.1.351 variant, there already has been data clearly demonstrating risk of reinfection with SARS-CoV-2 despite prior infection with the original strain of virus.”

The emergence of SARS-CoV-2 variants of concern that could escape natural and vaccine-related immunity “complicates matters further,” Rosemary J. Boyton, MBBS, and Daniel M. Altmann, PhD, both of Imperial College London, wrote in an accompanying comment in The Lancet.

“Emerging variants of concern might shift immunity below a protective margin, prompting the need for updated vaccines. Interestingly, vaccine responses even after single dose are substantially enhanced in individuals with a history of infection with SARS-CoV-2,” they added.

The current study confirms that “the hope of protective immunity through natural infections might not be within our reach, and a global vaccination program with high efficacy vaccines is the enduring solution,” Dr. Boyton and Dr. Altmann noted.

Cause for alarm?

Despite evidence that reinfection is relatively rare, “many will find the data reported by Hansen and colleagues about protection through natural infection relatively alarming,” Dr. Boyton and Dr. Altmann wrote in their commentary. The 80% protection rate from reinfection in general and the 47% rate among people aged 65 and older “are more concerning figures than offered by previous studies.”

Vaccines appear to provide better quality, quantity, and durability of protection against repeated infection – measured in terms of neutralizing antibodies and T cells – compared with previous infection with SARS-CoV-2, Dr. Boyton and Dr. Altmann wrote.
 

More research needed

The duration of natural protection against reinfection remains an unanswered question, the researchers noted, “because too little time has elapsed since the beginning of the pandemic.”

Future prospective and longitudinal cohort studies coupled with molecular surveillance are needed to characterize antibody titers and waning of protection against repeat infections, the authors noted. Furthermore, more answers are needed regarding how some virus variants might contribute to reinfection risk.

No funding for the study has been reported. Dr. Michlmayr, Dr. Hirschwerk, Dr. Wherry, Dr. Boyton, and Dr. Altmann have disclosed no relevant financial relationships.
 

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

In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

In a summary of abstracts presented at the ACTRIMS Forum 2021, Dr. Mark Freedman shares that he and his colleagues found no apparent increased risk of COVID-19 with long-term use of interferon β-1a in patients with multiple sclerosis (MS).

Dr. Freedman also highlights several abstracts examining the use of cladribine and ocrelizumab in older patients with MS.

A post hoc analysis of lymphocyte subsets in the combined safety populations of CLARITY, CLARITY Extension, and ORACLE-MS found that by week 96, the effects of cladribine tablets 3.5 mg/kg on CD19+ B, CD4+ T, and CD8+ T lymphocytes in younger and older patients with MS were similar, with steady recovery following nadir.

Another study on younger and older patients treated with cladribine tablets 3.5 mg/kg found that around a quarter of both groups had transient periods of Grade ≥3 lymphopenia during the study, and the rate of certain infection-related treatment-emergent adverse events was higher in the older patients.

A single-center study found that 25% of patients in the older population stopped ocrelizumab, the most common reasons being disease progression and repeated or severe infections.

Lastly, an evaluation of older patients with progressive MS found no statistical difference in 2-year clinical endpoints for patients taking ocrelizumab compared to prior to anti-CD20 therapy.

--

Mark S. Freedman, MSc, MD is a Professor, Department of Neurology, University of Ottawa and The Ottawa Hospital Research Institute; and Director, Multiple Sclerosis Research Unit, The Ottawa Hospital–General Campus.

Mark S. Freedman, MSc, MD, has disclosed the following relevant financial relationships:

Serve(d) on the advisory board, board of directors, or other similar groups for: Actelion (Janssen/Johnson and Johnson); Alexion; Atara Biotherapeutics; Bayer Healthcare; Biogen Idec; Celgene; Clene Nanomedicine; GRI Bio; Hoffmann-La Roche; Magenta Therapeutics; Merck Serono; MedDay Pharmaceuticals; Novartis; Sanofi Genzyme; Teva Canada.

Serve(d) as a member of a speakers bureau for: Sanofi Genzyme; EMD Serono.

Received honoraria or consultation fees for: Actelion (Janssen/Johnson and Johnson); Alexion; Biogen Idec; Celgene (BMS); EMD Inc; Sanofi Genzyme; Hoffmann-La Roche; Merck Serono; Novartis; Teva Canada.

Received research or educational grants from: EMD Inc; Hoffmann-La Roche; Sanofi Genzyme Canada.

Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

Joseph Berger, MD, Associate Chief of the Multiple Sclerosis Division at Perelman School of Medicine at the University of Pennsylvania, presents highlights in multiple sclerosis (MS) symptom management from the ACTRIMS Forum 2021.

A follow-up of participants in the self-management program called Fatigue: Take Control found that while patients did not report any significant improvement in fatigue 5-6 years later, they also did not have greater fatigue than at baseline, suggesting that fatigue may not be a progressive symptom.

Next, a literature review of efficacy studies in MS rodent models found a complementary pharmacology of CBD and other constituents of nabiximols that may add additional benefit and mitigate THC tolerability.

A small study looking at pain prevalence in patients with relapsing-remitting MS (RRMS) found that 76% of patients had a pain syndrome, and 48% had neuropathic pain. The study also found that gabapentin 900 mg per day for 30 days was effective in decreasing pain intensity and frequency.

A multi-site study of 282 patients with MS reporting fatigue between 2013 and 2014 found that 21% of patients reported using prescription opiates, 76% of whom reported regular daily use.

Lastly, participants in Spasticity: Take Control—an education and lower extremity stretching program—reported significantly decreased pain severity and interference at 6 months, compared with range-of-motion exercises.

--

Professor and Associate Chief, Department of Neurology, Multiple Sclerosis Division. Perelman School of Medicine at the University of Pennsylvania Philadelphia, Pennsylvania.

Joseph R. Berger, MD, has disclosed the following relevant financial relationships:

Received research grant from: Biogen; Roche/Genentech.

Received income in an amount ≥$250 from: Amgen; Biogen; Bristol Myers Squibb; Celgene; Encycle; Excision BioTherapeutics; Dr. Reddy; Genzyme; Inhibikase Therapeutics; Mapi-Pharma; Merck; Morphic Therapeutic; Novartis; Serono.

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

A baby girl who was born 3 weeks after her mom got the first dose of the Moderna COVID-19 vaccine has antibodies against the coronavirus, according to a preprint paper published on the medRxiv server Feb. 5. The paper hasn’t yet been peer reviewed.

The mom, a health care worker in Florida, developed COVID-19 antibodies after she received the shot. Testing showed that the antibodies passed through the placenta to the baby.

“Maternal vaccination for influenza and TDaP have been well studied in terms of safety and efficacy for protection of the newborn by placental passage of antibodies,” Paul Gilbert, MD, and Chad Rudnick, MD, pediatricians and researchers at Florida Atlantic University, wrote in the paper.

Previous research has indicated that moms who have recovered from COVID-19 can deliver babies with antibodies, according to Insider, but this may be the first report that shows how vaccination during pregnancy can provide antibodies as well.

Dr. Gilbert and Dr. Rudnick said they were fortunate to connect with the mom in Boca Raton. She hadn’t contracted COVID-19 and was able to get the vaccine at the end of her pregnancy in January. When the baby was born, they were able to test the cord blood to look for antibodies specifically from the vaccine.

“We were very excited to see, once the test result came back, that the antibodies from the mom’s vaccine did in fact pass through the placenta to the newborn,” Dr. Rudnick told WPTV, an NBC affiliate in West Palm Beach.

“We knew that we were going to be potentially one of the first in the world to report it, and that opportunity probably only comes once in a career,” Dr. Gilbert told WPTV.

In the preprint, Dr. Gilbert and Dr. Rudnick said a “vigorous, healthy, full-term” baby was born, and the mom received the second dose of the Moderna vaccine during the postpartum period. The newborn received a normal “well-infant” evaluation and was breastfeeding.

The two doctors called for a “significant and urgent need” to research the safety and efficacy of COVID-19 vaccines during pregnancy. They also encouraged other researchers to create pregnancy and breastfeeding registries to study COVID-19 vaccines in pregnant and breastfeeding moms and newborns.

Dr. Gilbert and Dr. Rudnick are now preparing their research for publication and hope future studies will investigate the amount and length of antibody response in newborns.

“Total antibody measurements may be used to determine how long protection is expected, which may help to determine when the best time would be to begin vaccination,” they wrote.

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

There is a Chinese curse which says “May he live in interesting times.” Like it or not, we live in interesting times. They are times of danger and uncertainty; but they are also more open to the creative energy of men than any other time in history.

–Robert Kennedy, Cape Town, South Africa, 1966
 

Well, you may not know it, but price transparency is coming to medicine, including dermatology. The transparency of coverage rule was finalized and released on Oct. 29, 2020, by the

Centers for Medicare & Medicaid Services. It has survived a challenge by the American Hospital Association in federal court, which generally means it is going to “stick.” Its effects should start to appear on Jan. 1, 2022.

The newly finalized rule will require insurers to publicly disclose in-network provider-negotiated rates, historical out-of-network allowed amounts, associated facility fees, and drug-pricing information in easily accessible machine-readable files. This information will be disclosed for the 500 most commonly billed physician services starting Jan. 1, 2022, and expanded to include all services the following year. Understand that you, as a practitioner, do not have to do anything, as insurers will do it for you, but your charge data will be on display. It is not clear if there is an appeal mechanism for physicians to correct erroneous data.

This should provide a fascinating look at just what things really cost, and may prove, as we suspect, small practices are less expensive. Important exemptions to reporting include emergency services, anesthesia, lab tests, and pathology fees, which will not be required, but recommended, to be disclosed.

Bear in mind that this rule was not designed to benefit physicians or hospitals, but rather to allow patients to comparison shop and drive down the cost of medical care. True price transparency may well accomplish this, particularly in our age of sky-high deductibles, if the information is accurate and readily accessible.

Although studies of patient behavior have shown that few patients actually use price comparison tools, the data required to be publicly disclosed and accessible will make this much easier. The Wall Street Journal or ProPublica will likely be all over this with applications to make comparisons easier. Still, many patients are price insensitive, particularly if they are Medicare recipients and only responsible for a nominal deductible.

Almost all the evaluation and management codes, as well as many dermatology procedure codes, are listed in the top 500 items and services included in the initial stage of the finalized rule. These include skin biopsies, destructions, drainages, several different benign and malignant excisions and, of course, Mohs surgery (but only the first stage, the 2nd stage will be listed in 2023).

While it is unlikely for patients to doctor shop for services that are performed on the same day as the office visit, such as a biopsies or destructions, we would expect comparisons for more expensive, planned procedures such as Mohs surgery and cancer excisions. Considering the rule, Mohs surgery may compare favorably to excisions performed in the hospital if the operating room charges are included, but not so well if the pathology and anesthesia charges are not included in the cost. It is inherently unfair to compare Mohs to excision in an operating room since the Mohs procedure has the anesthesia and pathology work embedded in the code (at 55% of the value of the code), and the multiple frozen sections taken by the surgeon in the operating room will not be listed as they are technically considered to be exempt additional pathology services.

This could put the Mohs surgeon in the interesting position of billing for excisions and frozen sections instead of Mohs surgery in order to compete with the hospital-based surgeon. This is not unbundling, if overall charges are lower and if distinctly different procedures are followed and different paperwork is generated. This is how I currently handle patients who demand Mohs surgery for inappropriate sites.

The effect on hospital groups that can charge facility fees could be quite dramatic, as it could be on large groups and on private equity groups who may have negotiated better rates. These increased costs will be revealed to consumers. In January 2023, the insurers will have to deploy a tool on their web site, updated monthly, that details rates for the 500 most common procedures for all in- and out-of-network providers and how much the patient can expect to pay out of pocket. All facility fees for procedures will be included. As noted earlier, we would expect third parties to already have done this. The historical and current costs for medications will also be included, which should make for interesting times in the pharmaceutical industry.

In January 2024, insurers will be required to post all the additional codes they cover, including complex closures, flaps, and grafts and any associated facility fees. Of course, a patient or a surgeon does not know what sort of repair a patient will need after Mohs surgery, but with high deductibles hitting harder, we would expect more patients requesting healing by second intent.

Whether these price comparisons will drive patients from relatively high-cost centers to less costly ones is unclear. This has certainly been the case for MRI and CT imaging. Price transparency for MRIs increased use of less costly providers and triggered provider competition.

Whether the price differentials will allow smaller practices some leverage in negotiating rates is also uncertain. Who knows, perhaps the out-of-network rate is greater than what your contract currently specifies, which could spur you to drop their network entirely. There may be great opportunity here for the smaller practitioner who has been boxed out of the big-group pricing and networks.

Be prepared in January 2022, to discuss these issues with patients and insurers, and be sure to check where you fall in cost comparisons. What possible logic could an insurer have for excluding you from a network where your average charges are less than their current panel? As noted before, this may be a boon for small practices that have been forced to the fringes of reimbursement and an opportunity to demonstrate that they are really much less expensive. We live in interesting times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Bishop is doing a fellowship in micrographic surgery and dermatologic oncology with Dr. Coldiron at the Skin Cancer Center in Cincinnati. Write to Dr. Coldiron at [email protected].

There is a Chinese curse which says “May he live in interesting times.” Like it or not, we live in interesting times. They are times of danger and uncertainty; but they are also more open to the creative energy of men than any other time in history.

–Robert Kennedy, Cape Town, South Africa, 1966
 

Well, you may not know it, but price transparency is coming to medicine, including dermatology. The transparency of coverage rule was finalized and released on Oct. 29, 2020, by the

Centers for Medicare & Medicaid Services. It has survived a challenge by the American Hospital Association in federal court, which generally means it is going to “stick.” Its effects should start to appear on Jan. 1, 2022.

The newly finalized rule will require insurers to publicly disclose in-network provider-negotiated rates, historical out-of-network allowed amounts, associated facility fees, and drug-pricing information in easily accessible machine-readable files. This information will be disclosed for the 500 most commonly billed physician services starting Jan. 1, 2022, and expanded to include all services the following year. Understand that you, as a practitioner, do not have to do anything, as insurers will do it for you, but your charge data will be on display. It is not clear if there is an appeal mechanism for physicians to correct erroneous data.

This should provide a fascinating look at just what things really cost, and may prove, as we suspect, small practices are less expensive. Important exemptions to reporting include emergency services, anesthesia, lab tests, and pathology fees, which will not be required, but recommended, to be disclosed.

Bear in mind that this rule was not designed to benefit physicians or hospitals, but rather to allow patients to comparison shop and drive down the cost of medical care. True price transparency may well accomplish this, particularly in our age of sky-high deductibles, if the information is accurate and readily accessible.

Although studies of patient behavior have shown that few patients actually use price comparison tools, the data required to be publicly disclosed and accessible will make this much easier. The Wall Street Journal or ProPublica will likely be all over this with applications to make comparisons easier. Still, many patients are price insensitive, particularly if they are Medicare recipients and only responsible for a nominal deductible.

Almost all the evaluation and management codes, as well as many dermatology procedure codes, are listed in the top 500 items and services included in the initial stage of the finalized rule. These include skin biopsies, destructions, drainages, several different benign and malignant excisions and, of course, Mohs surgery (but only the first stage, the 2nd stage will be listed in 2023).

While it is unlikely for patients to doctor shop for services that are performed on the same day as the office visit, such as a biopsies or destructions, we would expect comparisons for more expensive, planned procedures such as Mohs surgery and cancer excisions. Considering the rule, Mohs surgery may compare favorably to excisions performed in the hospital if the operating room charges are included, but not so well if the pathology and anesthesia charges are not included in the cost. It is inherently unfair to compare Mohs to excision in an operating room since the Mohs procedure has the anesthesia and pathology work embedded in the code (at 55% of the value of the code), and the multiple frozen sections taken by the surgeon in the operating room will not be listed as they are technically considered to be exempt additional pathology services.

This could put the Mohs surgeon in the interesting position of billing for excisions and frozen sections instead of Mohs surgery in order to compete with the hospital-based surgeon. This is not unbundling, if overall charges are lower and if distinctly different procedures are followed and different paperwork is generated. This is how I currently handle patients who demand Mohs surgery for inappropriate sites.

The effect on hospital groups that can charge facility fees could be quite dramatic, as it could be on large groups and on private equity groups who may have negotiated better rates. These increased costs will be revealed to consumers. In January 2023, the insurers will have to deploy a tool on their web site, updated monthly, that details rates for the 500 most common procedures for all in- and out-of-network providers and how much the patient can expect to pay out of pocket. All facility fees for procedures will be included. As noted earlier, we would expect third parties to already have done this. The historical and current costs for medications will also be included, which should make for interesting times in the pharmaceutical industry.

In January 2024, insurers will be required to post all the additional codes they cover, including complex closures, flaps, and grafts and any associated facility fees. Of course, a patient or a surgeon does not know what sort of repair a patient will need after Mohs surgery, but with high deductibles hitting harder, we would expect more patients requesting healing by second intent.

Whether these price comparisons will drive patients from relatively high-cost centers to less costly ones is unclear. This has certainly been the case for MRI and CT imaging. Price transparency for MRIs increased use of less costly providers and triggered provider competition.

Whether the price differentials will allow smaller practices some leverage in negotiating rates is also uncertain. Who knows, perhaps the out-of-network rate is greater than what your contract currently specifies, which could spur you to drop their network entirely. There may be great opportunity here for the smaller practitioner who has been boxed out of the big-group pricing and networks.

Be prepared in January 2022, to discuss these issues with patients and insurers, and be sure to check where you fall in cost comparisons. What possible logic could an insurer have for excluding you from a network where your average charges are less than their current panel? As noted before, this may be a boon for small practices that have been forced to the fringes of reimbursement and an opportunity to demonstrate that they are really much less expensive. We live in interesting times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Bishop is doing a fellowship in micrographic surgery and dermatologic oncology with Dr. Coldiron at the Skin Cancer Center in Cincinnati. Write to Dr. Coldiron at [email protected].

There is a Chinese curse which says “May he live in interesting times.” Like it or not, we live in interesting times. They are times of danger and uncertainty; but they are also more open to the creative energy of men than any other time in history.

–Robert Kennedy, Cape Town, South Africa, 1966
 

Well, you may not know it, but price transparency is coming to medicine, including dermatology. The transparency of coverage rule was finalized and released on Oct. 29, 2020, by the

Centers for Medicare & Medicaid Services. It has survived a challenge by the American Hospital Association in federal court, which generally means it is going to “stick.” Its effects should start to appear on Jan. 1, 2022.

The newly finalized rule will require insurers to publicly disclose in-network provider-negotiated rates, historical out-of-network allowed amounts, associated facility fees, and drug-pricing information in easily accessible machine-readable files. This information will be disclosed for the 500 most commonly billed physician services starting Jan. 1, 2022, and expanded to include all services the following year. Understand that you, as a practitioner, do not have to do anything, as insurers will do it for you, but your charge data will be on display. It is not clear if there is an appeal mechanism for physicians to correct erroneous data.

This should provide a fascinating look at just what things really cost, and may prove, as we suspect, small practices are less expensive. Important exemptions to reporting include emergency services, anesthesia, lab tests, and pathology fees, which will not be required, but recommended, to be disclosed.

Bear in mind that this rule was not designed to benefit physicians or hospitals, but rather to allow patients to comparison shop and drive down the cost of medical care. True price transparency may well accomplish this, particularly in our age of sky-high deductibles, if the information is accurate and readily accessible.

Although studies of patient behavior have shown that few patients actually use price comparison tools, the data required to be publicly disclosed and accessible will make this much easier. The Wall Street Journal or ProPublica will likely be all over this with applications to make comparisons easier. Still, many patients are price insensitive, particularly if they are Medicare recipients and only responsible for a nominal deductible.

Almost all the evaluation and management codes, as well as many dermatology procedure codes, are listed in the top 500 items and services included in the initial stage of the finalized rule. These include skin biopsies, destructions, drainages, several different benign and malignant excisions and, of course, Mohs surgery (but only the first stage, the 2nd stage will be listed in 2023).

While it is unlikely for patients to doctor shop for services that are performed on the same day as the office visit, such as a biopsies or destructions, we would expect comparisons for more expensive, planned procedures such as Mohs surgery and cancer excisions. Considering the rule, Mohs surgery may compare favorably to excisions performed in the hospital if the operating room charges are included, but not so well if the pathology and anesthesia charges are not included in the cost. It is inherently unfair to compare Mohs to excision in an operating room since the Mohs procedure has the anesthesia and pathology work embedded in the code (at 55% of the value of the code), and the multiple frozen sections taken by the surgeon in the operating room will not be listed as they are technically considered to be exempt additional pathology services.

This could put the Mohs surgeon in the interesting position of billing for excisions and frozen sections instead of Mohs surgery in order to compete with the hospital-based surgeon. This is not unbundling, if overall charges are lower and if distinctly different procedures are followed and different paperwork is generated. This is how I currently handle patients who demand Mohs surgery for inappropriate sites.

The effect on hospital groups that can charge facility fees could be quite dramatic, as it could be on large groups and on private equity groups who may have negotiated better rates. These increased costs will be revealed to consumers. In January 2023, the insurers will have to deploy a tool on their web site, updated monthly, that details rates for the 500 most common procedures for all in- and out-of-network providers and how much the patient can expect to pay out of pocket. All facility fees for procedures will be included. As noted earlier, we would expect third parties to already have done this. The historical and current costs for medications will also be included, which should make for interesting times in the pharmaceutical industry.

In January 2024, insurers will be required to post all the additional codes they cover, including complex closures, flaps, and grafts and any associated facility fees. Of course, a patient or a surgeon does not know what sort of repair a patient will need after Mohs surgery, but with high deductibles hitting harder, we would expect more patients requesting healing by second intent.

Whether these price comparisons will drive patients from relatively high-cost centers to less costly ones is unclear. This has certainly been the case for MRI and CT imaging. Price transparency for MRIs increased use of less costly providers and triggered provider competition.

Whether the price differentials will allow smaller practices some leverage in negotiating rates is also uncertain. Who knows, perhaps the out-of-network rate is greater than what your contract currently specifies, which could spur you to drop their network entirely. There may be great opportunity here for the smaller practitioner who has been boxed out of the big-group pricing and networks.

Be prepared in January 2022, to discuss these issues with patients and insurers, and be sure to check where you fall in cost comparisons. What possible logic could an insurer have for excluding you from a network where your average charges are less than their current panel? As noted before, this may be a boon for small practices that have been forced to the fringes of reimbursement and an opportunity to demonstrate that they are really much less expensive. We live in interesting times.

Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Dr. Bishop is doing a fellowship in micrographic surgery and dermatologic oncology with Dr. Coldiron at the Skin Cancer Center in Cincinnati. Write to Dr. Coldiron at [email protected].

The light at the end of the pandemic tunnel seems even brighter than it did just a month ago and in its glow it’s tempting to look back on the adjustments we have made in our lives and consider how many of those adjustments will solidify into new standards. Certainly, near the top of the changes wrought by SARS-CoV-2 is an explosive use of the Internet as a vehicle for group interaction and communication. Did you even know what Zoom was a year ago?

From remote education to international business meetings our screen time has increased dramatically. In homes across the country families have relaxed any restrictions they might have had on video exposure as they struggled to amuse and entertain children who have been shut off from their playmates. As reported in the Washington Post, the monitoring company Bark found that children sent and received 144% more Internet messages in 2020 than they had the year before..

Even families that I know who have been incredibly creative in finding physical activities, both indoor and outdoor, for their children have scaled back their restrictions on screen time. While the term “survival mode” is a bit too strong to describe this phenomenon, it was simply a matter of finding solutions given a limited supply of options.

The increase in screen time has prompted many parents to worry about its effect on their children. The American Academy of Pediatrics has already expressed concern about the cumulative effects of screen exposure on visual acuity. And it seems reasonable to expect that the obesity epidemic will accelerate as more children become more sedentary watching video screens. Whether the dire predictions of educators about lost learning will come true remains to be seen.

We can hope that this relaxation of screen time limits will be temporary. But that hope has a slim chance of becoming a reality as we have realized how powerful the Internet can be as an imperfect but effective educational tool. We have seen that apps such as Zoom, GoToMeeting, and FaceTime can allow families to connect on holidays when to face-to-face meetings are impractical. How should parents, and those of us who advise them, begin to restructure sensible and enforceable guidelines for screen time given the sea change we have just experienced?

There will certainly be significant resistance on the part of children to unlearn screen habits developed during the darkest hours of the pandemic: Texting a friend whom you will now be able to see in school, playing a video game instead of biking around the neighborhood with on a sunny afternoon, or, binging on sitcoms in the evening with your parents when they knew you didn’t have to get up early to catch the school bus.

It could be a herculean task to nudge the screen time pendulum back toward the prepandemic “norm.” In the past we haven’t done a very good job of promoting a healthy screen time diet for children. When the only screen in town was television the American Academy of Pediatrics’ focus was more on content than quantity. Quality is often difficult to assess and parents, like most everyone, seem more comfortable with guidelines that include a time metric – even if they don’t seem to be very good at enforcing it.

Maybe screen time is too big a boulder to roll up the hill. The good news is that during the pandemic, activity – particularly outdoor activity – has increased dramatically. Bicycles went off the shelves like toilet paper. National and state parks have been overflowing with families. While we must not ignore the downside of excess screen time, we should put more effort into promoting the healthy alternative of outdoor recreation. Let’s not allow a positive trend slip into becoming a short-lived fad.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The light at the end of the pandemic tunnel seems even brighter than it did just a month ago and in its glow it’s tempting to look back on the adjustments we have made in our lives and consider how many of those adjustments will solidify into new standards. Certainly, near the top of the changes wrought by SARS-CoV-2 is an explosive use of the Internet as a vehicle for group interaction and communication. Did you even know what Zoom was a year ago?

From remote education to international business meetings our screen time has increased dramatically. In homes across the country families have relaxed any restrictions they might have had on video exposure as they struggled to amuse and entertain children who have been shut off from their playmates. As reported in the Washington Post, the monitoring company Bark found that children sent and received 144% more Internet messages in 2020 than they had the year before..

Even families that I know who have been incredibly creative in finding physical activities, both indoor and outdoor, for their children have scaled back their restrictions on screen time. While the term “survival mode” is a bit too strong to describe this phenomenon, it was simply a matter of finding solutions given a limited supply of options.

The increase in screen time has prompted many parents to worry about its effect on their children. The American Academy of Pediatrics has already expressed concern about the cumulative effects of screen exposure on visual acuity. And it seems reasonable to expect that the obesity epidemic will accelerate as more children become more sedentary watching video screens. Whether the dire predictions of educators about lost learning will come true remains to be seen.

We can hope that this relaxation of screen time limits will be temporary. But that hope has a slim chance of becoming a reality as we have realized how powerful the Internet can be as an imperfect but effective educational tool. We have seen that apps such as Zoom, GoToMeeting, and FaceTime can allow families to connect on holidays when to face-to-face meetings are impractical. How should parents, and those of us who advise them, begin to restructure sensible and enforceable guidelines for screen time given the sea change we have just experienced?

There will certainly be significant resistance on the part of children to unlearn screen habits developed during the darkest hours of the pandemic: Texting a friend whom you will now be able to see in school, playing a video game instead of biking around the neighborhood with on a sunny afternoon, or, binging on sitcoms in the evening with your parents when they knew you didn’t have to get up early to catch the school bus.

It could be a herculean task to nudge the screen time pendulum back toward the prepandemic “norm.” In the past we haven’t done a very good job of promoting a healthy screen time diet for children. When the only screen in town was television the American Academy of Pediatrics’ focus was more on content than quantity. Quality is often difficult to assess and parents, like most everyone, seem more comfortable with guidelines that include a time metric – even if they don’t seem to be very good at enforcing it.

Maybe screen time is too big a boulder to roll up the hill. The good news is that during the pandemic, activity – particularly outdoor activity – has increased dramatically. Bicycles went off the shelves like toilet paper. National and state parks have been overflowing with families. While we must not ignore the downside of excess screen time, we should put more effort into promoting the healthy alternative of outdoor recreation. Let’s not allow a positive trend slip into becoming a short-lived fad.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

The light at the end of the pandemic tunnel seems even brighter than it did just a month ago and in its glow it’s tempting to look back on the adjustments we have made in our lives and consider how many of those adjustments will solidify into new standards. Certainly, near the top of the changes wrought by SARS-CoV-2 is an explosive use of the Internet as a vehicle for group interaction and communication. Did you even know what Zoom was a year ago?

From remote education to international business meetings our screen time has increased dramatically. In homes across the country families have relaxed any restrictions they might have had on video exposure as they struggled to amuse and entertain children who have been shut off from their playmates. As reported in the Washington Post, the monitoring company Bark found that children sent and received 144% more Internet messages in 2020 than they had the year before..

Even families that I know who have been incredibly creative in finding physical activities, both indoor and outdoor, for their children have scaled back their restrictions on screen time. While the term “survival mode” is a bit too strong to describe this phenomenon, it was simply a matter of finding solutions given a limited supply of options.

The increase in screen time has prompted many parents to worry about its effect on their children. The American Academy of Pediatrics has already expressed concern about the cumulative effects of screen exposure on visual acuity. And it seems reasonable to expect that the obesity epidemic will accelerate as more children become more sedentary watching video screens. Whether the dire predictions of educators about lost learning will come true remains to be seen.

We can hope that this relaxation of screen time limits will be temporary. But that hope has a slim chance of becoming a reality as we have realized how powerful the Internet can be as an imperfect but effective educational tool. We have seen that apps such as Zoom, GoToMeeting, and FaceTime can allow families to connect on holidays when to face-to-face meetings are impractical. How should parents, and those of us who advise them, begin to restructure sensible and enforceable guidelines for screen time given the sea change we have just experienced?

There will certainly be significant resistance on the part of children to unlearn screen habits developed during the darkest hours of the pandemic: Texting a friend whom you will now be able to see in school, playing a video game instead of biking around the neighborhood with on a sunny afternoon, or, binging on sitcoms in the evening with your parents when they knew you didn’t have to get up early to catch the school bus.

It could be a herculean task to nudge the screen time pendulum back toward the prepandemic “norm.” In the past we haven’t done a very good job of promoting a healthy screen time diet for children. When the only screen in town was television the American Academy of Pediatrics’ focus was more on content than quantity. Quality is often difficult to assess and parents, like most everyone, seem more comfortable with guidelines that include a time metric – even if they don’t seem to be very good at enforcing it.

Maybe screen time is too big a boulder to roll up the hill. The good news is that during the pandemic, activity – particularly outdoor activity – has increased dramatically. Bicycles went off the shelves like toilet paper. National and state parks have been overflowing with families. While we must not ignore the downside of excess screen time, we should put more effort into promoting the healthy alternative of outdoor recreation. Let’s not allow a positive trend slip into becoming a short-lived fad.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Buprenorphine for the treatment of opioid-use disorder (OUD) may also mitigate the risk associated with concomitant benzodiazepine and Z-drug use, which is frequent in this patient population, new research suggests.

A case-crossover study of more than 20,000 participants with OUD showed that drug treatment days in which benzodiazepines and Z-drugs were taken were associated with an 88% increase in nonfatal overdose; buprenorphine appeared to reduce this risk by almost 40%.

“One of our two primary findings is that patients with opioid use disorder can still benefit substantially from buprenorphine treatment, even if they have benzodiazepines on board,” lead author Kevin Xu, MD, a resident at the Washington University, St. Louis, told this news organization.

The other key finding was that “not all benzodiazepines are equal” and that some are associated with higher risk than others, Dr. Xu added.

“If anything, patients who are on buprenorphine and benzodiazepines do not necessarily need to be abruptly tapered off their benzodiazepines. Our data actually demonstrate that there are safe avenues for them,” he added.

The findings were published online March 3 in the American Journal of Psychiatry.
 

Cloudy relationship

Buprenorphine is commonly used to treat patients with OUD because of its ability to decrease all-cause mortality. However, up to 30% of these patients also take benzodiazepines for comorbid mood and anxiety disorders, Dr. Xu noted.

In addition, recent research shows that benzodiazepine/Z-drug use is associated with a variety of potential adverse effects, including respiratory depression, overdose, and addiction risk.

The relationship between benzodiazepine use and buprenorphine treatment outcomes is poorly characterized in individuals with OUD. Although some studies suggest benzodiazepines may enhance retention in buprenorphine maintenance treatment, others suggest a link to increased adverse events, including all-cause mortality, drug-related poisonings, and accidental injury–related emergency department visits.

In addition, there has been little research on the potential adverse effects associated with use of selective benzodiazepine receptor modulators in patients with OUD. These so-called Z-drugs include zolpidem, zaleplon, and eszopiclone.

Nevertheless, previous research in the general population shows that these medications have a range of adverse effects similar to those of benzodiazepines, with comparable dose-response effects on all-cause mortality.

“The challenge for any clinician is that many patients who are addicted to opioids are also polysubstance users,” said Dr. Xu. “There are so many hopeful articles regarding the benefits of buprenorphine treatment in opioid use disorder patients, but it seems like the individuals with polysubstance use are largely ignored in the setting of the opioid epidemic.”

“And this is really the back story that got me inspired to study this particular topic,” he added.
 

Improve, nullify, or reverse?

Given these questions, the researchers set out to quantify the odds of nonfatal drug-related poisoning, including overdoses, associated with benzodiazepine or Z-drug use by patients with OUD who were also taking buprenorphine.

“While the drug-related poisoning variable encompasses opioid overdoses, we used a broad definition per CDC guidelines to also include other types of drug overdoses – including poisoning events involving stimulants, overdoses involving sedatives, and overdoses involving psychotropic prescription drugs” that are commonly used by patients with OUD, said Dr. Xu.

They also wanted to determine whether the use of benzodiazepines or Z-drugs would improve, nullify, or reverse the protective effect of buprenorphine. The researchers also evaluated whether different sedative and hypnotic subtypes of these drugs were associated with different poisoning risks.

The researchers analyzed pharmaceutical claims data from 304,676 individuals (aged 12-64 years) in the IBM MarketScan Commercial and Multi-State Medicaid Databases. All had received buprenorphine treatment for OUD between Jan. 1, 2006, and Dec. 31, 2016.

Buprenorphine use was converted to a daily milligram dose and was classified as either greater than 12 mg or less than or equal to 12 mg, because previous research suggests there may be differences in treatment retention associated with this dose. Given the case-control nature of the investigation, patients who did not experience a drug-related poisoning were excluded from the analysis.

The study’s primary unit of observation was person-days, which were those days during which patients were enrolled in a health insurance plan. Participants were evaluated for 1 year before their first drug-related poisoning and 1 year after their first such poisoning. The primary outcome was nonfatal drug-related poisonings, including overdoses. The primary exposure was determined on the basis of benzodiazepine or Z-drug prescriptions.

The daily dose of benzodiazepines or Z-drugs was standardized as a function of diazepam-equivalent milligrams. Doses were classified as either high dose (diazepam-equivalent mg dose >30 mg) or low dose (≤30 mg). The drugs were also distinguished on the basis of their pharmacologic properties, such as whether they were short-acting or long-acting.
 

37% risk reduction

Of the original cohort of 304,676 patients with OUD, the study’s final analytic sample included 23,036 patients (mean age, 30 years; 51% men), representing 14,213,075 person-days of insurance coverage. Of these, 2,210,927 person-days (15.6%) entailed claims for buprenorphine (mean daily dose, 15.4 mg; SD, 7.31 mg).

A total of 474,181 person-days included claims for benzodiazepines or Z-drugs with concurrent buprenorphine treatment. The mean daily dose of any benzodiazepine or Z-drug was 23.4 diazepam-milligram equivalents. The mean daily dose of short-acting benzodiazepines, long-acting benzodiazepines, and Z-drugs was 25.3, 31.3, and 4.9 diazepam-milligram equivalents, respectively.

Buprenorphine treatment days were associated with a 37% lower chance of drug-related poisoning (95% confidence interval, 0.60-0.66) in comparison with nontreatment days. On the other hand, the odds of poisoning increased by 81% on days on which patients were treated with Z-drugs or benzodiazepines (95% CI, 1.73-1.91).

Interestingly, individual analyses showed that benzodiazepine and Z-drug treatment days were associated with increased odds of poisoning events (odds ratio, 1.29; 95% CI, 1.19-1.39). Odds of poisoning events on benzodiazepine-only treatment days, on the other hand, were markedly lower (OR, 1.88; 95% CI, 1.78-1.98).

Subgroup analyses revealed that both short-acting and long-acting benzodiazepine treatment days were associated with comparably elevated odds of drug-related poisoning (OR, 1.86 and 1.68, respectively). High-dose benzodiazepine treatment days were associated with higher increased odds of a poisoning event (122%) in comparison with low-dose treatment days (78%).

High-dose, but not low-dose, benzodiazepine or Z-drug treatment was linked to increased poisonings when the drug was taken concurrently with buprenorphine (OR, 1.64; 95% CI, 1.39-1.93). However, the risk was still lower than the risk associated with taking the agents without concurrent treatment with buprenorphine (low-dose OR, 1.69; high-dose OR, 2.23).
 

‘Not all benzodiazepines are bad’

Dr. Xu noted that the findings have potentially important implications for clinical practice, beginning with the dose-dependent relationship between benzodiazepine/Z-drug use and drug-related poisonings among individuals with OUD. This indicates that lowering doses or shortening treatment duration may reduce risk, he said.

Similarly, the lower risk associated with long-acting benzodiazepines relative to short-acting beonzodiazepines – as well as the substantially lower risk associated with Z-drugs, compared with either short- or long-acting benzodiazepines – suggests that switching from benzodiazepines to long-acting agents or Z-drugs may lower the risk for overdose, he added.

“Clinicians are often challenged by patients with opioid use disorder who are also on benzodiazepines or Z-drugs. There’s an inclination to say no to them, because they’re too high risk to start buprenorphine maintenance, or abruptly taper the benzodiazepines, which can be very destabilizing,” he noted.

“Our data show that people on benzodiazepines can absolutely receive buprenorphine and still get some benefit,” Dr. Xu said. “In addition, not all benzodiazepines are bad for these individuals. There are safer formulations and safer doses, too.”

However, he added, he would not initiate benzodiazepine treatment if he didn’t have to, especially long-term treatment.

“One of the messages from our data is that this clearly contributes to higher overdose risk. But we often inherit patients who already have benzodiazepines on board, so we need to figure out what to do. That is the question that nobody had really clearly addressed prior to this study,” Dr. Xu concluded.
 

Vigilance needed

Commenting on the findings for this news organization, Jerrold F. Rosenbaum, MD, Stanley Cobb Professor of Psychiatry, Harvard Medical School, Boston, urged caution when combining benzodiazepines with opioids.

“There are situations where you need to be circumspect about the use of benzodiazepines, and that’s clearly when people are being prescribed them in combination with other drugs that could be either sedating or respiratory depressant,” said Dr. Rosenbaum, who was not involved with the research.

“This paper reminds us that physicians need to be particularly vigilant about situations where patients might be combining the two agents,” he added.

Dr. Rosenbaum noted that patients who are using more medication than prescribed are at risk “for not appreciating the synergy” between the two treatments in terms of adverse events such as respiratory depression.

In addition, “if they’re intending to do themselves harm, the lethality of an overdose will be certainly far more than the benzodiazepines or opiates alone,” he said.

Another potential challenge for clinicians are situations in which patients are taking benzodiazepines for preexisting conditions that also require opiates. “Then you have to use special vigilance and try to use lowest doses to reduce the total burden of medication to minimize the potential risk,” said Dr. Rosenbaum.

The study was funded by the National Institutes of Health. Dr. Xu has reported no relevant financial relationships.

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

Buprenorphine for the treatment of opioid-use disorder (OUD) may also mitigate the risk associated with concomitant benzodiazepine and Z-drug use, which is frequent in this patient population, new research suggests.

A case-crossover study of more than 20,000 participants with OUD showed that drug treatment days in which benzodiazepines and Z-drugs were taken were associated with an 88% increase in nonfatal overdose; buprenorphine appeared to reduce this risk by almost 40%.

“One of our two primary findings is that patients with opioid use disorder can still benefit substantially from buprenorphine treatment, even if they have benzodiazepines on board,” lead author Kevin Xu, MD, a resident at the Washington University, St. Louis, told this news organization.

The other key finding was that “not all benzodiazepines are equal” and that some are associated with higher risk than others, Dr. Xu added.

“If anything, patients who are on buprenorphine and benzodiazepines do not necessarily need to be abruptly tapered off their benzodiazepines. Our data actually demonstrate that there are safe avenues for them,” he added.

The findings were published online March 3 in the American Journal of Psychiatry.
 

Cloudy relationship

Buprenorphine is commonly used to treat patients with OUD because of its ability to decrease all-cause mortality. However, up to 30% of these patients also take benzodiazepines for comorbid mood and anxiety disorders, Dr. Xu noted.

In addition, recent research shows that benzodiazepine/Z-drug use is associated with a variety of potential adverse effects, including respiratory depression, overdose, and addiction risk.

The relationship between benzodiazepine use and buprenorphine treatment outcomes is poorly characterized in individuals with OUD. Although some studies suggest benzodiazepines may enhance retention in buprenorphine maintenance treatment, others suggest a link to increased adverse events, including all-cause mortality, drug-related poisonings, and accidental injury–related emergency department visits.

In addition, there has been little research on the potential adverse effects associated with use of selective benzodiazepine receptor modulators in patients with OUD. These so-called Z-drugs include zolpidem, zaleplon, and eszopiclone.

Nevertheless, previous research in the general population shows that these medications have a range of adverse effects similar to those of benzodiazepines, with comparable dose-response effects on all-cause mortality.

“The challenge for any clinician is that many patients who are addicted to opioids are also polysubstance users,” said Dr. Xu. “There are so many hopeful articles regarding the benefits of buprenorphine treatment in opioid use disorder patients, but it seems like the individuals with polysubstance use are largely ignored in the setting of the opioid epidemic.”

“And this is really the back story that got me inspired to study this particular topic,” he added.
 

Improve, nullify, or reverse?

Given these questions, the researchers set out to quantify the odds of nonfatal drug-related poisoning, including overdoses, associated with benzodiazepine or Z-drug use by patients with OUD who were also taking buprenorphine.

“While the drug-related poisoning variable encompasses opioid overdoses, we used a broad definition per CDC guidelines to also include other types of drug overdoses – including poisoning events involving stimulants, overdoses involving sedatives, and overdoses involving psychotropic prescription drugs” that are commonly used by patients with OUD, said Dr. Xu.

They also wanted to determine whether the use of benzodiazepines or Z-drugs would improve, nullify, or reverse the protective effect of buprenorphine. The researchers also evaluated whether different sedative and hypnotic subtypes of these drugs were associated with different poisoning risks.

The researchers analyzed pharmaceutical claims data from 304,676 individuals (aged 12-64 years) in the IBM MarketScan Commercial and Multi-State Medicaid Databases. All had received buprenorphine treatment for OUD between Jan. 1, 2006, and Dec. 31, 2016.

Buprenorphine use was converted to a daily milligram dose and was classified as either greater than 12 mg or less than or equal to 12 mg, because previous research suggests there may be differences in treatment retention associated with this dose. Given the case-control nature of the investigation, patients who did not experience a drug-related poisoning were excluded from the analysis.

The study’s primary unit of observation was person-days, which were those days during which patients were enrolled in a health insurance plan. Participants were evaluated for 1 year before their first drug-related poisoning and 1 year after their first such poisoning. The primary outcome was nonfatal drug-related poisonings, including overdoses. The primary exposure was determined on the basis of benzodiazepine or Z-drug prescriptions.

The daily dose of benzodiazepines or Z-drugs was standardized as a function of diazepam-equivalent milligrams. Doses were classified as either high dose (diazepam-equivalent mg dose >30 mg) or low dose (≤30 mg). The drugs were also distinguished on the basis of their pharmacologic properties, such as whether they were short-acting or long-acting.
 

37% risk reduction

Of the original cohort of 304,676 patients with OUD, the study’s final analytic sample included 23,036 patients (mean age, 30 years; 51% men), representing 14,213,075 person-days of insurance coverage. Of these, 2,210,927 person-days (15.6%) entailed claims for buprenorphine (mean daily dose, 15.4 mg; SD, 7.31 mg).

A total of 474,181 person-days included claims for benzodiazepines or Z-drugs with concurrent buprenorphine treatment. The mean daily dose of any benzodiazepine or Z-drug was 23.4 diazepam-milligram equivalents. The mean daily dose of short-acting benzodiazepines, long-acting benzodiazepines, and Z-drugs was 25.3, 31.3, and 4.9 diazepam-milligram equivalents, respectively.

Buprenorphine treatment days were associated with a 37% lower chance of drug-related poisoning (95% confidence interval, 0.60-0.66) in comparison with nontreatment days. On the other hand, the odds of poisoning increased by 81% on days on which patients were treated with Z-drugs or benzodiazepines (95% CI, 1.73-1.91).

Interestingly, individual analyses showed that benzodiazepine and Z-drug treatment days were associated with increased odds of poisoning events (odds ratio, 1.29; 95% CI, 1.19-1.39). Odds of poisoning events on benzodiazepine-only treatment days, on the other hand, were markedly lower (OR, 1.88; 95% CI, 1.78-1.98).

Subgroup analyses revealed that both short-acting and long-acting benzodiazepine treatment days were associated with comparably elevated odds of drug-related poisoning (OR, 1.86 and 1.68, respectively). High-dose benzodiazepine treatment days were associated with higher increased odds of a poisoning event (122%) in comparison with low-dose treatment days (78%).

High-dose, but not low-dose, benzodiazepine or Z-drug treatment was linked to increased poisonings when the drug was taken concurrently with buprenorphine (OR, 1.64; 95% CI, 1.39-1.93). However, the risk was still lower than the risk associated with taking the agents without concurrent treatment with buprenorphine (low-dose OR, 1.69; high-dose OR, 2.23).
 

‘Not all benzodiazepines are bad’

Dr. Xu noted that the findings have potentially important implications for clinical practice, beginning with the dose-dependent relationship between benzodiazepine/Z-drug use and drug-related poisonings among individuals with OUD. This indicates that lowering doses or shortening treatment duration may reduce risk, he said.

Similarly, the lower risk associated with long-acting benzodiazepines relative to short-acting beonzodiazepines – as well as the substantially lower risk associated with Z-drugs, compared with either short- or long-acting benzodiazepines – suggests that switching from benzodiazepines to long-acting agents or Z-drugs may lower the risk for overdose, he added.

“Clinicians are often challenged by patients with opioid use disorder who are also on benzodiazepines or Z-drugs. There’s an inclination to say no to them, because they’re too high risk to start buprenorphine maintenance, or abruptly taper the benzodiazepines, which can be very destabilizing,” he noted.

“Our data show that people on benzodiazepines can absolutely receive buprenorphine and still get some benefit,” Dr. Xu said. “In addition, not all benzodiazepines are bad for these individuals. There are safer formulations and safer doses, too.”

However, he added, he would not initiate benzodiazepine treatment if he didn’t have to, especially long-term treatment.

“One of the messages from our data is that this clearly contributes to higher overdose risk. But we often inherit patients who already have benzodiazepines on board, so we need to figure out what to do. That is the question that nobody had really clearly addressed prior to this study,” Dr. Xu concluded.
 

Vigilance needed

Commenting on the findings for this news organization, Jerrold F. Rosenbaum, MD, Stanley Cobb Professor of Psychiatry, Harvard Medical School, Boston, urged caution when combining benzodiazepines with opioids.

“There are situations where you need to be circumspect about the use of benzodiazepines, and that’s clearly when people are being prescribed them in combination with other drugs that could be either sedating or respiratory depressant,” said Dr. Rosenbaum, who was not involved with the research.

“This paper reminds us that physicians need to be particularly vigilant about situations where patients might be combining the two agents,” he added.

Dr. Rosenbaum noted that patients who are using more medication than prescribed are at risk “for not appreciating the synergy” between the two treatments in terms of adverse events such as respiratory depression.

In addition, “if they’re intending to do themselves harm, the lethality of an overdose will be certainly far more than the benzodiazepines or opiates alone,” he said.

Another potential challenge for clinicians are situations in which patients are taking benzodiazepines for preexisting conditions that also require opiates. “Then you have to use special vigilance and try to use lowest doses to reduce the total burden of medication to minimize the potential risk,” said Dr. Rosenbaum.

The study was funded by the National Institutes of Health. Dr. Xu has reported no relevant financial relationships.

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

Buprenorphine for the treatment of opioid-use disorder (OUD) may also mitigate the risk associated with concomitant benzodiazepine and Z-drug use, which is frequent in this patient population, new research suggests.

A case-crossover study of more than 20,000 participants with OUD showed that drug treatment days in which benzodiazepines and Z-drugs were taken were associated with an 88% increase in nonfatal overdose; buprenorphine appeared to reduce this risk by almost 40%.

“One of our two primary findings is that patients with opioid use disorder can still benefit substantially from buprenorphine treatment, even if they have benzodiazepines on board,” lead author Kevin Xu, MD, a resident at the Washington University, St. Louis, told this news organization.

The other key finding was that “not all benzodiazepines are equal” and that some are associated with higher risk than others, Dr. Xu added.

“If anything, patients who are on buprenorphine and benzodiazepines do not necessarily need to be abruptly tapered off their benzodiazepines. Our data actually demonstrate that there are safe avenues for them,” he added.

The findings were published online March 3 in the American Journal of Psychiatry.
 

Cloudy relationship

Buprenorphine is commonly used to treat patients with OUD because of its ability to decrease all-cause mortality. However, up to 30% of these patients also take benzodiazepines for comorbid mood and anxiety disorders, Dr. Xu noted.

In addition, recent research shows that benzodiazepine/Z-drug use is associated with a variety of potential adverse effects, including respiratory depression, overdose, and addiction risk.

The relationship between benzodiazepine use and buprenorphine treatment outcomes is poorly characterized in individuals with OUD. Although some studies suggest benzodiazepines may enhance retention in buprenorphine maintenance treatment, others suggest a link to increased adverse events, including all-cause mortality, drug-related poisonings, and accidental injury–related emergency department visits.

In addition, there has been little research on the potential adverse effects associated with use of selective benzodiazepine receptor modulators in patients with OUD. These so-called Z-drugs include zolpidem, zaleplon, and eszopiclone.

Nevertheless, previous research in the general population shows that these medications have a range of adverse effects similar to those of benzodiazepines, with comparable dose-response effects on all-cause mortality.

“The challenge for any clinician is that many patients who are addicted to opioids are also polysubstance users,” said Dr. Xu. “There are so many hopeful articles regarding the benefits of buprenorphine treatment in opioid use disorder patients, but it seems like the individuals with polysubstance use are largely ignored in the setting of the opioid epidemic.”

“And this is really the back story that got me inspired to study this particular topic,” he added.
 

Improve, nullify, or reverse?

Given these questions, the researchers set out to quantify the odds of nonfatal drug-related poisoning, including overdoses, associated with benzodiazepine or Z-drug use by patients with OUD who were also taking buprenorphine.

“While the drug-related poisoning variable encompasses opioid overdoses, we used a broad definition per CDC guidelines to also include other types of drug overdoses – including poisoning events involving stimulants, overdoses involving sedatives, and overdoses involving psychotropic prescription drugs” that are commonly used by patients with OUD, said Dr. Xu.

They also wanted to determine whether the use of benzodiazepines or Z-drugs would improve, nullify, or reverse the protective effect of buprenorphine. The researchers also evaluated whether different sedative and hypnotic subtypes of these drugs were associated with different poisoning risks.

The researchers analyzed pharmaceutical claims data from 304,676 individuals (aged 12-64 years) in the IBM MarketScan Commercial and Multi-State Medicaid Databases. All had received buprenorphine treatment for OUD between Jan. 1, 2006, and Dec. 31, 2016.

Buprenorphine use was converted to a daily milligram dose and was classified as either greater than 12 mg or less than or equal to 12 mg, because previous research suggests there may be differences in treatment retention associated with this dose. Given the case-control nature of the investigation, patients who did not experience a drug-related poisoning were excluded from the analysis.

The study’s primary unit of observation was person-days, which were those days during which patients were enrolled in a health insurance plan. Participants were evaluated for 1 year before their first drug-related poisoning and 1 year after their first such poisoning. The primary outcome was nonfatal drug-related poisonings, including overdoses. The primary exposure was determined on the basis of benzodiazepine or Z-drug prescriptions.

The daily dose of benzodiazepines or Z-drugs was standardized as a function of diazepam-equivalent milligrams. Doses were classified as either high dose (diazepam-equivalent mg dose >30 mg) or low dose (≤30 mg). The drugs were also distinguished on the basis of their pharmacologic properties, such as whether they were short-acting or long-acting.
 

37% risk reduction

Of the original cohort of 304,676 patients with OUD, the study’s final analytic sample included 23,036 patients (mean age, 30 years; 51% men), representing 14,213,075 person-days of insurance coverage. Of these, 2,210,927 person-days (15.6%) entailed claims for buprenorphine (mean daily dose, 15.4 mg; SD, 7.31 mg).

A total of 474,181 person-days included claims for benzodiazepines or Z-drugs with concurrent buprenorphine treatment. The mean daily dose of any benzodiazepine or Z-drug was 23.4 diazepam-milligram equivalents. The mean daily dose of short-acting benzodiazepines, long-acting benzodiazepines, and Z-drugs was 25.3, 31.3, and 4.9 diazepam-milligram equivalents, respectively.

Buprenorphine treatment days were associated with a 37% lower chance of drug-related poisoning (95% confidence interval, 0.60-0.66) in comparison with nontreatment days. On the other hand, the odds of poisoning increased by 81% on days on which patients were treated with Z-drugs or benzodiazepines (95% CI, 1.73-1.91).

Interestingly, individual analyses showed that benzodiazepine and Z-drug treatment days were associated with increased odds of poisoning events (odds ratio, 1.29; 95% CI, 1.19-1.39). Odds of poisoning events on benzodiazepine-only treatment days, on the other hand, were markedly lower (OR, 1.88; 95% CI, 1.78-1.98).

Subgroup analyses revealed that both short-acting and long-acting benzodiazepine treatment days were associated with comparably elevated odds of drug-related poisoning (OR, 1.86 and 1.68, respectively). High-dose benzodiazepine treatment days were associated with higher increased odds of a poisoning event (122%) in comparison with low-dose treatment days (78%).

High-dose, but not low-dose, benzodiazepine or Z-drug treatment was linked to increased poisonings when the drug was taken concurrently with buprenorphine (OR, 1.64; 95% CI, 1.39-1.93). However, the risk was still lower than the risk associated with taking the agents without concurrent treatment with buprenorphine (low-dose OR, 1.69; high-dose OR, 2.23).
 

‘Not all benzodiazepines are bad’

Dr. Xu noted that the findings have potentially important implications for clinical practice, beginning with the dose-dependent relationship between benzodiazepine/Z-drug use and drug-related poisonings among individuals with OUD. This indicates that lowering doses or shortening treatment duration may reduce risk, he said.

Similarly, the lower risk associated with long-acting benzodiazepines relative to short-acting beonzodiazepines – as well as the substantially lower risk associated with Z-drugs, compared with either short- or long-acting benzodiazepines – suggests that switching from benzodiazepines to long-acting agents or Z-drugs may lower the risk for overdose, he added.

“Clinicians are often challenged by patients with opioid use disorder who are also on benzodiazepines or Z-drugs. There’s an inclination to say no to them, because they’re too high risk to start buprenorphine maintenance, or abruptly taper the benzodiazepines, which can be very destabilizing,” he noted.

“Our data show that people on benzodiazepines can absolutely receive buprenorphine and still get some benefit,” Dr. Xu said. “In addition, not all benzodiazepines are bad for these individuals. There are safer formulations and safer doses, too.”

However, he added, he would not initiate benzodiazepine treatment if he didn’t have to, especially long-term treatment.

“One of the messages from our data is that this clearly contributes to higher overdose risk. But we often inherit patients who already have benzodiazepines on board, so we need to figure out what to do. That is the question that nobody had really clearly addressed prior to this study,” Dr. Xu concluded.
 

Vigilance needed

Commenting on the findings for this news organization, Jerrold F. Rosenbaum, MD, Stanley Cobb Professor of Psychiatry, Harvard Medical School, Boston, urged caution when combining benzodiazepines with opioids.

“There are situations where you need to be circumspect about the use of benzodiazepines, and that’s clearly when people are being prescribed them in combination with other drugs that could be either sedating or respiratory depressant,” said Dr. Rosenbaum, who was not involved with the research.

“This paper reminds us that physicians need to be particularly vigilant about situations where patients might be combining the two agents,” he added.

Dr. Rosenbaum noted that patients who are using more medication than prescribed are at risk “for not appreciating the synergy” between the two treatments in terms of adverse events such as respiratory depression.

In addition, “if they’re intending to do themselves harm, the lethality of an overdose will be certainly far more than the benzodiazepines or opiates alone,” he said.

Another potential challenge for clinicians are situations in which patients are taking benzodiazepines for preexisting conditions that also require opiates. “Then you have to use special vigilance and try to use lowest doses to reduce the total burden of medication to minimize the potential risk,” said Dr. Rosenbaum.

The study was funded by the National Institutes of Health. Dr. Xu has reported no relevant financial relationships.

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

Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.

Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.¹ While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.^2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.³ Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.³

In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.

While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.⁴ In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.⁴ To my dismay, I’ve seen these statistics reflected in my own patient population.

Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.

While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.

2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.

Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.

Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.¹ While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.^2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.³ Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.³

In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.

While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.⁴ In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.⁴ To my dismay, I’ve seen these statistics reflected in my own patient population.

Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.

While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.

2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.

Obstetrician/gynecologists are often first-line providers in addressing mental health concerns for our patients. Routine screening for intimate partner violence, obtaining a history of sexual assault, and assessing patients for postpartum depression are among the many tools that we use to ascertain the psychological well-being of cisgender women. As transgender patients continue to seek care from ob.gyns., it is vital that we not only screen transgender patients for depression and intimate partner violence, but also assess factors relating to social support.

Mental health disorders disproportionately affect the transgender population. A large online survey showed that 41% of transgender patients had experienced suicidality, with rates among transgender youth even higher.¹ While the rates of sexual violence are higher among LGBTQ patients compared with cisgender counterparts, the rate of sexual assault is as high as 47% in the transgender population.^2,3 Additional surveys and studies have demonstrated that more than 70% of transgender individuals report discrimination in school (K-12), 27% have lost their jobs because of their gender identity; and 30% have experienced homelessness at some point.³ Tragically, these rates are further affected by race and ethnicity with American Indian (65%), multiracial (59%), Middle Eastern (58%), and Black (53%) respondents in the survey stating they were assaulted at some point.³

In a prepandemic world, mental health for transgender patients was influenced by several factors, such as stigmatization, health care disparities, limited access to health care, prolonged exposure to discrimination, lack of a supportive environment, and history of trauma or violence. During the pandemic, these factors have been magnified. Furthermore, many of the supportive services such as group meetings at LGBTQ centers, networking events/conferences, LGBTQ pride events, and social gatherings at bars or restaurants have been postponed, reduced to accommodate social distancing measures, or moved to virtual platforms.

While the pandemic has led to increased unemployment rates, concerns over housing and rent payments, and limiting one’s social circle in the general population, these rates are increased among LGBTQ adults. Data are limited on how significantly the pandemic has affected LGBTQ adults, but an analysis conducted by the Kaiser Family Foundation found that 56% of LGBTQ adults reported that they or someone they know lost a job, compared with 44% of non-LGBTQ adults.⁴ In addition, 75% of LGBTQ adults report that the pandemic has negatively affected their mental health, compared with 49% of the non-LGBTQ population.⁴ To my dismay, I’ve seen these statistics reflected in my own patient population.

Given this knowledge, it is even more crucial that obstetrician/gynecologists screen for depression, substance use, and intimate partner violence, in addition to assessing the patient’s social determinants for overall well-being. These often include determining a patient’s living situation, employment status, familial support, and social support. In my practice, if concerns are raised in any of these areas, we have a streamlined referral system connecting patients to a variety of therapists, psychologists, and/or social workers, with close follow-up on either a weekly or monthly basis depending on the particular issue the patient is facing. While many patients may be hesitant to go to in-office appointments or where transportation poses a barrier, telemedicine visits are useful adjuncts to assess patient’s overall well-being.

While the pandemic has been extraordinarily difficult for us all, it is important for us to be even stronger advocates for communities that have experienced further challenges as a result of this global tragedy.
 

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Karasic D. Mental health care for the adult transgender patient. In: Ferrando CA, ed. Comprehensive Care of the Transgender Patient. Philadelphia, PA: Elsevier; 2020:8-11.

2. Black MC et al. The National Intimate Partner and Sexual Violence Survey (NISVS): 2010 Summary Report. Atlanta: National Center for Injury Prevention and Control, Centers for Disease Control and Prevention; 2011.

3. James SE et al. The Report of the 2015 U.S. Transgender Survey. Washington, DC: National Center for Transgender Equality; 2016.

4. Dawson L et al. The impact of the COVID-19 pandemic on LGBT people. KFF COVID-19 Vaccine Monitor. Kaiser Family Foundation. March 11, 2021.

Many countries have “a long way to go” toward meeting the World Health Organization’s target for human papilloma virus (HPV) vaccination, according to researchers.

The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.

Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.

The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”

However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.

HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).

Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.

In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
 

HPV vaccination by region

The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.

In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.

The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.

In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.

Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).

Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.

Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.

The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
 

HPV vaccination by sex

By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).

Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.

From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
 

Obstacles and the path forward

The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.

An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.

While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.

“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”

Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:

• Secure sufficient and affordable HPV vaccines.
• Increase the quality and coverage of vaccination.
• Improve communication and social mobilization.
• Innovate to improve efficiency of vaccine delivery.

“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”

This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.

Many countries have “a long way to go” toward meeting the World Health Organization’s target for human papilloma virus (HPV) vaccination, according to researchers.

The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.

Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.

The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”

However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.

HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).

Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.

In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
 

HPV vaccination by region

The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.

In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.

The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.

In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.

Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).

Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.

Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.

The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
 

HPV vaccination by sex

By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).

Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.

From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
 

Obstacles and the path forward

The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.

An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.

While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.

“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”

Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:

• Secure sufficient and affordable HPV vaccines.
• Increase the quality and coverage of vaccination.
• Improve communication and social mobilization.
• Innovate to improve efficiency of vaccine delivery.

“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”

This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.

Many countries have “a long way to go” toward meeting the World Health Organization’s target for human papilloma virus (HPV) vaccination, according to researchers.

The WHO’s goal is to have HPV vaccines delivered to 90% of all adolescent girls by 2030, part of the organization’s larger goal to “eliminate” cervical cancer, or reduce the annual incidence of cervical cancer to below 4 cases per 100,000 people globally.

Laia Bruni, MD, PhD, of Catalan Institute of Oncology in Barcelona, and colleagues outlined the progress made thus far toward reaching the WHO’s goals in an article published in Preventive Medicine.

The authors noted that cervical cancer caused by HPV is a “major public health problem, especially in low- and middle-income countries (LMIC).”

However, vaccines against HPV have been available since 2006 and have been recommended by the WHO since 2009.

HPV vaccines have been introduced into many national immunization schedules. Among the 194 WHO member states, 107 (55%) had introduced HPV vaccination as of June 2020, according to estimates from the WHO and the United Nations International Children’s Emergency Fund (UNICEF).

Still, vaccine introduction and coverages are suboptimal, according to several studies and international agencies.

In their article, Dr. Bruni and colleagues describe the mid-2020 status of HPV vaccine introduction, based on WHO/UNICEF estimates of national HPV immunization coverage from 2010 to 2019.
 

HPV vaccination by region

The Americas and Europe are by far the WHO regions with the highest rates of HPV vaccination, with 85% and 77% of their countries, respectively, having already introduced HPV vaccination, either partially or nationwide.

In 2019, a record number of introductions, 16, were reported, mostly in LMICs where access has been limited. In prior years, the average had been a relatively steady 7-8 introductions per year.

The percentage of high-income countries (HICs) that have introduced HPV vaccination exceeds 80%. LMICs started introducing HPV vaccination later and at a slower pace, compared with HICs. By the end of 2019, only 41% of LMICs had introduced vaccination. However, of the new introductions in 2019, 87% were in LMICs.

In 2019, the average performance coverage for HPV vaccination programs in 99 countries (both HICs and LMICs) was around 67% for the first vaccine dose and 53% for the final dose.

Median performance coverage was higher in LMICs than in HICs for the first dose (80% and 72%, respectively), but mean dropout rates were higher in LMICs than in HICs (18% and 11%, respectively).

Coverage of more than 90% was achieved for the last dose in only five countries (6%). Twenty-two countries (21%) achieved coverages of 75% or higher, while 35 countries (40%) had final dose coverages of 50% or less.

Global coverage of the final HPV vaccine dose (weighted by population size) was estimated at 15%. According to the authors, that low percentage can be explained by the fact that many of the most populous countries have either not yet introduced HPV vaccination or have low performance.

The countries with highest cervical cancer burden have had limited secondary prevention and have been less likely to provide access to vaccination, the authors noted. However, this trend appears to be reversing, with 14 new LMICs providing HPV vaccination in 2019.
 

HPV vaccination by sex

By 2019, almost a third of the 107 HPV vaccination programs (n = 33) were “gender neutral,” with girls and boys receiving HPV vaccines. Generally, LMICs targeted younger girls (9-10 years) compared with HICs (11-13 years).

Dr. Bruni and colleagues estimated that 15% of girls and 4% of boys were vaccinated globally with the full course of vaccine. At least one dose was received by 20% of girls and 5% of boys.

From 2010 to 2019, HPV vaccination rates in HICs rose from 42% in girls and 0% in boys to 88% and 44%, respectively. In LMICs, over the same period, rates rose from 4% in girls and 0% in boys to 40% and 5%, respectively.
 

Obstacles and the path forward

The COVID-19 pandemic has halted HPV vaccine delivery in the majority of countries, Dr. Bruni and colleagues noted. About 70 countries had reported program interruptions by August 2020, and delays to HPV vaccine introductions were anticipated for other countries.

An economic downturn could have further far-reaching effects on plans to introduce HPV vaccines, Dr. Bruni and colleagues observed.

While meeting the 2030 target will be challenging, the authors noted that, in every geographic area, some programs are meeting the 90% target.

“HPV national programs should aim to get 90+% of girls vaccinated before the age of 15,” Dr. Bruni said in an interview. “This is a feasible goal, and some countries have succeeded, such as Norway and Rwanda. Average performance, however, is around 55%, and that shows that it is not an easy task.”

Dr. Bruni underscored the four main actions that should be taken to achieve 90% coverage of HPV vaccination, as outlined in the WHO cervical cancer elimination strategy:

• Secure sufficient and affordable HPV vaccines.
• Increase the quality and coverage of vaccination.
• Improve communication and social mobilization.
• Innovate to improve efficiency of vaccine delivery.

“Addressing vaccine hesitancy adequately is one of the biggest challenges we face, especially for the HPV vaccine,” Dr. Bruni said. “As the WHO document states, understanding social, cultural, societal, and other barriers affecting acceptance and uptake of the vaccine will be critical for overcoming vaccine hesitancy and countering misinformation.”

This research was funded by a grant from Instituto de Salud Carlos III and various other grants. Dr. Bruni and coauthors said they have no relevant disclosures.