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Pfizer: Vaccine shown 100% effective in children aged 12-15
The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.
The vaccinated children showed a strong antibody response with no serious side effects.
Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.
The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.
Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.
“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.
“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”
Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.
A version of this article first appeared on WebMD.com.
The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.
The vaccinated children showed a strong antibody response with no serious side effects.
Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.
The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.
Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.
“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.
“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”
Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.
A version of this article first appeared on WebMD.com.
The study enrolled 2,260 adolescents aged 12-15. No infections were reported in the group given the vaccine produced by Pfizer and its European partner, BioNTech, the release said. The placebo group reported 18 cases of COVID-19.
The vaccinated children showed a strong antibody response with no serious side effects.
Albert Bourla, PhD, chairman and CEO of Pfizer, said the company plans to seek Food and Drug Administration emergency use authorization, which could allow this age group to be vaccinated before the start of the next school year. Pfizer will also seek authorization from the European Medicines Agency.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” Dr. Bourla said in the release.
The clinical trials showed a stronger response in children aged 12-15 than the 95% effectiveness reported in clinical trials in adults. The Pfizer vaccine is now authorized to be given to people aged 16 and up in the United States.
Health experts said the clinical trials – while not peer-reviewed – amounted to very good news.
“The sooner that we can get vaccines into as many people as possible, regardless of their age, the sooner we will be able to really feel like we’re ending this pandemic for good,” Angela Rasmussen, PhD, a virologist affiliated with Georgetown University in Washington, told The New York Times.
Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently said that getting children vaccinated is an important step toward achieving herd immunity.
“We don’t really know what that magical point of herd immunity is, but we do know that if we get the overwhelming population vaccinated, we’re going to be in good shape,” he said earlier in March during a hearing of the Senate Health, Education, Labor, and Pensions Committee. “We ultimately would like to get and have to get children into that mix.”
Pfizer said it started clinical trials during the week of March 23 with children aged 5-11 and will next start trials with children aged 2-5, followed by children aged 6 months to 2 years. Vaccine makers Moderna and AstraZeneca also have started clinical trials in younger children.
A version of this article first appeared on WebMD.com.
Vaccine mismatch: What to do after dose 1 when plans change
Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.
After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.
But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.
So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.
It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.
For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.
Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”
In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.
On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.
Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.
But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.
Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.
And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
Mix only in ‘exceptional situations’
The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.
It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.
However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?
Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.
He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
Researcher says science backs mixing
A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.
“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”
In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.
For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.
In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.
For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.
But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.
A version of this article first appeared on Medscape.com.
Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.
After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.
But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.
So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.
It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.
For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.
Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”
In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.
On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.
Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.
But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.
Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.
And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
Mix only in ‘exceptional situations’
The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.
It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.
However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?
Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.
He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
Researcher says science backs mixing
A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.
“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”
In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.
For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.
In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.
For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.
But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.
A version of this article first appeared on Medscape.com.
Ideally, Americans receiving their Pfizer/BioNTech or Moderna COVID-19 vaccines will get both doses from the same manufacturer, said Gregory Poland, MD, a vaccinologist at the Mayo Clinic in Rochester, Minn.
After all, that’s how they were tested for efficacy and safety, and it was results from those studies that led to emergency use authorization (EUA) being granted by the Food and Drug Administration.
But states and countries have struggled to keep up with the demand for vaccine, and more flexible vaccination schedules could help.
So researchers are exploring whether it is safe and effective to get the first and second doses from different manufacturers. And they are even wondering whether mixing doses from different manufacturers could increase effectiveness, particularly in light of emerging variants.
It’s called the “interchangeability issue,” said Dr. Poland, who has gotten a steady stream of questions about it.
For example, a patient recently asked about options for his father, who had gotten his first dose of the AstraZeneca vaccine in Ecuador, but had since moved to the United States, where that product has not been approved for use.
Dr. Poland said in an interview that he prefaces each answer with: “I’ve got no science for what I’m about to tell you.”
In this particular case, he recommended that the man’s father talk with his doctor about his level of COVID-19 risk and consider whether he should gamble on the AstraZeneca vaccine getting approved in the United States soon, or whether he should ask for a second dose from one of the three vaccines currently approved.
On March 22, 2021, AstraZeneca released positive results from its phase 3 trial, which will likely speed its path toward use in the United States.
Although clinical trials have started to test combinations and boosters, there’s currently no definitive evidence from human trials on mixing COVID vaccines, Dr. Poland pointed out.
But a study of a mixed-vaccine regimen is currently underway in the United Kingdom.
Participants in that 13-month trial will be given the Oxford/AstraZeneca and Pfizer/BioNTech vaccines in different combinations and at different intervals. The first results from that trial are expected this summer.
And interim results from a trial combining Russia’s Sputnik V and the AstraZeneca vaccines are expected in 2 months, according to a Reuters report.
Mix only in ‘exceptional situations’
The Centers for Disease Control and Prevention has been hesitant to open the door to mixing Pfizer and Moderna vaccinations, noting that the two “are not interchangeable.” But CDC guidance has changed slightly. Now, instead of saying the two vaccines should not be mixed, CDC guidance says they can be mixed in “exceptional situations,” and that the second dose can be administered up to 6 weeks after the first dose.
It is reasonable to assume that mixing COVID-19 vaccines that use the same platform – such as the mRNA platform used by both the Pfizer and Moderna vaccines – will be acceptable, Dr. Poland said, although human trials have not proven that.
However, it is unclear whether vaccines that use different platforms can be mixed. Can the first dose of an mRNA vaccine be followed by an adenovirus-based vaccine, like the Johnson & Johnson product or Novavax, if that vaccine is granted an EUA?
Ross Kedl, PhD, a vaccine researcher and professor of immunology at the University of Colorado at Denver, Aurora, said matching vaccine platforms might not be the preferred vaccination strategy.
He disagreed that there’s a lack of science surrounding the issue, and said all signs point to mixing as not only a good option, but probably a better one.
Researcher says science backs mixing
A mix of two different vaccine platforms likely enhances immunity, Dr. Kedl said. The heterologous prime-boost strategy has been used in animal studies for decades, “and it is well known that this promotes a much better immune response than when immunizing with the same vaccine twice.
“If you think about it in a Venn diagram sort of way, it makes sense,” he said in an interview. “Each vaccine has a number of components in it that influence immunity in various ways, but between the two of them, they only have one component that is similar. In the case of the coronavirus vaccines, the one thing both have in common is the spike protein from SARS-CoV-2. In essence, this gives you two shots at generating immunity against the one thing in each vaccine you care most about, but only one shot for the other vaccine components in each platform, resulting in an amplified response against the common target.”
In fact, the heterologous prime-boost vaccination strategy has proven to be effective in humans in early studies.
For example, an Ebola regimen that consisted of an adenovirus vector, similar to the AstraZeneca COVID vaccine, and a modified vaccinia virus vector showed promise in a phase 1 study. And an HIV regimen that consisted of the combination of a DNA vaccine, similar to the Pfizer and Moderna mRNA vaccines, and another viral vector showed encouraging results in a proof-of-concept study.
In both these cases, the heterologous prime-boost strategy was far better than single-vaccine prime-boost regimens, Dr. Kedl pointed out. And neither study reported any safety issues with the combinations.
For now, it’s best to stick with the same manufacturer for both shots, as the CDC guidance suggests, he said, agreeing with Dr. Poland.
But “I would be very surprised if we didn’t move to a mixing of vaccine platforms for the population,” Dr. Kedl said.
A version of this article first appeared on Medscape.com.
COVID vaccines could lose their punch within a year, experts say
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a survey of 77 epidemiologists from 28 countries by the People’s Vaccine Alliance, 66.2% predicted that the world has a year or less before variants make current vaccines ineffective. The People’s Vaccine Alliance is a coalition of more than 50 organizations, including the African Alliance, Oxfam, Public Citizen, and UNAIDS (the Joint United Nations Programme on HIV/AIDS).
Almost a third (32.5%) of those surveyed said ineffectiveness would happen in 9 months or less; 18.2% said 6 months or less.
Paul A. Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, said in an interview that, while it’s hard to say whether vaccines could become ineffective in that time frame, “It’s perfectly reasonable to think it could happen.”
The good news, said Dr. Offit, who was not involved with the survey, is that SARS-CoV-2 mutates slowly, compared with other viruses such as influenza.
“To date,” he said, “the mutations that have occurred are not far enough away from the immunity induced by your natural infection or immunization such that one isn’t protected at least against severe and critical disease.”
That’s the goal of vaccines, he noted: “to keep people from suffering mightily.”
A line may be crossed
“And so far that’s happening, even with the variants,” Dr. Offit said. “That line has not been crossed. But I think we should assume that it might be.”
Dr. Offit said it will be critical to monitor anyone who gets hospitalized who is known to have been infected or fully vaccinated. Then countries need to get really good at sequencing those viruses.
The great majority of those surveyed (88%) said that persistently low vaccine coverage in many countries would make it more likely that vaccine-resistant mutations will appear.
Coverage comparisons between countries are stark.
Many countries haven’t given a single vaccine dose
While rich countries are giving COVID-19 vaccinations at the rate of a person a second, many of the poorest countries have given hardly any vaccines, the People’s Vaccine Alliance says.
Additionally, according to researchers at the Global Health Innovation Center at Duke University, Durham, N.C., high- and upper-middle–income countries, which represent one-fifth of the world’s population, have bought about 6 billion doses. But low- and lower-middle–income countries, which make up four-fifths of the population, have bought only about 2.6 billion, an article in Nature reports.
“You’re only as strong as your weakest country,” Dr. Offit said. “If we haven’t learned that what happens in other countries can [affect the global population], we haven’t been paying attention.”
Gregg Gonsalves, PhD, associate professor of epidemiology at Yale University, New Haven, Conn., one of the academic centers surveyed, didn’t specify a timeline for when vaccines would become ineffective, but said in a press release that the urgency for widespread global vaccination is real.
“Unless we vaccinate the world,” he said, “we leave the playing field open to more and more mutations, which could churn out variants that could evade our current vaccines and require booster shots to deal with them.”
“Dire, but not surprising”
Panagis Galiatsatos, MD, MHS, a pulmonologist at John Hopkins University, Baltimore, whose research focuses on health care disparities, said the survey findings were “dire, but not surprising.”
Johns Hopkins was another of the centers surveyed, but Dr. Galiatsatos wasn’t personally involved with the survey.
COVID-19, Dr. Galiatsatos pointed out, has laid bare disparities, both in who gets the vaccine and who’s involved in trials to develop the vaccines.
“It’s morally concerning and an ethical reckoning,” he said in an interview.
Recognition of the borderless swath of destruction the virus is exacting is critical, he said.
The United States “has to realize this can’t be a U.S.-centric issue,” he said. “We’re going to be back to the beginning if we don’t make sure that every country is doing well. We haven’t seen that level of uniform approach.”
He noted that scientists have always known that viruses mutate, but now the race is on to find the parts of SARS-CoV-2 that don’t mutate as much.
“My suspicion is we’ll probably need boosters instead of a whole different vaccine,” Dr. Galiatsatos said.
Among the strategies sought by the People’s Vaccine Alliance is for all pharmaceutical companies working on COVID-19 vaccines to openly share technology and intellectual property through the World Health Organization COVID-19 Technology Access Pool, to speed production and rollout of vaccines to all countries.
In the survey, 74% said that open sharing of technology and intellectual property could boost global vaccine coverage; 23% said maybe and 3% said it wouldn’t help.
The survey was carried out between Feb. 17 and March 25, 2021. Respondents included epidemiologists, virologists, and infection disease specialists from the following countries: Algeria, Argentina, Australia, Belgium, Bolivia, Canada, Denmark, Ethiopia, France, Guatemala, India, Italy, Kenya, Lebanon, Norway, Philippines, Senegal, Somalia, South Africa, South Sudan, Spain, United Arab Emirates, Uganda, United Kingdom, United States, Vietnam, Zambia, and Zimbabwe.
Dr. Offit and Dr. Galiatsatos reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
National Psoriasis Foundation recommends some stop methotrexate for 2 weeks after J&J vaccine
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
The , Joel M. Gelfand, MD, said at Innovations in Dermatology: Virtual Spring Conference 2021.
The new guidance states: “Patients 60 or older who have at least one comorbidity associated with an increased risk for poor COVID-19 outcomes, and who are taking methotrexate with well-controlled psoriatic disease, may, in consultation with their prescriber, consider holding it for 2 weeks after receiving the Ad26.COV2.S [Johnson & Johnson] vaccine in order to potentially improve vaccine response.”
The key word here is “potentially.” There is no hard evidence that a 2-week hold on methotrexate after receiving the killed adenovirus vaccine will actually provide a clinically meaningful benefit. But it’s a hypothetical possibility. The rationale stems from a small randomized trial conducted in South Korea several years ago in which patients with rheumatoid arthritis were assigned to hold or continue their methotrexate for the first 2 weeks after receiving an inactivated-virus influenza vaccine. The antibody response to the vaccine was better in those who temporarily halted their methotrexate, explained Dr. Gelfand, cochair of the NPF COVID-19 Task Force and professor of dermatology and of epidemiology at the University of Pennsylvania, Philadelphia.
“If you have a patient on methotrexate who’s 60 or older and whose psoriasis is completely controlled and quiescent and the patient is concerned about how well the vaccine is going to work, this is a reasonable thing to consider in someone who’s at higher risk for poor outcomes if they get infected,” he said.
If the informed patient wants to continue on methotrexate without interruption, that’s fine, too, in light of the lack of compelling evidence on this issue, the dermatologist added at the conference, sponsored by MedscapeLIVE! and the producers of the Hawaii Dermatology Seminar and Caribbean Dermatology Symposium.
The NPF task force does not extend the recommendation to consider holding methotrexate in recipients of the mRNA-based Moderna and Pfizer vaccines because of their very different mechanisms of action. Nor is it recommended to hold biologic agents after receiving any of the available COVID-19 vaccines. Studies have shown no altered immunologic response to influenza or pneumococcal vaccines in patients who continued on tumor necrosis factor inhibitors or interleukin-17 inhibitors. The interleukin-23 inhibitors haven’t been studied in this regard.
The task force recommends that most psoriasis patients should continue on treatment throughout the pandemic, and newly diagnosed patients should commence appropriate therapy as if there was no pandemic.
“We’ve learned that many patients who stopped their treatment for psoriatic disease early in the pandemic came to regret that decision because their psoriasis flared and got worse and required reinstitution of therapy,” Dr. Gelfand said. “The current data is largely reassuring that if there is an effect of our therapies on the risk of COVID, it must be rather small and therefore unlikely to be clinically meaningful for our patients.”
Dr. Gelfand reported serving as a consultant to and recipient of institutional research grants from Pfizer and numerous other pharmaceutical companies.
MedscapeLIVE and this news organization are owned by the same parent company.
FROM INNOVATIONS IN DERMATOLOGY
New COVID-19 cases rise again in children
The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.
For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.
There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.
The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.
The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.
For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.
There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.
The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.
The number of new COVID-19 cases in children increased for the second consecutive week in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.
That brings the number of children infected with the coronavirus to over 3.4 million since the beginning of the pandemic, or 13.4% of all reported cases, the AAP and CHA said in their weekly COVID-19 report.
For just the week of March 19-25, however, the proportion of all cases occurring in children was quite a bit higher, 19.1%. That’s higher than at any other point during the pandemic, passing the previous high of 18.7% set just a week earlier, based on the data collected by AAP/CHA from 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.
The national infection rate was 4,525 cases per 100,000 children for the week of March 19-25, compared with 4,440 per 100,000 the previous week. States falling the farthest from that national mark were Hawaii at 1,101 per 100,000 and North Dakota at 8,848, the AAP and CHA said.
There was double-digit increase, 11, in the number of child deaths, as the total went from 268 to 279 despite Virginia’s revising its mortality data downward. The mortality rate for children remains 0.01%, and children represent only 0.06% of all COVID-19–related deaths in the 43 states, along with New York City, Puerto Rico, and Guam, that are reporting deaths by age, the report shows.
The state/local-level data show that Texas has the highest number of child deaths (48), followed by Arizona (26), New York City (22), California (16), and Illinois (16), while nine states and the District of Columbia have not yet reported a death, the AAP and CHA said.
Cardiologist forks out $2M to resolve unnecessary testing claims
Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.
The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.
The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.
“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”
In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.
There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.
The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.
Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.
A version of this article first appeared on Medscape.com.
Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.
The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.
The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.
“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”
In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.
There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.
The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.
Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.
A version of this article first appeared on Medscape.com.
Michigan cardiologist Dinesh M. Shah, MD, has paid the United States $2 million to resolve claims he violated the False Claims Act by knowingly billing federal health care programs for diagnostic tests that were unnecessary or not performed, the Department of Justice announced.
The settlement resolves allegations that, from 2006 to 2017, Dr. Shah and his practice, Michigan Physicians Group (MPG), of which he is sole owner, billed Medicare, Medicaid, and TRICARE for unnecessary diagnostic tests, including ankle brachial index and toe brachial index tests that were routinely performed on patients without first being ordered by a physician and without regard to medical necessity.
The prosecutors also alleged that Dr. Shah was routinely ordering, and MPG was providing, unnecessary nuclear stress tests to some patients.
“Subjecting patients to unnecessary testing in order to fill one’s pockets with taxpayer funds will not be tolerated. Such practices are particularly concerning because overuse of some tests can be harmful to patients,” acting U.S. Attorney Saima Mohsin said in the news release. “With these lawsuits and the accompanying resolution, Dr. Shah and Michigan Physicians Group are being held to account for these exploitative and improper past practices.”
In addition to the settlement, Dr. Shah and MPG entered into an Integrity Agreement with the Office of Inspector General for the Department of Health & Human Services, which will provide oversight of Dr. Shah and MPG’s billing practices for a 3-year period.
There was “no determination of liability” with the settlement, according to the Department of Justice. Dr. Shah’s case was sparked by two whistleblower lawsuits filed by Arlene Klinke and Khrystyna Malva, both former MPG employees.
The settlement comes after a years-long investigation by the HHS acting on behalf of TRICARE, a health care program for active and retired military members. Allegations that William Beaumont Hospital in Royal Oak, Mich., paid eight physicians excessive compensation to increase patient referrals led to an $84.5 million settlement in 2018.
Dr. Shah was one of three private practice cardiologists who denied involvement in the scheme but were named in the settlement, according to Crain’s Detroit Business.
A version of this article first appeared on Medscape.com.
In U.S., lockdowns added 2 pounds per month
Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.
Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.
“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.
Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.
The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.
Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.
“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”
The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.
Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.
“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”
A version of this article first appeared on WebMD.com.
Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.
Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.
“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.
Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.
The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.
Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.
“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”
The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.
Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.
“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”
A version of this article first appeared on WebMD.com.
Americans gained nearly 2 pounds per month under COVID-19 shelter-in-place orders in 2020, according to a new study published March 22, 2021, in JAMA Network Open.
Those who kept the same lockdown habits could have gained 20 pounds during the past year, the study authors said.
“We know that weight gain is a public health problem in the U.S. already, so anything making it worse is definitely concerning, and shelter-in-place orders are so ubiquitous that the sheer number of people affected by this makes it extremely relevant,” Gregory Marcus, MD, the senior author and a cardiologist at the University of California, San Francisco, told the New York Times.
Dr. Marcus and colleagues analyzed more than 7,000 weight measurements from 269 people in 37 states who used Bluetooth-connected scales from Feb. 1 to June 1, 2020. Among the participants, about 52% were women, 77% were White, and they had an average age of 52 years.
The research team found that participants had a steady weight gain of more than half a pound every 10 days. That equals about 1.5-2 pounds per month.
Many of the participants were losing weight before the shelter-in-place orders went into effect, Dr. Marcus said. The lockdown effects could be even greater for those who weren’t losing weight before.
“It’s reasonable to assume these individuals are more engaged with their health in general, and more disciplined and on top of things,” he said. “That suggests we could be underestimating – that this is the tip of the iceberg.”
The small study doesn’t represent all of the nation and can’t be generalized to the U.S. population, the study authors noted, but it’s an indicator of what happened during the pandemic. The participants’ weight increased regardless of their location and chronic medical conditions.
Overall, people don’t move around as much during lockdowns, the UCSF researchers reported in another study published in Annals of Internal Medicine in November 2020. According to smartphone data, daily step counts decreased by 27% in March 2020. The step counts increased again throughout the summer but still remained lower than before the COVID-19 pandemic.
“The detrimental health outcomes suggested by these data demonstrate a need to identify concurrent strategies to mitigate weight gain,” the authors wrote in the JAMA Network Open study, “such as encouraging healthy diets and exploring ways to enhance physical activity, as local governments consider new constraints in response to SARS-CoV-2 and potential future pandemics.”
A version of this article first appeared on WebMD.com.
Drug-resistant TB trial stopped early after successful results
Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.
The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.
The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.
In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.
Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.
It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.
In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”
This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.
Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).
“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”
The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.
Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.
Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”
While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.
Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.
The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.
The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.
In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.
Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.
It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.
In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”
This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.
Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).
“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”
The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.
Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.
Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”
While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.
Médecins Sans Frontières (MSF/Doctors Without Borders) announced early closure of its phase 2/3 trial of a 6-month multidrug regimen for multidrug-resistant tuberculosis (MDR-TB) because an independent data safety and monitoring board (DSMB) determined that the drug combination in the study regimen was superior to current therapy, according to a press release.
The trial, called TB PRACTECAL, compared the current local standard of care with a 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin. The interim analysis included 242 patients and the randomized, controlled trial was conducted in sites in Belarus, South Africa, and Uzbekistan.
The preliminary data will be shared with the World Health Organization soon and will also be submitted to a peer-reviewed journal. If it withstands further reviews, as is anticipated, the trial would support the first solely oral regimen for MDR-TB.
In 2019, an estimated 465,000 people developed MDR-TB and 182,000 died. The global burden of TB at that time was about 10 million new cases, many with coexisting HIV.
Current treatment for MDR-TB lasts 9-20 months and is complicated by the need for painful shots and toxic antibiotics. Side effects can include psychiatric problems from quinolones, isoniazid, ethambutol, or cycloserine; deafness from aminoglycosides; and bone marrow suppression from linezolid, among other toxicities.
It’s hoped that the shorter regimen will reduce toxicity and improve patient compliance. Poor adherence to treatment is a major driver of further drug resistance. Current regimens require up to 20 pills per day as well as daily injections.
In a prepared statement from MSF, David Moore, MD, MSc, London School of Hygiene and Tropical Medicine, a member of the TB-PRACTECAL trial’s steering committee, concluded: “The findings could transform the way we treat patients with drug-resistant forms of TB worldwide, who have been neglected for too long.”
This good news is particularly welcome as, in the time of COVID-19, “an estimated 1.4 million fewer people received care for tuberculosis in 2020 than in 2019,” according to the WHO. The drop, an overall 21% reduction in patients beginning treatment, ranged as high as 42% in Indonesia.
Although awaiting complete data, Madhukar Pai, MD, PhD, associate director of the McGill International TB Centre, McGill University, Montreal, shares Dr. Moore’s enthusiasm. In an interview, Dr. Pai compared MDR-TB with extensively drug-resistant TB (XDR-TB).
“I’m excited about the possibility that these trial results might help shorten MDR-TB treatment to 6 months,” said Dr. Pai. “That will be a huge relief to all patients battling drug-resistant disease. The 6-month BPaL regimen (bedaquiline, pretomanid, and linezolid) regimen works well in XDR-TB. So, I would expect the TB PRACTECAL regimen with one added drug (moxifloxacin) to work well in MDR-TB, which is less severe than XDR-TB. Between these two regimens, if we can bring down MDR and XDR treatment to 6 months, all oral, that would be a huge advance.”
The expense of bedaquiline has been a long-standing concern in the global health community. Janssen, a subsidiary of Johnson & Johnson, has reduced the price to $340 per 6-month treatment course for more than 135 eligible low- and middle-income countries.
Previously, the tiered pricing structure was different for low-, middle-, and high-income countries (U.S. $900, $3,000, and $30,000, respectively). “The global TB community has asked Janssen to drop the price of bedaquiline to a level no higher than $32 per month – double the price at which researchers estimated bedaquiline could be sold for a profit,” according to the Treatment Action Group A major source of contention over pricing has been that there has been considerable public investment in the drug›s development.
Dr. Pai concluded: “Bedaquiline is likely the most important drug in both 6-month regimens. We need to work harder to make bedaquiline, an excellent drug, more affordable and accessible.”
While the full data is not yet publicly available, TB PRACTECAL was a randomized, controlled, multicenter study. The fact that enrollment was discontinued early by the DSMB suggests the efficacy data was compelling and that this completely oral regimen will become the standard of care.
Dr. Stone is an infectious disease specialist and author of Resilience: One Family’s Story of Hope and Triumph Over Evil and of Conducting Clinical Research, the essential guide to the topic. A version of this article first appeared on Medscape.com.
Vitamin D may protect against COVID-19, especially in Black patients
Higher levels of vitamin D than traditionally considered sufficient may help prevent COVID-19 infection – particularly in Black patients, shows a new single-center, retrospective study looking at the role of vitamin D in prevention of infection.
The study, published recently in JAMA Network Open, noted that expert opinion varies as to what “sufficient” levels of vitamin D are, some define this as 30 ng/mL, while others cite 40 ng/mL or greater.
In their discussion, the authors also noted that their results showed the “risk of positive COVID-19 test results decreased significantly with increased vitamin D level of 30 ng/mL or greater when measured as a continuous variable.”
“These new results tell us that having vitamin D levels above those normally considered sufficient is associated with decreased risk of testing positive for COVID-19, at least in Black individuals,” lead author, David Meltzer, MD, chief of hospital medicine at the University of Chicago, said in a press release from his institution.
“These findings suggest that randomized clinical trials to determine whether increasing vitamin D levels to greater than 30-40 ng/mL affect COVID-19 risk are warranted, especially in Black individuals,” he and his coauthors said.
Vitamin D at time of testing most strongly associated with COVID risk
An earlier study by the same researchers found that vitamin D deficiency (less than 20 ng/mL) may raise the risk of testing positive for COVID-19 in people from various ethnicities, as reported by this news organization.
Data for this latest study were drawn from electronic health records for 4,638 individuals at the University of Chicago Medicine and were used to examine whether the likelihood of a positive COVID-19 test was associated with a person’s most recent vitamin D level (within the previous year), and whether there was any effect of ethnicity on this outcome.
Mean age was 52.8 years, 69% were women, 49% were Black, 43% White, and 8% were another race/ethnicity. A total of 27% of the individuals were deficient in vitamin D (less than 20 ng/mL), 27% had insufficient levels (20-30 ng/mL), 22% had sufficient levels (30-40 ng/mL), and the remaining 24% had levels of 40 ng/mL or greater.
In total, 333 (7%) of people tested positive for COVID-19, including 102 (5%) Whites and 211 (9%) Blacks. And 36% of Black individuals who tested positive for COVID-19 were classified as vitamin D deficient, compared with 16% of Whites.
A positive test result for COVID-19 was not significantly associated with vitamin D levels in white individuals but was in Black individuals.
In Black people, compared with levels of at least 40 ng/mL, vitamin D levels of 30-40 ng/mL were associated with an incidence rate ratio of 2.64 for COVID-19 positivity (P = .01). For levels of 20-30 ng/mL, the IRR was 1.69 (P = 0.21); and for less than 20 ng/mL the IRR was 2.55 (P = .009).
The researchers also found that the risk of positive test results with lower vitamin D levels increased when those levels were lower just prior to the positive COVID-19 test, lending “support [to] the idea that vitamin D level at the time of testing is most strongly associated with COVID-19 risk,” they wrote.
Try upping vitamin D levels to 40 ng/mL or greater to prevent COVID?
In their discussion, the authors noted that significant association of vitamin D levels with COVID-19 risk in Blacks but not in Whites, “could reflect their higher COVID-19 risk, to which socioeconomic factors and structural inequities clearly contribute.
“Biological susceptibility to vitamin D deficiency may also be less frequent in White than Black individuals, since lighter skin increases vitamin D production in response to sunlight, and vitamin D binding proteins may vary by race and affect vitamin D bioavailability.”
Given less than 10% of U.S. adults have a vitamin D level greater than 40 ng/mL, the study findings increase the urgency to consider whether increased sun exposure or supplementation could reduce COVID-19 risk, according to the authors.
“When increased sun exposure is impractical, achieving vitamin D levels of 40 ng/mL or greater typically requires greater supplementation than currently recommended for most individuals of 600-800 IU/d vitamin D3,” they added.
However, Dr. Meltzer also acknowledged that “this is an observational study. We can see that there’s an association between vitamin D levels and likelihood of a COVID-19 diagnosis, but we don’t know exactly why that is, or whether these results are due to the vitamin D directly or other related biological factors.”
All in all, the authors suggested that randomized clinical trials are needed to understand if vitamin D can reduce COVID-19 risk, and as such they should include doses of supplements likely to increase vitamin D to at least 40 ng/mL, and perhaps even higher, although they pointed out that the latter must be achieved safely.
“Studies should also consider the role of vitamin D testing, loading doses, dose adjustments for individuals who are obese or overweight, risks for hypercalcemia, and strategies to monitor for and mitigate hypercalcemia, and that non-White populations, such as Black individuals, may have greater needs for supplementation,” they outlined.
They are now recruiting participants for two separate clinical trials testing the efficacy of vitamin D supplements for preventing COVID-19.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Higher levels of vitamin D than traditionally considered sufficient may help prevent COVID-19 infection – particularly in Black patients, shows a new single-center, retrospective study looking at the role of vitamin D in prevention of infection.
The study, published recently in JAMA Network Open, noted that expert opinion varies as to what “sufficient” levels of vitamin D are, some define this as 30 ng/mL, while others cite 40 ng/mL or greater.
In their discussion, the authors also noted that their results showed the “risk of positive COVID-19 test results decreased significantly with increased vitamin D level of 30 ng/mL or greater when measured as a continuous variable.”
“These new results tell us that having vitamin D levels above those normally considered sufficient is associated with decreased risk of testing positive for COVID-19, at least in Black individuals,” lead author, David Meltzer, MD, chief of hospital medicine at the University of Chicago, said in a press release from his institution.
“These findings suggest that randomized clinical trials to determine whether increasing vitamin D levels to greater than 30-40 ng/mL affect COVID-19 risk are warranted, especially in Black individuals,” he and his coauthors said.
Vitamin D at time of testing most strongly associated with COVID risk
An earlier study by the same researchers found that vitamin D deficiency (less than 20 ng/mL) may raise the risk of testing positive for COVID-19 in people from various ethnicities, as reported by this news organization.
Data for this latest study were drawn from electronic health records for 4,638 individuals at the University of Chicago Medicine and were used to examine whether the likelihood of a positive COVID-19 test was associated with a person’s most recent vitamin D level (within the previous year), and whether there was any effect of ethnicity on this outcome.
Mean age was 52.8 years, 69% were women, 49% were Black, 43% White, and 8% were another race/ethnicity. A total of 27% of the individuals were deficient in vitamin D (less than 20 ng/mL), 27% had insufficient levels (20-30 ng/mL), 22% had sufficient levels (30-40 ng/mL), and the remaining 24% had levels of 40 ng/mL or greater.
In total, 333 (7%) of people tested positive for COVID-19, including 102 (5%) Whites and 211 (9%) Blacks. And 36% of Black individuals who tested positive for COVID-19 were classified as vitamin D deficient, compared with 16% of Whites.
A positive test result for COVID-19 was not significantly associated with vitamin D levels in white individuals but was in Black individuals.
In Black people, compared with levels of at least 40 ng/mL, vitamin D levels of 30-40 ng/mL were associated with an incidence rate ratio of 2.64 for COVID-19 positivity (P = .01). For levels of 20-30 ng/mL, the IRR was 1.69 (P = 0.21); and for less than 20 ng/mL the IRR was 2.55 (P = .009).
The researchers also found that the risk of positive test results with lower vitamin D levels increased when those levels were lower just prior to the positive COVID-19 test, lending “support [to] the idea that vitamin D level at the time of testing is most strongly associated with COVID-19 risk,” they wrote.
Try upping vitamin D levels to 40 ng/mL or greater to prevent COVID?
In their discussion, the authors noted that significant association of vitamin D levels with COVID-19 risk in Blacks but not in Whites, “could reflect their higher COVID-19 risk, to which socioeconomic factors and structural inequities clearly contribute.
“Biological susceptibility to vitamin D deficiency may also be less frequent in White than Black individuals, since lighter skin increases vitamin D production in response to sunlight, and vitamin D binding proteins may vary by race and affect vitamin D bioavailability.”
Given less than 10% of U.S. adults have a vitamin D level greater than 40 ng/mL, the study findings increase the urgency to consider whether increased sun exposure or supplementation could reduce COVID-19 risk, according to the authors.
“When increased sun exposure is impractical, achieving vitamin D levels of 40 ng/mL or greater typically requires greater supplementation than currently recommended for most individuals of 600-800 IU/d vitamin D3,” they added.
However, Dr. Meltzer also acknowledged that “this is an observational study. We can see that there’s an association between vitamin D levels and likelihood of a COVID-19 diagnosis, but we don’t know exactly why that is, or whether these results are due to the vitamin D directly or other related biological factors.”
All in all, the authors suggested that randomized clinical trials are needed to understand if vitamin D can reduce COVID-19 risk, and as such they should include doses of supplements likely to increase vitamin D to at least 40 ng/mL, and perhaps even higher, although they pointed out that the latter must be achieved safely.
“Studies should also consider the role of vitamin D testing, loading doses, dose adjustments for individuals who are obese or overweight, risks for hypercalcemia, and strategies to monitor for and mitigate hypercalcemia, and that non-White populations, such as Black individuals, may have greater needs for supplementation,” they outlined.
They are now recruiting participants for two separate clinical trials testing the efficacy of vitamin D supplements for preventing COVID-19.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Higher levels of vitamin D than traditionally considered sufficient may help prevent COVID-19 infection – particularly in Black patients, shows a new single-center, retrospective study looking at the role of vitamin D in prevention of infection.
The study, published recently in JAMA Network Open, noted that expert opinion varies as to what “sufficient” levels of vitamin D are, some define this as 30 ng/mL, while others cite 40 ng/mL or greater.
In their discussion, the authors also noted that their results showed the “risk of positive COVID-19 test results decreased significantly with increased vitamin D level of 30 ng/mL or greater when measured as a continuous variable.”
“These new results tell us that having vitamin D levels above those normally considered sufficient is associated with decreased risk of testing positive for COVID-19, at least in Black individuals,” lead author, David Meltzer, MD, chief of hospital medicine at the University of Chicago, said in a press release from his institution.
“These findings suggest that randomized clinical trials to determine whether increasing vitamin D levels to greater than 30-40 ng/mL affect COVID-19 risk are warranted, especially in Black individuals,” he and his coauthors said.
Vitamin D at time of testing most strongly associated with COVID risk
An earlier study by the same researchers found that vitamin D deficiency (less than 20 ng/mL) may raise the risk of testing positive for COVID-19 in people from various ethnicities, as reported by this news organization.
Data for this latest study were drawn from electronic health records for 4,638 individuals at the University of Chicago Medicine and were used to examine whether the likelihood of a positive COVID-19 test was associated with a person’s most recent vitamin D level (within the previous year), and whether there was any effect of ethnicity on this outcome.
Mean age was 52.8 years, 69% were women, 49% were Black, 43% White, and 8% were another race/ethnicity. A total of 27% of the individuals were deficient in vitamin D (less than 20 ng/mL), 27% had insufficient levels (20-30 ng/mL), 22% had sufficient levels (30-40 ng/mL), and the remaining 24% had levels of 40 ng/mL or greater.
In total, 333 (7%) of people tested positive for COVID-19, including 102 (5%) Whites and 211 (9%) Blacks. And 36% of Black individuals who tested positive for COVID-19 were classified as vitamin D deficient, compared with 16% of Whites.
A positive test result for COVID-19 was not significantly associated with vitamin D levels in white individuals but was in Black individuals.
In Black people, compared with levels of at least 40 ng/mL, vitamin D levels of 30-40 ng/mL were associated with an incidence rate ratio of 2.64 for COVID-19 positivity (P = .01). For levels of 20-30 ng/mL, the IRR was 1.69 (P = 0.21); and for less than 20 ng/mL the IRR was 2.55 (P = .009).
The researchers also found that the risk of positive test results with lower vitamin D levels increased when those levels were lower just prior to the positive COVID-19 test, lending “support [to] the idea that vitamin D level at the time of testing is most strongly associated with COVID-19 risk,” they wrote.
Try upping vitamin D levels to 40 ng/mL or greater to prevent COVID?
In their discussion, the authors noted that significant association of vitamin D levels with COVID-19 risk in Blacks but not in Whites, “could reflect their higher COVID-19 risk, to which socioeconomic factors and structural inequities clearly contribute.
“Biological susceptibility to vitamin D deficiency may also be less frequent in White than Black individuals, since lighter skin increases vitamin D production in response to sunlight, and vitamin D binding proteins may vary by race and affect vitamin D bioavailability.”
Given less than 10% of U.S. adults have a vitamin D level greater than 40 ng/mL, the study findings increase the urgency to consider whether increased sun exposure or supplementation could reduce COVID-19 risk, according to the authors.
“When increased sun exposure is impractical, achieving vitamin D levels of 40 ng/mL or greater typically requires greater supplementation than currently recommended for most individuals of 600-800 IU/d vitamin D3,” they added.
However, Dr. Meltzer also acknowledged that “this is an observational study. We can see that there’s an association between vitamin D levels and likelihood of a COVID-19 diagnosis, but we don’t know exactly why that is, or whether these results are due to the vitamin D directly or other related biological factors.”
All in all, the authors suggested that randomized clinical trials are needed to understand if vitamin D can reduce COVID-19 risk, and as such they should include doses of supplements likely to increase vitamin D to at least 40 ng/mL, and perhaps even higher, although they pointed out that the latter must be achieved safely.
“Studies should also consider the role of vitamin D testing, loading doses, dose adjustments for individuals who are obese or overweight, risks for hypercalcemia, and strategies to monitor for and mitigate hypercalcemia, and that non-White populations, such as Black individuals, may have greater needs for supplementation,” they outlined.
They are now recruiting participants for two separate clinical trials testing the efficacy of vitamin D supplements for preventing COVID-19.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
What will neurology look like post pandemic?
Jose Angel Soria-Lopez, MD, has an unusually wide perspective on how neurology patients are responding to the coronavirus pandemic. He treats patients at two San Diego–area clinics, one in a poor neighborhood near the Mexican border and another in an upscale city about 65 miles to the north. While the patient populations are quite different, he’s noticed they’ve share one thing in common lately: An unusually intense focus on their personal health.
“All of a sudden people are really thinking about their health,” Dr. Soria-Lopez said. “There’s a sense that their health is even more important than it used to be.”
But patients are divided on how exactly they want their health care delivered. Some are embracing the convenience of telemedicine, while others want to be seen in person no matter what. Moving forward beyond the pandemic, Dr. Soria-Lopez expects the upswing of interest in health will persist. And he predicts two kinds of neurological care will emerge: “One based on ongoing relationships that rely on physical encounters as a culture, and a second kind of neurology service where other patients – perhaps the younger ones – will switch to convenient, online follow-ups.”
Telemedicine will endure post pandemic
While some don’t foresee such a big divide between in-person and online visits, several of Dr. Soria-Lopez’s colleagues from around the country agreed in interviews that . One neurologist, however, cautioned that telemedicine can worsen disparities in care. And he raised the alarm about another aspect of the pandemic that isn’t going to lift when it’s over: The rise in neurological disorders linked to infection with COVID-19.
Before the pandemic, neurologists said, they rarely if ever treated patients via telemedicine outside of specific settings such as remote stroke care. Over the past year, the use of telemedicine has dramatically increased in neurology as in medicine as a whole. But the levels of adoption differ markedly. Neurologist Andrew N. Wilner, MD, of University of Tennessee Health Science Center, said he has used telemedicine to see a single patient so far. But Johns Hopkins Center for Sleep neurologist Charlene Gamaldo, MD, said her clinic converted to 100% remote visits in March 2020 and remains at that level.
“Where [the rate of telemedicine use] will land will be based on insurance reimbursement and license reciprocation, so it is difficult to predict,” she said. “I imagine that sleep will likely remain a hybrid model if current allowances remain.”
Some patients, especially the older ones, resisted the telemedicine visits at first, Dr. Gamaldo said, and family members had to step in to help. Now, she said, patients prefer them because of their convenience.
Some neurological conditions, of course, can’t be easily evaluated via online video. Dr. Soria-Lopez, who has offices in Chula Vista and Temecula, Calif., prefers that a patient appear in person at first. “It really takes 1-2 physical encounters for there to be some level of trust,” he said, adding that “it’s hard to do the first few visits online unless it’s a very straightforward case with one or two symptoms.”
Neurologists have found that telemedicine is especially useful for med-check visits. Mitzi Joi Williams, MD, an Atlanta-area neurologist and multiple sclerosis specialist, said some patients previously drove 2-3 hours for these visits, which can easily be conducted online. Dr. Williams added that online software can allow her to show MRIs to patients remotely. She simply shares her screen and talks about what the images show.
Physical exams are more difficult online, of course, she said: “You can’t see nuances.” And it can be difficult to not have family members in the room to assist with the patient’s history. But some have joined via conference call and that’s been helpful, she said.
Neurologist Rhonda Voskuhl, MD, of the Brain Research Institute at the University of California, Los Angeles, whose clinic has gone to all-telemedicine visits, said telemedicine will make a huge difference for patients who live in remote areas or have mobility problems. In some cases, patients will actually be able to see their doctors more often, she said.
But she cautioned that it can be challenging to evaluate patients who are having difficulties with walking and sensation, although neurologists could try workarounds such as asking a patient to touch something cold. “We can do some things with coordination like watch patients walk, but walking motor strength is hard to check [via video],” she said. “The best thing to evaluate is cognition. You can talk to them and get a lot of it by asking questions.”
Carlos A. Pérez, MD, a neurologist at the University of Texas Health Science Center at Houston, noted that virtual visits can make it difficult to conduct comprehensive eye evaluations and examine vestibular and neuromuscular components such as weakness. “In multiple sclerosis patients, for example, diagnosing an MS relapse can be particularly difficult, especially when the patients present with mostly visual or sensory problems,” he said.
While he’s a fan of telemedicine overall, Dr. Pérez cautioned that low-income patients may lack computers and access to the Internet. “Access to resources in general seems to vary quite significantly,” he said. “Some patients use their cellphones for virtual visits, and that makes it extremely hard to examine them.”
Neurologist Amit Bar-Or, MD, of the University of Pennsylvania, Philadelphia, noted that in some cases, creativity can make a big difference in helping telemedicine visits to run smoothly. “In examining the cranial nerves, for example, you can get a lot of information. You need to have the person position the camera properly and get close to the camera so you can look at eye movements and facial symmetry.”
Still, he said, “if a patient wants to be seen in person, we should never deny them.”
As for other changes that will linger after the pandemic, San Diego–area neurologist Dr. Soria-Lopez said he expects that waiting rooms will continue to be less populated as patients wait elsewhere to avoid the spread of germs. He predicts there will be more use of “virtual waiting rooms” that allow patients to fill out paperwork remotely and get alerts when medical professionals are ready to see them.
Neurological sequelae from COVID-19
Dr. Pérez, the Houston neurologist, said his colleagues should expect another aspect of the pandemic to persist: an influx of patients with neurological sequelae from COVID-19. As he noted in a 2020 report in Neurology Clinical Practice, coronaviruses have been linked to numerous neurological complications during and after the infectious period. “I have seen a few cases of Guillain-Barré and even postinfectious encephalitis in the clinic [linked to COVID-19],” he said. “Neurologists in general should be aware of the risk for chronic, postinfectious neurologic complications from prior COVID-19 infection.”
And, he said, it’s reasonable for neurologists to add a question to patient histories. It’s a simple yet powerful query: Have you had COVID-19?
Jose Angel Soria-Lopez, MD, has an unusually wide perspective on how neurology patients are responding to the coronavirus pandemic. He treats patients at two San Diego–area clinics, one in a poor neighborhood near the Mexican border and another in an upscale city about 65 miles to the north. While the patient populations are quite different, he’s noticed they’ve share one thing in common lately: An unusually intense focus on their personal health.
“All of a sudden people are really thinking about their health,” Dr. Soria-Lopez said. “There’s a sense that their health is even more important than it used to be.”
But patients are divided on how exactly they want their health care delivered. Some are embracing the convenience of telemedicine, while others want to be seen in person no matter what. Moving forward beyond the pandemic, Dr. Soria-Lopez expects the upswing of interest in health will persist. And he predicts two kinds of neurological care will emerge: “One based on ongoing relationships that rely on physical encounters as a culture, and a second kind of neurology service where other patients – perhaps the younger ones – will switch to convenient, online follow-ups.”
Telemedicine will endure post pandemic
While some don’t foresee such a big divide between in-person and online visits, several of Dr. Soria-Lopez’s colleagues from around the country agreed in interviews that . One neurologist, however, cautioned that telemedicine can worsen disparities in care. And he raised the alarm about another aspect of the pandemic that isn’t going to lift when it’s over: The rise in neurological disorders linked to infection with COVID-19.
Before the pandemic, neurologists said, they rarely if ever treated patients via telemedicine outside of specific settings such as remote stroke care. Over the past year, the use of telemedicine has dramatically increased in neurology as in medicine as a whole. But the levels of adoption differ markedly. Neurologist Andrew N. Wilner, MD, of University of Tennessee Health Science Center, said he has used telemedicine to see a single patient so far. But Johns Hopkins Center for Sleep neurologist Charlene Gamaldo, MD, said her clinic converted to 100% remote visits in March 2020 and remains at that level.
“Where [the rate of telemedicine use] will land will be based on insurance reimbursement and license reciprocation, so it is difficult to predict,” she said. “I imagine that sleep will likely remain a hybrid model if current allowances remain.”
Some patients, especially the older ones, resisted the telemedicine visits at first, Dr. Gamaldo said, and family members had to step in to help. Now, she said, patients prefer them because of their convenience.
Some neurological conditions, of course, can’t be easily evaluated via online video. Dr. Soria-Lopez, who has offices in Chula Vista and Temecula, Calif., prefers that a patient appear in person at first. “It really takes 1-2 physical encounters for there to be some level of trust,” he said, adding that “it’s hard to do the first few visits online unless it’s a very straightforward case with one or two symptoms.”
Neurologists have found that telemedicine is especially useful for med-check visits. Mitzi Joi Williams, MD, an Atlanta-area neurologist and multiple sclerosis specialist, said some patients previously drove 2-3 hours for these visits, which can easily be conducted online. Dr. Williams added that online software can allow her to show MRIs to patients remotely. She simply shares her screen and talks about what the images show.
Physical exams are more difficult online, of course, she said: “You can’t see nuances.” And it can be difficult to not have family members in the room to assist with the patient’s history. But some have joined via conference call and that’s been helpful, she said.
Neurologist Rhonda Voskuhl, MD, of the Brain Research Institute at the University of California, Los Angeles, whose clinic has gone to all-telemedicine visits, said telemedicine will make a huge difference for patients who live in remote areas or have mobility problems. In some cases, patients will actually be able to see their doctors more often, she said.
But she cautioned that it can be challenging to evaluate patients who are having difficulties with walking and sensation, although neurologists could try workarounds such as asking a patient to touch something cold. “We can do some things with coordination like watch patients walk, but walking motor strength is hard to check [via video],” she said. “The best thing to evaluate is cognition. You can talk to them and get a lot of it by asking questions.”
Carlos A. Pérez, MD, a neurologist at the University of Texas Health Science Center at Houston, noted that virtual visits can make it difficult to conduct comprehensive eye evaluations and examine vestibular and neuromuscular components such as weakness. “In multiple sclerosis patients, for example, diagnosing an MS relapse can be particularly difficult, especially when the patients present with mostly visual or sensory problems,” he said.
While he’s a fan of telemedicine overall, Dr. Pérez cautioned that low-income patients may lack computers and access to the Internet. “Access to resources in general seems to vary quite significantly,” he said. “Some patients use their cellphones for virtual visits, and that makes it extremely hard to examine them.”
Neurologist Amit Bar-Or, MD, of the University of Pennsylvania, Philadelphia, noted that in some cases, creativity can make a big difference in helping telemedicine visits to run smoothly. “In examining the cranial nerves, for example, you can get a lot of information. You need to have the person position the camera properly and get close to the camera so you can look at eye movements and facial symmetry.”
Still, he said, “if a patient wants to be seen in person, we should never deny them.”
As for other changes that will linger after the pandemic, San Diego–area neurologist Dr. Soria-Lopez said he expects that waiting rooms will continue to be less populated as patients wait elsewhere to avoid the spread of germs. He predicts there will be more use of “virtual waiting rooms” that allow patients to fill out paperwork remotely and get alerts when medical professionals are ready to see them.
Neurological sequelae from COVID-19
Dr. Pérez, the Houston neurologist, said his colleagues should expect another aspect of the pandemic to persist: an influx of patients with neurological sequelae from COVID-19. As he noted in a 2020 report in Neurology Clinical Practice, coronaviruses have been linked to numerous neurological complications during and after the infectious period. “I have seen a few cases of Guillain-Barré and even postinfectious encephalitis in the clinic [linked to COVID-19],” he said. “Neurologists in general should be aware of the risk for chronic, postinfectious neurologic complications from prior COVID-19 infection.”
And, he said, it’s reasonable for neurologists to add a question to patient histories. It’s a simple yet powerful query: Have you had COVID-19?
Jose Angel Soria-Lopez, MD, has an unusually wide perspective on how neurology patients are responding to the coronavirus pandemic. He treats patients at two San Diego–area clinics, one in a poor neighborhood near the Mexican border and another in an upscale city about 65 miles to the north. While the patient populations are quite different, he’s noticed they’ve share one thing in common lately: An unusually intense focus on their personal health.
“All of a sudden people are really thinking about their health,” Dr. Soria-Lopez said. “There’s a sense that their health is even more important than it used to be.”
But patients are divided on how exactly they want their health care delivered. Some are embracing the convenience of telemedicine, while others want to be seen in person no matter what. Moving forward beyond the pandemic, Dr. Soria-Lopez expects the upswing of interest in health will persist. And he predicts two kinds of neurological care will emerge: “One based on ongoing relationships that rely on physical encounters as a culture, and a second kind of neurology service where other patients – perhaps the younger ones – will switch to convenient, online follow-ups.”
Telemedicine will endure post pandemic
While some don’t foresee such a big divide between in-person and online visits, several of Dr. Soria-Lopez’s colleagues from around the country agreed in interviews that . One neurologist, however, cautioned that telemedicine can worsen disparities in care. And he raised the alarm about another aspect of the pandemic that isn’t going to lift when it’s over: The rise in neurological disorders linked to infection with COVID-19.
Before the pandemic, neurologists said, they rarely if ever treated patients via telemedicine outside of specific settings such as remote stroke care. Over the past year, the use of telemedicine has dramatically increased in neurology as in medicine as a whole. But the levels of adoption differ markedly. Neurologist Andrew N. Wilner, MD, of University of Tennessee Health Science Center, said he has used telemedicine to see a single patient so far. But Johns Hopkins Center for Sleep neurologist Charlene Gamaldo, MD, said her clinic converted to 100% remote visits in March 2020 and remains at that level.
“Where [the rate of telemedicine use] will land will be based on insurance reimbursement and license reciprocation, so it is difficult to predict,” she said. “I imagine that sleep will likely remain a hybrid model if current allowances remain.”
Some patients, especially the older ones, resisted the telemedicine visits at first, Dr. Gamaldo said, and family members had to step in to help. Now, she said, patients prefer them because of their convenience.
Some neurological conditions, of course, can’t be easily evaluated via online video. Dr. Soria-Lopez, who has offices in Chula Vista and Temecula, Calif., prefers that a patient appear in person at first. “It really takes 1-2 physical encounters for there to be some level of trust,” he said, adding that “it’s hard to do the first few visits online unless it’s a very straightforward case with one or two symptoms.”
Neurologists have found that telemedicine is especially useful for med-check visits. Mitzi Joi Williams, MD, an Atlanta-area neurologist and multiple sclerosis specialist, said some patients previously drove 2-3 hours for these visits, which can easily be conducted online. Dr. Williams added that online software can allow her to show MRIs to patients remotely. She simply shares her screen and talks about what the images show.
Physical exams are more difficult online, of course, she said: “You can’t see nuances.” And it can be difficult to not have family members in the room to assist with the patient’s history. But some have joined via conference call and that’s been helpful, she said.
Neurologist Rhonda Voskuhl, MD, of the Brain Research Institute at the University of California, Los Angeles, whose clinic has gone to all-telemedicine visits, said telemedicine will make a huge difference for patients who live in remote areas or have mobility problems. In some cases, patients will actually be able to see their doctors more often, she said.
But she cautioned that it can be challenging to evaluate patients who are having difficulties with walking and sensation, although neurologists could try workarounds such as asking a patient to touch something cold. “We can do some things with coordination like watch patients walk, but walking motor strength is hard to check [via video],” she said. “The best thing to evaluate is cognition. You can talk to them and get a lot of it by asking questions.”
Carlos A. Pérez, MD, a neurologist at the University of Texas Health Science Center at Houston, noted that virtual visits can make it difficult to conduct comprehensive eye evaluations and examine vestibular and neuromuscular components such as weakness. “In multiple sclerosis patients, for example, diagnosing an MS relapse can be particularly difficult, especially when the patients present with mostly visual or sensory problems,” he said.
While he’s a fan of telemedicine overall, Dr. Pérez cautioned that low-income patients may lack computers and access to the Internet. “Access to resources in general seems to vary quite significantly,” he said. “Some patients use their cellphones for virtual visits, and that makes it extremely hard to examine them.”
Neurologist Amit Bar-Or, MD, of the University of Pennsylvania, Philadelphia, noted that in some cases, creativity can make a big difference in helping telemedicine visits to run smoothly. “In examining the cranial nerves, for example, you can get a lot of information. You need to have the person position the camera properly and get close to the camera so you can look at eye movements and facial symmetry.”
Still, he said, “if a patient wants to be seen in person, we should never deny them.”
As for other changes that will linger after the pandemic, San Diego–area neurologist Dr. Soria-Lopez said he expects that waiting rooms will continue to be less populated as patients wait elsewhere to avoid the spread of germs. He predicts there will be more use of “virtual waiting rooms” that allow patients to fill out paperwork remotely and get alerts when medical professionals are ready to see them.
Neurological sequelae from COVID-19
Dr. Pérez, the Houston neurologist, said his colleagues should expect another aspect of the pandemic to persist: an influx of patients with neurological sequelae from COVID-19. As he noted in a 2020 report in Neurology Clinical Practice, coronaviruses have been linked to numerous neurological complications during and after the infectious period. “I have seen a few cases of Guillain-Barré and even postinfectious encephalitis in the clinic [linked to COVID-19],” he said. “Neurologists in general should be aware of the risk for chronic, postinfectious neurologic complications from prior COVID-19 infection.”
And, he said, it’s reasonable for neurologists to add a question to patient histories. It’s a simple yet powerful query: Have you had COVID-19?