Infectious Diseases

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

The Food and Drug Administration on Tuesday signaled its resistance to President Donald J. Trump’s drive for an accelerated clearance of a COVID-19 vaccine, while medical and trade associations called for a thorough review of any such product before approval.

The FDA took the unusual step of posting background materials much earlier than usual for its planned Oct. 22 advisory committee meeting on potential vaccines for COVID-19. The FDA also on Tuesday afternoon released a new guidance document, expanding on a previous set of recommendations the agency released in June.

In the new guidance document, FDA officials outline what will be required for even a limited clearance, known as an emergency use authorization (EUA), for a COVID-19 vaccine.

“Data from phase 3 studies should include a median follow-up duration of at least 2 months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the FDA said in the document.

FDA staff have emphasized the higher bar that drugmakers and regulators face in considering approval of a COVID-19 vaccine.

“Vaccines are complex biological products, and an EUA for a COVID-19 vaccine may allow for rapid and widespread deployment for administration of the vaccine to millions of individuals, including healthy people,” the agency staff said in the briefing documents.

The FDA’s briefing document for the Oct. 22 meeting appears to be markedly at odds with the claim Trump made in a video Monday night, in which he told the American public that “vaccines are coming momentarily.”

Trump, who is in a tightly contested presidential race against Democratic candidate Joe Biden, has repeatedly made claims of the potential arrival of COVID vaccines that are at odds with timelines offered with guarded optimism by experts in infectious diseases.

But based on these new guidelines from the FDA, it appears that the White House may now endorse the FDA’s stance, according to a Wall Street Journal report based on “people familiar with the matter.”

The publication reports that the White House, which has yet to officially comment, “endorsed the U.S. Food and Drug Administration’s plans for assessing whether a Covid-19 vaccine should be given widely, casting aside objections to requirements that would likely mean a shot won’t be cleared until after Election Day, people familiar with the matter said.”

Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, on Monday night said during a virtual appearance at the twenty-first annual New Yorker Festival that there could be evidence as early as November or December about whether one of the vaccines now in testing will work out. He declared himself to have “cautious optimism” about potential rollout of vaccines as early as late 2020 or early 2021.

Peter Lurie, MD, MPH, who earlier served as the FDA’s associate commissioner for public health strategy and analysis, described the agency’s release of the briefing document as being a positive development.

News organizations, including the New York Times, have reported that the White House had sought to block the FDA from releasing further instructions for companies developing COVID-19 vaccines. The Associated Press on Tuesday said that a senior Trump administration official confirmed that the White House had blocked earlier FDA plans to formally publish the safety guidelines based on the 2-month data requirement, arguing that there was “no clinical or medical reason” for it.

“It is an encouraging sign that, despite opposition from the White House, the Food and Drug Administration has effectively published guidelines for emergency release of a vaccine for COVID-19 by disclosing the advice it has been providing to individual sponsors,” said Dr. Lurie, who is now executive director and president of the Center for Science in the Public Interest.

In a news release, he said the White House had sought to keep the FDA guidance under wraps “so it could maintain the public fiction that a safe and effective vaccine could be available before Election Day or even so that it could force emergency authorization of a vaccine with more limited follow-up.”

“Even the pharmaceutical industry has been clamoring for the release of these guidelines. We all want a safe and effective vaccine to end the pandemic, and we want it sooner rather than later,” Dr. Lurie said. “But we can’t afford for the Trump administration to bungle vaccine review the way they’ve bungled nearly every other aspect of its pandemic response.”

Tuesday also saw a flood of statements in support of FDA officials, including tweets from the chief executive of Pfizer, which is among the leaders in the race to develop a COVID-19 vaccine. Pfizer’s Albert Bourla, DVM, PhD, said that the FDA’s “public servants are known for their high integrity and scientific expertise and we have full faith in their ability to set appropriate standards for the approval of a COVID vaccine or treatment.”

The American Medical Association on Tuesday announced a public webinar on Wednesday where its president, Susan R. Bailey, MD, will discuss the COVID-19 vaccine review process with Peter Marks, MD, PhD, director of the Center for Biologics Evaluation and Research at the FDA. The AMA described this webinar as part of work “to restore trust in science and science-based decision-making among policymakers and the public.”

“To ensure media and the physician community are continuously informed about the federal review process for COVID-19 vaccine candidates, the AMA will host a webinar series to gain fact-based insights from the nation’s highest-ranking subject matter experts working to protect the health of the public,” the organization said in announcing the webinar.

In a statement, leaders of the Association of American Medical Colleges said that the FDA’s Vaccines and Related Biological Products Advisory Committee should evaluate any COVID-19 candidate vaccines prior to the FDA issuing an EUA.

“Full approval of a new vaccine or biologic requires demonstration of safety and effectiveness through a process that includes evaluation by the VRBPAC. Their recommendations are considered by FDA staff who ultimately have the authority to approve the new product,” said AAMC chief scientific officer Ross McKinney Jr, MD, and AAMC CEO David J. Skorton, MD, in the statement.

Thomas M. File Jr., MD, president of the Infectious Diseases Society of America, said in a statement that his association again asked the White House to “follow medical and scientific expertise in efforts to combat COVID-19.”

“It is imperative that a vaccine be approved on the basis of FDA’s quality standards and that its safety and efficacy are established before it is authorized,” Dr. File said. “A vaccine that has been approved with speed, rather than safety and efficacy, at the forefront will compound the challenges posed by this pandemic. FDA guidelines for approval that set standards the American people can trust are essential to the success of a vaccine.”

Stephen J. Ubl, chief executive of the Pharmaceutical Research and Manufacturers of America, said in a statement that his association “supports any efforts by FDA to provide clarifying guidance and we have engaged with the agency to support bringing greater transparency to the review process for COVID-19 vaccines.”

“To help address this public health crisis, our companies have also taken unprecedented steps to share vaccine clinical trial protocols and data in real time,” Mr. Ubl said. “We welcome the agency’s efforts to instill confidence in the rigorous safety of these potential vaccines.”

On Oct. 1, Michelle McMurry-Heath, MD, PhD, president and chief executive of the Biotechnology Innovation Organization, released publicly her letter urging Department of Health & Human Services Secretary Alex Azar to “publicly release all new guidance” related to a COVID-19 vaccine. Such a move would bolster public confidence in the vaccine, she said.

“We cannot allow a lack of transparency to undermine confidence in the vaccine development process. The public must have full faith in the scientific process and the rigor of FDA’s regulatory oversight if we are to end the pandemic,” she wrote in the Oct. 1 letter to Azar. “Releasing any additional guidance on granting emergency use authorization for a vaccine will go a long way in accomplishing this critical goal.”

This article first appeared on Medscape.com.

In a new review, a group of infectious disease experts have summarized and made recommendations about recent findings regarding infections that can occur during treatment with an evolving set of targeted and biologic therapies for rheumatoid arthritis and psoriatic arthritis.

“We claim for the need for multicenter registries and multidisciplinary approaches, for new vaccines trials in RA and PsA, and for better defining when and how biologics can be restarted after severe infections,” lead author Olivier Lortholary, MD, of the Institut Pasteur in Paris, and his coauthors wrote in Annals of the Rheumatic Diseases.

Assessing infection risk related to various inhibitors

Regarding infections caused by TNF-alpha inhibitors (TNFIs), the experts acknowledged a broad increase in risk for mycobacterial and fungal infections, especially tuberculosis and histoplasmosis. They added that patients on TNFIs are more prone to developing pneumonia and soft tissue infections, while smaller studies have indicated a higher risk of listeriosis, legionellosis, herpes zoster (HZ), and reactivation of chronic hepatitis B virus infection.

As for recommendations, they endorsed discontinuing TNFIs when a serious infection occurs and not restarting until after treatment and clinical response. Patients should be screened for latent tuberculosis infection (LTBI) before starting the drug, and anti-TB drugs should be presented to patients with LTBI so they do not progress to active TB.

Regarding other biologics, they cited several studies indicating that IL-6 inhibitors can increase infection risks in RA patients at a rate similar to TNFIs. Among the most common infections were pneumonia and cellulitis. In addition, although PsA patients on IL-17 inhibitors have a dose-dependent risk of mild to moderate mucocutaneous candidiasis, there was no increased risk of serious opportunistic infections like TB.

In assessing JAK inhibitors, they cited a pooled analysis that indicated pneumonia and skin and soft-tissue infections as the most common and noted the high incidence of HZ, compared with other infections. They added that abatacept (Orencia) did not appear to increase risk of infections in RA patients, such as HZ, dermatomycosis, candidiasis, or endemic mycoses. Those same patients did not see an increased overall infection risk after treatment with rituximab (Rituxan), and clinical trials containing treatment with apremilast (Otezla) reported a rare occurrence of serious infections.

Recommendation-wise, they endorsed screening for LTBI before starting IL-6 inhibitors and antiviral prophylaxis with acyclovir in particularly at-risk patients on JAK inhibitors. Age-appropriate influenza vaccinations were also recommended for rituximab, because of the development of rituximab-induced hypogammaglobulinemia.
 

Prediction and prevention

When it comes to predicting infections in patients on biologics, the experts wrote that it “remains a challenge.” The potential effects of pretreatment underlying disease, the lack of validated biomarkers, and the relatively low rate of infections all combine to stymie prediction. That said, they acknowledged ongoing efforts in monitoring lymphocyte subpopulation counts and immunoglobin levels, as well as a clinical score called the RABBIT Risk Score for Infections, which was validated in two separate cohorts.

“As Yogi Berra said, predictions are hard, especially about the future,” Dr. Kavanaugh said. “Discussions with your patient are always important.”

In regard to overall prevention, they acknowledged that most of their recommendations are of low evidence, except for antiviral prophylaxis for hepatitis B patients on rituximab and the aforementioned LTBI therapy in patients on TNFIs. Broadly, they advocated for all RA and PsA patients to receive a full infectious disease evaluation before the start of targeted and biologic therapies.

They also addressed vaccinations, recommending an evaluation of the patient’s immunization history and potentially planning a catch-up schedule for those in need of the influenza vaccine, a diphtheria-tetanus-pertussis booster, or the pneumococcal vaccine. More broadly, they stated that “a better response is expected if [non-live] vaccination is performed before the introduction of immunosuppressive drugs.” They added that live vaccines should be administered as soon as possible.
 

What rheumatologists can do

“So how do you mitigate risk?” Dr. Winthrop asked. “You have to be able to predict the risk, see what’s modifiable, and try to act on it. A lot of the risk of infection has more to do with the patient than the therapy.

“You try to minimize what you’re doing to the patient, particularly around steroids,” he said. “And then you think about screening and vaccinations. Rheumatologists need to be involved in those conversations because they’re the ones who know how these drugs interact with vaccines. A lot of the drugs might dumb down vaccine responses. Be sure to consider that and give the vaccines at times that will optimize their immunogenicity and likely efficacy.”

“Thankfully, infections are not that common,” Dr. Kavanaugh said. “Rheumatologists depend on data from trials, but more safety data comes from registry data and personal and shared experience.”

The authors declared no potential conflicts of interest.

SOURCE: Lortholary O et al. Ann Rheum Dis. 2020 Sep 22. doi: 10.1136/annrheumdis-2020-217092.

In a new review, a group of infectious disease experts have summarized and made recommendations about recent findings regarding infections that can occur during treatment with an evolving set of targeted and biologic therapies for rheumatoid arthritis and psoriatic arthritis.

“We claim for the need for multicenter registries and multidisciplinary approaches, for new vaccines trials in RA and PsA, and for better defining when and how biologics can be restarted after severe infections,” lead author Olivier Lortholary, MD, of the Institut Pasteur in Paris, and his coauthors wrote in Annals of the Rheumatic Diseases.

Assessing infection risk related to various inhibitors

Regarding infections caused by TNF-alpha inhibitors (TNFIs), the experts acknowledged a broad increase in risk for mycobacterial and fungal infections, especially tuberculosis and histoplasmosis. They added that patients on TNFIs are more prone to developing pneumonia and soft tissue infections, while smaller studies have indicated a higher risk of listeriosis, legionellosis, herpes zoster (HZ), and reactivation of chronic hepatitis B virus infection.

As for recommendations, they endorsed discontinuing TNFIs when a serious infection occurs and not restarting until after treatment and clinical response. Patients should be screened for latent tuberculosis infection (LTBI) before starting the drug, and anti-TB drugs should be presented to patients with LTBI so they do not progress to active TB.

Regarding other biologics, they cited several studies indicating that IL-6 inhibitors can increase infection risks in RA patients at a rate similar to TNFIs. Among the most common infections were pneumonia and cellulitis. In addition, although PsA patients on IL-17 inhibitors have a dose-dependent risk of mild to moderate mucocutaneous candidiasis, there was no increased risk of serious opportunistic infections like TB.

In assessing JAK inhibitors, they cited a pooled analysis that indicated pneumonia and skin and soft-tissue infections as the most common and noted the high incidence of HZ, compared with other infections. They added that abatacept (Orencia) did not appear to increase risk of infections in RA patients, such as HZ, dermatomycosis, candidiasis, or endemic mycoses. Those same patients did not see an increased overall infection risk after treatment with rituximab (Rituxan), and clinical trials containing treatment with apremilast (Otezla) reported a rare occurrence of serious infections.

Recommendation-wise, they endorsed screening for LTBI before starting IL-6 inhibitors and antiviral prophylaxis with acyclovir in particularly at-risk patients on JAK inhibitors. Age-appropriate influenza vaccinations were also recommended for rituximab, because of the development of rituximab-induced hypogammaglobulinemia.
 

Prediction and prevention

When it comes to predicting infections in patients on biologics, the experts wrote that it “remains a challenge.” The potential effects of pretreatment underlying disease, the lack of validated biomarkers, and the relatively low rate of infections all combine to stymie prediction. That said, they acknowledged ongoing efforts in monitoring lymphocyte subpopulation counts and immunoglobin levels, as well as a clinical score called the RABBIT Risk Score for Infections, which was validated in two separate cohorts.

“As Yogi Berra said, predictions are hard, especially about the future,” Dr. Kavanaugh said. “Discussions with your patient are always important.”

In regard to overall prevention, they acknowledged that most of their recommendations are of low evidence, except for antiviral prophylaxis for hepatitis B patients on rituximab and the aforementioned LTBI therapy in patients on TNFIs. Broadly, they advocated for all RA and PsA patients to receive a full infectious disease evaluation before the start of targeted and biologic therapies.

They also addressed vaccinations, recommending an evaluation of the patient’s immunization history and potentially planning a catch-up schedule for those in need of the influenza vaccine, a diphtheria-tetanus-pertussis booster, or the pneumococcal vaccine. More broadly, they stated that “a better response is expected if [non-live] vaccination is performed before the introduction of immunosuppressive drugs.” They added that live vaccines should be administered as soon as possible.
 

What rheumatologists can do

“So how do you mitigate risk?” Dr. Winthrop asked. “You have to be able to predict the risk, see what’s modifiable, and try to act on it. A lot of the risk of infection has more to do with the patient than the therapy.

“You try to minimize what you’re doing to the patient, particularly around steroids,” he said. “And then you think about screening and vaccinations. Rheumatologists need to be involved in those conversations because they’re the ones who know how these drugs interact with vaccines. A lot of the drugs might dumb down vaccine responses. Be sure to consider that and give the vaccines at times that will optimize their immunogenicity and likely efficacy.”

“Thankfully, infections are not that common,” Dr. Kavanaugh said. “Rheumatologists depend on data from trials, but more safety data comes from registry data and personal and shared experience.”

The authors declared no potential conflicts of interest.

SOURCE: Lortholary O et al. Ann Rheum Dis. 2020 Sep 22. doi: 10.1136/annrheumdis-2020-217092.

In a new review, a group of infectious disease experts have summarized and made recommendations about recent findings regarding infections that can occur during treatment with an evolving set of targeted and biologic therapies for rheumatoid arthritis and psoriatic arthritis.

“We claim for the need for multicenter registries and multidisciplinary approaches, for new vaccines trials in RA and PsA, and for better defining when and how biologics can be restarted after severe infections,” lead author Olivier Lortholary, MD, of the Institut Pasteur in Paris, and his coauthors wrote in Annals of the Rheumatic Diseases.

Assessing infection risk related to various inhibitors

Regarding infections caused by TNF-alpha inhibitors (TNFIs), the experts acknowledged a broad increase in risk for mycobacterial and fungal infections, especially tuberculosis and histoplasmosis. They added that patients on TNFIs are more prone to developing pneumonia and soft tissue infections, while smaller studies have indicated a higher risk of listeriosis, legionellosis, herpes zoster (HZ), and reactivation of chronic hepatitis B virus infection.

As for recommendations, they endorsed discontinuing TNFIs when a serious infection occurs and not restarting until after treatment and clinical response. Patients should be screened for latent tuberculosis infection (LTBI) before starting the drug, and anti-TB drugs should be presented to patients with LTBI so they do not progress to active TB.

Regarding other biologics, they cited several studies indicating that IL-6 inhibitors can increase infection risks in RA patients at a rate similar to TNFIs. Among the most common infections were pneumonia and cellulitis. In addition, although PsA patients on IL-17 inhibitors have a dose-dependent risk of mild to moderate mucocutaneous candidiasis, there was no increased risk of serious opportunistic infections like TB.

In assessing JAK inhibitors, they cited a pooled analysis that indicated pneumonia and skin and soft-tissue infections as the most common and noted the high incidence of HZ, compared with other infections. They added that abatacept (Orencia) did not appear to increase risk of infections in RA patients, such as HZ, dermatomycosis, candidiasis, or endemic mycoses. Those same patients did not see an increased overall infection risk after treatment with rituximab (Rituxan), and clinical trials containing treatment with apremilast (Otezla) reported a rare occurrence of serious infections.

Recommendation-wise, they endorsed screening for LTBI before starting IL-6 inhibitors and antiviral prophylaxis with acyclovir in particularly at-risk patients on JAK inhibitors. Age-appropriate influenza vaccinations were also recommended for rituximab, because of the development of rituximab-induced hypogammaglobulinemia.
 

Prediction and prevention

When it comes to predicting infections in patients on biologics, the experts wrote that it “remains a challenge.” The potential effects of pretreatment underlying disease, the lack of validated biomarkers, and the relatively low rate of infections all combine to stymie prediction. That said, they acknowledged ongoing efforts in monitoring lymphocyte subpopulation counts and immunoglobin levels, as well as a clinical score called the RABBIT Risk Score for Infections, which was validated in two separate cohorts.

“As Yogi Berra said, predictions are hard, especially about the future,” Dr. Kavanaugh said. “Discussions with your patient are always important.”

In regard to overall prevention, they acknowledged that most of their recommendations are of low evidence, except for antiviral prophylaxis for hepatitis B patients on rituximab and the aforementioned LTBI therapy in patients on TNFIs. Broadly, they advocated for all RA and PsA patients to receive a full infectious disease evaluation before the start of targeted and biologic therapies.

They also addressed vaccinations, recommending an evaluation of the patient’s immunization history and potentially planning a catch-up schedule for those in need of the influenza vaccine, a diphtheria-tetanus-pertussis booster, or the pneumococcal vaccine. More broadly, they stated that “a better response is expected if [non-live] vaccination is performed before the introduction of immunosuppressive drugs.” They added that live vaccines should be administered as soon as possible.
 

What rheumatologists can do

“So how do you mitigate risk?” Dr. Winthrop asked. “You have to be able to predict the risk, see what’s modifiable, and try to act on it. A lot of the risk of infection has more to do with the patient than the therapy.

“You try to minimize what you’re doing to the patient, particularly around steroids,” he said. “And then you think about screening and vaccinations. Rheumatologists need to be involved in those conversations because they’re the ones who know how these drugs interact with vaccines. A lot of the drugs might dumb down vaccine responses. Be sure to consider that and give the vaccines at times that will optimize their immunogenicity and likely efficacy.”

“Thankfully, infections are not that common,” Dr. Kavanaugh said. “Rheumatologists depend on data from trials, but more safety data comes from registry data and personal and shared experience.”

The authors declared no potential conflicts of interest.

SOURCE: Lortholary O et al. Ann Rheum Dis. 2020 Sep 22. doi: 10.1136/annrheumdis-2020-217092.

The Centers for Disease Control and Prevention acknowledged Oct. 5 in updated guidance that COVID-19 can sometimes be spread through the air, especially in enclosed spaces with poor ventilation, when people are more than 6 feet apart.

The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”

In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”

“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.

The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
 

Information deleted from website last month

On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”

The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.

A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”

The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.

It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.

The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”

Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”

Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.

Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.

“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention acknowledged Oct. 5 in updated guidance that COVID-19 can sometimes be spread through the air, especially in enclosed spaces with poor ventilation, when people are more than 6 feet apart.

The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”

In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”

“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.

The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
 

Information deleted from website last month

On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”

The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.

A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”

The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.

It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.

The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”

Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”

Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.

Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.

“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.

This article first appeared on Medscape.com.

The Centers for Disease Control and Prevention acknowledged Oct. 5 in updated guidance that COVID-19 can sometimes be spread through the air, especially in enclosed spaces with poor ventilation, when people are more than 6 feet apart.

The information reiterates, however, that “COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others.”

In a statement to the media, the CDC said, “Today’s update acknowledges the existence of some published reports showing limited, uncommon circumstances where people with COVID-19 infected others who were more than 6 feet away or shortly after the COVID-19–positive person left an area. In these instances, transmission occurred in poorly ventilated and enclosed spaces that often involved activities that caused heavier breathing, like singing or exercise. Such environments and activities may contribute to the buildup of virus-carrying particles.”

“This is HUGE and been long delayed. But glad it’s now CDC official,” tweeted Eric Feigl-Ding, MD, an epidemiologist and health economist at Harvard University, Boston on Oct. 5.

The CDC announcement follows an abrupt flip-flop on information last month surrounding the aerosol spread of the virus.
 

Information deleted from website last month

On September 18, the CDC had added to its existing guidance that the virus is spread “through respiratory droplets or small particles, such as those in aerosols, produced when an infected person coughs, sneezes, sings, talks, or breathes. These particles can be inhaled into the nose, mouth, airways, and lungs and cause infection.”

The CDC then deleted that guidance on Sept. 21, saying it was a draft update released in error.

A key element of the now-deleted guidance said, “this is thought to be the main way the virus spreads.”

The information updated today reverses the now-deleted guidance and says aerosol transmission is not the main way the virus spreads.

It states that people who are within 6 feet of a person with COVID-19 or have direct contact with that person have the greatest risk of infection.

The CDC reiterated in the statement to the media today, “People can protect themselves from the virus that causes COVID-19 by staying at least 6 feet away from others, wearing a mask that covers their nose and mouth, washing their hands frequently, cleaning touched surfaces often, and staying home when sick.”

Among the journals that have published evidence on aerosol spread is Clinical Infectious Diseases, which, on July 6, published the paper, “It Is Time to Address Airborne Transmission of Coronavirus Disease 2019,” which was supported by 239 scientists.

The authors wrote, “there is significant potential for inhalation exposure to viruses in microscopic respiratory droplets (microdroplets) at short to medium distances (up to several meters, or room scale).”

Aerosols and airborne transmission “are the only way to explain super-spreader events we are seeing,” said Kimberly Prather, PhD, an atmospheric chemist at the University of California at San Diego, in an interview Oct. 5 with the Washington Post.

Dr. Prather added that, once aerosolization is acknowledged, this becomes a “fixable” problem through proper ventilation.

“Wear masks at all times indoors when others are present,” Dr. Prather said. But when inside, she said, there’s no such thing as a completely safe social distance.

This article first appeared on Medscape.com.

Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.

A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.

In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.

Is nicotine protective?

Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”

Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.

However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.

Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.

“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”

Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”

The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.

EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
 

Racial disparities

Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.

Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).

In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.

Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10^–30).

This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10^–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).

Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.

Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.

Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10^–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2  P < 10^–25).

Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).

“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
 

Vulnerable populations

Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.

In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.

Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.

The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.

Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.

“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.

“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
 

‘Pretty convincing’

Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.

“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.

Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.

He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.

Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.

“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
 

Universal screening?

Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.

“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.

Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.

Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.

However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.

“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”

The report authors and Dr. Saxon have disclosed no relevant financial relationships.

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

Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.

A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.

In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.

Is nicotine protective?

Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”

Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.

However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.

Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.

“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”

Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”

The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.

EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
 

Racial disparities

Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.

Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).

In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.

Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10^–30).

This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10^–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).

Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.

Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.

Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10^–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2  P < 10^–25).

Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).

“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
 

Vulnerable populations

Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.

In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.

Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.

The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.

Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.

“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.

“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
 

‘Pretty convincing’

Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.

“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.

Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.

He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.

Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.

“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
 

Universal screening?

Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.

“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.

Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.

Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.

However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.

“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”

The report authors and Dr. Saxon have disclosed no relevant financial relationships.

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

Substance use disorders (SUD), particularly opioid addiction and smoking, are tied to an increased risk for COVID-19 and serious adverse outcomes including hospitalization and death, new research suggests.

A study funded by the National Institutes of Health assessed electronic health records of more than 73 million patients in the United States. Although only 10.3% of the participants had an SUD, “they represented 15.6% of the COVID-19 cases,” the investigators reported.

In addition, those with a recent diagnosis of SUD were eight times more likely to develop COVID-19 versus those without such a diagnosis. For specific SUDs, the greatest risk was for those with an opioid addiction followed by those who were addicted to cigarettes.

Is nicotine protective?

Dr. Volkow, her fellow senior author Rong Xu, PhD, Case Western Reserve University, Cleveland, and their team conducted the study because data released before the pandemic showed a significant increase in opioid overdose in 2019. “We were in an opioid crisis where we again saw an increase in mortality associated with overdose – and then COVID comes along. So the question was how are people who are already struggling faring? And if they were getting infected [with the coronavirus], what happened to them?”

Patients with SUDs have multiple medical comorbidities that are known risk factors for COVID-19, Dr. Volkow noted.

However, the only specific SUD that has been previously studied in this context is tobacco use disorder, she said. A report from Chinese investigators released early in the pandemic showed that smokers were more likely to be infected by coronavirus and more likely to die from COVID-19.

Interestingly, a cross-sectional study published in April suggested that smoking may be protective against COVID, and Dr. Volkow noted that a clinical study currently being conducted in France is assessing whether wearing a nicotine patch has the potential to prevent the virus.

“That’s very different from looking at a chronic smoker,” she pointed out. “It’s a potential that nicotine as a chemical [could be] a preventive measure as opposed to saying smoking will prevent you from getting COVID.”

Patients with SUDs, said Dr. Volkow, “are likely to be at greater risk because of the effects of drugs in the metabolic system and the interfering with oxygenation in the pulmonary vessels.”

The retrospective case-control study included EHR data from 73.1 million patients. In the study population, 54% were women, 55% were White, 10% Black, 2% Asian, 1% Hispanic/Latino, and the others were classified as other or unknown.

EHRs were collected through June 15 at 360 hospitals in all 50 states and were deidentified to ensure privacy. SUDs included alcohol, tobacco, cannabis, opioid, and cocaine.
 

Racial disparities

Results showed that about 7.5 million participants had a previous SUD diagnosis; of these, 722,370 had been diagnosed within the past year.

Tobacco use disorder was the most common diagnosis (n = 6,414,580), followed by alcohol (1,264,990), cannabis (490,420), opioid (471,520), and cocaine (222,680).

In addition, 12,030 (60% women) were diagnosed with COVID-19 and 1,880 had both COVID-19 and an SUD.

Adjusted analyses revealed that those who had a recent diagnosis of SUD were at a significantly greater increased risk for COVID-19 than individuals without an SUD (adjusted odds ratio, 8.7; 95% confidence interval, 8.4-9.0; P < 10^–30).

This increased risk was greatest in participants with opioid use disorder (aOR, 10.2; 95% CI, 9.1-11.5; P < 10^–30), followed by those with tobacco use disorder (aOR, 8.2; 95% CI, 7.9 - 8.5; P < 10–30).

Alcohol, cocaine, and cannabis had aORs of 7.7, 6.5, and 5.3, respectively. The aOR for lifetime SUD and COVID-19 was 1.5.

Among all patients with COVID-19, hospitalization rates were significantly greater in those with an SUD (43.8%) versus those without (30.1%), as were death rates at 9.6% versus 6.6%, respectively.

Race was a significant risk factor. Black patients with a recent SUD diagnosis were twice as likely as White patients to develop COVID-19 (aOR, 2.2; P < 10^–30), and those specifically with opioid use disorder were four times more likely to develop the disease (aOR, 4.2  P < 10^–25).

Black patients with both COVID-19 and lifetime SUD also had greater hospitalization and death rates versus their White peers (50.7% vs. 35.2% and 13% vs. 8.6%, respectively).

“This surprised me,” Dr. Volkow noted. “You can see the emergence of the racial disparities even under these conditions of really negative outcomes.”
 

Vulnerable populations

Cancer; obesity; HIV; diabetes; cardiovascular disease; and chronic kidney, liver, and lung diseases, which are all risk factors for COVID-19, were more prevalent in the group of patients with a recent SUD diagnosis versus those without.

In addition, asthma, type 2 diabetes, hypertension, obesity, and chronic kidney disease were more prevalent in the Black patents with a recent SUD than in the White patients.

Overall, the findings “identify individuals with SUD as a vulnerable population, especially African Americans with SUDs, who are at significantly increased risk for COVID-19 and its adverse outcomes,” the investigators wrote.

The results also highlight “the need to screen and treat individuals with SUD as part of the strategy to control the pandemic while ensuring no disparities in access to healthcare support,” they added.

Dr. Volkow noted that “marginalization” often occurs for individuals with addiction, making it more difficult for them to access health care services.

“It is incumbent upon clinicians to meet the unique challenges of caring for this vulnerable population, just as they would any other high-risk group,” she said.

“Patients should not just be treated for COVID, but should also be provided with treatment for their substance use disorder,” Dr. Volkow added.
 

‘Pretty convincing’

Andrew J. Saxon, MD, professor in the department of psychiatry and behavioral sciences at the University of Washington, Seattle, called the findings interesting.

“I found it pretty convincing that people who have substance use disorders are probably at higher risk for getting COVID-19 infection and more complications once they are infected,” he said.

Dr. Saxon, who was not involved with the research, is also director of the Center of Excellence in Substance Addiction Treatment and Education and is a member of the American Psychiatric Association’s Council on Addiction Psychiatry.

He noted that an important point from the study was not just about a patient having an SUD being at increased risk for COVID-19 “and a more severe disease trajectory.” Other factors associated with having an SUD, such as increased comorbidities, also likely play a part.

Dr. Saxon agreed that the ongoing opioid epidemic combined with the pandemic led to a “perfect storm” of problems.

“We were making slow but some progress getting more people the medications they need [to treat opioid use disorder], but the pandemic coming along disrupted those efforts. A lot of health care entities had to shut down for a while, seeing patients only remotely,” which led to barriers as many clinicians needed to learn how to proceed using telehealth options, said Dr. Saxon.
 

Universal screening?

Asked whether physicians should screen all patients for SUDs, Dr. Saxon said it’s a complicated question.

“Screening for tobacco and alcohol has a really good evidence base and practices should be doing that. The stigma is there but it’s a lot less than with illegal substances,” he said.

Screening for illegal substances or misuse of prescription substances may not be a good idea in health care settings “when it’s something they can’t do anything about. If you’re going to screen, you would have to have either referral processes in place or treatment available in your facility,” Dr. Saxon said.

Opioid use disorder is “especially amenable to treatment in a primary care or health care setting with prescribers,” he noted.

However, stimulant or cannabis use disorders “require fairly intensive behavioral interventions that are not easy to deliver in many health care settings. And we don›t have the workforce trained up to provide those treatments as widely as they should be,” said Dr. Saxon.

“Unless there’s some way to treat the issue, what’s the point of screening for it? That just creates frustration for patients and clinicians, as well,” he said. “It’s something we’re moving toward but we’re not quite there yet.”

The report authors and Dr. Saxon have disclosed no relevant financial relationships.

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

Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.

“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”

In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
 

Minority, socioeconomic status affect pediatric outcomes too

Overall, 207 (21%) of the children tested positive for COVID-19; of these 46% were Hispanic, 30% were non-Hispanic Black, and 7% were non-Hispanic White. The median age of the study population was 8 years, and approximately half were male.

The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.

Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).

After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).

The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.

“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.

Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
 

How to help

“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”

“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.

“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.

The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.

SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.

Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.

“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”

In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
 

Minority, socioeconomic status affect pediatric outcomes too

Overall, 207 (21%) of the children tested positive for COVID-19; of these 46% were Hispanic, 30% were non-Hispanic Black, and 7% were non-Hispanic White. The median age of the study population was 8 years, and approximately half were male.

The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.

Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).

After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).

The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.

“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.

Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
 

How to help

“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”

“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.

“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.

The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.

SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.

Black and Hispanic children comprised significantly more cases of COVID-19, compared with White children, based on data from a large, cross-sectional study of 1,000 cases.

“Data regarding disparities in SARS-CoV-2 infection and outcomes have been, thus far, mostly limited to adults,” wrote Monika K. Goyal, MD, of Children’s National Hospital, Washington, and colleagues. “Additional data further suggest that low socioeconomic status may further exacerbate health outcomes for racial and ethnic minorities.”

In a study published in Pediatrics, the researchers conducted a cross-sectional analysis of 1,000 children from a registry of non–acutely ill pediatric patients seen at a drive-through and walk-up COVID-19 test site.
 

Minority, socioeconomic status affect pediatric outcomes too

Overall, 207 (21%) of the children tested positive for COVID-19; of these 46% were Hispanic, 30% were non-Hispanic Black, and 7% were non-Hispanic White. The median age of the study population was 8 years, and approximately half were male.

The researchers also examined the association of median family income (MFI) using census block group estimates data from the American Community Survey (2014–2018) to represent socioeconomic status.

Infection rates were significantly higher among children in the lowest three quartiles of MFI (24%, 27%, and 38% for quartiles 3, 2, and 1, respectively), compared with the highest quartile of MFI (9%).

After adjusting for age, sex, and MFI, Hispanic children were six times more likely and non-Hispanic Black children were twice as likely to test positive for COVID-19 than non-Hispanic White children (adjusted odds ratios, 6.3 and 2.3, respectively).

The study findings were limited by several factors including the use of clinician-reported ethnicity and thus potential for misclassification, the researchers noted. In addition, the socioeconomic and racial disparities may be underestimated because these groups have less access to primary care, and the study did not allow for confounding variables including housing conditions or occupancy.

“Although it was beyond the scope of this study to understand the causes for these differential rates of infection, the causes may be multifactorial, including, but not limited to, structural factors, poorer access to health care, limited resources, and bias and discrimination,” the researchers noted. In addition, the high infection rate among minority children may be impacted by parents who are less able to telework, find child care, or avoid public transportation, Dr. Goyal and associates wrote.

Future research should address “the modifiable reasons for these observed disparities as well as their differential impact in terms of SARS-CoV-2–related morbidity and mortality outcomes to mitigate the spread of infection and its health effects,” they concluded.
 

How to help

“This study is important because we need to understand which groups of children are at highest risk for SARS-CoV-2 infection in order to maximize efforts for screening, allocating resources, and prioritizing vaccine administration,” Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

Dr. Kinsella said she was not surprised at the higher infection rates in general in minorities and low socioeconomic groups. “We already knew that adult COVID-19 rates were higher for people in certain racial/ethnic groups and those with socioeconomic disadvantages; however, I was shocked by the percentages. That is a huge burden for a population that already has disparities in health outcomes.”

“As the authors cite, this was not a research study of why these groups were more likely to be COVID-19 positive, but they speculated that crowded living conditions, multigenerational families living together, and many minorities being essential workers unable to work from home,” said Dr. Kinsella. Additional factors contributing to higher infection rates may include limited access to care, transportation issues, insurance coverage, schedule challenges, and fear of deportation. Some of these problems might be addressed by coming into communities in mobile vans, visiting community health centers and schools with free educational materials, using masks and hand sanitizer, and offering free access to testing.

“Future studies could confirm the cause of this discrepancy, as well as study community-based interventions and their outcomes,” Dr. Kinsella said. In the meantime, a take-home message for clinicians is the need to prioritize screening, resources, and vaccines to reflect the higher rates of SARS-CoV-2 infections in children from disadvantaged racial and socioeconomic backgrounds.

The study received no outside funding. The researchers had no financial conflicts to disclose, but lead author Dr. Goyal is a member of the Pediatrics editorial board. Dr. Kinsella had no financial conflicts to disclose, but serves on the Pediatric News editorial advisory board.

SOURCE: Goyal MK et al. Pediatrics. 2020 Sep 24. doi: 10.1542/peds.2020-009951.

Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.

Choreograph/Thinkstock

“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.

Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.

To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.

“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
 

Pandemic changes some parents’ plans

Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).

Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.

“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.

The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”

The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
 

Potential for ‘twindemic’ is real

The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.

“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.

Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.

“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.

“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.

Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”

Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”

However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.

The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.

“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”

Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.

“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.

In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.

Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.

SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.

Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.

Choreograph/Thinkstock

“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.

Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.

To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.

“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
 

Pandemic changes some parents’ plans

Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).

Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.

“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.

The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”

The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
 

Potential for ‘twindemic’ is real

The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.

“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.

Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.

“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.

“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.

Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”

Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”

However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.

The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.

“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”

Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.

“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.

In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.

Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.

SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.

Parents who did not vaccinate their children against influenza last year were significantly less likely to do so this year than parents whose children were vaccinated last year, based on survey data from more than 2,000 parents with babies and young children.

Choreograph/Thinkstock

“Pediatric vaccination will be an important component to mitigating a dual influenza/COVID-19 epidemic,” Rebeccah L. Sokol, PhD, of Wayne State University, Detroit, and Anna H. Grummon, PhD, of Harvard School of Public Health, Boston, reported in Pediatrics.

Although the pandemic has increased acceptance of some healthy behaviors including handwashing and social distancing, the impact on influenza vaccination rates remains unknown, they said.

To assess parents’ current intentions for flu vaccination of young children this season, the researchers conducted an online survey of 2,164 parents or guardians of children aged between 6 months and 5 years in the United States. The 15-minute online survey was conducted in May 2020 and participants received gift cards. The primary outcome was the impact of the COVID-19 pandemic on parental intentions for having their child vaccinated against seasonal flu this year.

“We measured change categorically, with response options ranging from 1 (I became much less likely to get my child the flu shot next year) to 5 (I became much more likely to get my child the flu shot next year),” the researchers said.
 

Pandemic changes some parents’ plans

Overall, 60% of parents said that the ongoing pandemic had altered their flu vaccination intentions for their children. About 34% percent of parents whose children did not receive flu vaccine last year said they would not seek the vaccine this year because of the pandemic, compared with 25% of parents whose children received last year’s flu vaccine, a statistically significant difference (P < .001).

Approximately 21% of parents whose children received no flu vaccine last year said the pandemic made them more likely to seek vaccination for the 2020-2021 season, compared with 38% of parents whose children received last year’s flu vaccine.

“These results suggest that overall seasonal influenza vaccination rates may not increase simply because of an ongoing infectious disease pandemic. Instead, a significant predictor of future behavior remains past behavior,” Dr. Sokol and Dr. Grummon said.

The study findings were limited by several factors including the use of a convenience sample and the timing of the survey in May 2020, meaning that survey results might not be generalizable this fall as the pandemic persists, they noted. “Additionally, we assessed intentions to vaccinate; future research will clarify the COVID-19 pandemic’s influence on actual vaccination behaviors.”

The challenge of how to increase uptake of the influenza vaccine during the era of COVID-19 remains, and targeted efforts could include social norms messaging through social media, mass media, or health care providers to increase parents’ intentions to vaccinate, as well as vaccination reminders and presumptive announcements from health care providers that present vaccination as the default option, the researchers added.
 

Potential for ‘twindemic’ is real

The uptake of flu vaccination is especially important this year, Christopher J. Harrison, MD, director of the vaccine and treatment evaluation unit and professor of pediatrics at the University of Missouri–Kansas City, said in an interview.

“This year we are entering a flu season where the certainty of the timing as well as the potential severity of the season are not known. That said, social distancing and wearing masks – to the extent that enough people conform to COVID-19 precautions – could delay or even blunt the usual influenza season,” he noted.

Unfortunately, the Centers for Disease Control and Prevention and the Food and Drug Administration have had their credibility damaged by the challenges of creating a successful response on the fly to a uniquely multifaceted virus to which previous rules do not apply, Dr. Harrison said. In addition, public confidence was eroded when information about testing and reopening policies were released by non-CDC nonscientists and labeled “CDC recommended,” with no opportunity for the scientific community to correct inaccuracies.

“The current study reveals that public trust in influenza vaccine and indirectly in health authorities has been affected by the pandemic,” said Dr. Harrison. “Vaccine hesitancy has increased somewhat even among previous vaccine accepters. One wonders if promises of a quick COVID-19 vaccine increased mistrust of the FDA because of safety concerns, even among the most ardent provaccine population, and whether these concerns are bleeding over into influenza vaccine concerns.

“This only adds to the anxiety that families feel about visiting any medical facility for routine vaccines while the pandemic rages, and we now are in a fall SARS-CoV-2 resurgence,” he added.

Although the current study data are concerning, “there could still be a net gain of pediatric influenza vaccine uptake this season because the 34% less likely to immunize among previously nonimmunizing families would be counterbalanced by 21% of the same group being more likely to immunize their children [theoretical net loss of 13%],” Dr. Harrison explained. “But the pandemic seems to have motivated previously influenza-immunizing families, i.e. while 24% were less likely, 39% are more likely to immunize [theoretical net gain of 15%]. That said, we would still be way short of the number needed to get to herd immunity.”

Dr. Harrison said he found the findings somewhat surprising, but perhaps he should not have. “I had hoped for more acceptance rather than most people staying in their prior vaccine ‘opinion lanes,’ ending up with likely little overall net change in plans to immunize despite increased health awareness caused by a pandemic.”

However, “the U.S. population has been polarized on vaccines and particularly influenza vaccines for more than 50 years, so why would a pandemic make us less polarized, particularly when the pandemic itself has been a polarizing event?” he questioned.

The greatest barriers to flu vaccination for children this year include a lack of motivation among families to visit immunization sites, given the ongoing need for social distancing and masks, Dr. Harrison said.

“Another barrier is the waning public confidence in our medical/scientific national leaders and organizations,” he emphasized. “This makes it crucial that primary care providers step up and be extra strong vaccine advocates, despite the fact that pandemic economics and necessary safety processes have stressed providers and devastated practices. Indeed, in times of medical stress, no one gets more trust from families than their own personal provider.”

Ultimately, avenues for future research include asking diverse groups of families what they feel they need to hear to be more engaged in immunizing children against influenza. But for now, the current study findings identify that “the public is not uniformly responding to the pandemic’s influence on their likelihood of immunizing their children against influenza,” Dr. Harrison said.

“We now know the size of the problem and hopefully governments, public health organizations, pediatric advocates and clinical care givers can find ways to magnify the message that a pandemic year is not a year to avoid seasonal influenza vaccine unless one has a true contraindication,” Dr. Harrison said.

In addition, “one wonders if the poll were taken today – post the president’s COVID-19 illness – would the answers be different?” he noted.

Dr. Sokol’s work was supported in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development but otherwise had no financial conflicts to disclose. Dr. Harrison disclosed that his institution receives grant funding from Merck, Pfizer, and GlaxoSmithKline for pediatric noninfluenza vaccine studies on which he is a subinvestigator, and support from the CDC for pediatric respiratory and gastrointestinal virus surveillance studies on which he is an investigator.

SOURCE: Sokol RL, Grummon AH. Pediatrics. 2020 Sep 30. doi: 10.1542/peds.2020-022871.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump’s COVID-19 diagnosis is raising fresh questions about the White House’s strategy for testing and containing the virus for a president whose cavalier attitude about the coronavirus has persisted since it landed on American shores.

The president has said others are tested before getting close to him, appearing to hold it as an iron shield of safety. He has largely eschewed mask-wearing and social distancing in meetings, travel and public events, while holding rallies for thousands of often maskless supporters.

The Trump administration has increasingly pinned its coronavirus testing strategy for the nation on antigen tests, which do not need a traditional lab for processing and quickly return results to patients. But the results are less accurate than those of the slower PCR tests. 

An early antigen test used by the White House was woefully inaccurate. But the new antigen test the White House is using has not been independently evaluated for accuracy and reliability. Moreover, this is the kit the Trump administration is pushing out to thousands of nursing homes to test residents and staff.

Testing “isn’t a ‘get out of jail free card,’” said Dr. Alan Wells, medical director of clinical labs at the University of Pittsburgh Medical Center and creator of its test for the novel coronavirus. In general, antigen tests can miss up to half the cases that are detected by polymerase chain reaction tests, depending on the population of patients tested, he said.

The White House said the president’s diagnosis was confirmed with a PCR test but declined to say which test delivered his initial result. The White House has been using a new antigen test from Abbott Laboratories to screen its staff for COVID-19, according to two administration officials. 

The test, known as BinaxNOW, received an emergency use authorization from the Food and Drug Administration in August. It produces results in 15 minutes. Yet little is independently known about how effective it is. According to the company, the test is 97% accurate in detecting positives and 98.5% accurate in identifying those without disease. Abbott’s stated performance of its antigen test was based on examining people within 7 days of COVID symptoms appearing.

The president and first lady have both had symptoms, according to White House chief of staff Mark Meadows and the first lady’s Twitter account. The president was admitted to Walter Reed National Military Medical Center on Friday evening “out of an abundance of caution,” White House press secretary Kayleigh McEnany said in a statement.

Vice President Mike Pence is also tested daily for the virus and tested negative, spokesperson Devin O’Malley said Friday, but he did not respond to a follow-up question about which test was used.

Trump heavily promoted another Abbott rapid testing device, the ID NOW, earlier this year. But that test relies on different technology than the newer Abbott antigen test.

“I have not seen any independent evaluation of the Binax assay in the literature or in the blogs,” Wells said. “It is an unknown.”

The Department of Health and Human Services announced in August that it had signed a $760 million contract with Abbott for 150 million BinaxNOW antigen tests, which are now being distributed to nursing homes and historically black colleges and universities, as well as to governors to help inform decisions about opening and closing schools. The Big Ten football conference has also pinned playing hopes on the deployment of antigen tests following Trump’s political pressure.

However, even senior federal officials concede that a test alone isn’t likely to stop the spread of a virus that has sickened more than 7 million Americans.

“Testing does not substitute for avoiding crowded indoor spaces, washing hands, or wearing a mask when you can’t physically distance; further, a negative test today does not mean that you won’t be positive tomorrow,” Adm. Brett Giroir, the senior HHS official helming the administration’s testing effort, said in a statement at the time.

Trump could be part of a “super-spreading event,” said Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Given the timing of Trump’s positive test — which he announced on Twitter early Friday – his infection “likely happened 5 or more days ago,” Osterholm said. “If so, then he was widely infectious as early as Tuesday,” the day of the first presidential debate in Cleveland.

At least seven people who attended a Rose Garden announcement last Saturday, when Trump announced his nomination of Judge Amy Coney Barrett to the Supreme Court, have since tested positive for the coronavirus. They include Trump’s former adviser Kellyanne Conway, Republican Sens. Mike Lee and Thom Tillis, and the president of the University of Notre Dame, the Rev. John Jenkins.

“Having that many infected people there all at one time, we’re still going to see transmission coming off that event for a couple days,” Osterholm said.

Osterholm notes that about 20% of infected people lead to 80% of COVID-19 cases, because “super spreaders” can infect so many people at once.

He notes that participants and audience members at Tuesday’s debate were separated by at least 6 feet. But 6 feet isn’t always enough to prevent infection, he said.

While many COVID-19 infections appear to be spread by respiratory droplets, which usually fall to the ground within 6 feet, people who are singing or speaking loudly can project virus much further. Evidence also suggests that the novel coronavirus can spread through aerosols, floating in the air like a speck of dust.

“I wonder how much virus was floating in that room that night,” Osterholm said.

Other experts say it’s too soon to say whether Trump was infected in a super-spreader event. “The president and his wife have had many exposures to many people in enclosed venues without protection,” so they could have been infected at any number of places, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine. 

Although Democratic presidential candidate and former Vice President Joe Biden tested negative for the virus with a PCR test Friday, experts note that false-negative results are common in the first few days after infection. Test results over the next several days will yield more useful information.

It can take more than a week for the virus to reproduce enough to be detected, Wells said: “You are probably not detectable for 3, 5, 7, even 10 days after you’re exposed.”

In Minnesota, where Trump held an outdoor campaign rally in Duluth with hundreds of attendees Wednesday, health officials warned that a 14-day quarantine is necessary, regardless of test results.

“Anyone who was a direct contact of President Trump or known COVID-19 cases needs to quarantine and should get tested,” the Minnesota Department of Health said.

Ongoing lapses in test result reporting could hamper efforts to track and isolate sick people. As of Sept. 10, 21 states and the District of Columbia were not reporting all antigen test results, according to a KHN investigation, a lapse in reporting that officials say leaves them blind to disease spread. Since then, public health departments in Arizona, North Carolina and South Dakota all have announced plans to add antigen testing to their case reporting.

Requests for comment to the D.C. Department of Health were referred to Mayor Muriel Bowser’s office, which did not respond. District health officials told KHN in early September that the White House does not report antigen test results to them – a potential violation of federal law under the CARES Act, which says any institution performing tests to diagnose COVID-19 must report all results to local or state public health departments.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins University Center for Health Security, said it’s not surprising that Trump tested positive, given that so many of his close associates – including his national security adviser and Secret Service officers – have also been infected by the virus.

“When you look at the number of social contacts and travel schedules, it’s not surprising,” Adalja said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Fecal microbiota transplantation (FMT) appears safe and effective as a treatment for most Clostridioides difficile infections as it is currently being administered, researchers say.

“We actually didn’t see any infections that were definitely transmissible via fecal transplant,” Colleen Kelly, MD, an associate professor of medicine at Brown University, Providence, R.I., said in an interview.

The findings, published online Oct. 1 in the journal Gastroenterology, come from the American Gastroenterological Association (AGA) NIH-funded FMT National Registry and could allay concerns about a treatment that has yet to gain full approval by the Food and Drug Administration, despite successful clinical trials.

C. diff infections are common and increasing in the United States, often can’t be cured with conventional treatments such as antibiotics, and can be deadly.

Transplanting fecal matter from a donor to the patient appears to work by restoring beneficial microorganisms to the patient’s gut. The procedure is also under investigation for a wide range of other ailments, from irritable bowel syndrome to mood disorders.

But much remains unknown. Researchers have counted a thousand bacterial species along with viruses, bacteriophages, archaea, and fungi in the human gut that interact in complex ways, not all of them beneficial.

The FDA has not enforced regulations that would prohibit the procedure, but in March, it warned about infections with enteropathogenic Escherichia coli and Shiga toxin–producing E. coli following fecal transplants.

As a result of these reports, and the theoretical risk of spreading SARS-CoV-2, OpenBiome, the largest stool bank in the United States, has suspended shipments except for emergency orders, and asked clinicians to quarantine any of its products they already have on hand.

In the meantime, long-term effects of the treatment have not been well documented. And clinical trials have excluded patients who might benefit, such as those who have been immunocompromised or have inflammatory bowel disease.
 

National registry follows patients outside clinical trials

To better understand how patients fare outside these trials, AGA and other organizations developed a national registry, funded by a grant from the National Institute of Allergy and Infectious Diseases.

The current report summarizes results on 259 patients enrolled between Dec. 5, 2017, and Sept. 2, 2019 at 20 sites.

At baseline, 44% of these patients suffered moderate and 36% mild C. diff infections. The duration of the diagnosis ranged from less than 1 week to 9 years, with a median duration of 20 weeks. They ranged from 1 to 15 episodes with a mean of 3.5.

Almost all had received vancomycin, and 62% had at least two courses. About 40% had received metronidazole and 28% had received fidaxomicin.

Almost all participants received stool from an unknown donor, mostly from stool banks, with OpenBiome accounting for 67%. About 85% of the transplants were administered through colonoscopy and 6% by upper endoscopy.

Out of 222 patients who returned for a 1-month follow-up, 90% met the investigators’ definition of cure: resolution of diarrhea without need for further anti–C. diff therapy. About 98% received only one transplant. An intent to treat analysis produced a cure rate of 86%.

Results were good in patients with comorbidities, including 12% who had irritable bowel syndrome, 9% who had ulcerative colitis, and 7% who had Crohn’s disease, Dr. Kelly said. “I hope everybody sees the importance of it. In these patients that are more complicated, who may have underlying comorbidities, who may not have been in the clinical trials, it looks effective in that group, and also incredibly safe.”

She added that the risk of transmitting SARS-CoV-2 is minor. “I think it would be a very, very unlikely way for someone to get a respiratory pathogen.”

Of the 112 participants who were cured at 1 month and returned for follow-up after 6 months, 4 developed recurrent C. diff infection. Eleven patients who were not cured in the first month returned after 6 months. Of these, seven were reported cured at this later follow-up.

Three complications occurred as result of the procedure: one colonoscopic perforation and two episodes of gastrointestinal bleeding.

About 45% of participants reported at least one symptom, with diarrhea not related to C. difficile the most common, followed by abdominal pain, bloating, and constipation.

Eleven patients suffered infections, including two which the investigators thought might be related to the procedure: Bacteroides fragilis in one participant with severe diarrhea, and enteropathogenic E. coli in another with loose stools. Other infections included four urinary tract infections, three cases of pneumonia, one E. coli bacteremia and one tooth infection.

Within a month of the procedure, 27 patients were hospitalized, with 3 of these cases considered possibly related to the procedure.
 

Findings may not apply to all clinical settings

Vincent B. Young, MD, PhD, a professor of medicine and infectious diseases at the University of Michigan, Ann Arbor, pointed out that the findings might not apply to all clinical settings. The participating clinicians were almost all gastroenterologists working in academic centers.

“Most of them are not Joe Doctor at the doctor’s office,” said Dr. Young, who was not involved with the study. Clinicians in other specialties, such as infectious diseases, might be more inclined to administer fecal transplants through capsules rather than colonoscopies.

And he added that the study does not address effects of the transplant that might develop over years. “Some people talk about how changes in the microbiota lead to increased risk for long-term complications, things like cancer or heart disease. You’re not going to see those in 6 months.”

Also, the study didn’t yield any findings on indications other than C. diff. “In no way, shape, or form does it mean you can use it for autism, depression, heart disease, or [irritable bowel syndrome],” he said.

Still, he said, the study “confirms the fact that fecal cell transplantation is an effective treatment for recurrent C. diff infection when administered as they administered it.”

The National Institute of Allergy and Infectious Diseases funded the registry. Dr. Kelly reported a relationship with Finch Therapeutics. Dr. Young reports financial relationships with Vedanta Biosciences and Bio-K+.

This story was updated on Oct. 4, 2020.

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

Fecal microbiota transplantation (FMT) appears safe and effective as a treatment for most Clostridioides difficile infections as it is currently being administered, researchers say.

“We actually didn’t see any infections that were definitely transmissible via fecal transplant,” Colleen Kelly, MD, an associate professor of medicine at Brown University, Providence, R.I., said in an interview.

The findings, published online Oct. 1 in the journal Gastroenterology, come from the American Gastroenterological Association (AGA) NIH-funded FMT National Registry and could allay concerns about a treatment that has yet to gain full approval by the Food and Drug Administration, despite successful clinical trials.

C. diff infections are common and increasing in the United States, often can’t be cured with conventional treatments such as antibiotics, and can be deadly.

Transplanting fecal matter from a donor to the patient appears to work by restoring beneficial microorganisms to the patient’s gut. The procedure is also under investigation for a wide range of other ailments, from irritable bowel syndrome to mood disorders.

But much remains unknown. Researchers have counted a thousand bacterial species along with viruses, bacteriophages, archaea, and fungi in the human gut that interact in complex ways, not all of them beneficial.

The FDA has not enforced regulations that would prohibit the procedure, but in March, it warned about infections with enteropathogenic Escherichia coli and Shiga toxin–producing E. coli following fecal transplants.

As a result of these reports, and the theoretical risk of spreading SARS-CoV-2, OpenBiome, the largest stool bank in the United States, has suspended shipments except for emergency orders, and asked clinicians to quarantine any of its products they already have on hand.

In the meantime, long-term effects of the treatment have not been well documented. And clinical trials have excluded patients who might benefit, such as those who have been immunocompromised or have inflammatory bowel disease.
 

National registry follows patients outside clinical trials

To better understand how patients fare outside these trials, AGA and other organizations developed a national registry, funded by a grant from the National Institute of Allergy and Infectious Diseases.

The current report summarizes results on 259 patients enrolled between Dec. 5, 2017, and Sept. 2, 2019 at 20 sites.

At baseline, 44% of these patients suffered moderate and 36% mild C. diff infections. The duration of the diagnosis ranged from less than 1 week to 9 years, with a median duration of 20 weeks. They ranged from 1 to 15 episodes with a mean of 3.5.

Almost all had received vancomycin, and 62% had at least two courses. About 40% had received metronidazole and 28% had received fidaxomicin.

Almost all participants received stool from an unknown donor, mostly from stool banks, with OpenBiome accounting for 67%. About 85% of the transplants were administered through colonoscopy and 6% by upper endoscopy.

Out of 222 patients who returned for a 1-month follow-up, 90% met the investigators’ definition of cure: resolution of diarrhea without need for further anti–C. diff therapy. About 98% received only one transplant. An intent to treat analysis produced a cure rate of 86%.

Results were good in patients with comorbidities, including 12% who had irritable bowel syndrome, 9% who had ulcerative colitis, and 7% who had Crohn’s disease, Dr. Kelly said. “I hope everybody sees the importance of it. In these patients that are more complicated, who may have underlying comorbidities, who may not have been in the clinical trials, it looks effective in that group, and also incredibly safe.”

She added that the risk of transmitting SARS-CoV-2 is minor. “I think it would be a very, very unlikely way for someone to get a respiratory pathogen.”

Of the 112 participants who were cured at 1 month and returned for follow-up after 6 months, 4 developed recurrent C. diff infection. Eleven patients who were not cured in the first month returned after 6 months. Of these, seven were reported cured at this later follow-up.

Three complications occurred as result of the procedure: one colonoscopic perforation and two episodes of gastrointestinal bleeding.

About 45% of participants reported at least one symptom, with diarrhea not related to C. difficile the most common, followed by abdominal pain, bloating, and constipation.

Eleven patients suffered infections, including two which the investigators thought might be related to the procedure: Bacteroides fragilis in one participant with severe diarrhea, and enteropathogenic E. coli in another with loose stools. Other infections included four urinary tract infections, three cases of pneumonia, one E. coli bacteremia and one tooth infection.

Within a month of the procedure, 27 patients were hospitalized, with 3 of these cases considered possibly related to the procedure.
 

Findings may not apply to all clinical settings

Vincent B. Young, MD, PhD, a professor of medicine and infectious diseases at the University of Michigan, Ann Arbor, pointed out that the findings might not apply to all clinical settings. The participating clinicians were almost all gastroenterologists working in academic centers.

“Most of them are not Joe Doctor at the doctor’s office,” said Dr. Young, who was not involved with the study. Clinicians in other specialties, such as infectious diseases, might be more inclined to administer fecal transplants through capsules rather than colonoscopies.

And he added that the study does not address effects of the transplant that might develop over years. “Some people talk about how changes in the microbiota lead to increased risk for long-term complications, things like cancer or heart disease. You’re not going to see those in 6 months.”

Also, the study didn’t yield any findings on indications other than C. diff. “In no way, shape, or form does it mean you can use it for autism, depression, heart disease, or [irritable bowel syndrome],” he said.

Still, he said, the study “confirms the fact that fecal cell transplantation is an effective treatment for recurrent C. diff infection when administered as they administered it.”

The National Institute of Allergy and Infectious Diseases funded the registry. Dr. Kelly reported a relationship with Finch Therapeutics. Dr. Young reports financial relationships with Vedanta Biosciences and Bio-K+.

This story was updated on Oct. 4, 2020.

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

Fecal microbiota transplantation (FMT) appears safe and effective as a treatment for most Clostridioides difficile infections as it is currently being administered, researchers say.

“We actually didn’t see any infections that were definitely transmissible via fecal transplant,” Colleen Kelly, MD, an associate professor of medicine at Brown University, Providence, R.I., said in an interview.

The findings, published online Oct. 1 in the journal Gastroenterology, come from the American Gastroenterological Association (AGA) NIH-funded FMT National Registry and could allay concerns about a treatment that has yet to gain full approval by the Food and Drug Administration, despite successful clinical trials.

C. diff infections are common and increasing in the United States, often can’t be cured with conventional treatments such as antibiotics, and can be deadly.

Transplanting fecal matter from a donor to the patient appears to work by restoring beneficial microorganisms to the patient’s gut. The procedure is also under investigation for a wide range of other ailments, from irritable bowel syndrome to mood disorders.

But much remains unknown. Researchers have counted a thousand bacterial species along with viruses, bacteriophages, archaea, and fungi in the human gut that interact in complex ways, not all of them beneficial.

The FDA has not enforced regulations that would prohibit the procedure, but in March, it warned about infections with enteropathogenic Escherichia coli and Shiga toxin–producing E. coli following fecal transplants.

As a result of these reports, and the theoretical risk of spreading SARS-CoV-2, OpenBiome, the largest stool bank in the United States, has suspended shipments except for emergency orders, and asked clinicians to quarantine any of its products they already have on hand.

In the meantime, long-term effects of the treatment have not been well documented. And clinical trials have excluded patients who might benefit, such as those who have been immunocompromised or have inflammatory bowel disease.
 

National registry follows patients outside clinical trials

To better understand how patients fare outside these trials, AGA and other organizations developed a national registry, funded by a grant from the National Institute of Allergy and Infectious Diseases.

The current report summarizes results on 259 patients enrolled between Dec. 5, 2017, and Sept. 2, 2019 at 20 sites.

At baseline, 44% of these patients suffered moderate and 36% mild C. diff infections. The duration of the diagnosis ranged from less than 1 week to 9 years, with a median duration of 20 weeks. They ranged from 1 to 15 episodes with a mean of 3.5.

Almost all had received vancomycin, and 62% had at least two courses. About 40% had received metronidazole and 28% had received fidaxomicin.

Almost all participants received stool from an unknown donor, mostly from stool banks, with OpenBiome accounting for 67%. About 85% of the transplants were administered through colonoscopy and 6% by upper endoscopy.

Out of 222 patients who returned for a 1-month follow-up, 90% met the investigators’ definition of cure: resolution of diarrhea without need for further anti–C. diff therapy. About 98% received only one transplant. An intent to treat analysis produced a cure rate of 86%.

Results were good in patients with comorbidities, including 12% who had irritable bowel syndrome, 9% who had ulcerative colitis, and 7% who had Crohn’s disease, Dr. Kelly said. “I hope everybody sees the importance of it. In these patients that are more complicated, who may have underlying comorbidities, who may not have been in the clinical trials, it looks effective in that group, and also incredibly safe.”

She added that the risk of transmitting SARS-CoV-2 is minor. “I think it would be a very, very unlikely way for someone to get a respiratory pathogen.”

Of the 112 participants who were cured at 1 month and returned for follow-up after 6 months, 4 developed recurrent C. diff infection. Eleven patients who were not cured in the first month returned after 6 months. Of these, seven were reported cured at this later follow-up.

Three complications occurred as result of the procedure: one colonoscopic perforation and two episodes of gastrointestinal bleeding.

About 45% of participants reported at least one symptom, with diarrhea not related to C. difficile the most common, followed by abdominal pain, bloating, and constipation.

Eleven patients suffered infections, including two which the investigators thought might be related to the procedure: Bacteroides fragilis in one participant with severe diarrhea, and enteropathogenic E. coli in another with loose stools. Other infections included four urinary tract infections, three cases of pneumonia, one E. coli bacteremia and one tooth infection.

Within a month of the procedure, 27 patients were hospitalized, with 3 of these cases considered possibly related to the procedure.
 

Findings may not apply to all clinical settings

Vincent B. Young, MD, PhD, a professor of medicine and infectious diseases at the University of Michigan, Ann Arbor, pointed out that the findings might not apply to all clinical settings. The participating clinicians were almost all gastroenterologists working in academic centers.

“Most of them are not Joe Doctor at the doctor’s office,” said Dr. Young, who was not involved with the study. Clinicians in other specialties, such as infectious diseases, might be more inclined to administer fecal transplants through capsules rather than colonoscopies.

And he added that the study does not address effects of the transplant that might develop over years. “Some people talk about how changes in the microbiota lead to increased risk for long-term complications, things like cancer or heart disease. You’re not going to see those in 6 months.”

Also, the study didn’t yield any findings on indications other than C. diff. “In no way, shape, or form does it mean you can use it for autism, depression, heart disease, or [irritable bowel syndrome],” he said.

Still, he said, the study “confirms the fact that fecal cell transplantation is an effective treatment for recurrent C. diff infection when administered as they administered it.”

The National Institute of Allergy and Infectious Diseases funded the registry. Dr. Kelly reported a relationship with Finch Therapeutics. Dr. Young reports financial relationships with Vedanta Biosciences and Bio-K+.

This story was updated on Oct. 4, 2020.

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

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

U.S. regulators eventually could safely approve vaccines for COVID-19 if the process is kept free of political pressure regarding time lines, study protocols, and safety standards, expert witnesses told a House panel investigating the process on Wednesday.

The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.

FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.

“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.

“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”

Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.

“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.

President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.

In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.

Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.

In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.

In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
 

Pushback on politics

Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.

“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”

Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.

Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.

Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.

“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.

Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.

“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.

Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.

COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.

Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
 

Debate on approaches for vaccine effectiveness

In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.

Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”

“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”

There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.

“Do you agree with those concerns? And either way, tell me why,” Griffith asked.

“I don’t agree,” Offit responded.

“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”

But other researchers also question the approaches used with the current crop of COVID-19 vaccines.

“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.

He fears consumers will not get what they might expect from the vaccines being tested.

“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.

This article first appeared on Medscape.com.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Clarence Troutman survived a 2-month hospital stay with COVID-19, then went home in early June. But he’s far from over the disease, still suffering from limited endurance, shortness of breath and hands that can be stiff and swollen.

“Before COVID, I was a 59-year-old, relatively healthy man,” said the broadband technician from Denver. “If I had to say where I’m at now, I’d say about 50% of where I was, but when I first went home, I was at 20%.”

He credits much of his progress to the “motivation and education” gleaned from a new program for post-COVID patients at the University of Colorado at Denver, Aurora, one of a small but growing number of clinics aimed at treating and studying those who have had the unpredictable coronavirus.

As the election nears, much attention is focused on daily infection numbers or the climbing death toll, but another measure matters: Patients who survive but continue to wrestle with a range of physical or mental effects, including lung damage, heart or neurologic concerns, anxiety, and depression.

“We need to think about how we’re going to provide care for patients who may be recovering for years after the virus,” said Sarah Jolley, MD, a pulmonologist with UCHealth University of Colorado Hospital and director of UCHealth’s Post-Covid Clinic, where Mr. Troutman is seen.

That need has jump-started post-COVID clinics, which bring together a range of specialists into a one-stop shop.

One of the first and largest such clinics is at Mount Sinai in New York City, but programs have also launched at the University of California,San Francisco; Stanford (Calif.) University Medical Center; and the University of Pennsylvania, Philadelphia. The Cleveland Clinic plans to open one early next year. And it’s not just academic medical centers: St. John’s Well Child and Family Center, part of a network of community clinics in south central Los Angeles, said this month it aims to test thousands of its patients who were diagnosed with COVID-19 since March for long-term effects.

The general idea is to bring together medical professionals across a broad spectrum, including physicians who specialize in lung disorders, heart issues, and brain and spinal cord problems. Mental health specialists are also involved, along with social workers and pharmacists. Many of the centers also do research studies, aiming to better understand why the virus hits certain patients so hard.

“Some of our patients, even those on a ventilator on death’s door, will come out remarkably unscathed,” said Lekshmi Santhosh, MD, an assistant professor of pulmonary critical care and a leader of the post-COVID program at UCSF, called the OPTIMAL clinic. “Others, even those who were never hospitalized, have disabling fatigue, ongoing chest pain, and shortness of breath, and there’s a whole spectrum in between.”
 

‘Staggering’ medical need

It’s too early to know how long the persistent medical effects and symptoms will linger, or to make accurate estimates on the percentage of patients affected.

Some early studies are sobering. An Austrian report released this month found that 76 of the first 86 patients studied had evidence of lung damage 6 weeks after hospital discharge, but that dropped to 48 patients at 12 weeks.

Some researchers and clinics say about 10% of U.S. COVID patients they see may have longer-running effects, said Zijian Chen, MD, medical director of the Center for Post-COVID Care at Mount Sinai, which has enrolled 400 patients so far.

If that estimate is correct – and Dr. Chen emphasized that more research is needed to make sure – it translates to patients entering the medical system in droves, often with multiple issues.

How health systems and insurers respond will be key, he said. More than 6.5 million U.S. residents have tested positive for the disease. If fewer than 10% – say 500,000 – already have long-lasting symptoms, “that number is staggering,” Dr. Chen said. “How much medical care will be needed for that?”

Though start-up costs could be a hurdle, the clinics themselves may eventually draw much-needed revenue to medical centers by attracting patients, many of whom have insurance to cover some or all of the cost of repeated visits.

Dr. Chen said the specialized centers can help lower health spending by providing more cost effective, coordinated care that avoids duplicative testing a patient might otherwise undergo.

“We’ve seen patients that when they come in, they’ve already had four MRI or CT scans and a stack of bloodwork,” he said.

The program consolidates those earlier results and determines if any additional testing is needed. Sometimes the answer to what’s causing patients’ long-lasting symptoms remains elusive. One problem for patients seeking help outside of dedicated clinics is that when there is no clear cause for their condition, they may be told the symptoms are imagined.

“I believe in the patients,” said Dr. Chen.

About half the clinic’s patients have received test results showing damage, said Dr. Chen, an endocrinologist and internal medicine physician. For those patients, the clinic can develop a treatment plan. But, frustratingly, the other half have inconclusive test results yet exhibit a range of symptoms.

“That makes it more difficult to treat,” said Dr. Chen.

Experts see parallels to a push in the past decade to establish special clinics to treat patients released from ICU wards, who may have problems related to long-term bed rest or the delirium many experience while hospitalized. Some of the current post-COVID clinics are modeled after the post-ICU clinics or are expanded versions of them.

The ICU Recovery Center at Vanderbilt University Medical Center, Nashville, Tenn., for instance, which opened in 2012, is accepting post-COVID patients.

There are about a dozen post-ICU clinics nationally, some of which are also now working with COVID patients, said James Jackson, director of long-term outcomes at the Vanderbilt center. In addition, he’s heard of at least another dozen post-COVID centers in development.

The centers generally do an initial assessment a few weeks after a patient is diagnosed or discharged from the hospital, often by video call. Check-in and repeat visits are scheduled every month or so after that.

“In an ideal world, with these post-COVID clinics, you can identify the patients and get them into rehab,” he said. “Even if the primary thing these clinics did was to say to patients: ‘This is real, it is not all in your head,’ that impact would be important.”
 

A question of feasibility

Financing is the largest obstacle, program proponents said. Many hospitals lost substantial revenue to canceled elective procedures during stay-at-home periods.

“So, it’s not a great time to be pitching a new activity that requires a start-up subsidy,” said Glenn Melnick, PhD, a professor of health economics at the University of Southern California.

At UCSF, a select group of faculty members staff the post-COVID clinics and some mental health professionals volunteer their time, said Dr. Santhosh.

Dr. Chen said he was able to recruit team members and support staff from the ranks of those whose elective patient caseload had dropped.

Dr. Jackson said unfortunately there’s not been enough research into the cost-and-clinical effectiveness of post-ICU centers.

“In the early days, there may have been questions about how much value does this add,” he noted. “Now, the question is not so much is it a good idea, but is it feasible?”

Right now, the post-COVID centers are foremost a research effort, said Len Nichols, an economist and nonresident fellow at the Urban Institute. “If these guys get good at treating long-term symptoms, that’s good for all of us. There’s not enough patients to make it a business model yet, but if they become the place to go when you get it, it could become a business model for some of the elite institutions.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.