Pediatric News

In patients with pediatric-onset multiple sclerosis (MS), increased abundance of Blautia stercoris and its variants in the gut is associated with an increased risk of relapse. No broad differences in gut bacterial composition, however, are associated with risk of relapse, according to the investigators. The findings were presented at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS–ACTRIMS) 2020, this year known as MSVirtual2020.

Previous research has found an association between Blautia stercoris and disease activity in other immune-mediated diseases such as systemic lupus. Although the current study is the largest in patients with MS that includes data about the microbiome and relapses, its findings require replication, said Mary Horton, a doctoral candidate in epidemiology at the University of California, Berkeley.

Gut microbes digest food, produce vitamins (for example, B12 and K), create a barrier against pathogens, and regulate the immune system, among other tasks. Most current knowledge about the gut microbiome in MS comes from studies of patients with adult-onset MS. In 2016, Tremlett et al. found an increase in Desulfovibrionaceae and a decrease in Lachnospiraceae and Ruminococcaceae in patients with pediatric-onset MS. They also found that a decrease in Fusobacteria was associated with risk of relapse in this population.
 

Advanced analytical methods

Using a larger sample size and newer analytical methods than in the study by Tremlett and colleagues, Ms. Horton’s group sought to determine whether features of the gut microbiome are associated with relapse. From 2014 to 2018, the investigators recruited 53 patients with pediatric-onset MS from the University of California, San Francisco, and six centers in the U.S. Network of Pediatric MS Centers. At baseline, they collected stool samples, blood samples, information about past relapses, medication records, demographics, and environmental factors. At each relapse, the investigators collected information about the patient’s current and past medication use and about relapses that the patient had had since the previous visit.

Ms. Horton and colleagues analyzed the stool samples using 16S rRNA sequencing of the V4 region. They identified amplicon sequence variants (ASVs), which are used to define species of bacteria, with the Divisive Amplicon Denoising Algorithm-2 (DADA2). Taxonomies were assigned using the naive Bayesian classifier method, and the read count was normalized using multiple rarefaction.

The investigators identified ASV clusters using weighted genetic correlation network analysis (WGCNA). To evaluate whether individual ASVs were associated with relapse, they used a Prentice, Williams, and Peterson (PWP) recurrent event model, an extension of the Cox proportional hazards model.
 

The role of methanogenesis

Ms. Horton and colleagues included 53 patients (72% girls) in their study. The population’s mean age was 14.3 years at disease onset and 15.5 years at stool sample collection. About 70% of patients were White, and about 36% were Hispanic. Mean disease duration was 1.3 years, and median Expanded Disability Status Scale score was 1.0.

Approximately 45% of participants had one relapse, and 30% had more than one relapse during the subsequent mean follow-up of 2.5 years. About 91% of patients used a disease-modifying therapy during follow-up.

Gut bacterial abundance was broadly similar between patients who relapsed during the study period and those who did not. Of 270 ASVs included in the analyses, 20 were nominally associated with risk of relapse. Blautia stercoris had the most significant association with relapse risk (hazard ratio, 2.50). Blautia massiliensis also was among the 20 ASVs associated with risk of relapse.

WGCNA identified six ASV clusters. Higher values of one cluster’s eigengene were significantly associated with higher relapse risk (HR, 1.23). The following four ASVs nominally associated with higher relapse risk were in this cluster: Blautia massiliensis, Dorea longicatena, Coprococcus comes, and an unknown species in genus Subdoligranulum.

When Ms. Horton and colleagues examined the pathways from these bacterial species, they found 10 that were significantly associated with the risk of relapse. Four of these 10 pathways are involved in methane production, which suggests the involvement of methanogenesis pathways in relapse.

Although the investigators used advanced techniques for genetic and statistical analysis, the study’s sample size is small, Ms. Horton acknowledged. In addition, the conclusions that can be drawn from observational data are limited.

These suggest several avenues for future research. “There is a big question about how the different treatments that people are on when they are experiencing relapses might impact the microbiome,” said Ms. Horton. “Is the microbiome impacting your treatment response, or is it the reverse?” Investigators also could examine why the methane production pathway is overrepresented among people with MS who have relapses. “Which specific archaea might be leading to that increase in methane is a ripe future study question. Just what that means for health is really unknown.”

The National MS Society and the National Institute of Neurological Disorders and Stroke provided funding for the study. Ms. Horton had no disclosures.

egreb@mdedge.com

SOURCE: Horton M et al. MSVirtual2020, Abstract LB01.05.

In patients with pediatric-onset multiple sclerosis (MS), increased abundance of Blautia stercoris and its variants in the gut is associated with an increased risk of relapse. No broad differences in gut bacterial composition, however, are associated with risk of relapse, according to the investigators. The findings were presented at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS–ACTRIMS) 2020, this year known as MSVirtual2020.

Previous research has found an association between Blautia stercoris and disease activity in other immune-mediated diseases such as systemic lupus. Although the current study is the largest in patients with MS that includes data about the microbiome and relapses, its findings require replication, said Mary Horton, a doctoral candidate in epidemiology at the University of California, Berkeley.

Gut microbes digest food, produce vitamins (for example, B12 and K), create a barrier against pathogens, and regulate the immune system, among other tasks. Most current knowledge about the gut microbiome in MS comes from studies of patients with adult-onset MS. In 2016, Tremlett et al. found an increase in Desulfovibrionaceae and a decrease in Lachnospiraceae and Ruminococcaceae in patients with pediatric-onset MS. They also found that a decrease in Fusobacteria was associated with risk of relapse in this population.
 

Advanced analytical methods

Using a larger sample size and newer analytical methods than in the study by Tremlett and colleagues, Ms. Horton’s group sought to determine whether features of the gut microbiome are associated with relapse. From 2014 to 2018, the investigators recruited 53 patients with pediatric-onset MS from the University of California, San Francisco, and six centers in the U.S. Network of Pediatric MS Centers. At baseline, they collected stool samples, blood samples, information about past relapses, medication records, demographics, and environmental factors. At each relapse, the investigators collected information about the patient’s current and past medication use and about relapses that the patient had had since the previous visit.

Ms. Horton and colleagues analyzed the stool samples using 16S rRNA sequencing of the V4 region. They identified amplicon sequence variants (ASVs), which are used to define species of bacteria, with the Divisive Amplicon Denoising Algorithm-2 (DADA2). Taxonomies were assigned using the naive Bayesian classifier method, and the read count was normalized using multiple rarefaction.

The investigators identified ASV clusters using weighted genetic correlation network analysis (WGCNA). To evaluate whether individual ASVs were associated with relapse, they used a Prentice, Williams, and Peterson (PWP) recurrent event model, an extension of the Cox proportional hazards model.
 

The role of methanogenesis

Ms. Horton and colleagues included 53 patients (72% girls) in their study. The population’s mean age was 14.3 years at disease onset and 15.5 years at stool sample collection. About 70% of patients were White, and about 36% were Hispanic. Mean disease duration was 1.3 years, and median Expanded Disability Status Scale score was 1.0.

Approximately 45% of participants had one relapse, and 30% had more than one relapse during the subsequent mean follow-up of 2.5 years. About 91% of patients used a disease-modifying therapy during follow-up.

Gut bacterial abundance was broadly similar between patients who relapsed during the study period and those who did not. Of 270 ASVs included in the analyses, 20 were nominally associated with risk of relapse. Blautia stercoris had the most significant association with relapse risk (hazard ratio, 2.50). Blautia massiliensis also was among the 20 ASVs associated with risk of relapse.

WGCNA identified six ASV clusters. Higher values of one cluster’s eigengene were significantly associated with higher relapse risk (HR, 1.23). The following four ASVs nominally associated with higher relapse risk were in this cluster: Blautia massiliensis, Dorea longicatena, Coprococcus comes, and an unknown species in genus Subdoligranulum.

When Ms. Horton and colleagues examined the pathways from these bacterial species, they found 10 that were significantly associated with the risk of relapse. Four of these 10 pathways are involved in methane production, which suggests the involvement of methanogenesis pathways in relapse.

Although the investigators used advanced techniques for genetic and statistical analysis, the study’s sample size is small, Ms. Horton acknowledged. In addition, the conclusions that can be drawn from observational data are limited.

These suggest several avenues for future research. “There is a big question about how the different treatments that people are on when they are experiencing relapses might impact the microbiome,” said Ms. Horton. “Is the microbiome impacting your treatment response, or is it the reverse?” Investigators also could examine why the methane production pathway is overrepresented among people with MS who have relapses. “Which specific archaea might be leading to that increase in methane is a ripe future study question. Just what that means for health is really unknown.”

The National MS Society and the National Institute of Neurological Disorders and Stroke provided funding for the study. Ms. Horton had no disclosures.

egreb@mdedge.com

SOURCE: Horton M et al. MSVirtual2020, Abstract LB01.05.

In patients with pediatric-onset multiple sclerosis (MS), increased abundance of Blautia stercoris and its variants in the gut is associated with an increased risk of relapse. No broad differences in gut bacterial composition, however, are associated with risk of relapse, according to the investigators. The findings were presented at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS–ACTRIMS) 2020, this year known as MSVirtual2020.

Previous research has found an association between Blautia stercoris and disease activity in other immune-mediated diseases such as systemic lupus. Although the current study is the largest in patients with MS that includes data about the microbiome and relapses, its findings require replication, said Mary Horton, a doctoral candidate in epidemiology at the University of California, Berkeley.

Gut microbes digest food, produce vitamins (for example, B12 and K), create a barrier against pathogens, and regulate the immune system, among other tasks. Most current knowledge about the gut microbiome in MS comes from studies of patients with adult-onset MS. In 2016, Tremlett et al. found an increase in Desulfovibrionaceae and a decrease in Lachnospiraceae and Ruminococcaceae in patients with pediatric-onset MS. They also found that a decrease in Fusobacteria was associated with risk of relapse in this population.
 

Advanced analytical methods

Using a larger sample size and newer analytical methods than in the study by Tremlett and colleagues, Ms. Horton’s group sought to determine whether features of the gut microbiome are associated with relapse. From 2014 to 2018, the investigators recruited 53 patients with pediatric-onset MS from the University of California, San Francisco, and six centers in the U.S. Network of Pediatric MS Centers. At baseline, they collected stool samples, blood samples, information about past relapses, medication records, demographics, and environmental factors. At each relapse, the investigators collected information about the patient’s current and past medication use and about relapses that the patient had had since the previous visit.

Ms. Horton and colleagues analyzed the stool samples using 16S rRNA sequencing of the V4 region. They identified amplicon sequence variants (ASVs), which are used to define species of bacteria, with the Divisive Amplicon Denoising Algorithm-2 (DADA2). Taxonomies were assigned using the naive Bayesian classifier method, and the read count was normalized using multiple rarefaction.

The investigators identified ASV clusters using weighted genetic correlation network analysis (WGCNA). To evaluate whether individual ASVs were associated with relapse, they used a Prentice, Williams, and Peterson (PWP) recurrent event model, an extension of the Cox proportional hazards model.
 

The role of methanogenesis

Ms. Horton and colleagues included 53 patients (72% girls) in their study. The population’s mean age was 14.3 years at disease onset and 15.5 years at stool sample collection. About 70% of patients were White, and about 36% were Hispanic. Mean disease duration was 1.3 years, and median Expanded Disability Status Scale score was 1.0.

Approximately 45% of participants had one relapse, and 30% had more than one relapse during the subsequent mean follow-up of 2.5 years. About 91% of patients used a disease-modifying therapy during follow-up.

Gut bacterial abundance was broadly similar between patients who relapsed during the study period and those who did not. Of 270 ASVs included in the analyses, 20 were nominally associated with risk of relapse. Blautia stercoris had the most significant association with relapse risk (hazard ratio, 2.50). Blautia massiliensis also was among the 20 ASVs associated with risk of relapse.

WGCNA identified six ASV clusters. Higher values of one cluster’s eigengene were significantly associated with higher relapse risk (HR, 1.23). The following four ASVs nominally associated with higher relapse risk were in this cluster: Blautia massiliensis, Dorea longicatena, Coprococcus comes, and an unknown species in genus Subdoligranulum.

When Ms. Horton and colleagues examined the pathways from these bacterial species, they found 10 that were significantly associated with the risk of relapse. Four of these 10 pathways are involved in methane production, which suggests the involvement of methanogenesis pathways in relapse.

Although the investigators used advanced techniques for genetic and statistical analysis, the study’s sample size is small, Ms. Horton acknowledged. In addition, the conclusions that can be drawn from observational data are limited.

These suggest several avenues for future research. “There is a big question about how the different treatments that people are on when they are experiencing relapses might impact the microbiome,” said Ms. Horton. “Is the microbiome impacting your treatment response, or is it the reverse?” Investigators also could examine why the methane production pathway is overrepresented among people with MS who have relapses. “Which specific archaea might be leading to that increase in methane is a ripe future study question. Just what that means for health is really unknown.”

The National MS Society and the National Institute of Neurological Disorders and Stroke provided funding for the study. Ms. Horton had no disclosures.

egreb@mdedge.com

SOURCE: Horton M et al. MSVirtual2020, Abstract LB01.05.

In the opinion of Lawrence F. Eichenfield, MD, recent advances in the medical treatment of acne make it “an exciting time” for treating patients with the condition.

During the virtual annual Masters of Aesthetics Symposium, he highlighted the following new acne treatment options:

• Trifarotene cream 0.005% (Aklief). This marks the first new retinoid indicated for acne in several decades. It is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older and has been studied in acne of the face, chest, and back. “It’s nice to have in our armamentarium,” he said.
• Tazarotene lotion 0.045% (Arazlo). The 0.1% formulation of tazarotene is commonly used for acne, but it can cause skin irritation, dryness, and erythema. The new 0.045% formulation was developed in a three-dimensional mesh matrix, with ingredients from an oil-in-water emulsion. “This allows for graduated dosing on the skin without as much irritation,” said Dr. Eichenfield, who is chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.
• Minocycline 4% topical foam (Amzeeq). This marks the first and only topical minocycline prescription treatment for acne. “Its hydrophobic composition allows for stable and efficient delivery of inherently unstable pharmaceutical ingredients,” he said. “There is no evidence of photosensitivity as you’d expect from a minocycline-based product, and there are low systemic levels compared with oral minocycline.”
• Clascoterone cream 1% (Winlevi). This first-in-class topical androgen receptor inhibitor has been approved for the treatment of acne in patients 12 years and older. It competes with dihydrotestosterone and selectively targets androgen receptors in sebocytes and hair papilla cells. “It has been studied on the face and trunk and has been shown to inhibit sebum production, reduce secretion of inflammatory cytokines, and inhibit inflammatory pathways,” said Dr. Eichenfield, who is also professor of dermatology and pediatrics at the University of California, San Diego.
• From a systemic standpoint, sarecycline, a new tetracycline class antibiotic, has been approved for the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris in patients 9 years and older. The once-daily drug can be taken with or without food in a weight-based dose. “This medicine appears to have a narrow spectrum of antibacterial activity compared with other tetracyclines,” he said. “It may have less of a negative effect on gut microbiome than traditional oral antibiotics.”

As for integrating these new options into existing clinical practice, Dr. Eichenfield predicts that the general approach to acne treatment will remain the same. “We’ll have to wait to see where the topical androgens fit into the treatment algorithms,” he said. “Our goal is to minimize scarring, minimize disease, and to modulate the disease course.”

Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Foamix, Galderma, L’Oreal, and Ortho Dermatologics.

dbrunk@mdedge.com

In the opinion of Lawrence F. Eichenfield, MD, recent advances in the medical treatment of acne make it “an exciting time” for treating patients with the condition.

During the virtual annual Masters of Aesthetics Symposium, he highlighted the following new acne treatment options:

• Trifarotene cream 0.005% (Aklief). This marks the first new retinoid indicated for acne in several decades. It is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older and has been studied in acne of the face, chest, and back. “It’s nice to have in our armamentarium,” he said.
• Tazarotene lotion 0.045% (Arazlo). The 0.1% formulation of tazarotene is commonly used for acne, but it can cause skin irritation, dryness, and erythema. The new 0.045% formulation was developed in a three-dimensional mesh matrix, with ingredients from an oil-in-water emulsion. “This allows for graduated dosing on the skin without as much irritation,” said Dr. Eichenfield, who is chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.
• Minocycline 4% topical foam (Amzeeq). This marks the first and only topical minocycline prescription treatment for acne. “Its hydrophobic composition allows for stable and efficient delivery of inherently unstable pharmaceutical ingredients,” he said. “There is no evidence of photosensitivity as you’d expect from a minocycline-based product, and there are low systemic levels compared with oral minocycline.”
• Clascoterone cream 1% (Winlevi). This first-in-class topical androgen receptor inhibitor has been approved for the treatment of acne in patients 12 years and older. It competes with dihydrotestosterone and selectively targets androgen receptors in sebocytes and hair papilla cells. “It has been studied on the face and trunk and has been shown to inhibit sebum production, reduce secretion of inflammatory cytokines, and inhibit inflammatory pathways,” said Dr. Eichenfield, who is also professor of dermatology and pediatrics at the University of California, San Diego.
• From a systemic standpoint, sarecycline, a new tetracycline class antibiotic, has been approved for the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris in patients 9 years and older. The once-daily drug can be taken with or without food in a weight-based dose. “This medicine appears to have a narrow spectrum of antibacterial activity compared with other tetracyclines,” he said. “It may have less of a negative effect on gut microbiome than traditional oral antibiotics.”

As for integrating these new options into existing clinical practice, Dr. Eichenfield predicts that the general approach to acne treatment will remain the same. “We’ll have to wait to see where the topical androgens fit into the treatment algorithms,” he said. “Our goal is to minimize scarring, minimize disease, and to modulate the disease course.”

Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Foamix, Galderma, L’Oreal, and Ortho Dermatologics.

dbrunk@mdedge.com

In the opinion of Lawrence F. Eichenfield, MD, recent advances in the medical treatment of acne make it “an exciting time” for treating patients with the condition.

During the virtual annual Masters of Aesthetics Symposium, he highlighted the following new acne treatment options:

• Trifarotene cream 0.005% (Aklief). This marks the first new retinoid indicated for acne in several decades. It is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older and has been studied in acne of the face, chest, and back. “It’s nice to have in our armamentarium,” he said.
• Tazarotene lotion 0.045% (Arazlo). The 0.1% formulation of tazarotene is commonly used for acne, but it can cause skin irritation, dryness, and erythema. The new 0.045% formulation was developed in a three-dimensional mesh matrix, with ingredients from an oil-in-water emulsion. “This allows for graduated dosing on the skin without as much irritation,” said Dr. Eichenfield, who is chief of pediatric and adolescent dermatology at Rady Children’s Hospital, San Diego.
• Minocycline 4% topical foam (Amzeeq). This marks the first and only topical minocycline prescription treatment for acne. “Its hydrophobic composition allows for stable and efficient delivery of inherently unstable pharmaceutical ingredients,” he said. “There is no evidence of photosensitivity as you’d expect from a minocycline-based product, and there are low systemic levels compared with oral minocycline.”
• Clascoterone cream 1% (Winlevi). This first-in-class topical androgen receptor inhibitor has been approved for the treatment of acne in patients 12 years and older. It competes with dihydrotestosterone and selectively targets androgen receptors in sebocytes and hair papilla cells. “It has been studied on the face and trunk and has been shown to inhibit sebum production, reduce secretion of inflammatory cytokines, and inhibit inflammatory pathways,” said Dr. Eichenfield, who is also professor of dermatology and pediatrics at the University of California, San Diego.
• From a systemic standpoint, sarecycline, a new tetracycline class antibiotic, has been approved for the treatment of inflammatory lesions of nonnodular moderate to severe acne vulgaris in patients 9 years and older. The once-daily drug can be taken with or without food in a weight-based dose. “This medicine appears to have a narrow spectrum of antibacterial activity compared with other tetracyclines,” he said. “It may have less of a negative effect on gut microbiome than traditional oral antibiotics.”

As for integrating these new options into existing clinical practice, Dr. Eichenfield predicts that the general approach to acne treatment will remain the same. “We’ll have to wait to see where the topical androgens fit into the treatment algorithms,” he said. “Our goal is to minimize scarring, minimize disease, and to modulate the disease course.”

Dr. Eichenfield disclosed that he has been an investigator and/or consultant for Almirall, Cassiopea, Dermata, Foamix, Galderma, L’Oreal, and Ortho Dermatologics.

dbrunk@mdedge.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.

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.

As the COVID-19 pandemic drove down the number of primary care visits and altered the method – moving many to telehealth appointments instead of in-person visits – the content of those appointments also changed, researchers reported in JAMA Network Open. Specifically, researchers found that preventive and chronic care for cardiovascular risk management dropped off during the first half of 2020 vs previous years.

For the study, G. Caleb Alexander, MD, from the Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, and colleagues analyzed data from the IQVIA National Disease and Therapeutic Index, a nationally representative audit of outpatient care in the United States, from the first quarter of 2018 through the second quarter of 2020.

Most primary care visits in 2018 and 2019 were office based, the authors noted. In the second quarter (Q2, April-May) of 2020, as the COVID-19 pandemic spread across the country, the total number of primary care encounters decreased by 21.4%, and the number of office visits dropped by 50.2%, compared with the average of visits during Q2 in 2018 and 2019.

At the same time, telemedicine visits increased from just 1.1% of total visits in Q2 of 2018 and 2019 to 4.1% of visits in the first quarter (January through March) of 2020 and to 35.3% of visits in Q2 of 2020.

The authors also found that the use of telemedicine in the first half of 2020 varied by geographical region and was not associated with the regional COVID-19 burden. In the Pacific region (Washington, Oregon, and California), 26.8% of encounters were virtual. By contrast, the proportion of telemedicine encounters accounted for only 15.1% of visits in the East North Central states (Wisconsin, Michigan, Illinois, Indiana, and Ohio).

Adults between the ages of 19 and 55 years were more likely to attend telemedicine visits than were those younger or older. Additionally, adults who were commercially insured were more likely to adopt telemedicine versus those with public or no insurance. The study did not find substantial differences in telemedicine use by payer type, nor evidence of a racial disparity between Black and White people in their use of telemedicine.
 

Drop-off in preventive and chronic care

During the second quarter of this year, the authors reported, the number of visits that included blood pressure assessments dropped by 50.1% and the number of visits in which cholesterol levels were assessed fell by 36.9%, compared with the Q2 of 2018 and 2019.

Visits in which providers prescribed new antihypertensive or cholesterol-lowering medications decreased by 26% in Q2 of 2020 versus the same periods in the previous 2 years. The number of visits in which such prescriptions were renewed dropped by 8.9%.

New treatments also decreased significantly in Q2 of 2020 for patients with chronic conditions, including hypertension, diabetes, high cholesterol, asthma, depression, and insomnia.

When the authors compared the content of telemedicine versus in-person visits in Q2 of 2020, they found a substantial difference. Blood pressure was assessed in 69.7% of office visits, compared with 9.6% of telemedicine. Similarly, cholesterol levels were evaluated in 21.6% of office visits versus 13.5% of telemedicine encounters. New medications were ordered in similar proportions of office-based and telemedicine visits.

The authors concluded that “the COVID-19 pandemic has been associated with changes in the structure of primary care delivery, with the content of telemedicine visits differing from that of office-based encounters.”

While limited in scope, the authors noted, their study is one of the first to evaluate the changes in the content of primary care visits during the pandemic. They attributed the decline in evaluations of cardiovascular risk factors such as blood pressure and cholesterol to “fewer total visits and less frequent assessments during telemedicine encounters.”

While pointing to the inherent limitations of telemedicine, the study did not mention the availability of digital home blood pressure cuffs or home cholesterol test kits. Both kinds of devices are available at consumer-friendly price points and can help people track their indicators, but they’re not considered a substitute for sphygmomanometers used in offices or conventional lab tests. It’s not known how many consumers with cardiovascular risk factors have this kind of home monitoring equipment or how many doctors look at this kind of data.

Dr. Alexander reported serving as a paid adviser to IQVIA; that he is a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and that he is a member of OptumRx’s National P&T Committee. One coauthor reported serving as an unpaid adviser to IQVIA and receiving personal fees from the states of California, Washington, and Alaska outside the submitted work. No other disclosures were reported.

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

As the COVID-19 pandemic drove down the number of primary care visits and altered the method – moving many to telehealth appointments instead of in-person visits – the content of those appointments also changed, researchers reported in JAMA Network Open. Specifically, researchers found that preventive and chronic care for cardiovascular risk management dropped off during the first half of 2020 vs previous years.

For the study, G. Caleb Alexander, MD, from the Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, and colleagues analyzed data from the IQVIA National Disease and Therapeutic Index, a nationally representative audit of outpatient care in the United States, from the first quarter of 2018 through the second quarter of 2020.

Most primary care visits in 2018 and 2019 were office based, the authors noted. In the second quarter (Q2, April-May) of 2020, as the COVID-19 pandemic spread across the country, the total number of primary care encounters decreased by 21.4%, and the number of office visits dropped by 50.2%, compared with the average of visits during Q2 in 2018 and 2019.

At the same time, telemedicine visits increased from just 1.1% of total visits in Q2 of 2018 and 2019 to 4.1% of visits in the first quarter (January through March) of 2020 and to 35.3% of visits in Q2 of 2020.

The authors also found that the use of telemedicine in the first half of 2020 varied by geographical region and was not associated with the regional COVID-19 burden. In the Pacific region (Washington, Oregon, and California), 26.8% of encounters were virtual. By contrast, the proportion of telemedicine encounters accounted for only 15.1% of visits in the East North Central states (Wisconsin, Michigan, Illinois, Indiana, and Ohio).

Adults between the ages of 19 and 55 years were more likely to attend telemedicine visits than were those younger or older. Additionally, adults who were commercially insured were more likely to adopt telemedicine versus those with public or no insurance. The study did not find substantial differences in telemedicine use by payer type, nor evidence of a racial disparity between Black and White people in their use of telemedicine.
 

Drop-off in preventive and chronic care

During the second quarter of this year, the authors reported, the number of visits that included blood pressure assessments dropped by 50.1% and the number of visits in which cholesterol levels were assessed fell by 36.9%, compared with the Q2 of 2018 and 2019.

Visits in which providers prescribed new antihypertensive or cholesterol-lowering medications decreased by 26% in Q2 of 2020 versus the same periods in the previous 2 years. The number of visits in which such prescriptions were renewed dropped by 8.9%.

New treatments also decreased significantly in Q2 of 2020 for patients with chronic conditions, including hypertension, diabetes, high cholesterol, asthma, depression, and insomnia.

When the authors compared the content of telemedicine versus in-person visits in Q2 of 2020, they found a substantial difference. Blood pressure was assessed in 69.7% of office visits, compared with 9.6% of telemedicine. Similarly, cholesterol levels were evaluated in 21.6% of office visits versus 13.5% of telemedicine encounters. New medications were ordered in similar proportions of office-based and telemedicine visits.

The authors concluded that “the COVID-19 pandemic has been associated with changes in the structure of primary care delivery, with the content of telemedicine visits differing from that of office-based encounters.”

While limited in scope, the authors noted, their study is one of the first to evaluate the changes in the content of primary care visits during the pandemic. They attributed the decline in evaluations of cardiovascular risk factors such as blood pressure and cholesterol to “fewer total visits and less frequent assessments during telemedicine encounters.”

While pointing to the inherent limitations of telemedicine, the study did not mention the availability of digital home blood pressure cuffs or home cholesterol test kits. Both kinds of devices are available at consumer-friendly price points and can help people track their indicators, but they’re not considered a substitute for sphygmomanometers used in offices or conventional lab tests. It’s not known how many consumers with cardiovascular risk factors have this kind of home monitoring equipment or how many doctors look at this kind of data.

Dr. Alexander reported serving as a paid adviser to IQVIA; that he is a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and that he is a member of OptumRx’s National P&T Committee. One coauthor reported serving as an unpaid adviser to IQVIA and receiving personal fees from the states of California, Washington, and Alaska outside the submitted work. No other disclosures were reported.

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

As the COVID-19 pandemic drove down the number of primary care visits and altered the method – moving many to telehealth appointments instead of in-person visits – the content of those appointments also changed, researchers reported in JAMA Network Open. Specifically, researchers found that preventive and chronic care for cardiovascular risk management dropped off during the first half of 2020 vs previous years.

For the study, G. Caleb Alexander, MD, from the Center for Drug Safety and Effectiveness, Johns Hopkins University, Baltimore, and colleagues analyzed data from the IQVIA National Disease and Therapeutic Index, a nationally representative audit of outpatient care in the United States, from the first quarter of 2018 through the second quarter of 2020.

Most primary care visits in 2018 and 2019 were office based, the authors noted. In the second quarter (Q2, April-May) of 2020, as the COVID-19 pandemic spread across the country, the total number of primary care encounters decreased by 21.4%, and the number of office visits dropped by 50.2%, compared with the average of visits during Q2 in 2018 and 2019.

At the same time, telemedicine visits increased from just 1.1% of total visits in Q2 of 2018 and 2019 to 4.1% of visits in the first quarter (January through March) of 2020 and to 35.3% of visits in Q2 of 2020.

The authors also found that the use of telemedicine in the first half of 2020 varied by geographical region and was not associated with the regional COVID-19 burden. In the Pacific region (Washington, Oregon, and California), 26.8% of encounters were virtual. By contrast, the proportion of telemedicine encounters accounted for only 15.1% of visits in the East North Central states (Wisconsin, Michigan, Illinois, Indiana, and Ohio).

Adults between the ages of 19 and 55 years were more likely to attend telemedicine visits than were those younger or older. Additionally, adults who were commercially insured were more likely to adopt telemedicine versus those with public or no insurance. The study did not find substantial differences in telemedicine use by payer type, nor evidence of a racial disparity between Black and White people in their use of telemedicine.
 

Drop-off in preventive and chronic care

During the second quarter of this year, the authors reported, the number of visits that included blood pressure assessments dropped by 50.1% and the number of visits in which cholesterol levels were assessed fell by 36.9%, compared with the Q2 of 2018 and 2019.

Visits in which providers prescribed new antihypertensive or cholesterol-lowering medications decreased by 26% in Q2 of 2020 versus the same periods in the previous 2 years. The number of visits in which such prescriptions were renewed dropped by 8.9%.

New treatments also decreased significantly in Q2 of 2020 for patients with chronic conditions, including hypertension, diabetes, high cholesterol, asthma, depression, and insomnia.

When the authors compared the content of telemedicine versus in-person visits in Q2 of 2020, they found a substantial difference. Blood pressure was assessed in 69.7% of office visits, compared with 9.6% of telemedicine. Similarly, cholesterol levels were evaluated in 21.6% of office visits versus 13.5% of telemedicine encounters. New medications were ordered in similar proportions of office-based and telemedicine visits.

The authors concluded that “the COVID-19 pandemic has been associated with changes in the structure of primary care delivery, with the content of telemedicine visits differing from that of office-based encounters.”

While limited in scope, the authors noted, their study is one of the first to evaluate the changes in the content of primary care visits during the pandemic. They attributed the decline in evaluations of cardiovascular risk factors such as blood pressure and cholesterol to “fewer total visits and less frequent assessments during telemedicine encounters.”

While pointing to the inherent limitations of telemedicine, the study did not mention the availability of digital home blood pressure cuffs or home cholesterol test kits. Both kinds of devices are available at consumer-friendly price points and can help people track their indicators, but they’re not considered a substitute for sphygmomanometers used in offices or conventional lab tests. It’s not known how many consumers with cardiovascular risk factors have this kind of home monitoring equipment or how many doctors look at this kind of data.

Dr. Alexander reported serving as a paid adviser to IQVIA; that he is a cofounding principal and equity holder in Monument Analytics, a health care consultancy whose clients include the life sciences industry as well as plaintiffs in opioid litigation; and that he is a member of OptumRx’s National P&T Committee. One coauthor reported serving as an unpaid adviser to IQVIA and receiving personal fees from the states of California, Washington, and Alaska outside the submitted work. No other disclosures were reported.

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

Primary care is not bouncing back to its prepandemic status, according to a new survey published by the Primary Care Collaborative (PCC) and Larry A. Green Center.

Since mid-March these organizations have issued short weekly and biweekly surveys to U.S. primary care physicians in an attempt to find the pulse of the county’s first line of care. “There is not a federal office for primary care, and it’s been anemically funded for decades,” Rebecca Etz, PhD, said in an interview. Yet these clinics represent the front lines of U.S. health care, and it’s where most Americans go for care and COVID-19 care, said Dr. Etz, director of the Virginia-based Larry A. Green Center, which is devoted to primary care research, development, and advocacy.

The latest survey responses, collected between Sept. 4 and 6, confirm what researchers had suspected: Primary care isn’t on solid footing. Eighty-one percent of respondents disagreed emphatically that primary care has bounced back, and another 13% said things were better than earlier this year but not normal.

Meanwhile, 35% of respondents said that revenue and pay are significantly lower than they were before the pandemic and net losses threaten their practices’ viability. Almost half (49%) said their mental exhaustion from work was at an all-time high.

“Because of how our system is set up – it’s a fee-for-service model – the more patients you see, the more money you get,” said Yalda Jabbarpour, MD, medical director at the Graham Center, a leading think tank on family medicine and health care policy. But the stay-at-home order, aversion to telehealth, and fear of in-person visits have been keeping patients away – and driving primary care revenue down. Even when practices transition to and expand their telehealth, payer reimbursement is not yet on parity with in-person visits.

Right now, primary care physicians are doing fewer procedures and spending more time on video visits. “So you may have the same overhead and time investment but you’re getting paid a fraction,” Dr. Etz said. In August, 50% of primary care physicians reported they were working the same or more hours per week as they did before the pandemic but for less money, according to an earlier survey from the Green Center and the PCC. That loss of revenue is compounded by the need for expensive personal protective equipment and preparation for the upcoming flu season, Dr. Etz said.
 

Ongoing surveys reveal stress

Over the last 20 weeks or so, the Green Center and PCC together have disseminated weekly (through June) or biweekly surveys to 100 professional organizations. Because there isn’t an entity that represents all of primary care and claims data take years to process, these surveys are intended to get real-time feedback from clinicians who are providing a lot of patient care during the pandemic.

The sample sizes are admittedly small, with the most recent survey including 489 clinicians. Dr. Jabbarpour noted, “489 – it’s a good number, but you would want more.” Generally, for a great survey response you’d want 20%-30% of the physician population because then you could assume you’re getting a good mix of geographies, practice sizes, and settings, she said.

Respondents to the most recent survey were from 49 different states; 70% identified their practice as family medicine. One-third had between one and three physicians in their practice and 40% had 10 or more clinicians. “It’s not perfect, but it sounds pretty representative of the primary care workforce,” Dr. Jabbarpour continued.

The latest Green Center-PCC survey, published last week, also found that one in five physicians surveyed said at least one clinician in their practice had opted for early retirement or left practice as a direct result of the pandemic. These declines in clinician staffing come as school reopenings threaten to cause a resurgence of COVID-19 cases and the 2021 flu season could complicate COVID-19 care and testing.
 

Shortfall could cascade to other specialties

News that primary care is both struggling and shrinking doesn’t come as a surprise to those who research this area, according to Dr. Jabbarpour. Yet it matters “because primary care is where the majority of Americans get their health care.” According to the Centers for Disease Control and Prevention, primary care accounts for 50% of all office visits. But the sector only encompasses 30% of the clinician workforce, according to a 2019 study of physician supply, and accounts for just 7% of national health expenditures, according to a separate 2019 study that measured primary care investment.

If primary care doesn’t bounce back, the shortfall could overwhelm the rest of the health care system, Dr. Jabbarpour said. “If primary care shortages increase, then urgent cares, ERs, and hospitals will become overwhelmed.”

Or public health could suffer as people don’t seek care at all. A study published earlier this summer found that up to 35% of excess deaths during the pandemic were not caused by COVID-19. Instead, they can be attributed to treatable causes, like heart disease, diabetes, and Alzheimers, the researchers concluded. In Dr. Etz’s estimation, this high cost is a glimpse of what happens when there isn’t adequate access to primary care.

When asked about the frequency of the PCC/Green Center surveys, Bianca Frogner, PhD, a health economist and deputy director at the University of Washington Primary Care Innovation Lab in Seattle, said it’s unusual to have this regularity. Also, it’s unique in that it offers a constant mix of physicians. “It’s a small sample, but it still gives a voice where there isn’t one.”

Smaller weekly surveys and secondary analysis projects from the Graham Center, an American Academy of Family Physicians affiliated research center, reinforce findings of the Green Center. The Graham Center surveys also found primary care is taking a financial hit, staff is being furloughed, and patient volume is down, according to Dr. Jabbarpour, who has been involved in most of the Graham Center’s work on COVID.

Dr. Frogner, Dr. Etz, and Dr. Jabbarpour agree that, as a nation, the United States has chronically underinvested in primary care, and now the system is in crisis. The hope is that the survey data gives policymakers, state leaders, and the federal government a better idea of what’s happening on the ground.

It’s also important for researchers “keeping an eye out for the available supply of primary care for certain populations,” Dr. Frogner said. The current conditions are especially a threat to rural and underserved areas, she added.

If primary health care isn’t near recovery that’s a problem for the entire population, Dr. Etz said. And what happens if there’s another surge of COVID-19 or even a second pandemic in our lifetime? Her recommendation: Treat it like disaster recovery. Step one is “Stop the hemorrhaging – they need immediate cash flow.”
 

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

Primary care is not bouncing back to its prepandemic status, according to a new survey published by the Primary Care Collaborative (PCC) and Larry A. Green Center.

Since mid-March these organizations have issued short weekly and biweekly surveys to U.S. primary care physicians in an attempt to find the pulse of the county’s first line of care. “There is not a federal office for primary care, and it’s been anemically funded for decades,” Rebecca Etz, PhD, said in an interview. Yet these clinics represent the front lines of U.S. health care, and it’s where most Americans go for care and COVID-19 care, said Dr. Etz, director of the Virginia-based Larry A. Green Center, which is devoted to primary care research, development, and advocacy.

The latest survey responses, collected between Sept. 4 and 6, confirm what researchers had suspected: Primary care isn’t on solid footing. Eighty-one percent of respondents disagreed emphatically that primary care has bounced back, and another 13% said things were better than earlier this year but not normal.

Meanwhile, 35% of respondents said that revenue and pay are significantly lower than they were before the pandemic and net losses threaten their practices’ viability. Almost half (49%) said their mental exhaustion from work was at an all-time high.

“Because of how our system is set up – it’s a fee-for-service model – the more patients you see, the more money you get,” said Yalda Jabbarpour, MD, medical director at the Graham Center, a leading think tank on family medicine and health care policy. But the stay-at-home order, aversion to telehealth, and fear of in-person visits have been keeping patients away – and driving primary care revenue down. Even when practices transition to and expand their telehealth, payer reimbursement is not yet on parity with in-person visits.

Right now, primary care physicians are doing fewer procedures and spending more time on video visits. “So you may have the same overhead and time investment but you’re getting paid a fraction,” Dr. Etz said. In August, 50% of primary care physicians reported they were working the same or more hours per week as they did before the pandemic but for less money, according to an earlier survey from the Green Center and the PCC. That loss of revenue is compounded by the need for expensive personal protective equipment and preparation for the upcoming flu season, Dr. Etz said.
 

Ongoing surveys reveal stress

Over the last 20 weeks or so, the Green Center and PCC together have disseminated weekly (through June) or biweekly surveys to 100 professional organizations. Because there isn’t an entity that represents all of primary care and claims data take years to process, these surveys are intended to get real-time feedback from clinicians who are providing a lot of patient care during the pandemic.

The sample sizes are admittedly small, with the most recent survey including 489 clinicians. Dr. Jabbarpour noted, “489 – it’s a good number, but you would want more.” Generally, for a great survey response you’d want 20%-30% of the physician population because then you could assume you’re getting a good mix of geographies, practice sizes, and settings, she said.

Respondents to the most recent survey were from 49 different states; 70% identified their practice as family medicine. One-third had between one and three physicians in their practice and 40% had 10 or more clinicians. “It’s not perfect, but it sounds pretty representative of the primary care workforce,” Dr. Jabbarpour continued.

The latest Green Center-PCC survey, published last week, also found that one in five physicians surveyed said at least one clinician in their practice had opted for early retirement or left practice as a direct result of the pandemic. These declines in clinician staffing come as school reopenings threaten to cause a resurgence of COVID-19 cases and the 2021 flu season could complicate COVID-19 care and testing.
 

Shortfall could cascade to other specialties

News that primary care is both struggling and shrinking doesn’t come as a surprise to those who research this area, according to Dr. Jabbarpour. Yet it matters “because primary care is where the majority of Americans get their health care.” According to the Centers for Disease Control and Prevention, primary care accounts for 50% of all office visits. But the sector only encompasses 30% of the clinician workforce, according to a 2019 study of physician supply, and accounts for just 7% of national health expenditures, according to a separate 2019 study that measured primary care investment.

If primary care doesn’t bounce back, the shortfall could overwhelm the rest of the health care system, Dr. Jabbarpour said. “If primary care shortages increase, then urgent cares, ERs, and hospitals will become overwhelmed.”

Or public health could suffer as people don’t seek care at all. A study published earlier this summer found that up to 35% of excess deaths during the pandemic were not caused by COVID-19. Instead, they can be attributed to treatable causes, like heart disease, diabetes, and Alzheimers, the researchers concluded. In Dr. Etz’s estimation, this high cost is a glimpse of what happens when there isn’t adequate access to primary care.

When asked about the frequency of the PCC/Green Center surveys, Bianca Frogner, PhD, a health economist and deputy director at the University of Washington Primary Care Innovation Lab in Seattle, said it’s unusual to have this regularity. Also, it’s unique in that it offers a constant mix of physicians. “It’s a small sample, but it still gives a voice where there isn’t one.”

Smaller weekly surveys and secondary analysis projects from the Graham Center, an American Academy of Family Physicians affiliated research center, reinforce findings of the Green Center. The Graham Center surveys also found primary care is taking a financial hit, staff is being furloughed, and patient volume is down, according to Dr. Jabbarpour, who has been involved in most of the Graham Center’s work on COVID.

Dr. Frogner, Dr. Etz, and Dr. Jabbarpour agree that, as a nation, the United States has chronically underinvested in primary care, and now the system is in crisis. The hope is that the survey data gives policymakers, state leaders, and the federal government a better idea of what’s happening on the ground.

It’s also important for researchers “keeping an eye out for the available supply of primary care for certain populations,” Dr. Frogner said. The current conditions are especially a threat to rural and underserved areas, she added.

If primary health care isn’t near recovery that’s a problem for the entire population, Dr. Etz said. And what happens if there’s another surge of COVID-19 or even a second pandemic in our lifetime? Her recommendation: Treat it like disaster recovery. Step one is “Stop the hemorrhaging – they need immediate cash flow.”
 

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

Primary care is not bouncing back to its prepandemic status, according to a new survey published by the Primary Care Collaborative (PCC) and Larry A. Green Center.

Since mid-March these organizations have issued short weekly and biweekly surveys to U.S. primary care physicians in an attempt to find the pulse of the county’s first line of care. “There is not a federal office for primary care, and it’s been anemically funded for decades,” Rebecca Etz, PhD, said in an interview. Yet these clinics represent the front lines of U.S. health care, and it’s where most Americans go for care and COVID-19 care, said Dr. Etz, director of the Virginia-based Larry A. Green Center, which is devoted to primary care research, development, and advocacy.

The latest survey responses, collected between Sept. 4 and 6, confirm what researchers had suspected: Primary care isn’t on solid footing. Eighty-one percent of respondents disagreed emphatically that primary care has bounced back, and another 13% said things were better than earlier this year but not normal.

Meanwhile, 35% of respondents said that revenue and pay are significantly lower than they were before the pandemic and net losses threaten their practices’ viability. Almost half (49%) said their mental exhaustion from work was at an all-time high.

“Because of how our system is set up – it’s a fee-for-service model – the more patients you see, the more money you get,” said Yalda Jabbarpour, MD, medical director at the Graham Center, a leading think tank on family medicine and health care policy. But the stay-at-home order, aversion to telehealth, and fear of in-person visits have been keeping patients away – and driving primary care revenue down. Even when practices transition to and expand their telehealth, payer reimbursement is not yet on parity with in-person visits.

Right now, primary care physicians are doing fewer procedures and spending more time on video visits. “So you may have the same overhead and time investment but you’re getting paid a fraction,” Dr. Etz said. In August, 50% of primary care physicians reported they were working the same or more hours per week as they did before the pandemic but for less money, according to an earlier survey from the Green Center and the PCC. That loss of revenue is compounded by the need for expensive personal protective equipment and preparation for the upcoming flu season, Dr. Etz said.
 

Ongoing surveys reveal stress

Over the last 20 weeks or so, the Green Center and PCC together have disseminated weekly (through June) or biweekly surveys to 100 professional organizations. Because there isn’t an entity that represents all of primary care and claims data take years to process, these surveys are intended to get real-time feedback from clinicians who are providing a lot of patient care during the pandemic.

The sample sizes are admittedly small, with the most recent survey including 489 clinicians. Dr. Jabbarpour noted, “489 – it’s a good number, but you would want more.” Generally, for a great survey response you’d want 20%-30% of the physician population because then you could assume you’re getting a good mix of geographies, practice sizes, and settings, she said.

Respondents to the most recent survey were from 49 different states; 70% identified their practice as family medicine. One-third had between one and three physicians in their practice and 40% had 10 or more clinicians. “It’s not perfect, but it sounds pretty representative of the primary care workforce,” Dr. Jabbarpour continued.

The latest Green Center-PCC survey, published last week, also found that one in five physicians surveyed said at least one clinician in their practice had opted for early retirement or left practice as a direct result of the pandemic. These declines in clinician staffing come as school reopenings threaten to cause a resurgence of COVID-19 cases and the 2021 flu season could complicate COVID-19 care and testing.
 

Shortfall could cascade to other specialties

News that primary care is both struggling and shrinking doesn’t come as a surprise to those who research this area, according to Dr. Jabbarpour. Yet it matters “because primary care is where the majority of Americans get their health care.” According to the Centers for Disease Control and Prevention, primary care accounts for 50% of all office visits. But the sector only encompasses 30% of the clinician workforce, according to a 2019 study of physician supply, and accounts for just 7% of national health expenditures, according to a separate 2019 study that measured primary care investment.

If primary care doesn’t bounce back, the shortfall could overwhelm the rest of the health care system, Dr. Jabbarpour said. “If primary care shortages increase, then urgent cares, ERs, and hospitals will become overwhelmed.”

Or public health could suffer as people don’t seek care at all. A study published earlier this summer found that up to 35% of excess deaths during the pandemic were not caused by COVID-19. Instead, they can be attributed to treatable causes, like heart disease, diabetes, and Alzheimers, the researchers concluded. In Dr. Etz’s estimation, this high cost is a glimpse of what happens when there isn’t adequate access to primary care.

When asked about the frequency of the PCC/Green Center surveys, Bianca Frogner, PhD, a health economist and deputy director at the University of Washington Primary Care Innovation Lab in Seattle, said it’s unusual to have this regularity. Also, it’s unique in that it offers a constant mix of physicians. “It’s a small sample, but it still gives a voice where there isn’t one.”

Smaller weekly surveys and secondary analysis projects from the Graham Center, an American Academy of Family Physicians affiliated research center, reinforce findings of the Green Center. The Graham Center surveys also found primary care is taking a financial hit, staff is being furloughed, and patient volume is down, according to Dr. Jabbarpour, who has been involved in most of the Graham Center’s work on COVID.

Dr. Frogner, Dr. Etz, and Dr. Jabbarpour agree that, as a nation, the United States has chronically underinvested in primary care, and now the system is in crisis. The hope is that the survey data gives policymakers, state leaders, and the federal government a better idea of what’s happening on the ground.

It’s also important for researchers “keeping an eye out for the available supply of primary care for certain populations,” Dr. Frogner said. The current conditions are especially a threat to rural and underserved areas, she added.

If primary health care isn’t near recovery that’s a problem for the entire population, Dr. Etz said. And what happens if there’s another surge of COVID-19 or even a second pandemic in our lifetime? Her recommendation: Treat it like disaster recovery. Step one is “Stop the hemorrhaging – they need immediate cash flow.”
 

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

Stroke may be the first presenting symptom of COVID-19 in younger patients, new research suggests. Investigators carried out a meta-analysis of data, including 160 patients with COVID-19 and stroke, and found that nearly half of patients under the age of 50 were asymptomatic at the time of stroke onset.

Although younger patients had the highest risk of stroke, the highest risk of death was in patients who were older, had other chronic conditions, and had more severe COVID-19–associated respiratory symptoms.

“One of the most eye-opening findings of this study is that, for patients under 50 years old, many were totally asymptomatic when they had a stroke related to COVID-19, [which] means that, for these patients, the stroke was their first symptom of the disease,” lead author Luciano Sposato, MD, MBA, associate professor and chair in stroke research at Western University, London, Ont.

The study was published online Sept. 15 in Neurology.
 

Anecdotal reports

“In early April of 2020, we realized that COVID-19 was a highly thrombogenic disease,” said Dr. Sposato. “Almost in parallel, I started to see anecdotal reports in social media of strokes occurring in patients with COVID-19, and there were also very few case reports.”

The investigators “thought it would be a good idea to put all the data together in one paper,” he said, and began by conducting a systematic review of 10 published studies of COVID-19 and stroke (n = 125 patients), which were then pooled with 35 unpublished cases from Canada, the United States, and Iran for a total of 160 cases.

The analysis examined in-hospital mortality rates of patients with stroke and COVID-19.

In addition, the researchers conducted a second review of 150 papers, encompassing a final cohort of 3,306 COVID-19 patients with stroke of any type and 5,322 with ischemic stroke.

“Some studies reported data for only ischemic stroke, and some reported data for all strokes considered together, which resulted in a different number of patients on each meta-analysis, with a lower number of ‘any stroke’ cases,” Dr. Sposato explained. “This review looked at the number of patients who developed a stroke during admission and included thousands of patients.”

Dr. Sposato noted that the first review was conducted on single case reports and small case series “to understand the clinical characteristics of strokes in patients with COVID-19 on an individual patient level,” since “large studies, including hundreds of thousands of patients, usually do not provide the level of detail for a descriptive analysis of the clinical characteristics of a disease.”

Cluster analyses were used to “identify specific clinical phenotypes and their relationship with death.” Patients were stratified into three age groups: <50, 50-70, and >70 years (“young,” “middle aged,” and “older,” respectively). The median age was 65 years and 43% were female.
 

Mortality ‘remarkably high’

The review showed that 1.8% (95% confidence interval, 0.9%-3.7%) of patients experienced a new stroke, while 1.5% (95% CI, 0.8%-2.8%) of these experienced an ischemic stroke. “These numbers are higher than historical data for other infectious diseases – for example, 0.75% in SARS-CoV-1, 0.78% in sepsis, and 0.2% in influenza,” Dr. Sposato commented.

Moreover, “this number may be an underestimate, given that many patients die without a confirmed diagnosis and that some patients did not come to the emergency department when experiencing mild symptoms during the first months of the pandemic,” he added.

Focusing on the review of 160 patients, the researchers described in-hospital mortality for strokes of all types and for ischemic strokes alone as “remarkably high” (34.4% [95% CI, 27.2%-42.4%] and 35.7% [95% CI, 27.5%-44.8%], respectively), with most deaths occurring among ischemic stroke patients.

“This high mortality rate is higher than the [roughly] 15% to 30% reported for stroke patients without COVID-19 admitted to intensive care units,” Dr. Sposato said.
 

High-risk phenotype

Many “young” COVID-19 patients (under age 50) who had a stroke (42.9%) had no previous risk factors or comorbidities. Moreover, in almost half of these patients (48.3%), stroke was more likely to occur before the onset of any COVID-19 respiratory symptoms.

Additionally, younger patients showed the highest frequency of elevated cardiac troponin compared with middle-aged and older patients (71.4% vs. 48.4% and 27.8%, respectively). On the other hand, mortality was 67% lower in younger versus older patients (odds ratio, 0.33; 95% CI, 0.12-0.94; P = .039).

Dr. Sposato noted that the proportion of ischemic stroke patients with large-vessel occlusion was “higher than previously reported” for patients with stroke without COVID-19 (47% compared with 29%, respectively).

“We should consider COVID-19 as a new cause or risk factor for stroke. At least, patients with stroke should probably be tested for SARS-CoV-2 infection if they are young and present with a large-vessel occlusion, even in the absence of typical COVID-19 respiratory symptoms,” he suggested.

The researchers identified a “high-risk phenotype” for death for all types of stroke considered together: older age, a higher burden of comorbidities, and severe COVID-19 respiratory symptoms. Patients with all three characteristics had the highest in-hospital mortality rate (58.6%) and a threefold risk of death, compared with the rest of the cohort (OR, 3.52; 95% CI, 1.53-8.09; P = .003).

“Several potential mechanisms can explain the increased risk of stroke among COVID-19 patients, but perhaps the most important one is increased thrombogenesis secondary to an exaggerated inflammatory response,” Dr. Sposato said.
 

Not just elders

Commenting on the study, Jodi Edwards, PhD, director of the Brain and Heart Nexus Research Program at the University of Ottawa Heart Institute, said the findings are “consistent with and underscore public health messaging emphasizing that COVID-19 does not only affect the elderly and those with underlying health conditions, but can have serious and even fatal consequences at any age.”

Dr. Edwards, who was not involved with the study, emphasized that “adherence to public health recommendations is critical to begin to reduce the rising incidence in younger adults.”

Dr. Sposato acknowledged that the study was small and that there “can be problems associated with a systematic review of case reports, such as publication bias, lack of completeness of data, etc, so more research is needed.”

Dr. Sposato is supported by the Kathleen & Dr. Henry Barnett Research Chair in Stroke Research at Western University, the Edward and Alma Saraydar Neurosciences Fund of the London Health Sciences Foundation, and the Opportunities Fund of the Academic Health Sciences Centre Alternative Funding Plan of the Academic Medical Organization of Southwestern Ontario. Dr. Sposato reported speaker honoraria from Boehringer Ingelheim, Pfizer, Gore, and Bayer and research/quality improvement grants from Boehringer Ingelheim and Bayer. The other authors’ disclosures are listed on the original article. Dr. Edwards has disclosed no relevant financial relationships.

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

Stroke may be the first presenting symptom of COVID-19 in younger patients, new research suggests. Investigators carried out a meta-analysis of data, including 160 patients with COVID-19 and stroke, and found that nearly half of patients under the age of 50 were asymptomatic at the time of stroke onset.

Although younger patients had the highest risk of stroke, the highest risk of death was in patients who were older, had other chronic conditions, and had more severe COVID-19–associated respiratory symptoms.

“One of the most eye-opening findings of this study is that, for patients under 50 years old, many were totally asymptomatic when they had a stroke related to COVID-19, [which] means that, for these patients, the stroke was their first symptom of the disease,” lead author Luciano Sposato, MD, MBA, associate professor and chair in stroke research at Western University, London, Ont.

The study was published online Sept. 15 in Neurology.
 

Anecdotal reports

“In early April of 2020, we realized that COVID-19 was a highly thrombogenic disease,” said Dr. Sposato. “Almost in parallel, I started to see anecdotal reports in social media of strokes occurring in patients with COVID-19, and there were also very few case reports.”

The investigators “thought it would be a good idea to put all the data together in one paper,” he said, and began by conducting a systematic review of 10 published studies of COVID-19 and stroke (n = 125 patients), which were then pooled with 35 unpublished cases from Canada, the United States, and Iran for a total of 160 cases.

The analysis examined in-hospital mortality rates of patients with stroke and COVID-19.

In addition, the researchers conducted a second review of 150 papers, encompassing a final cohort of 3,306 COVID-19 patients with stroke of any type and 5,322 with ischemic stroke.

“Some studies reported data for only ischemic stroke, and some reported data for all strokes considered together, which resulted in a different number of patients on each meta-analysis, with a lower number of ‘any stroke’ cases,” Dr. Sposato explained. “This review looked at the number of patients who developed a stroke during admission and included thousands of patients.”

Dr. Sposato noted that the first review was conducted on single case reports and small case series “to understand the clinical characteristics of strokes in patients with COVID-19 on an individual patient level,” since “large studies, including hundreds of thousands of patients, usually do not provide the level of detail for a descriptive analysis of the clinical characteristics of a disease.”

Cluster analyses were used to “identify specific clinical phenotypes and their relationship with death.” Patients were stratified into three age groups: <50, 50-70, and >70 years (“young,” “middle aged,” and “older,” respectively). The median age was 65 years and 43% were female.
 

Mortality ‘remarkably high’

The review showed that 1.8% (95% confidence interval, 0.9%-3.7%) of patients experienced a new stroke, while 1.5% (95% CI, 0.8%-2.8%) of these experienced an ischemic stroke. “These numbers are higher than historical data for other infectious diseases – for example, 0.75% in SARS-CoV-1, 0.78% in sepsis, and 0.2% in influenza,” Dr. Sposato commented.

Moreover, “this number may be an underestimate, given that many patients die without a confirmed diagnosis and that some patients did not come to the emergency department when experiencing mild symptoms during the first months of the pandemic,” he added.

Focusing on the review of 160 patients, the researchers described in-hospital mortality for strokes of all types and for ischemic strokes alone as “remarkably high” (34.4% [95% CI, 27.2%-42.4%] and 35.7% [95% CI, 27.5%-44.8%], respectively), with most deaths occurring among ischemic stroke patients.

“This high mortality rate is higher than the [roughly] 15% to 30% reported for stroke patients without COVID-19 admitted to intensive care units,” Dr. Sposato said.
 

High-risk phenotype

Many “young” COVID-19 patients (under age 50) who had a stroke (42.9%) had no previous risk factors or comorbidities. Moreover, in almost half of these patients (48.3%), stroke was more likely to occur before the onset of any COVID-19 respiratory symptoms.

Additionally, younger patients showed the highest frequency of elevated cardiac troponin compared with middle-aged and older patients (71.4% vs. 48.4% and 27.8%, respectively). On the other hand, mortality was 67% lower in younger versus older patients (odds ratio, 0.33; 95% CI, 0.12-0.94; P = .039).

Dr. Sposato noted that the proportion of ischemic stroke patients with large-vessel occlusion was “higher than previously reported” for patients with stroke without COVID-19 (47% compared with 29%, respectively).

“We should consider COVID-19 as a new cause or risk factor for stroke. At least, patients with stroke should probably be tested for SARS-CoV-2 infection if they are young and present with a large-vessel occlusion, even in the absence of typical COVID-19 respiratory symptoms,” he suggested.

The researchers identified a “high-risk phenotype” for death for all types of stroke considered together: older age, a higher burden of comorbidities, and severe COVID-19 respiratory symptoms. Patients with all three characteristics had the highest in-hospital mortality rate (58.6%) and a threefold risk of death, compared with the rest of the cohort (OR, 3.52; 95% CI, 1.53-8.09; P = .003).

“Several potential mechanisms can explain the increased risk of stroke among COVID-19 patients, but perhaps the most important one is increased thrombogenesis secondary to an exaggerated inflammatory response,” Dr. Sposato said.
 

Not just elders

Commenting on the study, Jodi Edwards, PhD, director of the Brain and Heart Nexus Research Program at the University of Ottawa Heart Institute, said the findings are “consistent with and underscore public health messaging emphasizing that COVID-19 does not only affect the elderly and those with underlying health conditions, but can have serious and even fatal consequences at any age.”

Dr. Edwards, who was not involved with the study, emphasized that “adherence to public health recommendations is critical to begin to reduce the rising incidence in younger adults.”

Dr. Sposato acknowledged that the study was small and that there “can be problems associated with a systematic review of case reports, such as publication bias, lack of completeness of data, etc, so more research is needed.”

Dr. Sposato is supported by the Kathleen & Dr. Henry Barnett Research Chair in Stroke Research at Western University, the Edward and Alma Saraydar Neurosciences Fund of the London Health Sciences Foundation, and the Opportunities Fund of the Academic Health Sciences Centre Alternative Funding Plan of the Academic Medical Organization of Southwestern Ontario. Dr. Sposato reported speaker honoraria from Boehringer Ingelheim, Pfizer, Gore, and Bayer and research/quality improvement grants from Boehringer Ingelheim and Bayer. The other authors’ disclosures are listed on the original article. Dr. Edwards has disclosed no relevant financial relationships.

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

Stroke may be the first presenting symptom of COVID-19 in younger patients, new research suggests. Investigators carried out a meta-analysis of data, including 160 patients with COVID-19 and stroke, and found that nearly half of patients under the age of 50 were asymptomatic at the time of stroke onset.

Although younger patients had the highest risk of stroke, the highest risk of death was in patients who were older, had other chronic conditions, and had more severe COVID-19–associated respiratory symptoms.

“One of the most eye-opening findings of this study is that, for patients under 50 years old, many were totally asymptomatic when they had a stroke related to COVID-19, [which] means that, for these patients, the stroke was their first symptom of the disease,” lead author Luciano Sposato, MD, MBA, associate professor and chair in stroke research at Western University, London, Ont.

The study was published online Sept. 15 in Neurology.
 

Anecdotal reports

“In early April of 2020, we realized that COVID-19 was a highly thrombogenic disease,” said Dr. Sposato. “Almost in parallel, I started to see anecdotal reports in social media of strokes occurring in patients with COVID-19, and there were also very few case reports.”

The investigators “thought it would be a good idea to put all the data together in one paper,” he said, and began by conducting a systematic review of 10 published studies of COVID-19 and stroke (n = 125 patients), which were then pooled with 35 unpublished cases from Canada, the United States, and Iran for a total of 160 cases.

The analysis examined in-hospital mortality rates of patients with stroke and COVID-19.

In addition, the researchers conducted a second review of 150 papers, encompassing a final cohort of 3,306 COVID-19 patients with stroke of any type and 5,322 with ischemic stroke.

“Some studies reported data for only ischemic stroke, and some reported data for all strokes considered together, which resulted in a different number of patients on each meta-analysis, with a lower number of ‘any stroke’ cases,” Dr. Sposato explained. “This review looked at the number of patients who developed a stroke during admission and included thousands of patients.”

Dr. Sposato noted that the first review was conducted on single case reports and small case series “to understand the clinical characteristics of strokes in patients with COVID-19 on an individual patient level,” since “large studies, including hundreds of thousands of patients, usually do not provide the level of detail for a descriptive analysis of the clinical characteristics of a disease.”

Cluster analyses were used to “identify specific clinical phenotypes and their relationship with death.” Patients were stratified into three age groups: <50, 50-70, and >70 years (“young,” “middle aged,” and “older,” respectively). The median age was 65 years and 43% were female.
 

Mortality ‘remarkably high’

The review showed that 1.8% (95% confidence interval, 0.9%-3.7%) of patients experienced a new stroke, while 1.5% (95% CI, 0.8%-2.8%) of these experienced an ischemic stroke. “These numbers are higher than historical data for other infectious diseases – for example, 0.75% in SARS-CoV-1, 0.78% in sepsis, and 0.2% in influenza,” Dr. Sposato commented.

Moreover, “this number may be an underestimate, given that many patients die without a confirmed diagnosis and that some patients did not come to the emergency department when experiencing mild symptoms during the first months of the pandemic,” he added.

Focusing on the review of 160 patients, the researchers described in-hospital mortality for strokes of all types and for ischemic strokes alone as “remarkably high” (34.4% [95% CI, 27.2%-42.4%] and 35.7% [95% CI, 27.5%-44.8%], respectively), with most deaths occurring among ischemic stroke patients.

“This high mortality rate is higher than the [roughly] 15% to 30% reported for stroke patients without COVID-19 admitted to intensive care units,” Dr. Sposato said.
 

High-risk phenotype

Many “young” COVID-19 patients (under age 50) who had a stroke (42.9%) had no previous risk factors or comorbidities. Moreover, in almost half of these patients (48.3%), stroke was more likely to occur before the onset of any COVID-19 respiratory symptoms.

Additionally, younger patients showed the highest frequency of elevated cardiac troponin compared with middle-aged and older patients (71.4% vs. 48.4% and 27.8%, respectively). On the other hand, mortality was 67% lower in younger versus older patients (odds ratio, 0.33; 95% CI, 0.12-0.94; P = .039).

Dr. Sposato noted that the proportion of ischemic stroke patients with large-vessel occlusion was “higher than previously reported” for patients with stroke without COVID-19 (47% compared with 29%, respectively).

“We should consider COVID-19 as a new cause or risk factor for stroke. At least, patients with stroke should probably be tested for SARS-CoV-2 infection if they are young and present with a large-vessel occlusion, even in the absence of typical COVID-19 respiratory symptoms,” he suggested.

The researchers identified a “high-risk phenotype” for death for all types of stroke considered together: older age, a higher burden of comorbidities, and severe COVID-19 respiratory symptoms. Patients with all three characteristics had the highest in-hospital mortality rate (58.6%) and a threefold risk of death, compared with the rest of the cohort (OR, 3.52; 95% CI, 1.53-8.09; P = .003).

“Several potential mechanisms can explain the increased risk of stroke among COVID-19 patients, but perhaps the most important one is increased thrombogenesis secondary to an exaggerated inflammatory response,” Dr. Sposato said.
 

Not just elders

Commenting on the study, Jodi Edwards, PhD, director of the Brain and Heart Nexus Research Program at the University of Ottawa Heart Institute, said the findings are “consistent with and underscore public health messaging emphasizing that COVID-19 does not only affect the elderly and those with underlying health conditions, but can have serious and even fatal consequences at any age.”

Dr. Edwards, who was not involved with the study, emphasized that “adherence to public health recommendations is critical to begin to reduce the rising incidence in younger adults.”

Dr. Sposato acknowledged that the study was small and that there “can be problems associated with a systematic review of case reports, such as publication bias, lack of completeness of data, etc, so more research is needed.”

Dr. Sposato is supported by the Kathleen & Dr. Henry Barnett Research Chair in Stroke Research at Western University, the Edward and Alma Saraydar Neurosciences Fund of the London Health Sciences Foundation, and the Opportunities Fund of the Academic Health Sciences Centre Alternative Funding Plan of the Academic Medical Organization of Southwestern Ontario. Dr. Sposato reported speaker honoraria from Boehringer Ingelheim, Pfizer, Gore, and Bayer and research/quality improvement grants from Boehringer Ingelheim and Bayer. The other authors’ disclosures are listed on the original article. Dr. Edwards has disclosed no relevant financial relationships.

A version of this article originally 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.

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.

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.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.

Black children and children living in urban areas are less likely to have opioid-related poisoning or withdrawal but more likely to experience abuse or dependence, compared with their White or rural/suburban counterparts, according to a study of 3.2 million Medicaid-enrolled children in North Carolina.

Analysis of the almost 138,000 prescription fills also showed that Black and urban children in North Carolina were less likely to fill a opioid prescription, suggesting a need “for future studies to explore racial and geographic opioid-related inequities in children,” Kelby W. Brown, MA, and associates at Duke University, Durham, N.C., said Oct. 5 in Health Affairs.

In 2016-2018, the prevalence of opioid-related adverse events, such as poisoning or withdrawal, was 24.0 per 100,000 children among Blacks aged 1-17 years, compared with 27.5 per 100,000 for whites. For other opioid-related harms such as abuse or dependence, the order was reversed: 60.2 for Blacks and 51.7 for Whites, the investigators reported. Children of all other races were lowest in both measures.

Geography also appears to play a part. The children in urban areas had the lowest rate of adverse events – 23.2 per 100,000 vs. 26.2 (suburban) and 26.7 (rural) – and the highest rate of other opioid-related harms – 58.1 vs. 49.0 (suburban) and 38.7 (rural), the Medicaid claims data showed.

Analysis of prescription fills revealed that black children aged 1-17 years had a significantly lower rate (2.7%) than Whites (3.1%) or those of other races (3.0%) and that urban children were significantly less likely to fill a prescription (2.7%) for opioids than the other two groups (suburban, 3.1%; rural, 3.4%), Mr. Brown and associates said.

The prescription data also showed that 48.4% of children aged 6-17 years who had an adverse event had filled a prescription for an opioid in the previous 6 months, compared with just 9.4% of those with other opioid-related harms. The median length of time since the last fill? Three days for children with an adverse event and 67 days for those with other harms, they said.

And those prescriptions, it turns out, were not coming just from the physicians of North Carolina. Physicians, with 35.5% of the prescription load, were the main source, but 33.3% of opioid fills in 2016-2018 came from dentists, and another 17.7% were written by advanced practice providers. Among physicians, the leading opioid-prescribing specialists were surgeons, with 17.3% of the total, the investigators reported.

“The distinct and separate groups of clinicians who prescribe opioids to children suggest the need for pediatric opioid prescribing guidelines, particularly for postprocedural pain,” Mr. Brown and associates wrote.

rfranki@mdedge.com

SOURCE: Brown KW et al. Health Aff. 2020;39(10):1737-42.