Feature

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

A panel of scientific experts is urging the nation to do more to track morbidity and mortality among health care workers (HCWs), given the large and disproportionate number who have been infected with or died from SARS-CoV-2.

The National Academies of Sciences, Engineering, and Medicine’s Standing Committee on Emerging Infectious Diseases and 21st Century Health Threats issued a 10-page “rapid expert consultation” on what is known about deaths and mental health problems among HCWs associated with the COVID-19 pandemic and how to protect workers.

“The absence of a uniform national framework and inconsistent requirements across states for collecting, recording, and reporting HCW mortality and morbidity data associated with COVID-19 impairs anyone’s ability to make comparisons, do combined analyses, or draw conclusions about the scale of the problem,” says the panel in the report.

Mental health, in particular, needs to be examined, it says. Although the data are still limited, the prevalence of burnout and suicide “points to a serious concern,” according to the report.

“As with mortality due to COVID-19, there are currently no national systems nor reporting standards for morbidity measures related to the pandemic, such as mental health status, provider well-being, and other psychological effects on HCWs,” the report says.

A more robust national system that collected data on circumstances and interventions that may raise or lower risk, as well as on where the infection occurred, “would support the adoption of effective mitigation strategies,” says the report. It would also facilitate epidemiologic studies on risk factors, such as face-to-face contact with COVID-19 patients and the availability and use of personal protective equipment (PPE). Studies could also examine the impact of institutional requirements for masking.

Studies have consistently shown that universal mask wearing and access to appropriate PPE support the physical safety and mental health of HCWs, says the report.
 

Track scale of crisis

The committee cited many gaps in the current system. The Occupational Safety and Health Administration, for instance, doesn’t count deaths from occupationally acquired infection. Many states don’t report COVID-19 deaths by profession. The Centers for Disease Control and Prevention (CDC) relies on case report forms from local health departments for all COVID-19 cases, which typically are lacking in specifics, such as occupation or job setting, says the committee’s report.

As of Nov. 3, the CDC had reported 786 deaths among HCWs that were attributable to COVID-19 – a far lower number than other sources have reported.

The committee notes that much could be done immediately. A National Academy of Medicine panel on clinician well-being and resilience in August recommended that the CDC establish a national epidemiologic tracking program to measure HCWs’ well-being, assess the acute and long-term effects of COVID-19 on those workers, and report on the outcomes of interventions.

Such a program “is needed to comprehensively acknowledge the scale of the COVID-19 crisis and protect the health care workforce that is already stretched to the breaking point in many locations,” the committee says in its report.
 

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

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

After last week’s ever-so-slightly positive news, the COVID-19 numbers in children have gone back to their old ways.

For the week ending Dec. 10, there were 178,823 new COVID-19 cases reported in U.S. children, the highest weekly total yet during the pandemic. The number of new cases had dropped the week before after setting a new high of almost 154,000 during the last full week of November, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

A new weekly high has been seen in 9 of the last 10 weeks, during which time the weekly total of child cases has gone from just over 40,000 (week ending Oct. 8) to almost 179,000, the two organizations said.

The cumulative number of child COVID-19 cases for the year is now almost 1.64 million, which means that 12.2% of all cases have occurred in children and that 2.1% of all children (2,179 per 100,000) in the United States have been infected with the coronavirus, the AAP and CHA said in their weekly report, which includes health department data from 49 states (New York does not report age distribution), the District of Columbia, New York City, Puerto Rico, and Guam.

The cumulative proportion of 12.2% has been exceeded in 27 states, as well as Puerto Rico and Guam, with the highest coming in Wyoming (21.3%), South Carolina (18.1%), and Tennessee (18.1%) and the lowest in Florida (6.7%, but the state uses an age range of 0-14 years) and New Jersey (7.6%), the AAP/CHA data show.

In a separate statement, AAP president Sally Goza, MD, welcomed the approval of the Pfizer-BioNTech COVID-19 vaccine but noted that the “virus is at unprecedented levels in nearly every community in the U.S., and in many areas, our health care system is terribly overburdened. The vaccine will not solve this overnight. I urge everyone to continue to practice social distancing, and wear masks or cloth face coverings, and get a flu shot, so we can protect the people we care about.”

Dr. Goza continued: “We applaud Pfizer-BioNTech for including children ages 12 through 17 in their clinical trials and we look forward to learning more about the data from children aged 12-15. We also want to acknowledge the discussion during the committee meeting on including 16- to 17-year-olds in the EUA [emergency-use authorization]. We believe that discussion underscores the need to keep expanding these trials to the pediatric population so we can collect robust data on this age group.”

rfranki@mdedge.com

 

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

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

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

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

The Department of Health & Human Services is proposing an overhaul of HIPAA that will make it easier to access patients’ personal health information, including the health records of patients with mental illness. The proposal would also do away with the requirement that all patients sign a notice of privacy practices.

The changes are contained in a 357-page proposed rule, which was unveiled by federal officials Dec. 10. Roger Severino, director of HHS’ Office for Civil Rights, said in a briefing that the sweeping proposal would empower patients, reduce the administrative burden for health care providers, and pave the way to better-coordinated care.

HHS estimated that the rule could save $3.2 billion over 5 years, but it’s not clear how much of that would accrue to clinical practices.

The most obvious cost-saving aspect for medical and dental practices is the proposal that practitioners would no longer have to provide and collect signed notifications of privacy practices.

“This has been a tremendous waste of time and effort and has caused massive confusion,” said Mr. Severino. He said some patients thought they were waiving privacy rights and that, in some cases, physicians refused to administer care unless patients signed the notices. “That was never the intent.”

Requiring that patients sign the form and that practices keep copies for 6 years is an “unnecessary burden,” said Mr. Severino. “We’ve lost whole forests from this regulation.”

Under the new proposal, health care providers would merely have to let patients know where to find their privacy policies.
 

Sharing mental health info

The rule would also ease the standard for sharing information about a patient who is in a mental health crisis, such as an exacerbation of a serious mental illness or a crisis related to a substance use disorder, including an overdose.

Currently, clinicians can choose to disclose protected health information – to a family member, a caregiver, a law enforcement official, a doctor, or an insurer – if they believe that doing so is advisable in their “professional judgment.” The rule proposes to ease that to a “good faith” belief that a disclosure would be in the best interest of the patient. In both instances, the patient can still object and block the disclosure.

As an example, HHS said that, in the case of a young adult who had experienced an overdose of opioids, a licensed health care professional could make the determination to “disclose relevant information to a parent who is involved in the patient’s treatment and who the young adult would expect, based on their relationship, to participate in or be involved with the patient’s recovery from the overdose.”

HHS is also proposing to let clinicians disclose information in cases in which an individual might be a threat to himself or others, provided the harm is “serious and reasonably foreseeable.”

Currently, information can only be disclosed if it appears there is a “serious and imminent” threat to health or safety. If an individual experienced suicidal ideation, for instance, a health care professional could notify family that the individual is at risk.
 

Fast, no-cost access

The rule also aims to make it easier for patients to get access to their own health care information quickly – within 15 days of a request – instead of the 30 days currently allowed, and sometimes at no cost.

The 30-day time frame is “a relic of a pre-Internet age that should be dispensed with,” said Mr. Severino.

Patients can also request that a treating physician get his or her records from a clinician who had previously treated the individual. The request would be fulfilled within 15 days, although extensions might be possible.

“That takes away the burden of coordination from the patient and puts it on those parties that are responsible for the actual provision of care and that are better positioned to do that coordination,” Mr. Severino said.

Health care professionals will also have to share with patients a fee schedule for records requests. However, if records are shared through a patient portal with view, download, and transmit capabilities, the provider can’t charge the patient for the time it took to upload the information into the system.

“We do not believe a patient’s personal medical record should be profit centers for providers,” Mr. Severino said.

Patients will be allowed to take photos with a smartphone of personal health information – such as an x-ray or sonogram – while receiving care.

The rule is open for public comment until mid-February. After that, it will become final in 180 days. The agency said it would not begin enforcement until 240 days after the final rule was published.

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

A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

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

A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

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

A public-private partnership, led by mental health advocate Patrick Kennedy and the head of the National Institute of Mental Health, Joshua Gordon, MD, PhD, want urgent action to address the wave of mental illness and suicide caused by COVID-19.

“Our country is in serious denial about the full impact of mental health in this country and certainly as part of this pandemic,” said former congressman Mr. Kennedy, cochair of the Action Alliance’s Mental Health & Suicide Prevention National Response to COVID-19, at a briefing unveiling the group’s new six-priority Action Plan.

“That’s reinforced when all we hear from is Dr. Fauci,” and only about the physical effects of the disease, said Mr. Kennedy, the founder of the Kennedy Forum, a nonprofit dedicated to changing the health system’s approach to mental health and substance use disorders.

“We’re seeing suffering on a whole new, unprecedented scale,” he said. Mr. Kennedy noted the huge effort to speed therapeutics and vaccines to the American public. “We need to bring that same sense of urgency to these deaths of despair hiding in plain sight.”

Dr. Gordon, NIMH’s director and a cochair of the National Response group, was also at the briefing.

“We know many people report experiencing symptoms of distress, including anxiety, sleep problems, depression, substance use, and suicidal thoughts at rates two to three times higher than we might expect in times before the pandemic. Just as the country has come together to mitigate the physical impacts of pandemic, we also have to identify how to mitigate the mental health impacts,” said Dr. Gordon.
 

Plan of action

Mr. Kennedy emphasized that it is crucial that federal lawmakers and regulators find a way to increase parity between mental and physical health.

Paramount in that effort would be ensuring stronger enforcement of the Mental Health Parity and Addiction Equity Act, he said.

That 1996 law requires health plans to ensure that benefits for physical and mental health were equivalent, but it has frequently been ignored. In 2019, a U.S. federal court found that one of the nation’s largest behavioral health insurers, United Behavioral Health, had been violating the law. Mr. Kennedy said he expects this decision to continue to have a positive impact on achieving parity.

In November, United was ordered by a federal judge to reprocess 67,000 claims that it illegally denied.

The Alliance’s Action Plan has six priorities:

• Change the national conversation about mental health and suicide.
• Increase access to evidence-based treatments for substance use and mental health disorders in specialty and primary care, and include better reimbursement for services and make permanent reimbursement for telehealth services.
• Increase the use of nonpunitive and supportive crisis intervention services, including keeping people out of the criminal justice system.
• Establish near real-time data collection systems to promptly identify changes in rates of suicide, overdose, and other key events, and of clusters or spikes.
• Ensure the equitable delivery of comprehensive and effective suicide prevention and mental health services for Black Americans, Latin Americans, American Indian/Alaskan Natives, LGBTQ individuals, and others disproportionately impacted by the pandemic.
• Invest in prevention and early intervention approaches that treat the root causes of suicide and mental health problems.

Uptick in distress

Dr. Gordon noted that recent data indicate that, although ED visits for children are still down in 2020, compared with previous years, mental health ED visits are back to prepandemic levels.

A September survey showed an increase in suicidal thoughts and attempts, anxiety, and depression pandemic in youth because of the pandemic. Almost one-quarter of those surveyed said they knew a peer who developed suicidal thoughts since the start of the pandemic and 5% reported making a suicide attempt themselves.

In early December, research reported in JAMA Psychiatry showed the overall rate of overdose-related cardiac arrests in 2020 was about 50% higher than trends in 2018 and 2019, and that all overdose-related incidents were about 17% above baseline in 2020.

COVID-19 also appears to be striking individuals who are living in behavioral health facilities, and some of those facilities are reducing inpatient care and other programs because they don’t have enough personal protective equipment, testing supplies, or staff to cope with the disease.

The facilities are not required to report infections to the federal government. Sen. Elizabeth Warren (D-Mass.), Rep. Carolyn Maloney (D-N.Y.), and Rep. Katie Porter (D-Calif.) issued a report based on their own offices’ survey of 10 large behavioral health program operators.

Eight of those operators – covering 376 facilities and more than 100,000 patients in 40 states and Puerto Rico – provided substantive responses.

More than half had at least one COVID case and 14% had large outbreaks of 10 or more cases. The infection rate for patients was in line with that of the general public.

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

With U.S. approval of one coronavirus vaccine likely imminent and approval of a second one expected soon after, physicians will likely be deluged with questions. Public attitudes about the vaccines vary by demographics, with a recent poll showing that men and older adults are more likely to choose vaccination, and women and people of color evincing more wariness.

Although the reasons for reluctance may vary, questions from patient will likely be similar. Some are related to the “warp speed” language about the vaccines. Other concerns arise from the fact that the platform – mRNA – has not been used in human vaccines before. And as with any vaccine, there are rumors and false claims making the rounds on social media.

In anticipation of the most common questions physicians may encounter, two experts, Krutika Kuppalli, MD, assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina, Charleston, and Angela Rasmussen, PhD, virologist and nonresident affiliate at Georgetown University’s Center for Global Health Science and Security, Washington, talked in an interview about what clinicians can expect and what evidence-based – as well as compassionate – answers might look like.
 

Q: Will this vaccine give me COVID-19?

“There is not an intact virus in there,” Dr. Rasmussen said. The mRNA-based vaccines cannot cause COVID-19 because they don’t use any part of the coronavirus itself. Instead, the Moderna and Pfizer vaccines contain manufactured mRNA molecules that carry the instructions for building the virus’ spike protein. After vaccine administration, the recipient’s own cells take up this mRNA, use it to build this bit of protein, and display it on their surfaces. The foreign protein flag triggers the immune system response.

The mRNA does not enter the cell nucleus or interact with the recipient’s DNA. And because it’s so fragile, it degrades quite quickly. To keep that from happening before cell entry, the mRNAs are cushioned in protective fats.

Q: Was this vaccine made too quickly?

“People have been working on this platform for 30 years, so it’s not that this is brand new,” Dr. Kuppalli said.

Researchers began working on mRNA vaccines in the 1990s. Technological developments in the last decade have meant that their use has become feasible, and they have been tested in animals against many viral diseases. The mRNA vaccines are attractive because they’re expected to be safe and easily manufactured from common materials. That’s what we’ve seen in the COVID-19 pandemic, the  Centers for Disease Control and Prevention says on its website. Design of the spike protein mRNA component began as soon as the viral genome became available in January.

Usually, rolling out a vaccine takes years, so less than a year under a program called Operation Warp Speed can seem like moving too fast, Dr. Rasmussen acknowledged. “The name has given people the impression that by going at warp speed, we’re cutting all the corners. [But] the reality is that Operation Warp Speed is mostly for manufacturing and distribution.”

What underlies the speed is a restructuring of the normal vaccine development process, Dr. Kuppalli said. The same phases of development – animal testing, a small initial human phase, a second for safety testing, a third large phase for efficacy – were all conducted as for any vaccine. But in this case, some phases were completed in parallel, rather than sequentially. This approach has proved so successful that there is already talk about making it the model for developing future vaccines.

Two other factors contributed to the speed, said Dr. Kuppalli and Dr. Rasmussen. First, gearing up production can slow a rollout, but with these vaccines, companies ramped up production even before anyone knew if the vaccines would work – the “warp speed” part. The second factor has been the large number of cases, making exposures more likely and thus accelerating the results of the efficacy trials. “There is so much COVID being transmitted everywhere in the United States that it did not take long to hit the threshold of events to read out phase 3,” Dr. Rasmussen said.

Q: This vaccine has never been used in humans. How do we know it’s safe?

The Pfizer phase 3 trial included more than 43,000 people, and Moderna’s had more than 30,000. The first humans received mRNA-based COVID-19 vaccines in March. The most common adverse events emerge right after a vaccination, Dr. Kuppalli said.

As with any vaccine that gains approval, monitoring will continue.

UK health officials have reported that two health care workers vaccinated in the initial rollout of the Pfizer vaccine had what seems to have been a severe allergic response. Both recipients had a history of anaphylactic allergic responses and carried EpiPens, and both recovered. During the trial, allergic reaction rates were 0.63% in the vaccine group and 0.51% in the placebo group.

As a result of the two reactions, UK regulators are now recommending that patients with a history of severe allergies not receive the vaccine at the current time.

Q: What are the likely side effects?

So far, the most common side effects are pain at the injection site and an achy, flu-like feeling, Dr. Kuppalli said. More severe reactions have been reported, but were not common in the trials.

Dr. Rasmussen noted that the common side effects are a good sign, and signal that the recipient is generating “a robust immune response.”

“Everybody I’ve talked to who’s had the response has said they would go through it again,” Dr. Kruppalli said. “I definitely plan on lining up and being one of the first people to get the vaccine.”

Q: I already had COVID-19 or had a positive antibody test. Do I still need to get the vaccine?

Dr. Rasmussen said that there are “too many unknowns” to say if a history of COVID-19 would make a difference. “We don’t know how long neutralizing antibodies last” after infection, she said. “What we know is that the vaccine tends to produce antibody titers towards the higher end of the spectrum,” suggesting better immunity with vaccination than after natural infection.

Q: Can patients of color feel safe getting the vaccine?

“People of color might be understandably reluctant to take a vaccine that was developed in a way that appears to be faster [than past development],” said Dr. Rasmussen. She said physicians should acknowledge and understand the history that has led them to feel that way, “everything from Tuskegee to Henrietta Lacks to today.”

Empathy is key, and “providers should meet patients where they are and not condescend to them.”

Dr. Kuppalli agreed. “Clinicians really need to work on trying to strip away their biases.”

Thus far there are no safety signals that differ by race or ethnicity, according to the companies. The Pfizer phase 3 trial enrolled just over 9% Black participants, 0.5% Native American/Alaska Native, 0.2% Native Hawaiian/Pacific Islander, 2.3% multiracial participants, and 28% Hispanic/Latinx. For its part, Moderna says that approximately 37% of participants in its phase 3 trial come from communities of color.

Q: What about children and pregnant women?

Although the trials included participants from many different age groups and backgrounds, children and pregnant or lactating women were not among them. Pfizer gained approval in October to include participants as young as age 12 years, and a Moderna spokesperson said in an interview that the company planned pediatric inclusion at the end of 2020, pending approval.

“Unfortunately, we don’t have data on pregnant and lactating women,” Dr. Kuppalli said. She said she hopes that public health organizations such as the CDC will address that in the coming weeks. Dr. Rasmussen called the lack of data in pregnant women and children “a big oversight.”

Dr. Rasmussen has disclosed no relevant financial relationships. Dr. Kuppalli is a consultant with GlaxoSmithKline.

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

With U.S. approval of one coronavirus vaccine likely imminent and approval of a second one expected soon after, physicians will likely be deluged with questions. Public attitudes about the vaccines vary by demographics, with a recent poll showing that men and older adults are more likely to choose vaccination, and women and people of color evincing more wariness.

Although the reasons for reluctance may vary, questions from patient will likely be similar. Some are related to the “warp speed” language about the vaccines. Other concerns arise from the fact that the platform – mRNA – has not been used in human vaccines before. And as with any vaccine, there are rumors and false claims making the rounds on social media.

In anticipation of the most common questions physicians may encounter, two experts, Krutika Kuppalli, MD, assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina, Charleston, and Angela Rasmussen, PhD, virologist and nonresident affiliate at Georgetown University’s Center for Global Health Science and Security, Washington, talked in an interview about what clinicians can expect and what evidence-based – as well as compassionate – answers might look like.
 

Q: Will this vaccine give me COVID-19?

“There is not an intact virus in there,” Dr. Rasmussen said. The mRNA-based vaccines cannot cause COVID-19 because they don’t use any part of the coronavirus itself. Instead, the Moderna and Pfizer vaccines contain manufactured mRNA molecules that carry the instructions for building the virus’ spike protein. After vaccine administration, the recipient’s own cells take up this mRNA, use it to build this bit of protein, and display it on their surfaces. The foreign protein flag triggers the immune system response.

The mRNA does not enter the cell nucleus or interact with the recipient’s DNA. And because it’s so fragile, it degrades quite quickly. To keep that from happening before cell entry, the mRNAs are cushioned in protective fats.

Q: Was this vaccine made too quickly?

“People have been working on this platform for 30 years, so it’s not that this is brand new,” Dr. Kuppalli said.

Researchers began working on mRNA vaccines in the 1990s. Technological developments in the last decade have meant that their use has become feasible, and they have been tested in animals against many viral diseases. The mRNA vaccines are attractive because they’re expected to be safe and easily manufactured from common materials. That’s what we’ve seen in the COVID-19 pandemic, the  Centers for Disease Control and Prevention says on its website. Design of the spike protein mRNA component began as soon as the viral genome became available in January.

Usually, rolling out a vaccine takes years, so less than a year under a program called Operation Warp Speed can seem like moving too fast, Dr. Rasmussen acknowledged. “The name has given people the impression that by going at warp speed, we’re cutting all the corners. [But] the reality is that Operation Warp Speed is mostly for manufacturing and distribution.”

What underlies the speed is a restructuring of the normal vaccine development process, Dr. Kuppalli said. The same phases of development – animal testing, a small initial human phase, a second for safety testing, a third large phase for efficacy – were all conducted as for any vaccine. But in this case, some phases were completed in parallel, rather than sequentially. This approach has proved so successful that there is already talk about making it the model for developing future vaccines.

Two other factors contributed to the speed, said Dr. Kuppalli and Dr. Rasmussen. First, gearing up production can slow a rollout, but with these vaccines, companies ramped up production even before anyone knew if the vaccines would work – the “warp speed” part. The second factor has been the large number of cases, making exposures more likely and thus accelerating the results of the efficacy trials. “There is so much COVID being transmitted everywhere in the United States that it did not take long to hit the threshold of events to read out phase 3,” Dr. Rasmussen said.

Q: This vaccine has never been used in humans. How do we know it’s safe?

The Pfizer phase 3 trial included more than 43,000 people, and Moderna’s had more than 30,000. The first humans received mRNA-based COVID-19 vaccines in March. The most common adverse events emerge right after a vaccination, Dr. Kuppalli said.

As with any vaccine that gains approval, monitoring will continue.

UK health officials have reported that two health care workers vaccinated in the initial rollout of the Pfizer vaccine had what seems to have been a severe allergic response. Both recipients had a history of anaphylactic allergic responses and carried EpiPens, and both recovered. During the trial, allergic reaction rates were 0.63% in the vaccine group and 0.51% in the placebo group.

As a result of the two reactions, UK regulators are now recommending that patients with a history of severe allergies not receive the vaccine at the current time.

Q: What are the likely side effects?

So far, the most common side effects are pain at the injection site and an achy, flu-like feeling, Dr. Kuppalli said. More severe reactions have been reported, but were not common in the trials.

Dr. Rasmussen noted that the common side effects are a good sign, and signal that the recipient is generating “a robust immune response.”

“Everybody I’ve talked to who’s had the response has said they would go through it again,” Dr. Kruppalli said. “I definitely plan on lining up and being one of the first people to get the vaccine.”

Q: I already had COVID-19 or had a positive antibody test. Do I still need to get the vaccine?

Dr. Rasmussen said that there are “too many unknowns” to say if a history of COVID-19 would make a difference. “We don’t know how long neutralizing antibodies last” after infection, she said. “What we know is that the vaccine tends to produce antibody titers towards the higher end of the spectrum,” suggesting better immunity with vaccination than after natural infection.

Q: Can patients of color feel safe getting the vaccine?

“People of color might be understandably reluctant to take a vaccine that was developed in a way that appears to be faster [than past development],” said Dr. Rasmussen. She said physicians should acknowledge and understand the history that has led them to feel that way, “everything from Tuskegee to Henrietta Lacks to today.”

Empathy is key, and “providers should meet patients where they are and not condescend to them.”

Dr. Kuppalli agreed. “Clinicians really need to work on trying to strip away their biases.”

Thus far there are no safety signals that differ by race or ethnicity, according to the companies. The Pfizer phase 3 trial enrolled just over 9% Black participants, 0.5% Native American/Alaska Native, 0.2% Native Hawaiian/Pacific Islander, 2.3% multiracial participants, and 28% Hispanic/Latinx. For its part, Moderna says that approximately 37% of participants in its phase 3 trial come from communities of color.

Q: What about children and pregnant women?

Although the trials included participants from many different age groups and backgrounds, children and pregnant or lactating women were not among them. Pfizer gained approval in October to include participants as young as age 12 years, and a Moderna spokesperson said in an interview that the company planned pediatric inclusion at the end of 2020, pending approval.

“Unfortunately, we don’t have data on pregnant and lactating women,” Dr. Kuppalli said. She said she hopes that public health organizations such as the CDC will address that in the coming weeks. Dr. Rasmussen called the lack of data in pregnant women and children “a big oversight.”

Dr. Rasmussen has disclosed no relevant financial relationships. Dr. Kuppalli is a consultant with GlaxoSmithKline.

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

With U.S. approval of one coronavirus vaccine likely imminent and approval of a second one expected soon after, physicians will likely be deluged with questions. Public attitudes about the vaccines vary by demographics, with a recent poll showing that men and older adults are more likely to choose vaccination, and women and people of color evincing more wariness.

Although the reasons for reluctance may vary, questions from patient will likely be similar. Some are related to the “warp speed” language about the vaccines. Other concerns arise from the fact that the platform – mRNA – has not been used in human vaccines before. And as with any vaccine, there are rumors and false claims making the rounds on social media.

In anticipation of the most common questions physicians may encounter, two experts, Krutika Kuppalli, MD, assistant professor of medicine in the division of infectious diseases at the Medical University of South Carolina, Charleston, and Angela Rasmussen, PhD, virologist and nonresident affiliate at Georgetown University’s Center for Global Health Science and Security, Washington, talked in an interview about what clinicians can expect and what evidence-based – as well as compassionate – answers might look like.
 

Q: Will this vaccine give me COVID-19?

“There is not an intact virus in there,” Dr. Rasmussen said. The mRNA-based vaccines cannot cause COVID-19 because they don’t use any part of the coronavirus itself. Instead, the Moderna and Pfizer vaccines contain manufactured mRNA molecules that carry the instructions for building the virus’ spike protein. After vaccine administration, the recipient’s own cells take up this mRNA, use it to build this bit of protein, and display it on their surfaces. The foreign protein flag triggers the immune system response.

The mRNA does not enter the cell nucleus or interact with the recipient’s DNA. And because it’s so fragile, it degrades quite quickly. To keep that from happening before cell entry, the mRNAs are cushioned in protective fats.

Q: Was this vaccine made too quickly?

“People have been working on this platform for 30 years, so it’s not that this is brand new,” Dr. Kuppalli said.

Researchers began working on mRNA vaccines in the 1990s. Technological developments in the last decade have meant that their use has become feasible, and they have been tested in animals against many viral diseases. The mRNA vaccines are attractive because they’re expected to be safe and easily manufactured from common materials. That’s what we’ve seen in the COVID-19 pandemic, the  Centers for Disease Control and Prevention says on its website. Design of the spike protein mRNA component began as soon as the viral genome became available in January.

Usually, rolling out a vaccine takes years, so less than a year under a program called Operation Warp Speed can seem like moving too fast, Dr. Rasmussen acknowledged. “The name has given people the impression that by going at warp speed, we’re cutting all the corners. [But] the reality is that Operation Warp Speed is mostly for manufacturing and distribution.”

What underlies the speed is a restructuring of the normal vaccine development process, Dr. Kuppalli said. The same phases of development – animal testing, a small initial human phase, a second for safety testing, a third large phase for efficacy – were all conducted as for any vaccine. But in this case, some phases were completed in parallel, rather than sequentially. This approach has proved so successful that there is already talk about making it the model for developing future vaccines.

Two other factors contributed to the speed, said Dr. Kuppalli and Dr. Rasmussen. First, gearing up production can slow a rollout, but with these vaccines, companies ramped up production even before anyone knew if the vaccines would work – the “warp speed” part. The second factor has been the large number of cases, making exposures more likely and thus accelerating the results of the efficacy trials. “There is so much COVID being transmitted everywhere in the United States that it did not take long to hit the threshold of events to read out phase 3,” Dr. Rasmussen said.

Q: This vaccine has never been used in humans. How do we know it’s safe?

The Pfizer phase 3 trial included more than 43,000 people, and Moderna’s had more than 30,000. The first humans received mRNA-based COVID-19 vaccines in March. The most common adverse events emerge right after a vaccination, Dr. Kuppalli said.

As with any vaccine that gains approval, monitoring will continue.

UK health officials have reported that two health care workers vaccinated in the initial rollout of the Pfizer vaccine had what seems to have been a severe allergic response. Both recipients had a history of anaphylactic allergic responses and carried EpiPens, and both recovered. During the trial, allergic reaction rates were 0.63% in the vaccine group and 0.51% in the placebo group.

As a result of the two reactions, UK regulators are now recommending that patients with a history of severe allergies not receive the vaccine at the current time.

Q: What are the likely side effects?

So far, the most common side effects are pain at the injection site and an achy, flu-like feeling, Dr. Kuppalli said. More severe reactions have been reported, but were not common in the trials.

Dr. Rasmussen noted that the common side effects are a good sign, and signal that the recipient is generating “a robust immune response.”

“Everybody I’ve talked to who’s had the response has said they would go through it again,” Dr. Kruppalli said. “I definitely plan on lining up and being one of the first people to get the vaccine.”

Q: I already had COVID-19 or had a positive antibody test. Do I still need to get the vaccine?

Dr. Rasmussen said that there are “too many unknowns” to say if a history of COVID-19 would make a difference. “We don’t know how long neutralizing antibodies last” after infection, she said. “What we know is that the vaccine tends to produce antibody titers towards the higher end of the spectrum,” suggesting better immunity with vaccination than after natural infection.

Q: Can patients of color feel safe getting the vaccine?

“People of color might be understandably reluctant to take a vaccine that was developed in a way that appears to be faster [than past development],” said Dr. Rasmussen. She said physicians should acknowledge and understand the history that has led them to feel that way, “everything from Tuskegee to Henrietta Lacks to today.”

Empathy is key, and “providers should meet patients where they are and not condescend to them.”

Dr. Kuppalli agreed. “Clinicians really need to work on trying to strip away their biases.”

Thus far there are no safety signals that differ by race or ethnicity, according to the companies. The Pfizer phase 3 trial enrolled just over 9% Black participants, 0.5% Native American/Alaska Native, 0.2% Native Hawaiian/Pacific Islander, 2.3% multiracial participants, and 28% Hispanic/Latinx. For its part, Moderna says that approximately 37% of participants in its phase 3 trial come from communities of color.

Q: What about children and pregnant women?

Although the trials included participants from many different age groups and backgrounds, children and pregnant or lactating women were not among them. Pfizer gained approval in October to include participants as young as age 12 years, and a Moderna spokesperson said in an interview that the company planned pediatric inclusion at the end of 2020, pending approval.

“Unfortunately, we don’t have data on pregnant and lactating women,” Dr. Kuppalli said. She said she hopes that public health organizations such as the CDC will address that in the coming weeks. Dr. Rasmussen called the lack of data in pregnant women and children “a big oversight.”

Dr. Rasmussen has disclosed no relevant financial relationships. Dr. Kuppalli is a consultant with GlaxoSmithKline.

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

Pfizer won’t be able to provide more COVID-19 vaccine doses to the United States until late June or July because other countries have bought up the available supply, according to The Washington Post.

The U.S. government signed a deal with the giant pharmaceutical company earlier this year to provide 100 million doses for $1.95 billion – enough for 50 million Americans to receive the two-dose vaccine. At that time, Pfizer officials encouraged Operation Warp Speed officials to purchase an additional 100 million doses, The New York Times first reported Dec. 7, but the federal officials declined.

Since then, other countries have signed vaccine deals with Pfizer, so the U.S. may not be able to receive a second major allotment until the summer of 2021, The Washington Post reported. Without a substantial number of additional doses, the U.S. may not be able to follow its schedule of vaccinating the majority of Americans against COVID-19 by April or May.

However, Trump administration officials told the newspaper that there won’t be issues, citing other vaccine companies such as Moderna.

“I’m not concerned about our ability to buy vaccines to offer to all of the American public,” Gen. Paul Ostrowski, who oversees logistics for Operation Warp Speed, told The Washington Post.

“It’s clear that Pfizer made plans with other countries. Many have been announced. We understand those pieces,” he said.

With Pfizer’s COVID-19 vaccine on the verge of FDA approval, federal officials contacted the company last weekend to buy another 100 million doses, but the company said its current supply is already committed, the newspaper reported.

The vaccine from Pfizer and BioNTech is expected to win emergency approval within days and has been shown to be effective against COVID-19.

Pfizer added that it may be able to provide 50 million doses at the end of the second quarter and another 50 million doses during the third quarter. However, the company can’t offer anything “substantial” until next summer.

Beyond the initial 100 million doses that the U.S. has already secured, Pfizer and federal officials would need to negotiate a new, “separate and mutually acceptable agreement,” Amy Rose, a spokeswoman for Pfizer, told the newspaper.

On Dec. 8, President Donald Trump was expected to sign an executive order prioritizing vaccination for Americans first before providing doses to other countries, according to Fox News.

The order will provide guidelines to the Department of Health and Human Services, the U.S. Agency for International Development and the U.S. International Development Finance Corporation for foreign assistance with vaccines, the news outlet reported.

It’s unclear whether the executive order is related to the Pfizer issue, whether the president can prevent a private company from fulfilling contracts with other countries, and whether President-elect Joe Biden will create his own policy, according to CNBC. The order may prove to be mostly symbolic.

The FDA could issue an emergency use authorization for Pfizer’s coronavirus vaccine this week and will likely approve Moderna’s vaccine next week. The U.S. has signed a contract with Moderna for 100 million doses.

During a call with reporters on Dec. 7, a spokeswoman for the Department of Health and Human Services said, “We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna.”

Federal officials are counting on vaccine candidates from AstraZeneca and Johnson & Johnson to seek FDA approval in January and be ready for shipment in February.

“We could have all of them,” Moncef Slaoui, the chief science adviser for Operation Warp Speed, told The Washington Post on Dec. 7.

“And for this reason, we feel confident we could cover the needs without a specific cliff,” he said. “We have planned things in such a way as we would indeed avoid a cliff.”

This article first appeared on WebMD.com.

Pfizer won’t be able to provide more COVID-19 vaccine doses to the United States until late June or July because other countries have bought up the available supply, according to The Washington Post.

The U.S. government signed a deal with the giant pharmaceutical company earlier this year to provide 100 million doses for $1.95 billion – enough for 50 million Americans to receive the two-dose vaccine. At that time, Pfizer officials encouraged Operation Warp Speed officials to purchase an additional 100 million doses, The New York Times first reported Dec. 7, but the federal officials declined.

Since then, other countries have signed vaccine deals with Pfizer, so the U.S. may not be able to receive a second major allotment until the summer of 2021, The Washington Post reported. Without a substantial number of additional doses, the U.S. may not be able to follow its schedule of vaccinating the majority of Americans against COVID-19 by April or May.

However, Trump administration officials told the newspaper that there won’t be issues, citing other vaccine companies such as Moderna.

“I’m not concerned about our ability to buy vaccines to offer to all of the American public,” Gen. Paul Ostrowski, who oversees logistics for Operation Warp Speed, told The Washington Post.

“It’s clear that Pfizer made plans with other countries. Many have been announced. We understand those pieces,” he said.

With Pfizer’s COVID-19 vaccine on the verge of FDA approval, federal officials contacted the company last weekend to buy another 100 million doses, but the company said its current supply is already committed, the newspaper reported.

The vaccine from Pfizer and BioNTech is expected to win emergency approval within days and has been shown to be effective against COVID-19.

Pfizer added that it may be able to provide 50 million doses at the end of the second quarter and another 50 million doses during the third quarter. However, the company can’t offer anything “substantial” until next summer.

Beyond the initial 100 million doses that the U.S. has already secured, Pfizer and federal officials would need to negotiate a new, “separate and mutually acceptable agreement,” Amy Rose, a spokeswoman for Pfizer, told the newspaper.

On Dec. 8, President Donald Trump was expected to sign an executive order prioritizing vaccination for Americans first before providing doses to other countries, according to Fox News.

The order will provide guidelines to the Department of Health and Human Services, the U.S. Agency for International Development and the U.S. International Development Finance Corporation for foreign assistance with vaccines, the news outlet reported.

It’s unclear whether the executive order is related to the Pfizer issue, whether the president can prevent a private company from fulfilling contracts with other countries, and whether President-elect Joe Biden will create his own policy, according to CNBC. The order may prove to be mostly symbolic.

The FDA could issue an emergency use authorization for Pfizer’s coronavirus vaccine this week and will likely approve Moderna’s vaccine next week. The U.S. has signed a contract with Moderna for 100 million doses.

During a call with reporters on Dec. 7, a spokeswoman for the Department of Health and Human Services said, “We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna.”

Federal officials are counting on vaccine candidates from AstraZeneca and Johnson & Johnson to seek FDA approval in January and be ready for shipment in February.

“We could have all of them,” Moncef Slaoui, the chief science adviser for Operation Warp Speed, told The Washington Post on Dec. 7.

“And for this reason, we feel confident we could cover the needs without a specific cliff,” he said. “We have planned things in such a way as we would indeed avoid a cliff.”

This article first appeared on WebMD.com.

Pfizer won’t be able to provide more COVID-19 vaccine doses to the United States until late June or July because other countries have bought up the available supply, according to The Washington Post.

The U.S. government signed a deal with the giant pharmaceutical company earlier this year to provide 100 million doses for $1.95 billion – enough for 50 million Americans to receive the two-dose vaccine. At that time, Pfizer officials encouraged Operation Warp Speed officials to purchase an additional 100 million doses, The New York Times first reported Dec. 7, but the federal officials declined.

Since then, other countries have signed vaccine deals with Pfizer, so the U.S. may not be able to receive a second major allotment until the summer of 2021, The Washington Post reported. Without a substantial number of additional doses, the U.S. may not be able to follow its schedule of vaccinating the majority of Americans against COVID-19 by April or May.

However, Trump administration officials told the newspaper that there won’t be issues, citing other vaccine companies such as Moderna.

“I’m not concerned about our ability to buy vaccines to offer to all of the American public,” Gen. Paul Ostrowski, who oversees logistics for Operation Warp Speed, told The Washington Post.

“It’s clear that Pfizer made plans with other countries. Many have been announced. We understand those pieces,” he said.

With Pfizer’s COVID-19 vaccine on the verge of FDA approval, federal officials contacted the company last weekend to buy another 100 million doses, but the company said its current supply is already committed, the newspaper reported.

The vaccine from Pfizer and BioNTech is expected to win emergency approval within days and has been shown to be effective against COVID-19.

Pfizer added that it may be able to provide 50 million doses at the end of the second quarter and another 50 million doses during the third quarter. However, the company can’t offer anything “substantial” until next summer.

Beyond the initial 100 million doses that the U.S. has already secured, Pfizer and federal officials would need to negotiate a new, “separate and mutually acceptable agreement,” Amy Rose, a spokeswoman for Pfizer, told the newspaper.

On Dec. 8, President Donald Trump was expected to sign an executive order prioritizing vaccination for Americans first before providing doses to other countries, according to Fox News.

The order will provide guidelines to the Department of Health and Human Services, the U.S. Agency for International Development and the U.S. International Development Finance Corporation for foreign assistance with vaccines, the news outlet reported.

It’s unclear whether the executive order is related to the Pfizer issue, whether the president can prevent a private company from fulfilling contracts with other countries, and whether President-elect Joe Biden will create his own policy, according to CNBC. The order may prove to be mostly symbolic.

The FDA could issue an emergency use authorization for Pfizer’s coronavirus vaccine this week and will likely approve Moderna’s vaccine next week. The U.S. has signed a contract with Moderna for 100 million doses.

During a call with reporters on Dec. 7, a spokeswoman for the Department of Health and Human Services said, “We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna.”

Federal officials are counting on vaccine candidates from AstraZeneca and Johnson & Johnson to seek FDA approval in January and be ready for shipment in February.

“We could have all of them,” Moncef Slaoui, the chief science adviser for Operation Warp Speed, told The Washington Post on Dec. 7.

“And for this reason, we feel confident we could cover the needs without a specific cliff,” he said. “We have planned things in such a way as we would indeed avoid a cliff.”

This article first appeared on WebMD.com.

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

Peripheral neuropathy is common in U.S. adults and is associated with an increased risk of death, even in the absence of diabetes, researchers reported  in Annals of Internal Medicine.

©mheim3011/thinkstockphotos.com

The findings do not necessarily mean that doctors should implement broader screening for peripheral neuropathy at this time, however, the investigators said.

“Doctors don’t typically screen for peripheral neuropathy in persons without diabetes,” senior author Elizabeth Selvin, PhD, MPH, professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health, Baltimore, said in an interview.

“Our study shows that peripheral neuropathy – as assessed by decreased sensation in the feet – is common, even in people without diabetes,” Dr. Selvin explained. “It is not yet clear whether we should be screening people without diabetes since we don’t have clear treatments, but our study does suggest that this condition is an underrecognized condition that is associated with poor outcomes.”

Patients with diabetes typically undergo annual foot examinations that include screening for peripheral neuropathy, but that’s not the case for most adults in the absence of diabetes.

“I don’t know if we can make the jump that we should be screening people without diabetes,” said first author Caitlin W. Hicks, MD, assistant professor of surgery, division of vascular surgery and endovascular therapy, Johns Hopkins University, Baltimore. “Right now, we do not exactly know what it means in the people without diabetes, and we definitely do not know how to treat it. So, screening for it will tell us that this person has this and is at higher risk of mortality than someone who doesn’t, but we do not know what to do with that information yet.”

Nevertheless, the study raises the question of whether physicians should pay more attention to peripheral neuropathy in people without diabetes, said Dr. Hicks, director of research at the university’s diabetic foot and wound service.
 

Heightened risk

To examine associations between peripheral neuropathy and all-cause and cardiovascular mortality in U.S. adults, Dr. Hicks and colleagues analyzed data from 7,116 adults aged 40 years or older who participated in the National Health and Nutrition Examination Survey (NHANES) between 1999 and 2004.

The study included participants who underwent monofilament testing for peripheral neuropathy. During testing, technicians used a standard 5.07 Semmes-Weinstein nylon monofilament to apply slight pressure to the bottom of each foot at three sites. If participants could not correctly identify where pressure was applied, the test was repeated. After participants gave two incorrect or undeterminable responses for a site, the site was defined as insensate. The researchers defined peripheral neuropathy as at least one insensate site on either foot.

The researchers determined deaths and causes of death using death certificate records from the National Death Index through 2015.

In all, 13.5% of the participants had peripheral neuropathy, including 27% of adults with diabetes and 11.6% of adults without diabetes. Those with peripheral neuropathy were older, were more likely to be male, and had lower levels of education, compared with participants without peripheral neuropathy. They also had higher body mass index, were more often former or current smokers, and had a higher prevalence of hypertension, hypercholesterolemia, and cardiovascular disease.

During a median follow-up of 13 years, 2,128 participants died, including 488 who died of cardiovascular causes.

The incidence rate of all-cause mortality per 1,000 person-years was 57.6 in adults with diabetes and peripheral neuropathy, 34.3 in adults with peripheral neuropathy but no diabetes, 27.1 in adults with diabetes but no peripheral neuropathy, and 13.0 in adults without diabetes or peripheral neuropathy.

Among participants with diabetes, the leading cause of death was cardiovascular disease (31% of deaths), whereas among participants without diabetes, the leading cause of death was malignant neoplasms (27% of deaths).

After adjustment for age, sex, race, or ethnicity, and risk factors such as cardiovascular disease, peripheral neuropathy was significantly associated with all-cause mortality (hazard ratio [HR], 1.49) and cardiovascular mortality (HR, 1.66) in participants with diabetes. In participants without diabetes, peripheral neuropathy was significantly associated with all-cause mortality (HR, 1.31), but its association with cardiovascular mortality was not statistically significant.

The association between peripheral neuropathy and all-cause mortality persisted in a sensitivity analysis that focused on adults with normoglycemia.
 

Related conditions

The study confirms findings from prior studies that examined the prevalence of loss of peripheral sensation in populations of older adults with and without diabetes, said Elsa S. Strotmeyer, PhD, MPH, associate professor of epidemiology at the University of Pittsburgh. “The clinical significance of the loss of peripheral sensation in older adults without diabetes is not fully appreciated,” she said.

A limitation of the study is that peripheral neuropathy was not a clinical diagnosis. “Monofilament testing at the foot is a quick clinical screen for decreased lower-extremity sensation that likely is a result of sensory peripheral nerve decline,” Dr. Strotmeyer said.

Another limitation is that death certificates are less accurate than medical records for determining cause of death.

“Past studies have indicated that peripheral nerve decline is related to common conditions in aging such as the metabolic syndrome and cardiovascular disease, cancer treatment, and physical function loss,” Dr. Strotmeyer said. “Therefore it is not surprising that is related to mortality as these conditions in aging are associated with increased mortality. Loss of peripheral sensation at the foot may also be related to fall injuries, and mortality from fall injuries has increased dramatically in older adults over the past several decades.”

Prior research has suggested that monofilament testing may play a role in screening for fall risk in older adults without diabetes, Dr. Strotmeyer added.

“For older adults both with and without diabetes, past studies have recommended monofilament testing be incorporated in geriatric screening for fall risk. Therefore, this article expands implications of clinical importance to understanding the pathology and consequences of loss of sensation at the foot in older patients,” she said.

The study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute. Dr. Hicks, Dr. Selvin, and a coauthor, Kunihiro Matsushita, MD, PhD, disclosed NIH grants. In addition, Dr. Selvin disclosed personal fees from Novo Nordisk and grants from the Foundation for the National Institutes of Health outside the submitted work, and Dr. Matsushita disclosed grants and personal fees from Fukuda Denshi outside the submitted work. Dr. Strotmeyer receives funding from the National Institute on Aging and the National Institute of Arthritis and Musculoskeletal and Skin Diseases and is chair of the health sciences section of the Gerontological Society of America.

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

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

COVID-19’s toll on member facilities pushed the American Academy of Sleep Medicine (AASM) recently to take a sizable gamble.

AASM announced in September that it would waive facility fees at all 2,648 AASM-accredited sleep facilities for 2021.

At $1,800-$2,600 for each facility, that will mean lost revenue of between $4.8 million and $6.9 million, but it’s a risk the academy felt it had to take.

AASM President Kannan Ramar, MBBS, MD, said in an interview that they are betting on the future of the field.

An internal survey of members, he said, found that nearly half (46%) of the 551 respondents thought they might have to close by the end of the year.

In addition, 66% reported a lower patient volume in the past month, and 36% reported that their practice or facility had to apply for loans or other financial assistance because of COVID-19, AASM said in its press release.

“We are hoping that if we help our members through this, they will be there for our patients,” Dr. Ramar said.

Other medical societies also are weighing options, straddling the line between needing income to provide resources for members but being acutely aware of the financial toll the pandemic is taking, according to one sampling.

As previously reported, primary care practices are projected to lose more than $68,000 in revenue per full-time physician in 2020, after steep drops in office visits and the collection of fees from March to May, according to a study led by researchers in the Blavatnik Institute at Harvard Medical School, Boston.

Those losses were calculated without considering a potential second wave of COVID-19 this year, the authors noted.
 

‘We can survive this’

Although AASM waived fees for its member facilities, individual physician fees have not been reduced so far. But the group is looking for more ways to help lower the economic burden on members, Dr. Ramar said.

“I don’t think we’ve ever been in this situation in the 45 years of the academy. This is a once-in-a-lifetime event for challenges we’re going through,” he said. “The board and the leadership realized that, if we’re going to do something, this is the time to do it.”

In addition to waiving the fees, AASM and the AASM Foundation are offering relief funding to state and regional sleep societies and research award recipients through programs created in response to COVID-19.

Some societies said they are not making changes to their dues or fees, some are forgoing cost-of-living fee increases, and some are waiving registration fees for annual meetings.

The American College of Allergy, Asthma and Immunology (ACAAI) waived most members’ registration fees for its annual meeting in November. Typically, that fee would be $500-$800 per member, plus charges for some premium sessions, Michael Blaiss, MD, ACAAI executive medical director, said.

Dr. Blaiss said in an interview that the college thought offering its 6,000 members essentially 25 free hours of CME would benefit them more than waiving annual membership dues, which are about $425 for physicians in the United States.

If the pandemic stretches through 2021, Dr. Blaiss said, “We can survive this. I’m not worried about that at all.”

But he acknowledged the painful effect on medical societies.

“I don’t think any organization would tell you it’s not having an effect on their income,” he said. “I know it is for us and for virtually any medical organization. A high percentage of income comes from the annual meeting.”

Waiving dues has not been a high priority among members in communications so far, Blaiss said.

American Academy of Dermatology President Bruce H. Thiers, MD, said in an interview that there will be no cost-of-living increase for 2021 dues, and AAD members can request a reduction in dues, which will be considered on a case-by-case basis.

“We understand that many members will have to make tough financial decisions,” he said.

In addition, AAD, which has more than 20,000 members, is exploring payment options to help members spread out the cost of membership.
 

ACP extends membership

The American College of Physicians, whose membership cycle starts in July, did not reduce dues but extended membership at no cost for 3 months through September to its 163,000 members, Phil Masters, MD, ACP’s vice president of membership, said in an interview.

It also expanded its educational offerings related to the pandemic, including webinars on physician wellness and issues regarding telemedicine.

He said expanding educational resources rather than waiving dues was an intentional decision after much discussion because “we’re primarily a services resource organization.”

Membership data are still being calculated, but early indications are that membership is not increasing this year, after seeing annual growth of about 2%-2.5%, Dr. Masters said. He noted that income is down “by several percent.” Annual membership dues average about $500 for physicians who have been practicing for 10 years.

“We’re well positioned to tolerate the ups and downs,” he said, but he acknowledged that “there’s no question the financial impact has been devastating on some practices.”

Like some other associations, ACP decided to cancel this year’s annual meeting, which had been planned for April. The 2021 annual meeting will be conducted online from April 29 to May 1.

Smaller organizations that rely heavily on income from the annual meeting will be severely challenged the longer the pandemic continues, Dr. Masters said.

The decision is not as simple as whether to reduce or eliminate dues, he noted. Organizations will have to reexamine their missions and structure their fees and offerings according to the needs of members.

“It’s a balance in doing things for the community at large and balancing the need to be sensitive to financial implications,” Dr. Masters said.

This article first appeared on Medscape.com.

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

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

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

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

Americans have made no secret of their skepticism of COVID-19 vaccines this year, with fears of political interference and a “warp speed” timeline blunting confidence in the shots. As recently as September, nearly half of U.S. adults said they didn’t intend to be inoculated.

But with two promising vaccines primed for release, likely within weeks, experts in ethics and immunization behavior say they expect attitudes to shift quickly from widespread hesitancy to urgent, even heated demand.

“People talk about the antivaccine people being able to kind of squelch uptake. I don’t see that happening,” Dr. Paul Offit, MD, a vaccinologist with Children’s Hospital of Philadelphia, told viewers of a recent JAMA Network webinar. “This, to me, is more like the Beanie Baby phenomenon. The attractiveness of a limited edition.”

Reports that vaccines produced by drugmakers Pfizer and BioNTech and Moderna appear to be safe and effective, along with the deliberate emphasis on science-based guidance from the incoming Biden administration, are likely to reverse uncertainty in a big way, said Arthur Caplan, PhD, director of the division of medical ethics at New York University.

“I think that’s going to flip the trust issue,” he said.

The shift is already apparent. A new poll by the Pew Research Center found that by the end of November 60% of Americans said they would get a vaccine for the coronavirus. This month, even as a federal advisory group met to hash out guidelines for vaccine distribution, a long list of advocacy groups – from those representing home-based health workers and community health centers to patients with kidney disease – were lobbying state and federal officials in hopes their constituents would be prioritized for the first scarce doses.

“As we get closer to the vaccine being a reality, there’s a lot of jockeying, to be sure,” said Katie Smith Sloan, chief executive of LeadingAge, a nonprofit organization pushing for staff and patients at long-term care centers to be included in the highest-priority category.

Certainly, some consumers remain wary, said Rupali Limaye, PhD, a social and behavioral health scientist at the Johns Hopkins Bloomberg School of Public Health, Baltimore. Fears that drugmakers and regulators might cut corners to speed a vaccine linger, even as details of the trials become public and the review process is made more transparent. Some health care workers, who are at the front of the line for the shots, are not eager to go first.

“There will be people who will say, ‘I will wait a little bit more for safety data,” Dr. Limaye said.

But those doubts likely will recede once the vaccines are approved for use and begin to circulate broadly, said Dr. Offit, who sits on the Food and Drug Administration advisory panel set to review the requests for emergency authorization Pfizer and Moderna have submitted.

He predicted demand for the COVID vaccines could rival the clamor that occurred in 2004, when production problems caused a severe shortage of flu shots just as influenza season began. That led to long lines, rationed doses and ethical debates over distribution.

“That was a highly desired vaccine,” Dr. Offit said. “I think in many ways that might happen here.”

Initially, vaccine supplies will be tight, with federal officials planning to ship 6.4 million doses within 24 hours of FDA authorization and up to 40 million doses by the end of the year. The CDC panel recommended that the first shots go to the 21 million health care workers in the United States and 3 million nursing home staff and residents, before being rolled out to other groups based on a hierarchy of risk factors.

Even before any vaccine is available, some people are trying to boost their chances of access, said Allison Kempe, MD, a professor of pediatrics at the University of Coloradoat Denver, Aurora, and expert in vaccine dissemination. “People have called me and said, ‘How can I get the vaccine?’” she said. “I think that not everyone will be happy to wait, that’s for sure. I don’t think there will be rioting in the streets, but there may be pressure brought to bear.”

That likely will include emotional debates over how, when, and to whom next doses should be distributed, said Dr. Caplan. Under the CDC recommendations, vulnerable groups next in line include 87 million workers whose jobs are deemed “essential” – a broad and ill-defined category – as well as 53 million adults age 65 and older.

“We’re going to have some fights about high-risk groups,” Dr. Caplan said.

The conversations will be complicated. Should prisoners, who have little control over their COVID exposure, get vaccine priority? How about professional sports teams, whose performance could bolster society’s overall morale? And what about residents of facilities providing care for people with intellectual and developmental disabilities, who are three times more likely to die from COVID-19 than the general population?

Control over vaccination allocation rests with the states, so that’s where the biggest conflicts will occur, Dr. Caplan said. “It’s a short fight, I hope, in the sense in which it gets done in a few months, but I think it will be pretty vocal.”

Once vaccine supplies become more plentiful, perhaps by May or June, another consideration is sure to boost demand: requirements for proof of COVID vaccination for work and travel.

“It’s inevitable that you’re going to see immunity passports or that you’re required to show a certificate on the train, airplane, bus, or subway,” Dr. Caplan predicted. “Probably also to enter certain hospitals, probably to enter certain restaurants and government facilities.”

But with a grueling winter surge ahead, and new predictions that COVID-19 will fell as many as 450,000 Americans by February, the tragic reality of the disease will no doubt fuel ample demand for vaccination.

“People now know someone who has gotten COVID, who has been hospitalized or has unfortunately died,” Dr. Limaye said.

“We’re all seeing this now,” said Dr. Kempe. “Even deniers are beginning to see what this illness can do.”

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

A tiny bit of light may have broken though the COVID-19 storm clouds.

The number of new cases in children in the United States did not set a new weekly high for the first time in months and the cumulative proportion of COVID-19 cases occurring in children did not go up for the first time since the pandemic started, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of reported COVID-19 cases in children is now up to 1.46 million, and the overall rate is 1,941 per 100,000 children. Comparable figures for states show that California has the most cumulative cases at over 139,000 and that North Dakota has the highest rate at over 6,800 per 100,000 children. Vermont, the state with the smallest child population, has the fewest cases (687) and the lowest rate (511 per 100,000), the report said.

The total number of COVID-19–related deaths in children has reached 154 in the 44 jurisdictions (43 states and New York City) reporting such data. That number represents 0.06% of all coronavirus deaths, a proportion that has changed little – ranging from 0.04% to 0.07% – over the course of the pandemic, the AAP and CHA said.

rfranki@mdedge.com

A tiny bit of light may have broken though the COVID-19 storm clouds.

The number of new cases in children in the United States did not set a new weekly high for the first time in months and the cumulative proportion of COVID-19 cases occurring in children did not go up for the first time since the pandemic started, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of reported COVID-19 cases in children is now up to 1.46 million, and the overall rate is 1,941 per 100,000 children. Comparable figures for states show that California has the most cumulative cases at over 139,000 and that North Dakota has the highest rate at over 6,800 per 100,000 children. Vermont, the state with the smallest child population, has the fewest cases (687) and the lowest rate (511 per 100,000), the report said.

The total number of COVID-19–related deaths in children has reached 154 in the 44 jurisdictions (43 states and New York City) reporting such data. That number represents 0.06% of all coronavirus deaths, a proportion that has changed little – ranging from 0.04% to 0.07% – over the course of the pandemic, the AAP and CHA said.

rfranki@mdedge.com

A tiny bit of light may have broken though the COVID-19 storm clouds.

The number of new cases in children in the United States did not set a new weekly high for the first time in months and the cumulative proportion of COVID-19 cases occurring in children did not go up for the first time since the pandemic started, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The total number of reported COVID-19 cases in children is now up to 1.46 million, and the overall rate is 1,941 per 100,000 children. Comparable figures for states show that California has the most cumulative cases at over 139,000 and that North Dakota has the highest rate at over 6,800 per 100,000 children. Vermont, the state with the smallest child population, has the fewest cases (687) and the lowest rate (511 per 100,000), the report said.

The total number of COVID-19–related deaths in children has reached 154 in the 44 jurisdictions (43 states and New York City) reporting such data. That number represents 0.06% of all coronavirus deaths, a proportion that has changed little – ranging from 0.04% to 0.07% – over the course of the pandemic, the AAP and CHA said.

rfranki@mdedge.com