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CDC: Vaccinated people can gather indoors without masks
People who are fully vaccinated against COVID-19 can safely gather unmasked and inside with nonvulnerable people who are not yet immunized, according to long-awaited guidance released by the CDC.
“Today’s action represents an important first step. It is not our final destination,” CDC Director Rochelle Walensky, MD, said March 8 at a White House briefing. “As more people get vaccinated, levels of COVID-19 infection decline in communities, and as our understanding of COVID immunity improves, we look forward to updating these recommendations to the public.”
According to the new guidance, people who are at least 2 weeks out from their last dose can:
- Visit with other fully vaccinated people indoors without wearing masks or physical distancing.
- Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing
- Avoid quarantine and testing following exposure to someone if they remain asymptomatic.
However, there are still restrictions that will remain until further data are collected. Those who are fully vaccinated must still:
- Wear masks and physically distance in public settings and around people at high risk for severe disease.
- Wear masks and physically distance when visiting unvaccinated people from more than one household.
- Avoid medium- and large-sized gatherings.
- Avoid travel.
People considered at high risk for severe disease include older adults and those with cancer, chronic kidney disease, COPD, Down syndrome, heart disease, heart failure, a weakened immune system, obesity, sickle cell disease, and type 2 diabetes. The category also includes pregnant women and smokers.
“In public spaces, fully vaccinated people should continue to follow guidance to protect themselves and others, including wearing a well-fitted mask, physical distancing (at least 6 feet), avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, washing hands often, and following any applicable workplace or school guidance,” the guidance says. “Fully vaccinated people should still watch for symptoms of COVID-19, especially following an exposure to someone with suspected or confirmed COVID-19.”
Respecting travel restrictions is still crucial, Dr. Walensky said, given past surges and variants that have emerged after periods of increased travel.
"We would like to give the opportunity for vaccinated grandparents to visit children and grandchildren who are healthy and local,” Dr. Walensky said.
But, she said, “It’s important to realize as we’re working through this that over 90% of the population is not yet vaccinated.”
For now, there are not enough data on transmission rates from those who are vaccinated to the rest of the public. However, Anthony Fauci, MD, said at a briefing last month that preliminary data are “pointing in a very favorable direction.”
Studies from Spain and Israel published last month showed the amount of viral load – or the amount of the COVID-19 virus in someone’s body – is significantly lower if someone gets infected after they’ve been vaccinated, compared with people who get infected and didn’t have the vaccine. Lower viral load means much lower chances of passing the virus to someone else, Dr. Fauci said.
“The science of COVID-19 is complex,” Dr. Walensky said, “and our understanding of it continues to evolve.”
A version of this article first appeared on WebMD.com.
People who are fully vaccinated against COVID-19 can safely gather unmasked and inside with nonvulnerable people who are not yet immunized, according to long-awaited guidance released by the CDC.
“Today’s action represents an important first step. It is not our final destination,” CDC Director Rochelle Walensky, MD, said March 8 at a White House briefing. “As more people get vaccinated, levels of COVID-19 infection decline in communities, and as our understanding of COVID immunity improves, we look forward to updating these recommendations to the public.”
According to the new guidance, people who are at least 2 weeks out from their last dose can:
- Visit with other fully vaccinated people indoors without wearing masks or physical distancing.
- Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing
- Avoid quarantine and testing following exposure to someone if they remain asymptomatic.
However, there are still restrictions that will remain until further data are collected. Those who are fully vaccinated must still:
- Wear masks and physically distance in public settings and around people at high risk for severe disease.
- Wear masks and physically distance when visiting unvaccinated people from more than one household.
- Avoid medium- and large-sized gatherings.
- Avoid travel.
People considered at high risk for severe disease include older adults and those with cancer, chronic kidney disease, COPD, Down syndrome, heart disease, heart failure, a weakened immune system, obesity, sickle cell disease, and type 2 diabetes. The category also includes pregnant women and smokers.
“In public spaces, fully vaccinated people should continue to follow guidance to protect themselves and others, including wearing a well-fitted mask, physical distancing (at least 6 feet), avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, washing hands often, and following any applicable workplace or school guidance,” the guidance says. “Fully vaccinated people should still watch for symptoms of COVID-19, especially following an exposure to someone with suspected or confirmed COVID-19.”
Respecting travel restrictions is still crucial, Dr. Walensky said, given past surges and variants that have emerged after periods of increased travel.
"We would like to give the opportunity for vaccinated grandparents to visit children and grandchildren who are healthy and local,” Dr. Walensky said.
But, she said, “It’s important to realize as we’re working through this that over 90% of the population is not yet vaccinated.”
For now, there are not enough data on transmission rates from those who are vaccinated to the rest of the public. However, Anthony Fauci, MD, said at a briefing last month that preliminary data are “pointing in a very favorable direction.”
Studies from Spain and Israel published last month showed the amount of viral load – or the amount of the COVID-19 virus in someone’s body – is significantly lower if someone gets infected after they’ve been vaccinated, compared with people who get infected and didn’t have the vaccine. Lower viral load means much lower chances of passing the virus to someone else, Dr. Fauci said.
“The science of COVID-19 is complex,” Dr. Walensky said, “and our understanding of it continues to evolve.”
A version of this article first appeared on WebMD.com.
People who are fully vaccinated against COVID-19 can safely gather unmasked and inside with nonvulnerable people who are not yet immunized, according to long-awaited guidance released by the CDC.
“Today’s action represents an important first step. It is not our final destination,” CDC Director Rochelle Walensky, MD, said March 8 at a White House briefing. “As more people get vaccinated, levels of COVID-19 infection decline in communities, and as our understanding of COVID immunity improves, we look forward to updating these recommendations to the public.”
According to the new guidance, people who are at least 2 weeks out from their last dose can:
- Visit with other fully vaccinated people indoors without wearing masks or physical distancing.
- Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing
- Avoid quarantine and testing following exposure to someone if they remain asymptomatic.
However, there are still restrictions that will remain until further data are collected. Those who are fully vaccinated must still:
- Wear masks and physically distance in public settings and around people at high risk for severe disease.
- Wear masks and physically distance when visiting unvaccinated people from more than one household.
- Avoid medium- and large-sized gatherings.
- Avoid travel.
People considered at high risk for severe disease include older adults and those with cancer, chronic kidney disease, COPD, Down syndrome, heart disease, heart failure, a weakened immune system, obesity, sickle cell disease, and type 2 diabetes. The category also includes pregnant women and smokers.
“In public spaces, fully vaccinated people should continue to follow guidance to protect themselves and others, including wearing a well-fitted mask, physical distancing (at least 6 feet), avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, washing hands often, and following any applicable workplace or school guidance,” the guidance says. “Fully vaccinated people should still watch for symptoms of COVID-19, especially following an exposure to someone with suspected or confirmed COVID-19.”
Respecting travel restrictions is still crucial, Dr. Walensky said, given past surges and variants that have emerged after periods of increased travel.
"We would like to give the opportunity for vaccinated grandparents to visit children and grandchildren who are healthy and local,” Dr. Walensky said.
But, she said, “It’s important to realize as we’re working through this that over 90% of the population is not yet vaccinated.”
For now, there are not enough data on transmission rates from those who are vaccinated to the rest of the public. However, Anthony Fauci, MD, said at a briefing last month that preliminary data are “pointing in a very favorable direction.”
Studies from Spain and Israel published last month showed the amount of viral load – or the amount of the COVID-19 virus in someone’s body – is significantly lower if someone gets infected after they’ve been vaccinated, compared with people who get infected and didn’t have the vaccine. Lower viral load means much lower chances of passing the virus to someone else, Dr. Fauci said.
“The science of COVID-19 is complex,” Dr. Walensky said, “and our understanding of it continues to evolve.”
A version of this article first appeared on WebMD.com.
How to make resident mental health care stigma free
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.
Sarah Sofka, MD, FACP, noticed a pattern. As program director for the internal medicine (IM) residency at West Virginia University, Morgantown, she was informed when residents were sent to counseling because they were affected by burnout, depression, or anxiety. When trainees returned from these visits, many told her the same thing: They wished they had sought help sooner.
IM residents and their families had access to free counseling at WVU, but few used the resource, says Dr. Sofka. “So, we thought, let’s just schedule all of our residents for a therapy visit so they can go and see what it’s like,” she said. “This will hopefully decrease the stigma for seeking mental health care. If everybody’s going, it’s not a big deal.”
In July 2015, Dr. Sofka and her colleagues launched a universal well-being assessment program for the IM residents at WVU. The program leaders automatically scheduled first- and second-year residents for a visit to the faculty staff assistance program counselors. The visits were not mandatory, and residents could choose not to go; but if they did go, they received the entire day of their visit off from work.
Five and a half years after launching their program, Dr. Sofka and her colleagues conducted one of the first studies of the efficacy of an opt-out approach for resident mental wellness. They found that , suggesting that residents were seeking help proactively after having to at least consider it.
Opt-out counseling is a recent concept in residency programs – one that’s attracting interest from training programs across the country. Brown University, Providence, R.I.; the University of Colorado at Denver, Aurora; University of Pennsylvania, Philadelphia; and the University of California, San Francisco have at least one residency program that uses the approach.
Lisa Meeks, PhD, an assistant professor of family medicine at Michigan Medicine, in Ann Arbor, and other experts also believe opt-out counseling could decrease stigma and help normalize seeking care for mental health problems in the medical community while lowering the barriers for trainees who need help.
No time, no access, plenty of stigma
Burnout and mental health are known to be major concerns for health care workers, especially trainees. College graduates starting medical education have lower rates of burnout and depression, compared with demographically matched peers; however, once they’ve started training, medical students, residents, and fellows are more likely to be burned out and exhibit symptoms of depression. The ongoing COVID-19 pandemic is further fraying the well-being of overworked and traumatized health care professionals, and experts predict a mental health crisis will follow the viral crisis.
The Accreditation Council for Graduate Medical Education recently mandated that programs offer wellness services to trainees. Yet this doesn’t mean they are always used; well-known barriers stand between residents, medical students, and physicians and their receiving effective mental health treatment.
Two of the most obvious are access and time, given the grueling and often inflexible schedules of most trainees, says Jessica Gold, MD, a psychiatrist at Washington University, St. Louis, who specializes in treating medical professionals. Dr. Gold also points out that, to be done correctly, these programs require institutional support and investment – resources that aren’t always adequate.
“A lack of transparency and clear messaging around what is available, who provides the services, and how to access these services can be a major barrier,” says Erene Stergiopoulos, MD, a second-year psychiatry resident at the University of Toronto. In addition, there can be considerable lag between when a resident realizes they need help and when they manage to find a provider and schedule an appointment, says Dr. Meeks.
Even when these logistical barriers are overcome, trainees and physicians have to contend with the persistent stigma associated with mental health treatment in the culture of medicine, says Dr. Gold. A recent survey by the American College of Emergency Physicians found that 73% of surveyed physicians feel there is stigma in their workplace about seeking mental health treatment. Many state medical licensing boards still require physicians to disclose mental health treatment, which discourages many trainees and providers from seeking proactive care, says Mary Moffit, PhD, associate professor of psychiatry and director of the resident and faculty wellness program at Oregon Health & Science University, Portland.
How the opt-out approach works
“The idea is by making it opt-out, you really normalize it,” says Maneesh Batra, MD, MPH, associate director of the University of Washington, Seattle, Children’s Hospital residency program. Similar approaches have proven effective at shaping human behavior in other health care settings, including boosting testing rates for HIV and increasing immunization rates for childhood vaccines, Dr. Batra says.
In general, opt-out programs acknowledge that people are busy and won’t take that extra step or click that extra button if they don’t have to, says Oana Tomescu, MD, PhD, associate professor of clinical medicine and pediatrics at the University of Pennsylvania, Philadelphia.
In 2018, Dr. Sofka and her colleagues at WVU conducted a survey that showed that a majority of residents thought favorably of their opt-out program and said they would return to counseling for follow-up care. In their most recent study, published in the Journal of Graduate Medical Education in 2021, Dr. Sofka and her colleagues found that residents did just that – only 8 of 239 opted out of universally scheduled visits. Resident-initiated visits increased significantly from zero during the 2014-2015 academic year to 23 in 2018-2019. Between those periods, program-mandated visits decreased significantly from 12 to 3.
The initiative has succeeded in creating a culture of openness and caring at WVU, says 2nd-year internal medicine resident Nistha Modi, MD. “It sets the tone for the program – we talk about mental health openly,” says Dr. Modi.
Crucially, the counselors work out of a different building than the hospital where Dr. Modi and her fellow residents work and use a separate electronic medical record system to protect resident privacy. This is hugely important for medical trainees, note Dr. Tomescu, Dr. Gold, and many other experts. The therapists understand residency and medical education, and there is no limit to the number of visits a resident or fellow can make with the program counselors, says Dr. Modi.
Opt-out programs offer a counterbalance to many negative tendencies in residency, says Dr. Meeks. “We’ve normalized so many things that are not healthy and productive. ... We need to counterbalance that with normalizing help seeking. And it’s really difficult to normalize something that’s not part of a system.”
Costs, concerns, and systematic support
Providing unlimited, free counseling for trainees can be very beneficial, but it requires adequate funding and personnel resources. Offering unlimited access means that an institution has to follow through in making this degree of care available while also ensuring that the system doesn’t get overwhelmed or is unable to accommodate very sick individuals, says Dr. Gold.
Another concern that experts like Dr. Batra, Dr. Moffit, and Dr. Gold share is that residents who go to their scheduled appointments may not completely buy into the experience because it wasn’t their idea in the first place. Participation alone doesn’t necessarily indicate full acceptance. Program personnel don’t intend for these appointments to be thought of as mandatory, yet residents may still experience them that way. Several leading resident well-being programs instead emphasize outreach to trainees, institutional support, and accessible mental health resources that are – and feel – entirely voluntary.
“If I tell someone that they have to do something, it’s very different than if they arrive at that conclusion for themselves,” says Dr. Batra. “That’s how life works.”
When it comes to cost, a recent study published in Academic Medicine provides encouraging data. At the University of Colorado, an opt-out pilot program for IM and pediatrics interns during the 2017-2018 academic year cost just $940 total, equal to $11.75 per intern. As in West Virginia, the program in Colorado covered the cost of the visit, interns were provided a half day off (whether they attended their appointment or not), and the visits and surveys were entirely optional and confidential. During the 1-year pilot program, 29% of 80 interns attended the scheduled appointment, 56% opted out in advance, and 15% didn’t show up. The majority of interns who were surveyed (85%), however, thought the program should continue and that it had a positive effect on their wellness even if they didn’t attend their appointment.
In West Virginia, program costs are higher. The program has $20,000 in annual funding to cover the opt-out program and unlimited counseling visits for residents and fellows. With that funding, Dr. Sofka and her colleagues were also able to expand the program slightly last year to schedule all the critical care faculty for counseling visits. Cost is a barrier to expanding these services to the entire institution, which Dr. Sofka says she hopes to do one day.
Research in this area is still preliminary. The WVU and Colorado studies provide some of the first evidence in support of an opt-out approach. Eventually, it would be beneficial for multicenter studies and longitudinal research to track the effects of such programs over time, say Dr. Sofka and Ajay Major, MD, MBA, one of the study’s coauthors and a hematology/oncology fellow at the University of Chicago.
Whether a program goes with an opt-out approach or not, the systematic supports – protecting resident privacy, providing flexible scheduling, and more – are crucial.
As Dr. Tomescu notes, wellness shouldn’t be just something trainees have to do. “The key with really working on burnout at a huge level is for all programs and schools to recognize that it’s a shared responsibility.”
“I felt very fortunate that I was able to get some help throughout residency,” says Dr. Modi. “About how to be a better daughter. How to be content with things I have in life. How to be happy, and grateful. With the kind of job we have, I think we sometimes forget to be grateful.”
A version of this article first appeared on Medscape.com.
RECOVERY trial of COVID-19 treatments stops colchicine arm
On the advice of its independent data monitoring committee (DMC), the RECOVERY trial has stopped recruitment to the colchicine arm for lack of efficacy in patients hospitalized with COVID-19.
“The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any prespecified subgroup,” the British investigators announced on March 5.
“The RECOVERY trial has already identified two anti-inflammatory drugs – dexamethasone and tocilizumab – that improve the chances of survival for patients with severe COVID-19. So, it is disappointing that colchicine, which is widely used to treat gout and other inflammatory conditions, has no effect in these patients,” cochief investigator Martin Landray, MBChB, PhD, said in a statement.
“We do large, randomized trials to establish whether a drug that seems promising in theory has real benefits for patients in practice. Unfortunately, colchicine is not one of those,” said Dr. Landry, University of Oxford (England).
The RECOVERY trial is evaluating a range of potential treatments for COVID-19 at 180 hospitals in the United Kingdom, Indonesia, and Nepal, and was designed with the expectation that drugs would be added or dropped as the evidence changes. Since November 2020, the trial has included an arm comparing colchicine with usual care alone.
As part of a routine meeting March 4, the DMC reviewed data from a preliminary analysis based on 2,178 deaths among 11,162 patients, 94% of whom were being treated with a corticosteroid such as dexamethasone.
The results showed no significant difference in the primary endpoint of 28-day mortality in patients randomized to colchicine versus usual care alone (20% vs. 19%; risk ratio, 1.02; 95% confidence interval, 0.94-1.11; P = .63).
Follow-up is ongoing and final results will be published as soon as possible, the investigators said. Thus far, there has been no convincing evidence of an effect of colchicine on clinical outcomes in hospitalized COVID-19 patients.
Recruitment will continue to all other treatment arms – aspirin, baricitinib, Regeneron’s antibody cocktail, and, in select hospitals, dimethyl fumarate – the investigators said.
Cochief investigator Peter Hornby, MD, PhD, also from the University of Oxford, noted that this has been the largest trial ever of colchicine. “Whilst we are disappointed that the overall result is negative, it is still important information for the future care of patients in the U.K. and worldwide.”
A version of this article first appeared on Medscape.com.
On the advice of its independent data monitoring committee (DMC), the RECOVERY trial has stopped recruitment to the colchicine arm for lack of efficacy in patients hospitalized with COVID-19.
“The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any prespecified subgroup,” the British investigators announced on March 5.
“The RECOVERY trial has already identified two anti-inflammatory drugs – dexamethasone and tocilizumab – that improve the chances of survival for patients with severe COVID-19. So, it is disappointing that colchicine, which is widely used to treat gout and other inflammatory conditions, has no effect in these patients,” cochief investigator Martin Landray, MBChB, PhD, said in a statement.
“We do large, randomized trials to establish whether a drug that seems promising in theory has real benefits for patients in practice. Unfortunately, colchicine is not one of those,” said Dr. Landry, University of Oxford (England).
The RECOVERY trial is evaluating a range of potential treatments for COVID-19 at 180 hospitals in the United Kingdom, Indonesia, and Nepal, and was designed with the expectation that drugs would be added or dropped as the evidence changes. Since November 2020, the trial has included an arm comparing colchicine with usual care alone.
As part of a routine meeting March 4, the DMC reviewed data from a preliminary analysis based on 2,178 deaths among 11,162 patients, 94% of whom were being treated with a corticosteroid such as dexamethasone.
The results showed no significant difference in the primary endpoint of 28-day mortality in patients randomized to colchicine versus usual care alone (20% vs. 19%; risk ratio, 1.02; 95% confidence interval, 0.94-1.11; P = .63).
Follow-up is ongoing and final results will be published as soon as possible, the investigators said. Thus far, there has been no convincing evidence of an effect of colchicine on clinical outcomes in hospitalized COVID-19 patients.
Recruitment will continue to all other treatment arms – aspirin, baricitinib, Regeneron’s antibody cocktail, and, in select hospitals, dimethyl fumarate – the investigators said.
Cochief investigator Peter Hornby, MD, PhD, also from the University of Oxford, noted that this has been the largest trial ever of colchicine. “Whilst we are disappointed that the overall result is negative, it is still important information for the future care of patients in the U.K. and worldwide.”
A version of this article first appeared on Medscape.com.
On the advice of its independent data monitoring committee (DMC), the RECOVERY trial has stopped recruitment to the colchicine arm for lack of efficacy in patients hospitalized with COVID-19.
“The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any prespecified subgroup,” the British investigators announced on March 5.
“The RECOVERY trial has already identified two anti-inflammatory drugs – dexamethasone and tocilizumab – that improve the chances of survival for patients with severe COVID-19. So, it is disappointing that colchicine, which is widely used to treat gout and other inflammatory conditions, has no effect in these patients,” cochief investigator Martin Landray, MBChB, PhD, said in a statement.
“We do large, randomized trials to establish whether a drug that seems promising in theory has real benefits for patients in practice. Unfortunately, colchicine is not one of those,” said Dr. Landry, University of Oxford (England).
The RECOVERY trial is evaluating a range of potential treatments for COVID-19 at 180 hospitals in the United Kingdom, Indonesia, and Nepal, and was designed with the expectation that drugs would be added or dropped as the evidence changes. Since November 2020, the trial has included an arm comparing colchicine with usual care alone.
As part of a routine meeting March 4, the DMC reviewed data from a preliminary analysis based on 2,178 deaths among 11,162 patients, 94% of whom were being treated with a corticosteroid such as dexamethasone.
The results showed no significant difference in the primary endpoint of 28-day mortality in patients randomized to colchicine versus usual care alone (20% vs. 19%; risk ratio, 1.02; 95% confidence interval, 0.94-1.11; P = .63).
Follow-up is ongoing and final results will be published as soon as possible, the investigators said. Thus far, there has been no convincing evidence of an effect of colchicine on clinical outcomes in hospitalized COVID-19 patients.
Recruitment will continue to all other treatment arms – aspirin, baricitinib, Regeneron’s antibody cocktail, and, in select hospitals, dimethyl fumarate – the investigators said.
Cochief investigator Peter Hornby, MD, PhD, also from the University of Oxford, noted that this has been the largest trial ever of colchicine. “Whilst we are disappointed that the overall result is negative, it is still important information for the future care of patients in the U.K. and worldwide.”
A version of this article first appeared on Medscape.com.
MIS-C follow-up proves challenging across pediatric hospitals
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
The discovery of any novel disease or condition means a steep learning curve as physicians must develop protocols for diagnosis, management, and follow-up on the fly in the midst of admitting and treating patients. Medical society task forces and committees often release interim guidance during the learning process, but each institution ultimately has to determine what works for them based on their resources, clinical experience, and patient population.
But when the novel condition demands the involvement of multiple different specialties, the challenge of management grows even more complex – as does follow-up after patients are discharged. Such has been the story with multisystem inflammatory syndrome in children (MIS-C), a complication of COVID-19 that shares some features with Kawasaki disease.
The similarities to Kawasaki provided physicians a place to start in developing appropriate treatment regimens and involved a similar interdisciplinary team from, at the least, cardiology and rheumatology, plus infectious disease since MIS-C results from COVID-19.
“It literally has it in the name – multisystem essentially hints that there are multiple specialties involved, multiple hands in the pot trying to manage the kids, and so each specialty has their own kind of unique role in the patient’s care even on the outpatient side,” said Samina S. Bhumbra, MD, an infectious disease pediatrician at Riley Hospital for Children and assistant professor of clinical pediatrics at Indiana University in Indianapolis. “This isn’t a disease that falls under one specialty.”
By July, the American College of Rheumatology had issued interim clinical guidance for management that most children’s hospitals have followed or slightly adapted. But ACR guidelines could not address how each institution should handle outpatient follow-up visits, especially since those visits required, again, at least cardiology and rheumatology if not infectious disease or other specialties as well.
“When their kids are admitted to the hospital, to be told at discharge you have to be followed up by all these specialists is a lot to handle,” Dr. Bhumbra said. But just as it’s difficult for parents to deal with the need to see several different doctors after discharge, it can be difficult at some institutions for physicians to design a follow-up schedule that can accommodate families, especially families who live far from the hospital in the first place.
“Some of our follow-up is disjointed because all of our clinics had never been on the same day just because of staff availability,” Dr. Bhumbra said. “But it can be a 2- to 3-hour drive for some of our patients, depending on how far they’re coming.”
Many of them can’t make that drive more than once in the same month, much less the same week.
“If you have multiple visits, it makes it more likely that they’re not showing up,” said Ryan M. Serrano, MD, a pediatric cardiologist at Riley and assistant professor of pediatrics at Indiana University. Riley used telehealth when possible, especially if families could get labs done near home. But pediatric echocardiograms require technicians who have experience with children, so families need to come to the hospital.
Children’s hospitals have therefore had to adapt scheduling strategies or develop pediatric specialty clinics to coordinate across the multiple departments and accommodate a complex follow-up regimen that is still evolving as physicians learn more about MIS-C.
Determining a follow-up regimen
Even before determining how to coordinate appointments, hospitals had to decide what follow-up itself should be.
“How long do we follow these patients and how often do we follow them?” said Melissa S. Oliver, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University.
“We’re seeing that a lot of our patients rapidly respond when they get appropriate therapy, but we don’t know about long-term outcomes yet. We’re all still learning.”
At Children’s Hospital of Philadelphia, infectious disease follows up 4-6 weeks post discharge. The cardiology division came up with a follow-up plan that has evolved over time, said Matthew Elias, MD, an attending cardiologist at CHOP’s Cardiac Center and clinical assistant professor of pediatrics at the University of Pennsylvania, Philadelphia.
Patients get an EKG and echocardiogram at 2 weeks and, if their condition is stable, 6 weeks after discharge. After that, it depends on the patient’s clinical situation. Patients with moderately diminished left ventricular systolic function are recommended to get an MRI scan 3 months after discharge and, if old enough, exercise stress tests. Otherwise, they are seen at 6 months, but that appointment is optional for those whose prior echos have consistently been normal.
Other institutions, including Riley, are following a similar schedule of 2-week, 6-week, and 6-month postdischarge follow-ups, and most plan to do a 1-year follow-up as well, although that 1-year mark hasn’t arrived yet for most. Most do rheumatology labs at the 2-week appointment and use that to determine steroids management and whether labs are needed at the 6-week appointment. If labs have normalized, they aren’t done at 6 months. Small variations in follow-up management exist across institutions, but all are remaining open to changes. Riley, for example, is considering MRI screening for ongoing cardiac inflammation at 6 months to a year for all patients, Dr. Serrano said.
The dedicated clinic model
The two challenges Riley needed to address were the lack of a clear consensus on what MIS-C follow-up should look like and the need for continuity of care, Dr. Serrano said.
Regular discussion in departmental meetings at Riley “progressed from how do we take care of them and what treatments do we give them to how do we follow them and manage them in outpatient,” Dr. Oliver said. In the inpatient setting, they had an interdisciplinary team, but how could they maintain that for outpatients without overwhelming the families?
“I think the main challenge is for the families to identify who is leading the care for them,” said Martha M. Rodriguez, MD, a rheumatologist at Riley and assistant professor of clinical pediatrics at Indiana University. That sometimes led to families picking which follow-up appointments they would attend and which they would skip if they could not make them all – and sometimes they skipped the more important ones. “They would go to the appointment with me and then miss the cardiology appointments and the echocardiogram, which was more important to follow any abnormalities in the heart,” Dr. Rodriguez said.
After trying to coordinate separate follow-up appointments for months, Riley ultimately decided to form a dedicated clinic for MIS-C follow-up – a “one-stop shop” single appointment at each follow-up, Dr. Bhumbra said, that covers labs, EKG, echocardiogram, and any other necessary tests.
“Our goal with the clinic is to make life easier for the families and to be able to coordinate the appointments,” Dr. Rodriguez said. “They will be able to see the three of us, and it would be easier for us to communicate with each other about their plan.”
The clinic began Feb. 11 and occurs twice a month. Though it’s just begun, Dr. Oliver said the first clinic went well, and it’s helping them figure out the role each specialty needs to play in follow-up care.
“For us with rheumatology, after lab values have returned to normal and they’re off steroids, sometimes we think there isn’t much more we can contribute to,” she said. And then there are the patients who didn’t see any rheumatologists while inpatients.
“That’s what we’re trying to figure out as well,” Dr. Oliver said. “Should we be seeing every single kid regardless of whether we were involved in their inpatient [stay] or only seeing the ones we’ve seen?” She expects the coming months will help them work that out.
Texas Children’s Hospital in Houston also uses a dedicated clinic, but they set it up before the first MIS-C patient came through the doors, said Sara Kristen Sexson Tejtel, MD, a pediatric cardiologist at Texas Children’s. The hospital already has other types of multidisciplinary clinics, and they anticipated the challenge of getting families to come to too many appointments in a short period of time.
“Getting someone to come back once is hard enough,” Dr. Sexson Tejtel said. “Getting them to come back twice is impossible.”
Infectious disease is less involved at Texas Children’s, so it’s primarily Dr. Sexson Tejtel and her rheumatologist colleague who see the patients. They hold the clinic once a week, twice if needed.
“It does make the appointment a little longer, but I think the patients appreciate that everything can be addressed with that one visit,” Dr. Sexson Tejtel said. “Being in the hospital as long as some of these kids are is so hard, so making any of that easy as possible is so helpful.” A single appointment also allows the doctors to work together on what labs are needed so that children don’t need multiple labs drawn.
At the appointment, she and the rheumatologist enter the patient’s room and take the patient’s history together.
“It’s nice because it makes the family not to have to repeat things and tell the same story over and over,” she said. “Sometimes I ask questions that then the rheumatologist jumps off of, and then sometimes he’ll ask questions, and I’ll think, ‘Ooh, I’ll ask more questions about that.’ ”
In fact, this team approach at all clinics has made her a more thoughtful, well-rounded physician, she said.
“I have learned so much going to all of my multidisciplinary clinics, and I think I’m able to better care for my patients because I’m not just thinking about it from a cardiac perspective,” she said. “It takes some work, but it’s not hard and I think it is beneficial both for the patient and for the physician. This team approach is definitely where we’re trying to live right now.”
Separate but coordinated appointments
A dedicated clinic isn’t the answer for all institutions, however. At Children’s Hospital of Philadelphia, the size of the networks and all its satellites made a one-stop shop impractical.
“We talked about a consolidated clinic early on, when MIS-C was first emerging and all our groups were collaborating and coming up with our inpatient and outpatient care pathways,” said Sanjeev K. Swami, MD, an infectious disease pediatrician at CHOP and associate professor of clinical pediatrics at the University of Pennsylvania. But timing varies on when each specialist wants to see the families return, and existing clinic schedules and locations varied too much.
So CHOP coordinates appointments individually for each patient, depending on where the patient lives and sometimes stacking them on the same day when possible. Sometimes infectious disease or rheumatology use telehealth, and CHOP, like the other hospitals, prioritizes cardiology, especially for the patients who had cardiac abnormalities in the hospital, Dr. Swami said.
“All three of our groups try to be as flexible as possible. We’ve had a really good collaboration between our groups,” he said, and spreading out follow-up allows specialists to ask about concerns raised at previous appointments, ensuring stronger continuity of care.
“We can make sure things are getting followed up on,” Dr. Swami said. “I think that has been beneficial to make sure things aren’t falling through the cracks.”
CHOP cardiologist Dr. Elias said that ongoing communication, among providers and with families, has been absolutely crucial.
“Everyone’s been talking so frequently about our MIS-C patients while inpatient that by the time they’re an outpatient, it seems to work smoothly, where families are hearing similar items but with a different flair, one from infectious, one from rheumatology, and one from cardiology,” he said.
Children’s Mercy in Kansas City, Mo., also has multiple satellite clinics and follows a model similar to that of CHOP. They discussed having a dedicated multidisciplinary team for each MIS-C patient, but even the logistics of that were difficult, said Emily J. Fox, MD, a rheumatologist and assistant professor of pediatrics at the University of Missouri-Kansas City.
Instead, Children’s Mercy tries to coordinate follow-up appointments to be on the same day and often use telehealth for the rheumatology appointments. Families that live closer to the hospital’s location in Joplin, Mo., go in for their cardiology appointment there, and then Dr. Fox conducts a telehealth appointment with the help of nurses in Joplin.
“We really do try hard, especially since these kids are in the hospital for a long time, to make the coordination as easy as possible,” Dr. Fox said. “This was all was very new, especially in the beginning, but I think at least our group is getting a little bit more comfortable in managing these patients.”
Looking ahead
The biggest question that still looms is what happens to these children, if anything, down the line.
“What was unique about this was this was a new disease we were all learning about together with no baseline,” Dr. Swami said. “None of us had ever seen this condition before.”
So far, the prognosis for the vast majority of children is good. “Most of these kids survive, most of them are doing well, and they almost all recover,” Dr. Serrano said. Labs tend to normalize by 6 weeks post discharge, if not much earlier, and not much cardiac involvement is showing up at later follow-ups. But not even a year has passed, so there’s plenty to learn. “We don’t know if there’s long-term risk. I would not be surprised if 20 years down the road we’re finding out things about this that we had no idea” about, Dr. Serrano said. “Everybody wants answers, and nobody has any, and the answers we have may end up being wrong. That’s how it goes when you’re dealing with something you’ve never seen.”
Research underway will ideally begin providing those answers soon. CHOP is a participating site in an NIH-NHLBI–sponsored study, called COVID MUSIC, that is tracking long-term outcomes for MIS-C at 30 centers across the United States and Canada for 5 years.
“That will really definitely be helpful in answering some of the questions about long-term outcomes,” Dr. Elias said. “We hope this is going to be a transient issue and that patients won’t have any long-term manifestations, but we don’t know that yet.”
Meanwhile, one benefit that has come out of the pandemic is strong collaboration, Dr. Bhumbra said.
“The biggest thing we’re all eagerly waiting and hoping for is standard guidelines on how best to follow-up on these kids, but I know that’s a ways away,” Dr. Bhumbra said. So for now, each institution is doing what it can to develop protocols that they feel best serve the patients’ needs, such as Riley’s new dedicated MIS-C clinic. “It takes a village to take care of these kids, and MIS-C has proven that having a clinic with all three specialties at one clinic is going to be great for the families.”
Dr. Fox serves on a committee for Pfizer unrelated to MIS-C. No other doctors interviewed for this story had relevant conflicts of interest to disclose.
Dining restrictions, mask mandates tied to less illness, death, CDC reaffirms
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The numbers are in to back up two policies designed to restrict the spread of the COVID-19 pandemic.
Researchers at the Centers for Disease Control and Prevention) found that when states lifted restrictions on dining on premises at restaurants, rates of daily COVID-19 cases jumped 41-100 days later. COVID-19-related deaths also increased significantly after 60 days.
On the other hand, the same report demonstrates that state mask mandates slowed the spread of SARS-CoV-2 within a few weeks.
The study was published online March 5 in the CDC Morbidity and Mortality Weekly Report.
The investigators did not distinguish between outdoor and indoor restaurant dining. But they did compare COVID-19 case and death rates before and after most states banned restaurants from serving patrons on-premises in March and April 2020.
They found, for example, that COVID-19 daily cases increased by 0.9% at 41-60 days after on-premise dining was permitted. Similarly, rates jumped by 1.2% at 61-80 days, and 1.1% at 81-100 days after the restaurant restrictions were lifted.
The differences were statistically significant, with P values of .02, <.01, and .04, respectively.
COVID-19–related death rates did not increase significantly at first – but did jump 2.2% between 61 and 80 days after the return of on-premises dining, for example. Deaths also increased by 3% at 81-100 days.
Both these differences were statistically significant (P < .01).
This is not the first report where the CDC announced reservations about in-person dining. In September 2020, CDC investigators implicated the inability to wear a mask while eating and drinking as likely contributing to the heightened risk.
Masks make a difference
The CDC report also provided more evidence to back mask-wearing policies for public spaces. Between March 1 and Dec. 31, 2020, 74% of U.S. counties issued mask mandates.
Investigators found that these policies had a more immediate effect, reducing daily COVID-19 cases by 0.5% in the first 20 days. Mask mandates likewise were linked to daily cases dropping 1.1% between 21 and 40 days, 1.5% between 41 and 60 days, 1.7% between 61 and 80 days, and 1.8% between 81 and 100 days.
These decreases in daily COVID-19 cases were statistically significant (P < .01) compared with a reference period before March 1, 2020.
The CDC also linked mask mandates to lower mortality. For example, these state policies were associated with 0.7% fewer deaths at 1-20 days post implementation. The effect increased thereafter – 1.0% drop at 21-40 days, 1.4% decrease at 41-60 days, 1.6% drop between 61 and 80 days, and 1.9% fewer deaths between 81 and 100 days.
The decrease in deaths was statistically significant at 1-20 days after the mask mandate (P = .03), as well as during the other periods (each P < .01) compared with the reference period.
CDC Director Rochelle Walensky, MD, reacted to the new findings at a White House press briefing. She cited how increases in COVID-19 cases and death rates “slowed significantly within 20 days of putting mask mandates into place. This is why I’m asking you to double down on prevention measures.
“We have seen this movie before,” Dr. Walensky added. “When prevention measures like mask-wearing mandates are lifted, cases go up.”
Recently, multiple states have announced plans to roll back restrictions related to the pandemic, including mask mandates, which prompted warnings from some public health officials.
These are not the first CDC data to show that mask mandates make a difference.
In February 2021, for example, the agency pointed out that state-wide mask mandates reduced COVID-19 hospitalizations by 5.5% among adults 18-64 years old within 3 weeks of implementation.
Restrictions regarding on-premises restaurant dining and implementation of state-wide mask mandates are two tactics within a more comprehensive CDC strategy to reduce the spread of SARS-CoV-2. The researchers note that “such efforts are increasingly important given the emergence of highly transmissible SARS-CoV-2 variants in the United States.”
The researchers have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Primary care clinicians neglect hearing loss, survey finds
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
But asking a single question – “Do you think you have hearing loss?” – may be an efficient way to identify patients who should receive further evaluation, researchers said.
Only 20% of adults aged 50-80 years report that their primary care physician has asked about their hearing in the past 2 years, according to the National Poll on Healthy Aging, published online March 2. Among adults who rated their hearing as fair or poor, only 26% said they had been asked about their hearing.
Michael McKee, MD, MPH, a family medicine physician and health services researcher at Michigan Medicine, the University of Michigan’s academic medical center, and colleagues surveyed 2,074 adults aged 50-80 years in June 2020. They asked participants about the screening and testing of hearing that they had undergone. The researchers weighted the sample to reflect population figures from the U.S. Census Bureau.
Men were more likely than women to have been asked about their hearing (24% vs. 17%), and adults aged 65-80 years were more likely than younger adults to have been asked about their hearing (25% vs. 16%).
The survey also found that 23% of adults had undergone a hearing test by a health care professional; 62% felt that it was at least somewhat important to have their hearing tested at least once every 2 years.
Overall, 16% of adults rated their hearing as fair or poor. Approximately a third rated their hearing as good, and about half rated their hearing as excellent or very good. Fair or poor hearing was more commonly reported by men than women (20% vs. 12%) and by older adults than younger adults (19% vs. 14%).
In all, 6% used a hearing aid or cochlear implant. Of the adults who used these devices, 13% rated their hearing as fair or poor.
Those with worse physical or mental health were more likely to rate their hearing as fair or poor and were less likely to have undergone testing.
Although “screening for hearing loss is expected as part of the Medicare Annual Wellness Visit,” the data suggest that most adults aged 65-80 years have not been screened recently, the researchers say.
“One efficient way to increase hearing evaluations among older adults in primary care is to use a single-question screener,” Dr. McKee and coauthors wrote.
“The response to the question ‘Do you think you have hearing loss?’ has been shown to be highly predictive of true hearing loss ... Age-related hearing loss remains a neglected primary care and public health concern. Consistent use of screening tools and improved access to assistive devices that treat hearing loss can enhance the health and well-being of older adults,” they wrote.
Philip Zazove, MD, chair of the department of family medicine at the University of Michigan, Ann Arbor, and one of the authors of the report, noted in a news release that health insurance coverage varies widely for hearing screening by primary care providers, testing by audiologists, and hearing aids and cochlear implants.
Implementing the single-question screener is “easy to do,” Dr. Zazove said in an interview. “The major barrier is remembering, considering all the things primary care needs to do.” Electronic prompts may be an effective reminder.
If a patient answers yes, then clinicians should discuss referral for testing. Still, some patients may not be ready for further testing or treatment, possibly owing to vanity, misunderstandings, or cultural barriers, Dr. Zazove said. “Unfortunately, most physicians are not comfortable dealing with hearing loss. We get relatively little education on that in medical school and even residency,” he said.
“Hearing screening isn’t difficult,” and primary care providers can accomplish it “with one quick screening question – as the authors note,” said Jan Blustein, MD, PhD, professor of health policy and medicine at New York University. “I believe that some providers may be reluctant to screen or make a referral because they know that many people can’t afford hearing aids ... However, I also believe that many providers just don’t appreciate how disabling hearing loss is. And many didn’t receive training in this area in medical school. Training in disability gets very short shrift at most schools, in my experience. This needs to change.”
The survey does not address whether screening practices for hearing loss has changed during the COVID-19 pandemic, though Dr. Zazove suspects that screening has decreased as a result. Even if patients are screened, some may not present for audiology testing “because of fear of COVID or the audiologist not being open,” he said.
Hearing loss is associated with increased risk for hospitalization and readmission, dementia, and depression. “We believe, though studies are needed to verify, that detection and intervention for these patients can ameliorate the adverse health, social, and economic outcomes,” Dr. Zazove said.
A version of this article first appeared on Medscape.com.
Routine vaccinations missed by older adults during pandemic
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
Physicians are going to have to play catch-up when it comes to getting older patients their routine, but important, vaccinations missed during the pandemic.
and have recovered only partially and gradually, according to a report by Kai Hong, PhD, and colleagues at the Centers for Disease Control and Prevention, published in the Morbidity and Mortality Weekly Report. “As the pandemic continues,” the investigators stated, “vaccination providers should continue efforts to resolve disruptions in routine adult vaccination.”
The CDC issued guidance recommending postponement of routine adult vaccination in response to the March 13, 2020, COVID-19 national emergency declaration by the U.S. government and also to state and local shelter-in-place orders. Health care facility operations were restricted because of safety concerns around exposure to the SARS-CoV-2 virus. The result was a significant drop in routine medical care including adult vaccinations.
The investigators examined Medicare enrollment and claims data to assess the change in weekly receipt of four routine adult vaccines by Medicare beneficiaries aged ≥65 during the pandemic: (13-valent pneumococcal conjugate vaccine [PCV13], 23-valent pneumococcal polysaccharide vaccine [PPSV23], tetanus-diphtheria or tetanus-diphtheria-acellular pertussis vaccine [Td/Tdap], and recombinant zoster vaccine [RZV]). The comparison periods were Jan. 6–July 20, 2019, and Jan. 5–July 18, 2020.
Of the Medicare enrollees in the study sample, 85% were White, 7% Black, 2% Asian, 2% Hispanic, and 4% other racial and ethnic groups. For each of the four vaccines overall, weekly rates of vaccination declined sharply after the emergency declaration, compared with corresponding weeks in 2019. In the period prior to the emergency declaration (Jan. 5–March 14, 2020), weekly percentages of Medicare beneficiaries vaccinated with PPSV23, Td/Tdap, and RZV were consistently higher than rates during the same period in 2019.
After the March 13 declaration, while weekly vaccination rates plummeted 25% for PPSV23 and 62% for RZV in the first week, the greatest weekly declines were during April 5-11, 2020, for PCV13, PPSV23, and Td/Tdap, and during April 12-18, 2020, for RZV. The pandemic weekly vaccination rate nadirs revealed declines of 88% for PCV13, 80% for PPSV23, 70% for Td/Tdap, and 89% for RZV.
Routine vaccinations increased midyear
Vaccination rates recovered gradually. For the most recently assessed pandemic week (July 12-18, 2020), the rate for PPSV23 was 8% higher than in the corresponding period in 2019. Weekly corresponding rates for other examined vaccines, however, remained much lower than in 2019: 44% lower for RZV, 24% lower for Td/Tdap and 43% lower for PCV13. The CDC Advisory Committee on Immunization Practices voted in June 2019 to stop recommending PCV13 for adults aged ≥65 years and so vaccination with PCV13 among this population declined in 2020, compared with that in 2019.
Another significant drop in the rates of adult vaccinations may have occurred because of the surge in COVID-19 infections in the fall of 2020 and subsequent closures and renewal of lockdown in many localities.
Disparities in routine vaccination trends
Dr. Hong and colleagues noted that their findings are consistent with prior reports of declines in pediatric vaccine ordering, administration, and coverage during the pandemic. While the reductions were similar across all racial and ethnic groups, the magnitudes of recovery varied, with vaccination rates lower among racial and ethnic minority adults than among White adults.
In view of the disproportionate COVID-19 pandemic effects among some racial and ethnic minorities, the investigators recommended monitoring and subsequent early intervention to mitigate similar indirect pandemic effects, such as reduced utilization of other preventive services. “Many members of racial and ethnic minority groups face barriers to routine medical care, which means they have fewer opportunities to receive preventive interventions such as vaccination,” Dr. Hong said in an interview. “When clinicians are following up with patients who have missed vaccinations, it is important for them to remember that patients may face new barriers to vaccination such as loss of income or health insurance, and to work with them to remove those barriers,” he added.
“If vaccination is deferred, older adults and adults with underlying medical conditions who subsequently become infected with a vaccine-preventable disease are at increased risk for complications,” Dr. Hong said. “The most important thing clinicians can do is identify patients who are due for or who have missed vaccinations, and contact them to schedule visits. Immunization Information Systems and electronic health records may be able to support this work. In addition, the vaccination status of all patients should be assessed at every health care visit to reduce missed opportunities for vaccination.”
FROM MMWR
BMI, age, and sex affect COVID-19 vaccine antibody response
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The capacity to mount humoral immune responses to COVID-19 vaccinations may be reduced among people who are heavier, older, and male, new findings suggest.
The data pertain specifically to the mRNA vaccine, BNT162b2, developed by BioNTech and Pfizer. The study was conducted by Italian researchers and was published Feb. 26 as a preprint.
The study involved 248 health care workers who each received two doses of the vaccine. Of the participants, 99.5% developed a humoral immune response after the second dose. Those responses varied by body mass index (BMI), age, and sex.
“The findings imply that female, lean, and young people have an increased capacity to mount humoral immune responses, compared to male, overweight, and older populations,” Raul Pellini, MD, professor at the IRCCS Regina Elena National Cancer Institute, Rome, and colleagues said.
“To our knowledge, this study is the first to analyze Covid-19 vaccine response in correlation to BMI,” they noted.
“Although further studies are needed, this data may have important implications to the development of vaccination strategies for COVID-19, particularly in obese people,” they wrote. If the data are confirmed by larger studies, “giving obese people an extra dose of the vaccine or a higher dose could be options to be evaluated in this population.”
Results contrast with Pfizer trials of vaccine
The BMI finding seemingly contrasts with final data from the phase 3 clinical trial of the vaccine, which were reported in a supplement to an article published Dec. 31, 2020, in the New England Journal of Medicine. In that study, vaccine efficacy did not differ by obesity status.
Akiko Iwasaki, PhD, professor of immunology at the Howard Hughes Medical Institute and an investigator at Yale University, New Haven, Conn., noted that, although the current Italian study showed somewhat lower levels of antibodies in people with obesity, compared with people who did not have obesity, the phase 3 trial found no difference in symptomatic infection rates.
“These results indicate that even with a slightly lower level of antibody induced in obese people, that level was sufficient to protect against symptomatic infection,” Dr. Iwasaki said in an interview.
Indeed, Dr. Pellini and colleagues pointed out that responses to vaccines against influenza, hepatitis B, and rabies are also reduced in those with obesity, compared with lean individuals.
However, they said, it was especially important to study the effectiveness of COVID-19 vaccines in people with obesity, because obesity is a major risk factor for morbidity and mortality in COVID-19.
“The constant state of low-grade inflammation, present in overweight people, can weaken some immune responses, including those launched by T cells, which can directly kill infected cells,” the authors noted.
Findings reported in British newspapers
The findings of the Italian study were widely covered in the lay press in the United Kingdom, with headlines such as “Pfizer Vaccine May Be Less Effective in People With Obesity, Says Study” and “Pfizer Vaccine: Overweight People Might Need Bigger Dose, Italian Study Says.” In tabloid newspapers, some headlines were slightly more stigmatizing.
The reports do stress that the Italian research was published as a preprint and has not been peer reviewed, or “is yet to be scrutinized by fellow scientists.”
Most make the point that there were only 26 people with obesity among the 248 persons in the study.
“We always knew that BMI was an enormous predictor of poor immune response to vaccines, so this paper is definitely interesting, although it is based on a rather small preliminary dataset,” Danny Altmann, PhD, a professor of immunology at Imperial College London, told the Guardian.
“It confirms that having a vaccinated population isn’t synonymous with having an immune population, especially in a country with high obesity, and emphasizes the vital need for long-term immune monitoring programs,” he added.
Antibody responses differ by BMI, age, and sex
In the Italian study, the participants – 158 women and 90 men – were assigned to receive a priming BNT162b2 vaccine dose with a booster at day 21. Blood and nasopharyngeal swabs were collected at baseline and 7 days after the second vaccine dose.
After the second dose, 99.5% of participants developed a humoral immune response; one person did not respond. None tested positive for SARS-CoV-2.
Titers of SARS-CoV-2–binding antibodies were greater in younger than in older participants. There were statistically significant differences between those aged 37 years and younger (453.5 AU/mL) and those aged 47-56 years (239.8 AU/mL; P = .005), those aged 37 years and younger versus those older than 56 years (453.5 vs 182.4 AU/mL; P < .0001), and those aged 37-47 years versus those older than 56 years (330.9 vs. 182.4 AU/mL; P = .01).
Antibody response was significantly greater for women than for men (338.5 vs. 212.6 AU/mL; P = .001).
Humoral responses were greater in persons of normal-weight BMI (18.5-24.9 kg/m2; 325.8 AU/mL) and those of underweight BMI (<18.5 kg/m2; 455.4 AU/mL), compared with persons with preobesity, defined as BMI of 25-29.9 (222.4 AU/mL), and those with obesity (BMI ≥30; 167.0 AU/mL; P < .0001). This association remained after adjustment for age (P = .003).
“Our data stresses the importance of close vaccination monitoring of obese people, considering the growing list of countries with obesity problems,” the researchers noted.
Hypertension was also associated with lower antibody titers (P = .006), but that lost statistical significance after matching for age (P = .22).
“We strongly believe that our results are extremely encouraging and useful for the scientific community,” Dr. Pellini and colleagues concluded.
The authors disclosed no relevant financial relationships. Dr. Iwasaki is a cofounder of RIGImmune and is a member of its scientific advisory board.
This article was updated on 3/8/21.
A version of this article first appeared on Medscape.com.
The Physician Support Line: One psychiatrist strives to make a difference
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
Have you ever had a really good idea about how to improve the delivery of mental health services? An idea that would help people, but that would require passion, innovation, and hard work to implement, and one that immediately is beset with a list of reasons why it can not be implemented?
Mona Masood, DO, had an idea. The Pennsylvania psychiatrist was asked to help moderate a Facebook group started by one of her infectious disease colleagues last winter – a private Facebook group for physicians working with COVID-19 patients.
“The group was getting posts from frontline workers about how depressed and hopeless they were feeling.” Dr. Masood said. “People were posting about how they were having escape fantasies and how they regretted becoming physicians. It became clear that there was a need for more support.”
psychiatrist volunteers would take calls from physicians who needed someone to talk to – the psychiatrist would provide a sympathetic ear and have a list of resources, but this would be support, not treatment. There would be no prescriptions, no treatment relationship, no reporting to licensing boards or employers. The calls would be anonymous.
She posted her idea on the Facebook group, and the response was immediate. “There were a lot of emails – 200 psychiatrists responded saying: “Sign me up.” A Zoom meeting was set up, and the process was set in motion.
Dr. Masood used a Google document for weekly sign-ups so the volunteer psychiatrists could choose times. “We had to pay for an upgraded Google suite package for that many users. Getting this up and running was like the saying about building a plane as you fly it,” Dr. Masood said. “It forced so much so quickly because there was this acknowledgment that the need was there.”
Initially, the support line launched with a telehealth platform, but there was a problem. “Many doctors don’t want to be seen; they worry about being recognized.” Dr. Masood researched hotline phone services and was able to get one for a reduced fee. The volunteers have an App on their smartphones that enables them to log in at the start of their shifts and log out at the end. In addition to the logistics of coordinating the volunteers – now numbering over 700 – the group found a health care law firm that provided pro bono services to review the policies and procedures.
Now that the support line is running, Dr. Masood is able to set up the day’s volunteers for the support line connection in a few minutes each morning, but the beginning was not easy. Her private practice transitioned to telemedicine, and her two children were home with one in virtual school. “At first, it was like another full-time job.” She still remains available for trouble-shooting during the day. It’s a project she has taken on with passion.
The support line began as a response to watching colleagues struggle with COVID. Since it launched, there have been approximately 2,000 calls. Calls typically last for 20 to 90 minutes, and no one has called with a suicidal crisis. It is now open to doctors and medical students looking for support for any reason. “Physicians call with all kinds of issues. In the first 3 months, it was COVID, but then they called with other concerns – there were doctors who called with election anxiety, really anything that affects the general public also affects us.”
The group has also offered Saturday didactic sessions for volunteers and weekly debriefing sessions. Dr. Masood has been approached by Vibrant Emotional Health, the administrator of the National Suicide Prevention Lifeline, about resources to help with funding – until now, this endeavor has had no financing – and she is hopeful that their financial support will allow the support line to sustain itself and grow. Future directions include advocating for systemic change in how physician mental health and wellness issues are addressed.
The Physician Support Line was one psychiatrist’s vision for how to address a problem. Like so many things related to this pandemic, it happened quickly and with surprising efficiency. Implementing this service, however, was not easy – it required hard work, innovative thinking, and passion. Those looking for someone to listen can call 1-888-409-0141 and psychiatrists who wish to volunteer can sign up at physiciansupportline.com/volunteer-info.
Dr. Miller is coauthor of “Committed: The Battle Over Involuntary Psychiatric Care” (Johns Hopkins University Press, 2018). She has a private practice and is assistant professor of psychiatry and behavioral sciences at Johns Hopkins University, both in Baltimore.
ACIP recommendations for COVID-19 vaccines—and more
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
The year 2020 was challenging for public health agencies and especially for the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP). In a normal year, the ACIP meets in person 3 times for a total of 6 days of deliberations. In 2020, there were 10 meetings (all but 1 using Zoom) covering 14 days. Much of the time was dedicated to the COVID-19 pandemic, the vaccines being developed to prevent COVID-19, and the prioritization of those who should receive the vaccines first.
The ACIP also made recommendations for the use of influenza vaccines in the 2020-2021 season, approved the adult and pediatric immunization schedules for 2021, and approved the use of 2 new vaccines, one to protect against meningococcal meningitis and the other to prevent Ebola virus disease. The influenza recommendations were covered in the October 2020 Practice Alert,1 and the immunization schedules can be found on the CDC website at www.cdc.gov/vaccines/schedules/hcp/index.html.
COVID-19 vaccines
Two COVID-19 vaccines have been approved for use in the United States. The first was the Pfizer-BioNTech COVID-19 vaccine, approved by the Food and Drug Administration (FDA) on December 11 and recommended for use by the ACIP on December 12.2 The second vaccine, from Moderna, was approved by the FDA on December 18 and recommended by the ACIP on December 19.3 Both were approved by the FDA under an Emergency Use Authorization (EUA) and were approved by the ACIP for use while the EUA is in effect. Both vaccines must eventually undergo regular approval by the FDA and will be reconsidered by the ACIP regarding use in non–public health emergency conditions. A description of the EUA process and measures taken to assure efficacy and safety, before and after approval, were discussed in the September 2020 audiocast.
Both COVID-19 vaccines consist of nucleoside-modified mRNA encapsulated with lipid nanoparticles, which encode for a spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both vaccines require 2 doses (separated by 3 weeks for the Pfizer vaccine and 4 weeks for the Moderna vaccine) and are approved for use only in adults and older adolescents (ages ≥ 16 years for the Pfizer vaccine and ≥ 18 years for the Moderna vaccine) (TABLE 12-5).
In anticipation of vaccine shortages immediately after approval for use and a high demand for the vaccine, the ACIP developed a list of high-priority groups who should receive the vaccine in ranked order.6 States are encouraged, but not required, to follow this priority list (TABLE 26).
Caveats with usage. Both COVID-19 vaccines are very reactogenic, causing local and systemic adverse effects that patients should be warned about (TABLE 37,8). These reactions are usually mild to moderate and last 24 hours or less. Acetaminophen can alleviate these symptoms but should not be used to prevent them. In addition, both vaccines have stringent cold-storage requirements; once the vaccines are thawed, they must be used within a defined time-period.
Neither vaccine is listed as preferred. And they are not interchangeable; both recommended doses should be completed with the same vaccine. More details about the use of these vaccines were discussed in the January 2021 audiocast (www.mdedge.com/familymedicine/article/234239/coronavirus-updates/covid-19-vaccines-rollout-risks-and-reason-still) and can be located on the CDC website (www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html; www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html).
Continue to: Much remains unknown...
Much remains unknown regarding the use of these COVID-19 vaccines:
- What is their duration of protection, and will booster doses be needed?
- Will they protect against asymptomatic infection and carrier states, and thereby prevent transmission?
- Can they be co-administered with other vaccines?
- Will they be efficacious and safe to use during pregnancy and breastfeeding?
These issues will need to be addressed before they are recommended for non–public health emergency use.
Quadrivalent meningococcal conjugate vaccine (MenACWY)
In June 2020, the ACIP added a third quadrivalent meningococcal conjugate vaccine to its recommended list of vaccines that are FDA-approved for meningococcal disease (TABLE 49). The new vaccine fills a void left by the meningococcal polysaccharide vaccine (MPSV4), which is no longer marketed in the United States. MPSV4 was previously the only meningococcal vaccine approved for individuals 55 years and older.
The new vaccine, MenACWY-TT (MenQuadfi), is approved for those ages 2 years and older, including those > 55 years. It is anticipated that MenQuadfi will, in the near future, be licensed and approved for individuals 6 months and older and will replace MenACWY-D (Menactra). (Both are manufactured by Sanofi Pasteur.)
Groups for whom a MenACWY vaccine is recommended are listed in TABLE 5.9 A full description of current, updated recommendations for the prevention of meningococcal disease is also available.9
Continue to: Ebola virus (EBOV) vaccine
Ebola virus (EBOV) vaccine
A vaccine to prevent Ebola virus disease (EVD) is available by special request in the United States. Recombinant vesicular stomatitis virus-based Ebola virus vaccine, abbreviated as rVSVΔG-ZEBOV-GP (brand name, ERVBO) is manufactured by Merck and received approval by the FDA on December 19, 2019, for use in those ages 18 years and older. It is a live, attenuated vaccine.
The ACIP has recommended pre-exposure vaccination with rVSVΔG-ZEBOV-GP for adults 18 years or older who are at risk of exposure to EBOV while responding to an outbreak of EVD; while working as health care personnel at a federally designated Ebola Treatment Center; or while working at biosafety-level 4 facilities.10 The vaccine is protective against just 1 of 4 EBOV species, Zaire ebolavirus, which has been the cause of most reported EVD outbreaks, including the 2 largest EVD outbreaks in history that occurred in West Africa and the Republic of Congo.
It is estimated that EBOV outbreaks have infected more than 31,000 people and resulted in more than 12,000 deaths worldwide.11 Only 11 people infected with EBOV have been treated in the United States, all related to the 2014-2016 large outbreaks in West Africa. Nine of these cases were imported and only 1 resulted in transmission, to 2 people.10 The mammalian species that are suspected as intermediate hosts for EBOV are not present in the United States, which prevents EBOV from becoming endemic here.
The rVSVΔG-ZEBOV-GP vaccine was tested in a large trial in Africa during the 2014 outbreak. Its effectiveness was 100% (95% confidence interval, 63.5%-100%). The most common adverse effects were injection site pain, swelling, and redness. Mild-to-moderate systemic symptoms can occur within the first 2 days following vaccination, and include headache (37%), fever (34%), muscle pain (33%), fatigue (19%), joint pain (18%), nausea (8%), arthritis (5%), rash (4%), and
Since the vaccine contains a live virus that causes stomatitis in animals, it is possible that the virus could be transmitted to humans and other animals through close contact. Accordingly, the CDC has published some precautions including, but not limited to, not donating blood and, for 6 weeks after vaccination, avoiding contact with those who are immunosuppressed.10 The vaccine is not commercially available in the United States and must be obtained from the CDC. Information on requesting the vaccine is available at www.cdc.gov/vhf/ebola/clinicians/vaccine/.
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
1. Campos-Outcalt D. Prospects and challenges for the upcoming influenza season. J Fam Pract 2020;69:406-411.
2. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69:1922-1924.
3. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Moderna COVID-19 vaccine-United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1653-1656.
4. CDC. Pfizer-BioNTech COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/index.html
5. CDC. Moderna COVID-19 vaccine. Accessed February 17, 2021. www.cdc.gov/vaccines/covid-19/info-by-product/moderna/index.html#:~:text=How%20to%20Store%20the%20Moderna%20COVID%2D19%20Vaccine&text=Vaccine%20may%20be%20stored%20in,for%20this%20vaccine%20is%20tighter
6. Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ updated interim recommendation for allocation of COVID-19 Vaccine—United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021;69:1657-1660.
7. FDA. Fact sheet for healthcare providers administering vaccine. [Pfizer–BioNTech]. Accessed February 17, 2021. www.fda.gov/media/144413/download
8. FDA. Fact sheet for healthcare providers administering vaccine. [Moderna]. Accessed February 17, 2021. www.fda.gov/media/144637/download
9. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69:1-41.
10. Choi MJ, Cossaboom CM, Whitesell AN, et al. Use of Ebola vaccine: Recommendations of the Advisory Committee on Immunization Practices—United States, 2020. MMWR Recomm Rep. 2021;70:1-12.
11. CDC. Ebola background. Accessed February 17, 2021. www.cdc.gov/vaccines/acip/meetings/downloads/slides-2020-02/Ebola-02-Choi-508.pdf
AT PRESS TIME
The US Food and Drug Administration issued an Emergency Use Authorization for a third COVID-19 vaccine. The single-dose vaccine was developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. For more information, go to www.mdedge.com/familymedicine
