MDedge Psychiatry

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The use of patient portals that provide access to electronic health records has dramatically increased in the past several years, and patients whose health care practitioner encouraged them to use their online portal accessed them at a higher rate than those who were not encouraged to do so.

These were among the top-line results of a national survey of U.S. adults conducted by the National Institutes of Health from January 2020 to April 2020. Although the COVID-19 pandemic hit the United States in the middle of that period, a report on the survey by the Office of the National Coordinator for Health IT stated, “These findings largely reflect prepandemic rates of individuals being offered and subsequently using their online medical record, also known as a patient portal.”

But with more patient access can come additional work for physicians and other health care practitioners, ranging from an onslaught of patient communications to managing data sent to them by patients.

According to the report, 59% of individuals were offered access to their patient portal, and 38% accessed their record at least once in 2020. By comparison, in 2014, just 42% were offered access to their portal, and 25% used it. But these percentages hardly changed from 2019 to 2020.

The increase in the percentage of people who accessed portals reflects the fact that more people were offered access. In addition, there were signs of rising activity among portal users.

Among patients offered access to their patient portal, 64% accessed it at least once in 2020 – 11 percentage points more than in 2017. Twenty-seven percent of those who had access to a portal used it once or twice; 20% accessed it three to five times; and 18% used it six or more times. The latter two percentages were significantly higher than in 2017.

Of the respondents who were offered access to portals but didn’t use them, 69% said they didn’t access the portal because they preferred to speak with their health care practitioner directly. Sixty-three percent said they didn’t see a need to use their online medical record. This was similar to the percentage 3 years earlier. Other reasons included respondents’ concerns about the privacy/security of online medical records (24%), their lack of comfort with computers (20%), and their lack of Internet access (13%).
 

The pros and cons of patient portals, greater access

Among portal users who accessed their records through a mobile health app, 51% used the app to facilitate discussions with their health care practitioner in 2020, an 8–percentage point increase from 2017. Fifty-percent of the mobile health app users utilized it to make a decision about how to treat an illness or condition, up from 45% in 2017. And 71% of these individuals used their app to track progress on a health-related goal, just a bit more than in 2017.

Individuals who were encouraged by their health care practitioner to use their patient portal viewed clinical notes and exchanged secure messages with their practitioner at higher rates than those who had not been encouraged. This is not surprising, but it reflects an unintended result of patient portals that many physicians have found burdensome, especially during the pandemic: overflowing electronic in-boxes.

Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, recently tweeted, “We’re seeing huge uptick in in-box messages for MDs during COVID – now seems like biggest driver of MD burnout. The fundamental problem: We turned on 24/7/365 access for patients (who of course like it) with no operational or business model to handle it. Crucial that we fix this.”

Steven Waldren, MD, vice president and chief medical informatics officer at the American Academy of Family Physicians, told this news organization that he agrees that this is a major challenge. “In-box management is a burden on physicians and practices,” he said. “However, it can be done better, either through a team in-box or through better use of technology.”

The team in-box he refers to is a mechanism for triaging patient messages. For example, a triage nurse can look at the messages and decide which ones can be handled by staff and which ones the doctor needs to see. Or physicians and front office staff can see the messages at the same time; a nurse can triage some messages according to protocols, and the physician can respond to any message, depending on what he or she knows about the patient.

Technology can also be enlisted in the effort, he suggested, perhaps by automating the triaging of messages such as prescription refill requests or using artificial intelligence to sort messages by content.

Making patient records portable

Nearly 40% of portal users accessed it using a smartphone app (17%) or with both their smartphone app and their computer (22%). Sixty-one percent of users relied exclusively on computers to access their portals.

About a third of patient portal users downloaded their online medical records in 2020. This proportion has nearly doubled from 17% since 2017, the ONC report noted.

Although the survey didn’t ask about multiple downloads, it appears that most people had to download their records separately from the patient portal of each practitioner who cared for them. Although the Apple Health app allows people to download records to their iPhones from multiple portals using a standard application programming interface, the ONC report says that only 5% of respondents transmitted their records to a service or app, up slightly from 3% in 2017.

Dr. Waldren hopes most patients will have the ability to download and integrate records from multiple practitioners in a few years, but he wouldn’t bet on it.

“A fair amount of work needs to be done on the business side and on figuring out how the data get connected together,” he said. “And there are still privacy concerns with apps.”

Overall, 21% of portal users transmitted their data to at least one outside party in 2020, compared with 14% in 2017. Seventeen percent of them sent their records to another health care practitioner, up from 10% in 2017. Five percent of the users transmitted their records to a caregiver, slightly more than in 2017.

Managing data is a challenge

Asked how physicians feel about portal users adding information to their record or correcting inaccurate information, Dr. Waldren says, “Doctors are already comfortable with patient-generated data. The challenge is managing it. If the patient provides data that’s not easy to put in the EHR, that’s going to add work, and they don’t want to see 100 blood pressure readings.

“You’d be hard-pressed to find a doctor who doesn’t welcome additional information about the patient’s health, but it can be onerous and can take time to enter the data,” Dr. Waldren said.

Overall, he said, “Giving patients the ability to take more ownership of their health and participate in their own care is good and can help us move forward. How this will be integrated into patient care is another question.”

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

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

The Food and Drug Administration has approved atogepant (Qulipta), a novel calcitonin gene-related peptide (CGRP) receptor antagonist, for the prevention of episodic migraine, the manufacturer announced in a release.

The once-daily medication will be available in doses of 10 mg, 30 mg, and 60 mg.

“Qulipta provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients,” coinvestigator Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at the University of California, Los Angeles, and King’s College London, said in the release.

Approval was based partly on the findings from the phase 3 ADVANCE trial, in which patients with episodic migraine were randomly assigned to receive placebo or a 10-mg, 30-mg, or 60-mg daily dose of atogepant for 12 weeks.

As reported by this news organization, all three doses of atogepant reduced the number of mean monthly migraine days.

With this approval, neurologists will be able to choose from four monoclonal antibodies and two gepants for the preventive treatment of migraine.

“Having another gepant that can also be given preventively is a good idea, because one may be better than the other for a patient,” Alan M. Rapoport, MD, past president of the International Headache Society and founder and director emeritus of the New England Center for Headache, Stamford, Conn., told this news organization.

“Once we have a year or so of experience with atogepant, we’ll have a pretty good idea of which one works better preventively,” said Dr. Rapoport, who was not involved with the research.
 

Practice changing?

In the ADVANCE trial, there was a reduction of 3.69 migraine days with the 10-mg dose, 3.86 days with the 30-mg dose, and 4.2 days with the 60-mg dose. Placebo was associated with a reduction of 2.48 migraine days.

In addition, more than half of patients in each atogepant arm achieved a reduction in mean monthly migraine days of 50% or greater. This outcome occurred in 55.6% of the 10-mg atogepant group, 58.7% of the 30-mg group, and 60.8% of the 60-mg group. Approximately 29% patients who received placebo achieved this outcome.

The data indicated that atogepant has a favorable safety profile. The most common adverse events associated with treatment were constipation, nausea, and upper respiratory tract infection.

Dr. Rapoport, who is also a clinical professor of neurology at UCLA, noted that he was impressed with the efficacy.

“I’m not as impressed with the adverse events, but they’re not serious, and they don’t necessarily last,” he said.

Although being able to prescribe a single drug for acute and preventive treatment may be an advantage, it remains to be seen whether the tolerability and price of atogepant will be barriers for patients, Dr. Rapoport added.

How the approval will affect clinical practice is also unclear, he noted.

“If you’re going to start someone on a preventive, especially if it’s a woman of childbearing potential, you might just consider one of the two gepants. Doctors will decide once they see how they work,” said Dr. Rapoport.
 

Not a ‘breakthrough’ treatment

Also commenting ahead of the approval, Elizabeth W. Loder, MD, vice chair for academic affairs in the department of neurology at Brigham and Women’s Hospital, Boston, noted that the “safety of these CGRP medications in pregnancy is uncertain, and there are theoretical reasons to be concerned about it.”

Unlike injectable CGRP medications, atogepant is eliminated from the body relatively quickly after the patient stops taking it, said Dr. Loder, who is also professor of neurology at Harvard Medical School, Boston. However, atogepant may not otherwise differ greatly from other medications of its type.

“I don’t see a reason to think that one of these oral CGRP medicines is much more effective than another one,” said Dr. Loder.

“In my mind, as a clinician who will be prescribing these for patients, it will be cost and the ease of getting it covered that makes the difference,” she added.

These questions may raise concerns. “Those of us who treat patients who do not have private insurance find it very difficult to get these medications for them, even in situations where they have exhausted other alternatives,” said Dr. Loder.

Patients insured by Medicare or Medicaid “usually have no avenue to get some of these new, expensive treatments,” she said.

The approval of atogepant for acute and preventive treatment shows that the distinction between these indications may be artificial, Dr. Loder noted. The approval “will, I hope, help people think more flexibly about the way in which we use medications.”

It is a positive that atogepant has emerged as another option for preventive therapy, but the treatment cannot be considered a breakthrough, Dr. Loder added. The efficacy of atogepant, like that of other preventive treatments for migraine, is modest.

“It would be so nice if we could find things that were more effective than the treatments we currently have,” said Dr. Loder.

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Smokers are 80% more likely to be admitted to the hospital with COVID-19 than nonsmokers, according to an Oxford (England) University–led study.

Observational data was analyzed alongside hospital coronavirus test data and UK Biobank genetic information for the first time, and the findings are published in Thorax.

The data cover 421,469 people overall. Of these, 3.2% took a polymerase chain reaction swab test, 0.4% of these tested positive, 0.2% of them required hospitalization for COVID-19, and 0.1% of them died because of COVID-19.

When it came to smoking status, 59% had never smoked, 37% were ex-smokers, and 3% were current smokers.

Current smokers were 80% more likely to be admitted to hospital, and significantly more likely to die from COVID-19, than nonsmokers.
 

Time to quit

Heavy smokers who smoked more than 20 cigarettes a day were 6.11 times more likely to die from COVID-19 than people who had never smoked.

Analysis also showed those with a genetic predisposition to being smokers had a 45% higher infection risk, and 60% higher hospitalization risk.

The authors wrote: “Overall, the congruence of observational analyses indicating associations with recent smoking behaviors and [Mendelian randomization] analyses indicating associations with lifelong predisposition to smoking and smoking heaviness support a causal effect of smoking on COVID-19 severity.”

In a linked podcast, lead researcher Dr. Ashley Clift, said: “Our results strongly suggest that smoking is related to your risk of getting severe COVID, and just as smoking affects your risk of heart disease, different cancers, and all those other conditions we know smoking is linked to, it appears that it’s the same for COVID. So now might be as good a time as any to quit cigarettes and quit smoking.”

These results contrast with previous studies that have suggested a protective effect of smoking against COVID-19. In a linked editorial,  Anthony Laverty, PhD, and Christopher Millet, PhD, Imperial College London, wrote: “The idea that tobacco smoking may protect against COVID-19 was always an improbable one.”

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

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Results of a phase 3 study show that treatment with lumateperone (Caplyta) significantly improved depressive symptoms for patients with major depressive episodes associated with both bipolar I and bipolar II disorders.

“Bipolar depression represents the most prevalent and debilitating presentation of bipolar disorder. There is a critical need for more treatments that are effective and have favorable safety profiles,” study investigator Gary S. Sachs, MD, associate clinical professor in psychiatry, Harvard Medical School, Boston, said in a company news release.

“The strong efficacy and impressive safety results reported in this trial for a broad patient population position lumateperone as a potentially important advancement in the treatment of this disorder,” said Dr. Sachs, who is also founding director of the Bipolar Clinic and Research Program at Massachusetts General Hospital, Boston.

The findings were published online September 23 in the American Journal of Psychiatry.
 

First-in-class antipsychotic

Lumateperone is a first-in-class antipsychotic that acts synergistically through the serotonergic, dopaminergic, and glutamatergic systems.

It was approved by the U.S. Food and Drug Administration in late 2019 for the treatment of adults with schizophrenia, as reported at the time by this news organization.

The current study included 377 patients who had received a clinical diagnosis of bipolar I or bipolar II disorder and were subject to major depressive episodes. All were randomly allocated in a 1:1 ratio to receive 6 weeks of lumateperone monotherapy at 42 mg/d or matching placebo.

At day 43, lumateperone treatment was associated with significantly greater improvement from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score in comparison with placebo (drug-placebo difference, -4.6 points; P < .0001; effect size = -0.56), which met the study’s primary endpoint.

The study drug led to significant improvement in MADRS total score as early as the first week, which was the first time point measured. Improvement continued throughout the study.

Treatment with lumateperone also led to significantly greater improvement in the key secondary endpoints of total score on the severity scale of the Clinical Global Impressions Scale–Bipolar Version (CGI-BP-S) (P < .0001; effect size = -0.46) and the CGI-BP-S depression score (P < .001; effect size = -50).

In addition, it was superior to placebo both for patients with bipolar I disorder and those with bipolar II disorder.

Somnolence and nausea were the most commonly reported adverse events associated with lumateperone. Minimal changes were observed in weight and vital signs and in results of metabolic or endocrine assessments. These findings are in line with previous studies involving patients with schizophrenia.

The incidence of extrapyramidal symptom–related events was low and was similar to those with placebo.

The company has submitted a supplemental new drug application for lumateperone for the treatment of bipolar depression, which is currently under review with the FDA. The target action date is December 17.

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

Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.

In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.

In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.

They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.

“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”

Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.

Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.

“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”

Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.

“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”

His group cautions, however, that this is an observational study that cannot establish direct causation.

“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.

“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
 

Study results

In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.

The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.

“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.

Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.

Among the survey findings were:

• Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
• 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
• Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
• Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
• Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.

In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.

• For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
• Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.

“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.

This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.

Some coauthors are employed by the Norfolk County Council that commissioned the survey.
 

Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.

In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.

In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.

They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.

“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”

Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.

Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.

“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”

Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.

“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”

His group cautions, however, that this is an observational study that cannot establish direct causation.

“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.

“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
 

Study results

In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.

The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.

“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.

Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.

Among the survey findings were:

• Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
• 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
• Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
• Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
• Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.

In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.

• For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
• Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.

“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.

This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.

Some coauthors are employed by the Norfolk County Council that commissioned the survey.
 

Good nutrition has long been linked to better behavior and academic performance in schoolchildren, as longstanding breakfast and lunch programs in U.S. schools attest. Now British researchers report that nutrition, a modifiable risk factor that can adversely impact mental health, should be part of public health strategies to boost children’s psychological wellness.

In a cross-sectional study published online Sept. 27 in BMJ Nutrition, Prevention & Health, a team from the University of East Anglia in Norwich, England, found a nutritious breakfast and lunch were linked to emotional well-being in schoolchildren of both primary and secondary school age. They also found that some school kids ate neither breakfast nor lunch.

In particular, eating more fruits and vegetables was significantly associated with better mental health in secondary schoolchildren, while a nutritious breakfast and lunch were linked to emotional well-being in students across the age spectrum, according to senior lecturer Richard P. Hayhoe, PhD, of East Anglia University and Anglia Ruskin University in Norwich and colleagues.

They found that primary school pupils who ate only a snack for breakfast had mental well-being scores 5.50 units lower than those eating a substantial breakfast, while having no lunch was tied to scores more than 6 units lower.

“The importance of good-quality nutrition for childhood growth and development is well established,” the authors wrote. “As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being.”

Their current analysis examined data on 7,570 secondary and 1,253 primary school children from 50 schools participating in the Norfolk Children and Young People Health and Well-being Survey 2017.

Multivariable linear regression measured the association between nutritional factors and mental well-being assessed by the Warwick-Edinburgh Mental Well-being Scale for secondary school pupils or by the Stirling Children’s Well-being Scale for primary school pupils. All analyses were adjusted for covariates including demographic, health variables, living/home situations, and adverse experiences.

“The 2017 survey provided a means for Norfolk children and young people to share their feelings on topics such as healthy lifestyles and nutrition, relationships, school experiences, bullying, and their mental well-being,” Dr. Hayhoe said in an interview. “Initial analysis of the data suggested an association between nutrition and well-being and so we decided to investigate this further.”

Dr. Hayhoe added that, as in the United States, youngsters in England get a high proportion of their daily calories from ultraprocessed convenience foods of lesser nutritional value.

“But what we didn’t know was whether the dietary habits of children in our survey had any association with their mental well-being,” he said. “Our current findings suggest that increasing fruit and vegetable consumption and ensuring all schoolchildren eat a nutritional breakfast and lunch may be of benefit to their mental well-being.”

His group cautions, however, that this is an observational study that cannot establish direct causation.

“This study provides the first insights into how fruit and vegetable intake affects children’s mental health, and contributes to the emerging evidence around ‘food and mood,’ ” said Sumantra Ray, MD, executive director of the NNEdPro Global Centre for Nutrition and Health in Cambridge, England.

“The findings are timely, not only because of the impact the pandemic has had on mental well-being, food security, and diet quality, especially in school children, but also in light of the recently published National Food Strategy for England, which highlighted gaps in school meal provision,” added Dr. Ray, who was not involved in the study.
 

Study results

In total, 10,853 schoolchildren completed the survey: 9% of Norfolk primary school children aged 9-11 and 22% of secondary school students, with approximately 6% of these in the 17- and 18-year-old age bracket. Comprehensive dietary questions explored fruit and vegetable intake, as well as type of breakfast and lunch eaten, alcohol intake, eligibility for free school meals, and satisfaction with weight.

The survey also gathered information on parameters ranging from having one’s own bedroom and bed and exposure to violence or discord in the home.

“Some of these were found to be associated with lower mental well-being scores, but we did not specifically investigate the interaction between these factors and the nutritional factors,” Dr. Hayhoe said. However, the difference in mental well-being between children who ate the most fruit and vegetables and those who ate the least was on a similar scale to those reporting daily, or almost daily, arguing or violence at home, he said.

Average mental health was assessed using validated age-appropriate measures. The mean mental health score of participants was 46.6 out of 70 for secondary school students and 46 out of 60 for primary school pupils.

Among the survey findings were:

• Just 25% of secondary school participants and 28.5% of primary school pupils reported eating the recommended five portions of fruits and vegetables a day, with 10% and 9%, respectively, eating none.
• 21% of secondary and 12% of primary school pupils consumed only a non–energy drink or nothing for breakfast, while 11.5% of secondary schoolchildren ate no lunch. In one high school class of 30, for example, four had nothing to eat or drink before starting classes in the morning, and three had nothing to eat or drink before starting classes in the afternoon.
• Higher combined fruit and vegetable intake was significantly associated in dose-related fashion with higher mental health scores: 3.73 (95% confidence interval, 2.94- 4.53) units higher in those consuming five or more fruits and vegetables (P < .001), compared with none.
• Breakfast or lunch type also correlated with significant differences in well-being scores. Compared with children consuming a conventional breakfast (porridge, toast, cereal, yogurt, fruit, or a cooked meal), those eating no breakfast had mean well-being scores that were 2.73 (95% CI, 2.11-3.35) units lower (P < .001). Those consuming only an energy drink scored even worse: 3.14 (95% CI, 1.20- 5.09) units lower (P = .002).
• Skipping lunch resulted in a 2.95-unit drop in well-being score (95% CI, 2.22-3.68, P < .001), compared with consuming a packed lunch.

In terms of the amounts of fruits and vegetables consumed, one or two daily portions were associated with a score 1.42 units higher, while three or four portions correlated with a score 2.34 units higher. Those eating five or more portions scored 3.73 units higher.

• For primary school pupils, eating only a snack for breakfast was associated with a score 5.50 units lower, and consuming only a non–energy drink was tied to a score 2.67 units lower than eating a conventional breakfast. Not eating any breakfast was associated with a score 3.62 units lower.
• Eating school food versus a packed lunch was associated with a score 1.27 units lower, although this wasn’t statistically significant. Having no lunch was associated with a score 6.08 units lower, although only a few children fell into this group.

“As a potentially modifiable factor, both at an individual and societal level, nutrition may therefore represent an important public health target for strategies to address childhood mental well-being,” the authors wrote, calling for further investigation of the association between nutrition and mental well-being.

This study was commissioned by Norfolk County Council Public Health and the Norfolk Safeguarding Children Board. The University of East Anglia and Social Care Partners provided funding to support Dr. Hayhoe’s work on this project.

Some coauthors are employed by the Norfolk County Council that commissioned the survey.
 

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

The U.S. Drug Enforcement Administration has issued a public safety alert over an “alarming” increase in fake prescription pills laced with the synthetic opioid fentanyl or the stimulant methamphetamine.

“The United States is facing an unprecedented crisis of overdose deaths fueled by illegally manufactured fentanyl and methamphetamine,” DEA Administrator Anne Milgram said in the alert.

“Counterfeit pills that contain these dangerous and extremely addictive drugs are more lethal and more accessible than ever before. DEA is focusing resources on taking down the violent drug traffickers causing the greatest harm and posing the greatest threat to the safety and health of Americans,” Ms. Milgram said.

Criminal drug networks are mass-producing fake fentanyl- and methamphetamine-laced pills and deceptively marketing them as legitimate prescription pills, the DEA warns.

These lethal counterfeit pills are made to look like legitimate prescription opioid medications such as oxycodone (Oxycontin, Percocet), hydrocodone (Vicodin), and alprazolam (Xanax); or stimulants like amphetamines (Adderall).

The agency has seized fake pills in every U.S. state. More than 9.5 million fake pills have been seized so far this year – more than the last 2 years combined.

The number of seized counterfeit pills with fentanyl has jumped nearly 430% since 2019. DEA lab tests reveal that two out of every five pills with fentanyl contain a potentially lethal dose.

These deadly pills are widely accessible and often sold on social media and e-commerce platforms – making them available to anyone with a smartphone, including minors, the DEA warns.

More than 93,000 people died of a drug overdose in the United States last year, according to federal statistics, and fentanyl is the primary driver of this alarming increase in overdose deaths, the DEA says.

The agency has launched a “One Pill Can Kill” public awareness campaign to educate the public of the dangers of counterfeit pills purchased outside of a licensed pharmacy. These pills are “illegal, dangerous, and potentially lethal,” the DEA warns.

This alert does not apply to legitimate pharmaceutical medications prescribed by doctors and dispensed by licensed pharmacists, the DEA says.

“The legitimate prescription supply chain is not impacted. Anyone filling a prescription at a licensed pharmacy can be confident that the medications they receive are safe when taken as directed by a medical professional,” the agency says.

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

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Confusion continues to circulate in the wake of decisions on booster doses of the Pfizer/BioNTech COVID-19 vaccine, all announced within 1 week. Many people – including those now eligible and those who officially have to wait for their shot at a third dose – have questions.

Micah Young/istockphoto.com

Multiple agencies are involved in the booster decisions, and they have put out multiple – and sometimes conflicting – messages about booster doses, leaving more questions than answers for many people.

On Sept. 22, the Food and Drug Administration granted an emergency use authorization (EUA) for a booster dose of the Pfizer mRNA COVID-19 vaccine for those 65 and older and those at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection – such as frontline health care workers.

The Centers for Disease Control and Prevention Director Rochelle Walensky, MD, then overruled advice from the agency’s Advisory Committee on Immunization Practices (ACIP) to recommend boosters for essential workers such as those working on the front lines during the pandemic.

As it stands now, the CDC recommends that the following groups should get a third dose of the Pfizer vaccine:

• People aged 65 years and older.
• People aged 18 years and older in long-term care settings.
• People aged 50-64 years with underlying medical conditions.

The CDC also recommends that the following groups may receive a booster shot of the Pfizer vaccine, based on their individual benefits and risks:

• People aged 18-49 years with underlying medical conditions.
• People aged 18-64 years at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting.

The CDC currently considers the following groups at increased risk for COVID-19:

• First responders (health care workers, firefighters, police, congregate care staff).
• Education staff (teachers, support staff, day care workers).
• Food and agriculture workers.
• Manufacturing workers.
• Corrections workers.
• U.S. Postal Service workers.
• Public transit workers.
• Grocery store workers.

Health care professionals, among the most trusted sources of COVID-19 information, are likely to encounter a number of patients wondering how all this will work.

“It’s fantastic that boosters will be available for those who the data supports need [them],” Rachael Piltch-Loeb, PhD, said during a media briefing on Sept. 23, held between the FDA and CDC decisions.

“But we’re really in a place where we have a lot more questions and answers about what the next phase of the vaccine availability and updates are going to be in the United States,” added Dr. Piltch-Loeb, preparedness fellow in the division of policy translation and leadership development and a research associate in the department of biostatistics at the Harvard T. H. Chan School of Public Health in Boston.

To provide some initial answers, this news organization spoke with multiple COVID-19 experts.

1. What is the biggest concern you are hearing from patients about getting a booster?

“The biggest concerns are that everyone wants it and they don’t know where to get it. In health care’s defense, the CDC just figured out what to do,” said Janet Englund, MD, professor of pediatric infectious diseases and an infectious disease and virology expert at Seattle Children’s Hospital in Washington.

“Everyone thinks they should be eligible for a booster ... people in their 50s who are not yet 65+, people with young grandchildren, etc.,” she added. “I’m at Seattle Children’s Hospital, so people are asking about booster shots and about getting their children vaccinated.”

Boosters for all COVID-19 vaccines are completely free.

“All COVID-19 vaccines, including booster doses, will be provided free of charge to the U.S. population,” the CDC has said.

2. Will patients need to prove they meet eligibility criteria for a booster shot or will it be the honor system?

“No, patients will only need to attest that they fall into one of the high-risk groups for whom a booster vaccine is authorized,” said Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston.

Dr. Piltch-Loeb agreed. “It is likely to be an honor system. It is very unlikely that there will be punishments or other ramifications ... if doses are administered, beyond the approved usage.”

3. If a patient who had the Moderna or the Johnson and Johnson vaccination requests a booster, can health care workers give them Pfizer? 

The short answer is no. “This only applies to individuals who have received the Pfizer vaccine,” Dr. Piltch-Loeb said.

More data will be needed before other vaccine boosters are authorized, she added.

“My understanding is the Moderna people have just recently submitted their information, all of their data to the FDA and J&J is in line to do that very shortly,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University in Nashville, Tenn. “I would hope that within the next month to 6 weeks, we will get information about both of those vaccines,” Dr. Schaffner said.

4. When are the “mix-and-match” vaccine study results expected to come out?

“We expect that data from the study will be available in the coming weeks,” said Dr. Atmar, who is the national co-principal investigator of a mix-and-match booster trial launched in June 2021.

5. Are side effects of a booster vaccine expected to be about the same as what people experienced during their first or second immunization? 

“I’m expecting the side effects will be similar to the second dose,” Dr. Englund said.

“The data presented ... at ACIP suggests that the side effects from the third shot are either the same or actually less than the first two shots,” said Carlos del Rio, MD, distinguished professor of medicine, epidemiology, and global health, and executive associate dean of Emory University School of Medicine at Grady Health System in Atlanta.

”Everyone reacts very differently to vaccines, regardless of vaccine type,” said Eric Ascher, MD, a family medicine physician at Lenox Hill Hospital in New York City. “I have had patients (as well as personal experience) where there were none to minimal symptoms, and others who felt they had a mild flu for 24 hours.”

“I expect no side effects greater than what was felt with you prior doses,” he said. “The vaccine is very safe and the benefit of vaccination outweighs the risks of any mild side effects.”

6. Is it unethical to give a booster to someone outside the approved groups if there are doses remaining at the end of the day in an open vial? 

“Offering a booster shot to someone outside of approved groups if remaining doses will go to waste at the end of the day seems like a prudent decision, and relatively harmless action,” said Faith Fletcher, PhD, assistant professor at the Center for Medical Ethics and Health Policy at Baylor College of Medicine.

“However, if doses continue to fall in the laps of unapproved groups, we must evaluate the vaccine systems and structures that advantage some groups and disadvantage others,” she added. “We know that the distribution of COVID-19 vaccines has not been equitable – and some groups have been left behind.”

“I am not an ethicist and there are many competing concerns that this question addresses,” Dr. Atmar said. For example, “there is not a limitation of vaccine supply in the U.S., so that using leftover vaccine to prevent waste is no longer a major concern in the U.S.”

It could be more of a legal than ethical question, Dr. Atmar said. For an individual outside the authorized groups, legally, the FDA’s EUA for boosting does not allow the vaccine to be administered to this person, he said.

“The rationale for the restricted use in the EUA is that at this time the safety and risks associated with such administration are not known, and the benefits also have not been determined,” Dr. Atmar said. “Members of the ACIP raised concerns about other individuals who may potentially benefit from a booster but are not eligible and the importance of making boosters available to them, but from a legal standpoint – I am also not a lawyer, so this is my understanding – administration of the vaccine is limited to those identified in the EUA.”

7. What is the likelihood that one shot will combine COVID and flu protection in the near future? 

It is not likely, Dr. Englund said. “The reason is that the flu vaccine changes so much, and it already has four different antigens. This is assuming we keep the same method of making the flu vaccine – the answer could be different if the flu vaccine becomes an mRNA vaccine in the future.”

Companies such as Moderna and Novavax are testing single-dose shots for COVID-19 and influenza, but they are still far from having anything ready for this flu season in the United States.

8. Is there any chance a booster shot distributed now will need to be redesigned for a future variant? 

“Absolutely,” Dr. Englund said. “And a booster dose is the time we may want to consider re-engineering a vaccine.”

9. Do you think the FDA/CDC limitations on who is eligible for a booster was in any way influenced by the World Health Organization call for prioritizing shots for the unvaccinated in lower-resource countries?

“This is absolutely still a global problem,” Dr. Piltch-Loeb said. “We need to get more vaccine to more countries and more people as soon as possible, because if there’s anything we’ve seen about the variants it is that ... they can come from all different places.”

“That being said, I think that it is unlikely to change the course of action in the U.S.,” she added, when it comes to comparing the global need with the domestic policy priorities of the administration.

Dr. Atmar was more direct. “No,” he said. “The WHO recommends against boosting of anyone. The U.S. decisions about boosting those in this country who are eligible are aimed toward addressing perceived needs domestically at the same time that vaccines are being provided to other countries.

“The philosophy is to address both ‘needs’ at the same time,” Dr. Atmar said.

10. What does the future hold for booster shots?

“Predicting the future is really hard, especially when it involves COVID,” Dr. del Rio said. 

“Having said that, COVID is not the flu, so I doubt there will be need for annual boosters. I think the population eligible for boosters will be expanded ... and the major population not addressed at this point is the people that received either Moderna or J&J [vaccines].”
 

Kelly Davis contributed to this feature. A version of this article first appeared on Medscape.com.

Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.

Among children aged 4 months to 17 years, 34.9% got less than the recommended amount of sleep for their age and just 33.9% had a regular bedtime, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.

Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.

Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.

Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.

Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.

Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.

[email protected]

Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.

Among children aged 4 months to 17 years, 34.9% got less than the recommended amount of sleep for their age and just 33.9% had a regular bedtime, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.

Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.

Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.

Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.

Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.

Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.

[email protected]

Just over one-third of children in the United States get less sleep than recommended, with higher rates occurring among several racial/ethnic and socioeconomic groups, according to a report from the Centers for Disease Control and Prevention.

Among children aged 4 months to 17 years, 34.9% got less than the recommended amount of sleep for their age and just 33.9% had a regular bedtime, Anne G. Wheaton, PhD, and Angelika H. Claussen, PhD, said in the Morbidity and Mortality Weekly Report.

Unlike previous reports, this analysis showed that adolescents were less likely than infants to have short sleep duration, 31.2% vs. 40.3%. These latest data are based on the 2016-2018 editions of the National Survey of Children’s Health, and the “difference might be explained by NSCH’s reliance on parent report rather than self-report with Youth Risk Behavior Surveys,” they suggested.

Black children had the highest prevalence of any group included in the study, as parents reported that 50.8% of all ages were not getting the recommended amount of sleep, compared with 39.1% among Hispanics, 34.6% for other races, and 28.8% for Whites. The figure for Black infants was 64.2%, almost double the prevalence for White infants (32.9%), said Dr. Wheaton and Dr. Claussen of the CDC.

Short sleep duration also was more common in children from lower-income families and among those with less educated parents. Geography had an effect as well, with prevalence “highest in the Southeast, similar to geographic variation in adequate sleep observed for adults,” they noted.

Previous research has shown that “sleep disparity was associated with various social determinants of health (e.g., poverty, food insecurity, and perceived racism), which can increase chronic and acute stress and result in environmental and psychological factors that negatively affect sleep duration and can compound long-term health risks,” the investigators wrote.

Short sleep duration by age group was defined as less the following amounts: Twelve hours for infants (4-11 months), 11 hours for children aged 1-2 years, 10 hours for children aged 3-5 years, 9 hours for children aged 6-12, and 8 hours for adolescents (13-17 years), they explained. Responses for the survey’s sleep-duration question totaled 99,842 for the 3 years included.

[email protected]

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

The director of the Centers for Disease Control and Prevention late Thursday overruled the recommendation of the agency’s advisory panel to broaden the number of Americans who are now eligible for a third dose of the Pfizer COVID-19 vaccine.

The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.

But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”

Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:

• Adults ages 65 and up and residents of long-term care facilities
• Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
• Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.

About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose.  About 13.6 million of them are over the age of 65.  Another 5.3 million are ages 50 to 64.

In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.

This is the group Dr. Walensky added to the eligible list on her own.

Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville.  Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.

“There was a real split in the committee,” he said.

The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.

“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”

She was not alone in feeling cautious.

“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.

“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”

The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
 

How much will the U.S. benefit from boosters?

Some felt squeamish about broadly recommending boosters at all.

“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.

Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”

Others agreed.

“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”

ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.

“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.

Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
 

Next steps

People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.

The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.

While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.

More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.

“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.

A version of this article first appeared on WebMD.com.

How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.

Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.

Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.

Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.

Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?

Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.

Maskot/Getty Images

When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.

As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? Perhaps teachers, guardians, health care providers, and the government need to play a role in teaching and training individuals how to manage their social media consumption. This multifaceted problem requires a multidisciplinary approach.

Leanna M.W. Lui is an MSc candidate at the University of Toronto.

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

How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.

Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.

Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.

Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.

Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?

Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.

Maskot/Getty Images

When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.

As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? Perhaps teachers, guardians, health care providers, and the government need to play a role in teaching and training individuals how to manage their social media consumption. This multifaceted problem requires a multidisciplinary approach.

Leanna M.W. Lui is an MSc candidate at the University of Toronto.

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

How often do you find yourself on social media? The first thing I do when I wake up is check my email and text messages, as well as my Facebook, Snapchat, and Instagram notifications.

Some 150,000 messages are shared on Facebook each minute; 293 million daily active users worldwide were recorded on Snapchat during the second quarter of 2021; 127.2 million monthly active users in the United States are projected to be on Instagram by 2023.

Social media has gained the hearts and wonder of many around the world. It’s absolutely incredible how ingrained it has become in our lives as a medium for creativity, outlet for communication, and platform for information. In fact, these online network tools have now become essential during COVID-19 to ensure productive workflow, keep in touch with our loved ones, and, overall, maintain social capital. Social media has truly emerged as a powerful form of living beyond our physical selves.

Yet, increased (and addictive) social media use is associated with negative health outcomes, especially among adolescents. For example, in a study reporting parent and adolescent accounts of social media use, it was reported that social media use was associated with hyperactivity/impulsivity, depression, anxiety, loneliness, and a fear of missing out. Furthermore, a meta-analysis investigating the relationship between social media use and depressive symptoms among adolescents found a small but significant and positive relationship between the two. However, additional research is required to elucidate this association.

Notwithstanding, the addictive nature of social media has previously been called out as analogous to the addictive nature of gambling. Let’s think about it. Whether you’re on Instagram, TikTok, or a similar platform, you can’t help but scroll from one video to the next. It’s one 5- to 10-second video after the next, and before you know it, you’ve spent the past hour going through random videos – but you can’t stop. Why is that so?

Social media actually “rewires” our brain such that we expect instant gratification. In other words, when we get a notification, message, like, or share, we expect fast and short-term pleasure/reward because the brain will produce a “hit of dopamine.” However, it is important to note that the reward system is not delimited to the dopaminergic pathway and, in fact, should be understood as a complex network system (i.e., governed by changes in brain morphology through addiction and excessive behavior). Given the quick pace of the social media world, the reward pathways in our brain change and there’s an increasing demand for attention, perpetuating an addictive mindset.

Maskot/Getty Images

When we refresh our page, we expect instant gratification. But what happens when we don’t get a like, or a message, or some sort of “reward”? Recounts of social media use by adolescents have likened online attention to popularity. Accordingly, a lack of constant attention on social media has created a vicious cycle of anxiety, loneliness, and depression because of a failure to receive “virtual” reward. Taken together, social media may be harmful because it distorts our self-image, and while social media platforms help connect us, they can also ironically make us feel isolated, lower our self-confidence, and diminish our overall sense of well-being.

As the platforms for communication and information have evolved so rapidly over the past decade, there is a need to establish boundaries between what is beneficial and what is potentially detrimental to our mental health. While social media companies should play a role in mitigating addictive social network behavior, it would also seem counterintuitive to the general business model. In that case, who takes charge? Perhaps teachers, guardians, health care providers, and the government need to play a role in teaching and training individuals how to manage their social media consumption. This multifaceted problem requires a multidisciplinary approach.

Leanna M.W. Lui is an MSc candidate at the University of Toronto.

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