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Nicotine vaping tapers off among teens
Levels of nicotine and marijuana vaping among adolescents remain elevated but did not increase significantly in the past year, data from the annual Monitoring the Future survey show.
The 2020 survey included responses from 11,821 individuals in 112 schools across the United States from Feb. 11, 2020, to March 14, 2020, at which time data collection ended prematurely because of the COVID-19 pandemic.
A key positive finding in this year’s survey was the relatively stable levels of nicotine vaping from 2019 to 2020, following a trend of notably increased use annually since vaping was added to the survey in 2017.
During the years 2017-2019, the percentage of teens who reported vaping nicotine in the past 12 months increased from 7.5% to 16.5% among 8th graders, from 15.8% to 30.7% among 10th graders, and from 18.8% to 35.3% among 12th graders. However, in 2020, the percentages of teens who reported past-year nicotine vaping were relatively steady at 16.6%, 30.7%, and 34.5%, for 8th-, 10th-, and 12th-grade students, respectively. In addition, reports of daily or near-daily nicotine vaping (defined as 20 occasions in the past 30 days) decreased significantly, from 6.8% to 3.6% among 10th graders and from 11.6% to 5.3% among 12th graders.
“The rapid rise of teen nicotine vaping in recent years has been unprecedented and deeply concerning since we know that nicotine is highly addictive and can be delivered at high doses by vaping devices, which may also contain other toxic chemicals that may be harmful when inhaled,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse in a press release accompanying the release of the findings. “It is encouraging to see a leveling off of this trend though the rates still remain very high.”
Reports of past-year marijuana vaping remained similar to 2019 levels after a twofold increase in the past 2 years, according to the survey. In early 2020, 8.1%, 19.1%, and 22.1% of 8th, 10th, and 12th graders reported past-year use. However, daily marijuana vaping decreased by more than half from 2019, to 1.1% among 10th graders and 1.5% among 12th graders.
Past-year use of the JUUL devices specifically also declined among older teens, from 28.7% in 2019 to 20% in 2020 among 10th graders and from 28.4% in 2019 to 22.7% in 2020 among 12th graders.
Other trends this year included the increased past-year use of amphetamines, inhalants, and cough medicines among 8th graders, and relatively low reported use among 12th graders of LSD (3.9%), synthetic cannabinoids (2.4%), cocaine (2.9%), ecstasy (1.8%), methamphetamine (1.4%), and heroin (0.3%).
The findings were published in JAMA Pediatrics.
Early data show progress
“The MTF survey is the most referenced and reliable longitudinal study reporting current use of tobacco, drugs, and alcohol among young people,” said Mark S. Gold, MD, of Washington University, St. Louis, in an interview.
“The new data, collected before data collection stopped prematurely due to the COVID-19 pandemic, suggests that some progress is being made in slowing the increase in substance use among these, the most vulnerable,” he said.
“The best news was that nicotine vaping decreased significantly after its meteoric increase over the past few years,” Dr. Gold emphasized. “Past-year vaping of marijuana remained steady at alarming levels in 2020, with 8.1% of 8th graders, 19.1% of 10th graders, and 22.1% of 12th graders reporting past-year use, following a two-fold increase over the past 2 years.” The use of all forms of marijuana, including smoking and vaping, did not significantly change in any of the three grades for lifetime use, past 12-month use, past 30-day use, and daily use from 2019 to 2020.
“Teen alcohol use has not significantly changed over the past 5 years,” and cigarette smoking in the last 30 days did not significantly change from 2019 to 2020, said Dr. Gold. However, “as with adults, psychostimulant use is increasing. Past year nonmedical use of amphetamines among 8th graders increased, from 3.5% in 2017 to 5.3% in 2020.”
COVID-era limitations
“The data suggest that pre-COVID pandemic vaping, smoking cigarettes, marijuana, and alcohol use had stabilized,” Dr. Gold said. “However, it is very difficult to predict what the COVID era data will show as many young people are at home, on the streets, and unsupervised; while adult substance misuse, substance use disorders, and overdoses are increasing. Drug supplies and access have increased for alcohol, cannabis, vaping, and tobacco as have supply synthetics like methamphetamine and fentanyl.”
In addition, “access to evaluation, intervention, and treatment have been curtailed during the pandemic,” Dr. Gold said. “The loss of peer role models, daily routine, and teacher or other adult supervision and interventions may interact with increasing despair, social isolation, depression, and anxiety in ways that are unknown. “It will not be clear until the next survey if perceived dangerousness has changed in ways that can protect these 8th, 10th, and 12th graders and increase the numbers of never users or current nonusers.”
The Monitoring the Future survey is conducted each year by the University of Michigan’s Institute for Social Research, Ann Arbor, and supported by NIDA, part of the National Institutes of Health. Dr. Gold had no relevant financial conflicts to disclose.
Levels of nicotine and marijuana vaping among adolescents remain elevated but did not increase significantly in the past year, data from the annual Monitoring the Future survey show.
The 2020 survey included responses from 11,821 individuals in 112 schools across the United States from Feb. 11, 2020, to March 14, 2020, at which time data collection ended prematurely because of the COVID-19 pandemic.
A key positive finding in this year’s survey was the relatively stable levels of nicotine vaping from 2019 to 2020, following a trend of notably increased use annually since vaping was added to the survey in 2017.
During the years 2017-2019, the percentage of teens who reported vaping nicotine in the past 12 months increased from 7.5% to 16.5% among 8th graders, from 15.8% to 30.7% among 10th graders, and from 18.8% to 35.3% among 12th graders. However, in 2020, the percentages of teens who reported past-year nicotine vaping were relatively steady at 16.6%, 30.7%, and 34.5%, for 8th-, 10th-, and 12th-grade students, respectively. In addition, reports of daily or near-daily nicotine vaping (defined as 20 occasions in the past 30 days) decreased significantly, from 6.8% to 3.6% among 10th graders and from 11.6% to 5.3% among 12th graders.
“The rapid rise of teen nicotine vaping in recent years has been unprecedented and deeply concerning since we know that nicotine is highly addictive and can be delivered at high doses by vaping devices, which may also contain other toxic chemicals that may be harmful when inhaled,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse in a press release accompanying the release of the findings. “It is encouraging to see a leveling off of this trend though the rates still remain very high.”
Reports of past-year marijuana vaping remained similar to 2019 levels after a twofold increase in the past 2 years, according to the survey. In early 2020, 8.1%, 19.1%, and 22.1% of 8th, 10th, and 12th graders reported past-year use. However, daily marijuana vaping decreased by more than half from 2019, to 1.1% among 10th graders and 1.5% among 12th graders.
Past-year use of the JUUL devices specifically also declined among older teens, from 28.7% in 2019 to 20% in 2020 among 10th graders and from 28.4% in 2019 to 22.7% in 2020 among 12th graders.
Other trends this year included the increased past-year use of amphetamines, inhalants, and cough medicines among 8th graders, and relatively low reported use among 12th graders of LSD (3.9%), synthetic cannabinoids (2.4%), cocaine (2.9%), ecstasy (1.8%), methamphetamine (1.4%), and heroin (0.3%).
The findings were published in JAMA Pediatrics.
Early data show progress
“The MTF survey is the most referenced and reliable longitudinal study reporting current use of tobacco, drugs, and alcohol among young people,” said Mark S. Gold, MD, of Washington University, St. Louis, in an interview.
“The new data, collected before data collection stopped prematurely due to the COVID-19 pandemic, suggests that some progress is being made in slowing the increase in substance use among these, the most vulnerable,” he said.
“The best news was that nicotine vaping decreased significantly after its meteoric increase over the past few years,” Dr. Gold emphasized. “Past-year vaping of marijuana remained steady at alarming levels in 2020, with 8.1% of 8th graders, 19.1% of 10th graders, and 22.1% of 12th graders reporting past-year use, following a two-fold increase over the past 2 years.” The use of all forms of marijuana, including smoking and vaping, did not significantly change in any of the three grades for lifetime use, past 12-month use, past 30-day use, and daily use from 2019 to 2020.
“Teen alcohol use has not significantly changed over the past 5 years,” and cigarette smoking in the last 30 days did not significantly change from 2019 to 2020, said Dr. Gold. However, “as with adults, psychostimulant use is increasing. Past year nonmedical use of amphetamines among 8th graders increased, from 3.5% in 2017 to 5.3% in 2020.”
COVID-era limitations
“The data suggest that pre-COVID pandemic vaping, smoking cigarettes, marijuana, and alcohol use had stabilized,” Dr. Gold said. “However, it is very difficult to predict what the COVID era data will show as many young people are at home, on the streets, and unsupervised; while adult substance misuse, substance use disorders, and overdoses are increasing. Drug supplies and access have increased for alcohol, cannabis, vaping, and tobacco as have supply synthetics like methamphetamine and fentanyl.”
In addition, “access to evaluation, intervention, and treatment have been curtailed during the pandemic,” Dr. Gold said. “The loss of peer role models, daily routine, and teacher or other adult supervision and interventions may interact with increasing despair, social isolation, depression, and anxiety in ways that are unknown. “It will not be clear until the next survey if perceived dangerousness has changed in ways that can protect these 8th, 10th, and 12th graders and increase the numbers of never users or current nonusers.”
The Monitoring the Future survey is conducted each year by the University of Michigan’s Institute for Social Research, Ann Arbor, and supported by NIDA, part of the National Institutes of Health. Dr. Gold had no relevant financial conflicts to disclose.
Levels of nicotine and marijuana vaping among adolescents remain elevated but did not increase significantly in the past year, data from the annual Monitoring the Future survey show.
The 2020 survey included responses from 11,821 individuals in 112 schools across the United States from Feb. 11, 2020, to March 14, 2020, at which time data collection ended prematurely because of the COVID-19 pandemic.
A key positive finding in this year’s survey was the relatively stable levels of nicotine vaping from 2019 to 2020, following a trend of notably increased use annually since vaping was added to the survey in 2017.
During the years 2017-2019, the percentage of teens who reported vaping nicotine in the past 12 months increased from 7.5% to 16.5% among 8th graders, from 15.8% to 30.7% among 10th graders, and from 18.8% to 35.3% among 12th graders. However, in 2020, the percentages of teens who reported past-year nicotine vaping were relatively steady at 16.6%, 30.7%, and 34.5%, for 8th-, 10th-, and 12th-grade students, respectively. In addition, reports of daily or near-daily nicotine vaping (defined as 20 occasions in the past 30 days) decreased significantly, from 6.8% to 3.6% among 10th graders and from 11.6% to 5.3% among 12th graders.
“The rapid rise of teen nicotine vaping in recent years has been unprecedented and deeply concerning since we know that nicotine is highly addictive and can be delivered at high doses by vaping devices, which may also contain other toxic chemicals that may be harmful when inhaled,” said Nora D. Volkow, MD, director of the National Institute on Drug Abuse in a press release accompanying the release of the findings. “It is encouraging to see a leveling off of this trend though the rates still remain very high.”
Reports of past-year marijuana vaping remained similar to 2019 levels after a twofold increase in the past 2 years, according to the survey. In early 2020, 8.1%, 19.1%, and 22.1% of 8th, 10th, and 12th graders reported past-year use. However, daily marijuana vaping decreased by more than half from 2019, to 1.1% among 10th graders and 1.5% among 12th graders.
Past-year use of the JUUL devices specifically also declined among older teens, from 28.7% in 2019 to 20% in 2020 among 10th graders and from 28.4% in 2019 to 22.7% in 2020 among 12th graders.
Other trends this year included the increased past-year use of amphetamines, inhalants, and cough medicines among 8th graders, and relatively low reported use among 12th graders of LSD (3.9%), synthetic cannabinoids (2.4%), cocaine (2.9%), ecstasy (1.8%), methamphetamine (1.4%), and heroin (0.3%).
The findings were published in JAMA Pediatrics.
Early data show progress
“The MTF survey is the most referenced and reliable longitudinal study reporting current use of tobacco, drugs, and alcohol among young people,” said Mark S. Gold, MD, of Washington University, St. Louis, in an interview.
“The new data, collected before data collection stopped prematurely due to the COVID-19 pandemic, suggests that some progress is being made in slowing the increase in substance use among these, the most vulnerable,” he said.
“The best news was that nicotine vaping decreased significantly after its meteoric increase over the past few years,” Dr. Gold emphasized. “Past-year vaping of marijuana remained steady at alarming levels in 2020, with 8.1% of 8th graders, 19.1% of 10th graders, and 22.1% of 12th graders reporting past-year use, following a two-fold increase over the past 2 years.” The use of all forms of marijuana, including smoking and vaping, did not significantly change in any of the three grades for lifetime use, past 12-month use, past 30-day use, and daily use from 2019 to 2020.
“Teen alcohol use has not significantly changed over the past 5 years,” and cigarette smoking in the last 30 days did not significantly change from 2019 to 2020, said Dr. Gold. However, “as with adults, psychostimulant use is increasing. Past year nonmedical use of amphetamines among 8th graders increased, from 3.5% in 2017 to 5.3% in 2020.”
COVID-era limitations
“The data suggest that pre-COVID pandemic vaping, smoking cigarettes, marijuana, and alcohol use had stabilized,” Dr. Gold said. “However, it is very difficult to predict what the COVID era data will show as many young people are at home, on the streets, and unsupervised; while adult substance misuse, substance use disorders, and overdoses are increasing. Drug supplies and access have increased for alcohol, cannabis, vaping, and tobacco as have supply synthetics like methamphetamine and fentanyl.”
In addition, “access to evaluation, intervention, and treatment have been curtailed during the pandemic,” Dr. Gold said. “The loss of peer role models, daily routine, and teacher or other adult supervision and interventions may interact with increasing despair, social isolation, depression, and anxiety in ways that are unknown. “It will not be clear until the next survey if perceived dangerousness has changed in ways that can protect these 8th, 10th, and 12th graders and increase the numbers of never users or current nonusers.”
The Monitoring the Future survey is conducted each year by the University of Michigan’s Institute for Social Research, Ann Arbor, and supported by NIDA, part of the National Institutes of Health. Dr. Gold had no relevant financial conflicts to disclose.
Moderna COVID-19 vaccine wins decisive recommendation from FDA panel
The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.
The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.
Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.
FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.
“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”
In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.
Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.
The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.
Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.
In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.
The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.
“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”
mRNA vaccines in the lead
An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.
In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”
“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.
The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.
The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.
Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.
FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.
“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”
In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.
Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.
The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.
Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.
In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.
The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.
“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”
mRNA vaccines in the lead
An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.
In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”
“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.
The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.
This article first appeared on Medscape.com.
The US Food and Drug Administration (FDA) put Moderna’s application before its Vaccines and Related Biological Products Advisory Committee. The panel voted 20-0 on this question: “Based on the totality of scientific evidence available, do the benefits of the Moderna COVID-19 Vaccine outweigh its risks for use in individuals 18 years of age and older?” There was one abstention.
The FDA is not bound to act on the recommendations of its advisers, but the agency usually takes the panel’s advice. The FDA cleared the similar Pfizer-BioNTech vaccine on December 11 through an emergency use authorization (EUA), following a positive vote for the product at a December 10 advisory committee meeting. In this case, the FDA staff appeared to be pushing for a broad endorsement of the Moderna vaccine, for which the agency appears likely to soon also grant an EUA.
Marion Gruber, PhD, director of the Office of Vaccines Research and Review at FDA’s Center for Biologics Evaluation and Research, earlier rebuffed attempts by some of the panelists to alter the voting question. Some panelists wanted to make tweaks, including a rephrasing to underscore the limited nature of an EUA, compared with a more complete approval through the biologics license application (BLA) process.
FDA panelist Michael Kurilla, MD, PhD, of the National Institutes of Health was the only panelist to abstain from voting. He said he was uncomfortable with the phrasing of the question.
“In the midst of a pandemic and with limited vaccine supply available, a blanket statement for individuals 18 years and older is just too broad,” he said. “I’m not convinced that for all of those age groups the benefits do actually outweigh the risks.”
In general, though, there was strong support for Moderna’s vaccine. FDA panelist James Hildreth Sr, MD, PhD, of Meharry Medical College in Nashville, Tennessee spoke of the “remarkable achievement” seen in having two vaccines ready for clearance by December for a virus that only emerged as a threat this year.
Study data indicate the primary efficacy endpoint demonstrated vaccine efficacy (VE) of 94.1% (95% CI, 89.3% - 96.8%) for the Moderna vaccine, with 11 COVID-19 cases in the vaccine group and 185 COVID-19 cases in the placebo group, the FDA staff noted during the meeting.
The advisers and FDA staff also honed in on several key issues with COVID-19 vaccines, including the challenge of having people in the placebo groups of studies seek to get cleared vaccines. Also of concern to the panel were early reports of allergic reactions seen with the Pfizer product.
Doran L. Fink, MD, PhD, an FDA official who has been closely involved with the COVID-19 vaccines, told the panel that two healthcare workers in Alaska had allergic reactions minutes after receiving the Pfizer vaccine, one of which was a case of anaphylactic reaction that resulted in hospitalization.
In the United Kingdom, there were two cases reported of notable allergic reactions, leading regulators there to issue a warning that people who have a history of significant allergic reactions should not currently receive the Pfizer-BioNTech vaccine.
The people involved in these incidents have recovered or are recovering, Fink said. But the FDA expects there will be additional reports of allergic reactions to COVID-19 vaccines.
“These cases underscores the need to remain vigilant during the early phase of the vaccination campaign,” Fink said. “To this end, FDA is working with Pfizer to further revise factsheets and prescribing information for their vaccine to draw attention to CDC guidelines for post- vaccination monitoring and management of immediate allergic reactions.”
mRNA vaccines in the lead
An FDA emergency clearance for Moderna’s product would be another vote of confidence in a new approach to making vaccines. Both the Pfizer-BioNTech and Moderna vaccines provide the immune system with a kind of blueprint in the form of genetic material, mRNA. The mRNA sets the stage for the synthesis of the signature spike protein that the SARS-CoV-2 virus uses to attach to and infect human cells.
In a December 15 commentary for this news organization Michael E. Pichichero, MD, wrote that the “revolutionary aspect of mRNA vaccines is the speed at which they can be designed and produced.”
“This is why they lead the pack among the SARS-CoV-2 vaccine candidates and why the National Institute of Allergy and Infectious Diseases provided financial, technical, and/or clinical support. Indeed, once the amino acid sequence of a protein can be determined (a relatively easy task these days) it’s straightforward to synthesize mRNA in the lab — and it can be done incredibly fast,” he wrote.
The FDA allowed one waiver for panelist James K. Hildreth in connection with his personal relationship to a trial participant and his university’s participation in vaccine testing.
This article first appeared on Medscape.com.
Consider C. difficile early in children with cancer with GI symptoms
Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.
Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.
Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.
Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.
Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.
Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.
In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?
Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.
Dr. Murphy had no financial conflicts of interest to declare.
Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.
Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.
Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.
Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.
Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.
Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.
In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?
Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.
Dr. Murphy had no financial conflicts of interest to declare.
Children with cancer are at increased risk of potentially life-threatening Clostridioides difficile infections (CDI), and Brianna Murphy, DO, reported at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
CDI are characterized by diarrhea, fever, and loss of appetite. The clinical features are caused by the release of toxins A and B by this gram-positive bacterium. In pediatric groups, CDI are a leading cause of antibiotic-associated gastric illness. This in turn can lead to a protracted stay in hospital and increases risk of mortality. The rising incidence in the United States over the last 2 decades prompted Dr. Murphy, a pediatric hematology oncology fellow working at the department of pediatric research at the University of Texas MD Anderson Cancer Center, Houston, to investigate further. A search of the literature found limited information regarding CDI and pediatric oncology patients.
Recognized factors for contracting CDI include the presence of other illnesses, a weakened immune system because of drugs or disease, enteral nutrition, usage of medicines such as proton pump inhibitors which decrease gastric acid production, and classically, treatment with broad spectrum antibiotics.
Dr. Murphy’s study included patients aged 1-18 years, all of whom had a cancer diagnosis and a positive stool culture for C. difficile. Presenting symptoms were three or more loose stools per day or acute onset ileus. The study evaluated data for the years 2000-2017 and included 11,366 children; 207 CDI (0.98%) cases were identified among pediatric oncology patients during the study period. This compares with historical data showing an incidence of 0.14% among hospitalized children in general.
Malignancy data were then subdivided into three groups: hematologic, nonneural solid tumors (NNST), and neural tumors. Hematologic malignancies had a CDI prevalence higher than the average for oncologic patients at 5.4%. Inside this group those suffering with acute myeloid leukemia had a rate of 10.5%. In the NNST and neural tumor groups, CDI rates were lower and closer to the overall average.
Dr. Murphy then looked at her patient population in more detail. Poor clinical outcomes (PCOs) were defined as severe, refractory, recurrent, or multiple infections. Severe CDI included features such as toxic megacolon, gastrointestinal perforation, or need for surgical intervention. Refractory CDI were defined as continuation of symptoms beyond 7 days of appropriate therapy, and recurrent CDI were classed as reinfection within 8 weeks of a previous CDI. Ultimately, 51% of patients in this study died. Patients with severe CDI experienced increased mortality (P = .02). There was no difference shown when looking at the type of cancer, age, gender, or patient ethnicity.
Next, Dr. Murphy looked for associations. Hematologic and biochemical testing identified that elevated creatinine was statistically associated with the likelihood of PCOs, compared with leukocytosis and neutropenia, particularly in the NNST group. Treatment modality also was studied. Here radiation therapy was the only treatment shown to increase PCOs in patients with CDI. One-fifth (22%) of radiation therapy recipients experienced multiple CDI, compared with 12% of the total population.
In commenting on her paper, Louis Bent, MD, from the Netherlands raised the issue of deaths in septic patients. What was the origin of the responsible organism, for example from the GI tract or from central lines, and were patients receiving appropriate antibiotic treatment?
Dr. Kelly responded that sepsis was generally believed to occur as a result of infection with mixed bacterial translocation through the bowel wall, notably Escherichia coli. Patients were usually on a cocktail of antibiotics targeting CDI, but also other infections illustrating the serious nature of the situation.
Dr. Murphy had no financial conflicts of interest to declare.
FROM ESPID 2020
Vaccine rollout on track, expect 300 million doses through March: Feds
If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.
The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”
Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.
Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”
The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”
The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.
Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.
The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
Antibody treatments underutilized
The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”
The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.
The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.
Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
Up to 3 billion vaccine doses possible
“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.
In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.
Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.
With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”
This article first appeared on Medscape.com.
If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.
The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”
Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.
Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”
The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”
The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.
Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.
The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
Antibody treatments underutilized
The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”
The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.
The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.
Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
Up to 3 billion vaccine doses possible
“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.
In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.
Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.
With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”
This article first appeared on Medscape.com.
If the initial success of the Pfizer-BioNTech rollout continues, and emergency use authorization (EAU) is granted to Moderna and Johnson & Johnson vaccines in development, Operation Warp Speed officials expect to have 300 million doses of COVID-19 vaccines to distribute across the United States between now and March 31.
The initial rollout remains on track, said Alex Azar, US Department of Health and Human Services (HHS) secretary, during a media briefing today. “We continue to have good news to report. As of today, shipments of vaccine will have been delivered to every delivery site identified by public health jurisdictions for our first wave of shipments.”
Anomalies in shipments to California and Alabama arose when temperature monitors showed the Pfizer vaccine dropped lower than the recommended -80 ºC (-112 °F). These vaccine trays remained on delivery trucks and were returned to Pfizer for prompt replacement, said Operation Warp Speed Chief Operating Officer Gen. Gustave F. Perna.
Azar estimated another 2 million doses of the Pfizer vaccine will be available next week. “And if the Moderna vaccine is authorized by the FDA in the coming days, we have allocated nearly 5.9 million doses of that product.”
The Moderna vaccine data released this week look promising, said Moncef Slaoui, PhD, Operation Warp Speed chief scientific adviser. “In the short term, I expect the protection to be quite significant.”
The findings in the first 2 weeks after the first dose show up to 65% protection, he said, and predicted the second-dose efficacy data will be coming in the next few weeks.
Enrollment in the phase 3 Johnson & Johnson trial with nearly 44,000 participants is expected to end December 17. Initial efficacy results are anticipated by early January, with more complete efficacy numbers by late January, Slaoui said.
The AstraZeneca COVID-19 vaccine trial also is underway with enrollment continuing. “We expect accruement to end in late December or early next year, with first results expected probably in February,” Slaoui said.
Antibody treatments underutilized
The media briefing also addressed COVID-19 therapeutics. Azar reported low uptake of available antibody therapies. “I want to remind Americans that there are two authorized antibody treatments that Operation Warp Speed has supported. They can help prevent hospitalization in those patients with the highest risk for severe disease.”
The higher-risk group includes those who are 65 and older and people with comorbid conditions that put them at increased risk for COVID-19 hospitalization.
The federal government allocated more than 330,000 doses of these treatments and many states have product available, Azar said.
Slaoui agreed, saying there is a “disappointing level of usage of monoclonal antibody therapy in hospitals. We look forward to that improving.”
Up to 3 billion vaccine doses possible
“We now have more than 900 million doses of the vaccine we have contracted delivery for,” Azar said. The government has options to increase that to a total of 3 billion doses.
In addition to the 100 million Pfizer vaccine doses and 100 million Moderna doses already ordered, the government just took an option for another 100 million Moderna doses for the second quarter of 2021. Operation Warp Speed officials are negotiating with Pfizer for additional product as well.
Azar added that there are 100 million doses of the Johnson & Johnson vaccine in active production and expects AstraZeneca can provide 300 million doses of their product.
With the possibility of three or more vaccine products and with 330 million Americans, minus the 70 million or so children under age 16, “we believe we will actually have surplus supplies,” Azar said. Plans are to take the US surplus vaccine and surplus manufacturing capacity “and use that for the benefit of the world community.”
This article first appeared on Medscape.com.
Should we use antibiotics to treat sore throats?
The use of antibiotics to treat a sore throat remains contentious, with guidelines from around the world providing contradictory advice. This topic generated a lively debate at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
Lauri Ivaska, MD, of the department of pediatrics and adolescent medicine at Turku (Finland) University Hospital, argued for the use of antibiotics, while Borbála Zsigmond, MD, of Heim Pál Children’s Hospital in Budapest, made the case against their use. Interestingly, this debate occurred against the background of a poll conducted before the debate, which found that only 11% of the audience voted in favor of using antibiotics to treat sore throats.
Both speakers began by exploring their approach to the treatment of a recent clinical case involving a 4-year-old girl presenting with sore throat. Dr. Ivaska stressed the difference between a sore throat, pharyngitis, and tonsillitis: the latter two refer to a physical finding, while the former is a subjective symptom.
International guidelines differ on the subject
The debate moved to discussing the international guidelines for treating pharyngitis and tonsillitis. Dr. Zsigmond believes that these are flawed and unhelpful, arguing that they differ depending on what part of the world a physician is practicing in. For example, the 2012 Infectious Diseases Society of America guidelines recommend using best clinical judgment and then backing this up by testing. If testing proves positive for group A Streptococcus pyogenes (GAS), the physician should universally treat. By comparison, the European Society of Clinical Microbiology and Infectious Diseases Sore Throat Guideline Group focuses on severity rather than the cause of the infection. If the case is deemed to be serious, antibiotics can be prescribed without a positive test.
Sore throat is frequently associated with a common cold. In a recent study, more that 80% of students with an acute viral respiratory tract infection had soreness at the beginning of their illness.
Reporting from his own research, Dr. Ivaska argued that viruses can be detected in almost two-thirds of children with pharyngitis using polymerase chain reaction analysis. He thinks antibiotics should be reserved for those 30%-40% of patients with a confirmed GAS infection. The potential role of Fusobacterium necrophorum was raised, but there is no evidence of the benefits of antibiotic treatment in such cases.
There are diagnostic aids for GAS infection
It was suggested that, instead of concentrating on sore throat, the debate should be about whether to use antibiotics to treat GAS infection. But how can the diagnosis be confirmed simply in a clinical setting? Dr. Ivaska recommended adopting diagnostic aids such as Centor, McIsaac, and FeverPAIN, which award scores for several common disease features – the higher the score, the more likely a patient is to be suffering from a GAS infection.
Dr. Zsigmond also likes scoring symptoms but believes they are often inaccurate, especially in young children. She pointed to a report that examined the use of the Centor tool among 441 children attending a pediatric ED. The authors concluded that the Centor criteria were ineffective in predicting a positive GAS culture in throat swabs taken from symptomatic patients.
When are antibiotics warranted?
It is widely accepted that antibiotics should be avoided for viral infections. Returning to the case described at the start of this debate, Dr. Zsigmond calculated that her patient with a 2-day history of sore throat, elevated temperature, pussy tonsils, and enlarged cervical lymph glands but no cough or rhinitis had a FeverPAIN score of 4-5 and a Centor score of 4, meaning that, according to the European guidelines, she should receive antibiotic treatment. However, viral swabs proved positive for adenovirus.
Dr. Ivaska responded with his recent experiences of a similar case, where a 5-year-old boy had a FeverPAIN score of 4-5 and Centor score of 3. Cultures from his throat were GAS positive, illustrating the problem of differentiating between bacterial and viral infections.
But does a GAS-positive pharyngeal culture necessarily mean that antibiotic treatment is indicated? Dr. Ivaska believes it does, citing the importance of preventing serious complications such as rheumatic fever. Dr. Zsigmind countered by pointing out the low levels of acute rheumatic fever in developed nations. In her own country, Hungary, there has not been a case in the last 30 years. Giving antibiotics for historical reasons cannot, in her view, be justified.
Dr. Ivaska responded that perhaps this is because of early treatment in children with sore throats.
Another complication of tonsillitis is quinsy. Dr. Zsigmond cited a study showing that there is no statistically significant evidence demonstrating that antibiotics prevent quinsy. She attributed this to quinsy appearing quickly, typically within 2 days. Delay in seeking help means that the window to treat is often missed. However, should symptoms present early, there is no statistical evidence that prior antibiotic use can prevent quinsy. Also, given the rarity of this condition, prevention would mean excessive use of antibiotics.
Are there other possible benefits of antibiotic treatment in patients with a sore throat? Dr. Ivaska referred to a Cochrane review that found a shortening in duration of throat soreness and fever. Furthermore, compared with placebo, antibiotics reduced the incidence of suppurative complications such as acute otitis media and sinusitis following a sore throat. Other studies have also pointed to the potential benefits of reduced transmission in families where one member with pharyngitis was GAS positive.
As the debate ended, Dr. Zsigmond reported evidence of global antibiotic overprescribing for sore throat ranging from 53% in Europe to 94% in Australia. She also highlighted risks such as altered gut flora, drug resistance, and rashes.
Robin Marlow from the University of Bristol (England), PhD, MBBS, commented that “one of the most enjoyable parts of the ESPID meeting is hearing different viewpoints rationally explained from across the world. As [antibiotic prescription for a sore throat is] a clinical conundrum that faces pediatricians every day, I thought this debate was a really great example of how, despite our different health care systems and ways of working, we are all striving together to improve children’s health using the best evidence available.”
The presenters had no financial conflicts of interest to declare.
The use of antibiotics to treat a sore throat remains contentious, with guidelines from around the world providing contradictory advice. This topic generated a lively debate at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
Lauri Ivaska, MD, of the department of pediatrics and adolescent medicine at Turku (Finland) University Hospital, argued for the use of antibiotics, while Borbála Zsigmond, MD, of Heim Pál Children’s Hospital in Budapest, made the case against their use. Interestingly, this debate occurred against the background of a poll conducted before the debate, which found that only 11% of the audience voted in favor of using antibiotics to treat sore throats.
Both speakers began by exploring their approach to the treatment of a recent clinical case involving a 4-year-old girl presenting with sore throat. Dr. Ivaska stressed the difference between a sore throat, pharyngitis, and tonsillitis: the latter two refer to a physical finding, while the former is a subjective symptom.
International guidelines differ on the subject
The debate moved to discussing the international guidelines for treating pharyngitis and tonsillitis. Dr. Zsigmond believes that these are flawed and unhelpful, arguing that they differ depending on what part of the world a physician is practicing in. For example, the 2012 Infectious Diseases Society of America guidelines recommend using best clinical judgment and then backing this up by testing. If testing proves positive for group A Streptococcus pyogenes (GAS), the physician should universally treat. By comparison, the European Society of Clinical Microbiology and Infectious Diseases Sore Throat Guideline Group focuses on severity rather than the cause of the infection. If the case is deemed to be serious, antibiotics can be prescribed without a positive test.
Sore throat is frequently associated with a common cold. In a recent study, more that 80% of students with an acute viral respiratory tract infection had soreness at the beginning of their illness.
Reporting from his own research, Dr. Ivaska argued that viruses can be detected in almost two-thirds of children with pharyngitis using polymerase chain reaction analysis. He thinks antibiotics should be reserved for those 30%-40% of patients with a confirmed GAS infection. The potential role of Fusobacterium necrophorum was raised, but there is no evidence of the benefits of antibiotic treatment in such cases.
There are diagnostic aids for GAS infection
It was suggested that, instead of concentrating on sore throat, the debate should be about whether to use antibiotics to treat GAS infection. But how can the diagnosis be confirmed simply in a clinical setting? Dr. Ivaska recommended adopting diagnostic aids such as Centor, McIsaac, and FeverPAIN, which award scores for several common disease features – the higher the score, the more likely a patient is to be suffering from a GAS infection.
Dr. Zsigmond also likes scoring symptoms but believes they are often inaccurate, especially in young children. She pointed to a report that examined the use of the Centor tool among 441 children attending a pediatric ED. The authors concluded that the Centor criteria were ineffective in predicting a positive GAS culture in throat swabs taken from symptomatic patients.
When are antibiotics warranted?
It is widely accepted that antibiotics should be avoided for viral infections. Returning to the case described at the start of this debate, Dr. Zsigmond calculated that her patient with a 2-day history of sore throat, elevated temperature, pussy tonsils, and enlarged cervical lymph glands but no cough or rhinitis had a FeverPAIN score of 4-5 and a Centor score of 4, meaning that, according to the European guidelines, she should receive antibiotic treatment. However, viral swabs proved positive for adenovirus.
Dr. Ivaska responded with his recent experiences of a similar case, where a 5-year-old boy had a FeverPAIN score of 4-5 and Centor score of 3. Cultures from his throat were GAS positive, illustrating the problem of differentiating between bacterial and viral infections.
But does a GAS-positive pharyngeal culture necessarily mean that antibiotic treatment is indicated? Dr. Ivaska believes it does, citing the importance of preventing serious complications such as rheumatic fever. Dr. Zsigmind countered by pointing out the low levels of acute rheumatic fever in developed nations. In her own country, Hungary, there has not been a case in the last 30 years. Giving antibiotics for historical reasons cannot, in her view, be justified.
Dr. Ivaska responded that perhaps this is because of early treatment in children with sore throats.
Another complication of tonsillitis is quinsy. Dr. Zsigmond cited a study showing that there is no statistically significant evidence demonstrating that antibiotics prevent quinsy. She attributed this to quinsy appearing quickly, typically within 2 days. Delay in seeking help means that the window to treat is often missed. However, should symptoms present early, there is no statistical evidence that prior antibiotic use can prevent quinsy. Also, given the rarity of this condition, prevention would mean excessive use of antibiotics.
Are there other possible benefits of antibiotic treatment in patients with a sore throat? Dr. Ivaska referred to a Cochrane review that found a shortening in duration of throat soreness and fever. Furthermore, compared with placebo, antibiotics reduced the incidence of suppurative complications such as acute otitis media and sinusitis following a sore throat. Other studies have also pointed to the potential benefits of reduced transmission in families where one member with pharyngitis was GAS positive.
As the debate ended, Dr. Zsigmond reported evidence of global antibiotic overprescribing for sore throat ranging from 53% in Europe to 94% in Australia. She also highlighted risks such as altered gut flora, drug resistance, and rashes.
Robin Marlow from the University of Bristol (England), PhD, MBBS, commented that “one of the most enjoyable parts of the ESPID meeting is hearing different viewpoints rationally explained from across the world. As [antibiotic prescription for a sore throat is] a clinical conundrum that faces pediatricians every day, I thought this debate was a really great example of how, despite our different health care systems and ways of working, we are all striving together to improve children’s health using the best evidence available.”
The presenters had no financial conflicts of interest to declare.
The use of antibiotics to treat a sore throat remains contentious, with guidelines from around the world providing contradictory advice. This topic generated a lively debate at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
Lauri Ivaska, MD, of the department of pediatrics and adolescent medicine at Turku (Finland) University Hospital, argued for the use of antibiotics, while Borbála Zsigmond, MD, of Heim Pál Children’s Hospital in Budapest, made the case against their use. Interestingly, this debate occurred against the background of a poll conducted before the debate, which found that only 11% of the audience voted in favor of using antibiotics to treat sore throats.
Both speakers began by exploring their approach to the treatment of a recent clinical case involving a 4-year-old girl presenting with sore throat. Dr. Ivaska stressed the difference between a sore throat, pharyngitis, and tonsillitis: the latter two refer to a physical finding, while the former is a subjective symptom.
International guidelines differ on the subject
The debate moved to discussing the international guidelines for treating pharyngitis and tonsillitis. Dr. Zsigmond believes that these are flawed and unhelpful, arguing that they differ depending on what part of the world a physician is practicing in. For example, the 2012 Infectious Diseases Society of America guidelines recommend using best clinical judgment and then backing this up by testing. If testing proves positive for group A Streptococcus pyogenes (GAS), the physician should universally treat. By comparison, the European Society of Clinical Microbiology and Infectious Diseases Sore Throat Guideline Group focuses on severity rather than the cause of the infection. If the case is deemed to be serious, antibiotics can be prescribed without a positive test.
Sore throat is frequently associated with a common cold. In a recent study, more that 80% of students with an acute viral respiratory tract infection had soreness at the beginning of their illness.
Reporting from his own research, Dr. Ivaska argued that viruses can be detected in almost two-thirds of children with pharyngitis using polymerase chain reaction analysis. He thinks antibiotics should be reserved for those 30%-40% of patients with a confirmed GAS infection. The potential role of Fusobacterium necrophorum was raised, but there is no evidence of the benefits of antibiotic treatment in such cases.
There are diagnostic aids for GAS infection
It was suggested that, instead of concentrating on sore throat, the debate should be about whether to use antibiotics to treat GAS infection. But how can the diagnosis be confirmed simply in a clinical setting? Dr. Ivaska recommended adopting diagnostic aids such as Centor, McIsaac, and FeverPAIN, which award scores for several common disease features – the higher the score, the more likely a patient is to be suffering from a GAS infection.
Dr. Zsigmond also likes scoring symptoms but believes they are often inaccurate, especially in young children. She pointed to a report that examined the use of the Centor tool among 441 children attending a pediatric ED. The authors concluded that the Centor criteria were ineffective in predicting a positive GAS culture in throat swabs taken from symptomatic patients.
When are antibiotics warranted?
It is widely accepted that antibiotics should be avoided for viral infections. Returning to the case described at the start of this debate, Dr. Zsigmond calculated that her patient with a 2-day history of sore throat, elevated temperature, pussy tonsils, and enlarged cervical lymph glands but no cough or rhinitis had a FeverPAIN score of 4-5 and a Centor score of 4, meaning that, according to the European guidelines, she should receive antibiotic treatment. However, viral swabs proved positive for adenovirus.
Dr. Ivaska responded with his recent experiences of a similar case, where a 5-year-old boy had a FeverPAIN score of 4-5 and Centor score of 3. Cultures from his throat were GAS positive, illustrating the problem of differentiating between bacterial and viral infections.
But does a GAS-positive pharyngeal culture necessarily mean that antibiotic treatment is indicated? Dr. Ivaska believes it does, citing the importance of preventing serious complications such as rheumatic fever. Dr. Zsigmind countered by pointing out the low levels of acute rheumatic fever in developed nations. In her own country, Hungary, there has not been a case in the last 30 years. Giving antibiotics for historical reasons cannot, in her view, be justified.
Dr. Ivaska responded that perhaps this is because of early treatment in children with sore throats.
Another complication of tonsillitis is quinsy. Dr. Zsigmond cited a study showing that there is no statistically significant evidence demonstrating that antibiotics prevent quinsy. She attributed this to quinsy appearing quickly, typically within 2 days. Delay in seeking help means that the window to treat is often missed. However, should symptoms present early, there is no statistical evidence that prior antibiotic use can prevent quinsy. Also, given the rarity of this condition, prevention would mean excessive use of antibiotics.
Are there other possible benefits of antibiotic treatment in patients with a sore throat? Dr. Ivaska referred to a Cochrane review that found a shortening in duration of throat soreness and fever. Furthermore, compared with placebo, antibiotics reduced the incidence of suppurative complications such as acute otitis media and sinusitis following a sore throat. Other studies have also pointed to the potential benefits of reduced transmission in families where one member with pharyngitis was GAS positive.
As the debate ended, Dr. Zsigmond reported evidence of global antibiotic overprescribing for sore throat ranging from 53% in Europe to 94% in Australia. She also highlighted risks such as altered gut flora, drug resistance, and rashes.
Robin Marlow from the University of Bristol (England), PhD, MBBS, commented that “one of the most enjoyable parts of the ESPID meeting is hearing different viewpoints rationally explained from across the world. As [antibiotic prescription for a sore throat is] a clinical conundrum that faces pediatricians every day, I thought this debate was a really great example of how, despite our different health care systems and ways of working, we are all striving together to improve children’s health using the best evidence available.”
The presenters had no financial conflicts of interest to declare.
FROM ESPID 2020
E-cigarette use tied to increased COPD, asthma risk
Results from a large national prospective cohort study of adults demonstrated that the use of electronic cigarettes is associated with an increased risk of asthma, chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis – independent of cigarette smoking and other combustible tobacco product use.
“Our longitudinal results are consistent with the findings of prior population studies,” researchers led by Wubin Xie, DrPH, MPH, wrote in a study published online in JAMA Network Open. “With a more refined study design assessing multiple respiratory conditions and extensive sensitivity checks to mitigate bias from reverse causation and residual confounding by cigarette smoking and other tobacco product use, our results strengthen the evidence of the potential role of e-cigarette use in pulmonary disease pathogenesis. The findings may be used to inform counseling of patients on the potential risks of e-cigarette use.”
Dr. Xie of Boston University, and colleagues used data from the Population Assessment of Tobacco and Health (PATH) study waves 1-4 to examine the association of e-cigarette use with incident respiratory conditions, including COPD, emphysema, chronic bronchitis, and asthma. An earlier analysis of PATH data found an association between e-cigarette use with a composite respiratory disease outcome, but it did not consider the timing of respiratory events over follow-up and was underpowered to evaluate specific respiratory conditions.
The current analysis included data from 21,618 U.S. adults who were surveyed in four waves of PATH between 2013 and 2018. Of these, 49% were men, 65% were non-Hispanic White, 12% were non-Hispanic Black, 16% were Hispanic, and the remainder were non-Hispanic other. Their mean pack-years was 6.7 at baseline, 26% had self-reported hypertension, and their mean body mass index was 27.8 kg/m2. The analysis was limited to data from the wave 1 cohort of adults and the prospective follow-up at waves 2-4 from public use files. It excluded adults who reported a history of a respiratory condition such as COPD, emphysema, chronic bronchitis, or asthma at wave 1 (baseline).
Two-thirds of respondents (66%) were never e-cigarette users, 12% were former e-cigarette users, and 5% were current e-cigarette users. After the researchers adjusted for cigarette and other combustible tobacco product use, demographic characteristics, and chronic health conditions, they observed an increased risk of respiratory disease among former e-cigarette users (incidence rate ratio, 1.28) and current e-cigarette users (IRR, 1.31). Among respondents with good self-reported health, the IRR for former e-cigarette users was 1.21 and the IRR for current e-cigarette users was 1.43. As for specific respiratory diseases among current e-cigarette users, the IRR was 1.33 for chronic bronchitis, 1.69 for emphysema, 1.57 for COPD, and 1.31 for asthma.
“Our findings on clinical outcome were consistent with studies assessing in vivo biomarkers of e-cigarette exposure in animal subjects, human participants, and population studies,” the authors wrote. “Studies have documented that exclusive e-cigarette use may be associated with higher exposure to harmful and potentially harmful constituents, compared with tobacco nonuse. The potential mechanisms of the association of e-cigarette exposure with pulmonary diseases include pulmonary inflammation, increased oxidative stress, and inhibited immune response. Animal studies have generated substantial evidence on e-cigarette exposure and emphysematous lung destruction, loss of pulmonary capillaries, reduced small airway function, and airway hyperresponsiveness, suggesting the plausibility of e-cigarettes causing chronic lung diseases.”
They acknowledged certain limitations of the study, including its reliance on self-reported measures of e-cigarette and other tobacco product use and its reliance on self-reported diagnoses of respiratory diseases.
The study was supported by grants from the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; and the American Lung Association Public Policy Research Award. Dr. Xie reported having no financial disclosures. His coauthors reported having received research grants and personal fees from a variety of sources.
SOURCE: Xie W et al. JAMA Netw Open. 2020 Nov 12. doi: 10.1001/jamanetworkopen.2020.20816
Results from a large national prospective cohort study of adults demonstrated that the use of electronic cigarettes is associated with an increased risk of asthma, chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis – independent of cigarette smoking and other combustible tobacco product use.
“Our longitudinal results are consistent with the findings of prior population studies,” researchers led by Wubin Xie, DrPH, MPH, wrote in a study published online in JAMA Network Open. “With a more refined study design assessing multiple respiratory conditions and extensive sensitivity checks to mitigate bias from reverse causation and residual confounding by cigarette smoking and other tobacco product use, our results strengthen the evidence of the potential role of e-cigarette use in pulmonary disease pathogenesis. The findings may be used to inform counseling of patients on the potential risks of e-cigarette use.”
Dr. Xie of Boston University, and colleagues used data from the Population Assessment of Tobacco and Health (PATH) study waves 1-4 to examine the association of e-cigarette use with incident respiratory conditions, including COPD, emphysema, chronic bronchitis, and asthma. An earlier analysis of PATH data found an association between e-cigarette use with a composite respiratory disease outcome, but it did not consider the timing of respiratory events over follow-up and was underpowered to evaluate specific respiratory conditions.
The current analysis included data from 21,618 U.S. adults who were surveyed in four waves of PATH between 2013 and 2018. Of these, 49% were men, 65% were non-Hispanic White, 12% were non-Hispanic Black, 16% were Hispanic, and the remainder were non-Hispanic other. Their mean pack-years was 6.7 at baseline, 26% had self-reported hypertension, and their mean body mass index was 27.8 kg/m2. The analysis was limited to data from the wave 1 cohort of adults and the prospective follow-up at waves 2-4 from public use files. It excluded adults who reported a history of a respiratory condition such as COPD, emphysema, chronic bronchitis, or asthma at wave 1 (baseline).
Two-thirds of respondents (66%) were never e-cigarette users, 12% were former e-cigarette users, and 5% were current e-cigarette users. After the researchers adjusted for cigarette and other combustible tobacco product use, demographic characteristics, and chronic health conditions, they observed an increased risk of respiratory disease among former e-cigarette users (incidence rate ratio, 1.28) and current e-cigarette users (IRR, 1.31). Among respondents with good self-reported health, the IRR for former e-cigarette users was 1.21 and the IRR for current e-cigarette users was 1.43. As for specific respiratory diseases among current e-cigarette users, the IRR was 1.33 for chronic bronchitis, 1.69 for emphysema, 1.57 for COPD, and 1.31 for asthma.
“Our findings on clinical outcome were consistent with studies assessing in vivo biomarkers of e-cigarette exposure in animal subjects, human participants, and population studies,” the authors wrote. “Studies have documented that exclusive e-cigarette use may be associated with higher exposure to harmful and potentially harmful constituents, compared with tobacco nonuse. The potential mechanisms of the association of e-cigarette exposure with pulmonary diseases include pulmonary inflammation, increased oxidative stress, and inhibited immune response. Animal studies have generated substantial evidence on e-cigarette exposure and emphysematous lung destruction, loss of pulmonary capillaries, reduced small airway function, and airway hyperresponsiveness, suggesting the plausibility of e-cigarettes causing chronic lung diseases.”
They acknowledged certain limitations of the study, including its reliance on self-reported measures of e-cigarette and other tobacco product use and its reliance on self-reported diagnoses of respiratory diseases.
The study was supported by grants from the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; and the American Lung Association Public Policy Research Award. Dr. Xie reported having no financial disclosures. His coauthors reported having received research grants and personal fees from a variety of sources.
SOURCE: Xie W et al. JAMA Netw Open. 2020 Nov 12. doi: 10.1001/jamanetworkopen.2020.20816
Results from a large national prospective cohort study of adults demonstrated that the use of electronic cigarettes is associated with an increased risk of asthma, chronic obstructive pulmonary disease (COPD), emphysema, and chronic bronchitis – independent of cigarette smoking and other combustible tobacco product use.
“Our longitudinal results are consistent with the findings of prior population studies,” researchers led by Wubin Xie, DrPH, MPH, wrote in a study published online in JAMA Network Open. “With a more refined study design assessing multiple respiratory conditions and extensive sensitivity checks to mitigate bias from reverse causation and residual confounding by cigarette smoking and other tobacco product use, our results strengthen the evidence of the potential role of e-cigarette use in pulmonary disease pathogenesis. The findings may be used to inform counseling of patients on the potential risks of e-cigarette use.”
Dr. Xie of Boston University, and colleagues used data from the Population Assessment of Tobacco and Health (PATH) study waves 1-4 to examine the association of e-cigarette use with incident respiratory conditions, including COPD, emphysema, chronic bronchitis, and asthma. An earlier analysis of PATH data found an association between e-cigarette use with a composite respiratory disease outcome, but it did not consider the timing of respiratory events over follow-up and was underpowered to evaluate specific respiratory conditions.
The current analysis included data from 21,618 U.S. adults who were surveyed in four waves of PATH between 2013 and 2018. Of these, 49% were men, 65% were non-Hispanic White, 12% were non-Hispanic Black, 16% were Hispanic, and the remainder were non-Hispanic other. Their mean pack-years was 6.7 at baseline, 26% had self-reported hypertension, and their mean body mass index was 27.8 kg/m2. The analysis was limited to data from the wave 1 cohort of adults and the prospective follow-up at waves 2-4 from public use files. It excluded adults who reported a history of a respiratory condition such as COPD, emphysema, chronic bronchitis, or asthma at wave 1 (baseline).
Two-thirds of respondents (66%) were never e-cigarette users, 12% were former e-cigarette users, and 5% were current e-cigarette users. After the researchers adjusted for cigarette and other combustible tobacco product use, demographic characteristics, and chronic health conditions, they observed an increased risk of respiratory disease among former e-cigarette users (incidence rate ratio, 1.28) and current e-cigarette users (IRR, 1.31). Among respondents with good self-reported health, the IRR for former e-cigarette users was 1.21 and the IRR for current e-cigarette users was 1.43. As for specific respiratory diseases among current e-cigarette users, the IRR was 1.33 for chronic bronchitis, 1.69 for emphysema, 1.57 for COPD, and 1.31 for asthma.
“Our findings on clinical outcome were consistent with studies assessing in vivo biomarkers of e-cigarette exposure in animal subjects, human participants, and population studies,” the authors wrote. “Studies have documented that exclusive e-cigarette use may be associated with higher exposure to harmful and potentially harmful constituents, compared with tobacco nonuse. The potential mechanisms of the association of e-cigarette exposure with pulmonary diseases include pulmonary inflammation, increased oxidative stress, and inhibited immune response. Animal studies have generated substantial evidence on e-cigarette exposure and emphysematous lung destruction, loss of pulmonary capillaries, reduced small airway function, and airway hyperresponsiveness, suggesting the plausibility of e-cigarettes causing chronic lung diseases.”
They acknowledged certain limitations of the study, including its reliance on self-reported measures of e-cigarette and other tobacco product use and its reliance on self-reported diagnoses of respiratory diseases.
The study was supported by grants from the National Heart, Lung, and Blood Institute; the Food and Drug Administration Center for Tobacco Products; and the American Lung Association Public Policy Research Award. Dr. Xie reported having no financial disclosures. His coauthors reported having received research grants and personal fees from a variety of sources.
SOURCE: Xie W et al. JAMA Netw Open. 2020 Nov 12. doi: 10.1001/jamanetworkopen.2020.20816
FROM JAMA NETWORK OPEN
Pediatricians want kids to be part of COVID vaccine trials
If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.
The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.
It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.
Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.
Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.
COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.
Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.
Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”
The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.
“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”
Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.
Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.
“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.
But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.
But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”
In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.
Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.
In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.
“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”
And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.
“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.
The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.
It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.
Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.
Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.
COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.
Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.
Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”
The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.
“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”
Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.
Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.
“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.
But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.
But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”
In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.
Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.
In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.
“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”
And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.
“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
If clinical trials for COVID-19 vaccines aren’t expanded soon to include children, it’s unlikely that even kids in their teens will be vaccinated in time for the next school year.
The hurdle is that COVID vaccine makers are only in the early stages of testing their products on children. The Pfizer vaccine authorized for use by the Food and Drug Administration on Friday was greenlighted only for people aged 16 years and older. Moderna just started trials for 12- to 17-year-olds for its vaccine, likely to be authorized later this month.
It will take months to approve use of the vaccines for middle- and high school–aged kids, and months more to test them in younger children. But some pediatricians say that concerns about the safety of the front-runner vaccines make the wait worthwhile.
Although most pediatricians believe the eventual vaccination of children will be crucial to subduing the COVID virus, they’re split on how fast to move toward that, says James Campbell, MD, professor of pediatrics at the University of Maryland’s Center for Vaccine Development and Global Health in Baltimore. Dr. Campbell and colleagues said it’s a matter of urgency to get the vaccines tested in kids, while others want to hold off on those trials until millions of adults have been safely vaccinated.
Much of the debate centers on two issues: the degree of harm COVID-19 causes children and the extent to which children are spreading the virus to their friends, teachers, parents and grandparents.
COVID-19’s impact on children represents a tiny fraction of the suffering and death experienced by vulnerable adults. Yet it would qualify as a pretty serious childhood disease, having caused 154 deaths and more than 7,500 hospitalizations as of Dec. 3 among aged people 19 years and younger in the United States. Those numbers rank it as worse than a typical year of influenza, and worse than diseases like mumps or hepatitis B in children before the vaccination era.
Studies thus far show that 1%-2% of children infected with the virus end up requiring intensive care, Stanley Plotkin, MD, professor emeritus of pediatrics at the University of Pennsylvania, Philadelphia told a federal panel. That’s in line with the percentage who become gravely ill as result of infections like Haemophilus influenzae type B, for which doctors have vaccinated children since the 1980s, he pointed out.
Dr. Campbell, who with colleagues has developed a plan for how to run pediatric COVID vaccine trials, pointed out that, “in a universe where COVID mainly affected children the way it’s affecting them now, and we had potential vaccines, people would be clamoring for them.”
The evidence that teens can transmit the disease is pretty clear, and transmission has been documented in children as young as 8. Fear of spread by children has been enough to close schools, and led the American Academy of Pediatrics to demand that children be quickly included in vaccine testing.
“The longer we take to start kids in trials, the longer it will take them to get vaccinated and to break the chains of transmission,” said Yvonne Maldonado, MD, a professor of pediatrics at Stanford (Calif.) University who chairs the AAP’s infectious disease committee. “If you want kids to go back to school and not have the teachers union terrified, you have to make sure they aren’t a risk.”
Other pediatricians worry that early pediatric trials could backfire. Cody Meissner, MD, chief of pediatric infectious diseases at Tufts Medical Center and a member of the FDA’s advisory committee on vaccines, is worried that whatever causes multisystem inflammatory syndrome in children, a rare but frightening COVID-related disorder, might also be triggered, however rarely, by vaccination.
Dr. Meissner abstained from the committee’s vote Thursday that supported, by a 17-4 vote, an emergency authorization of the Pfizer vaccine for people aged 16 years and older.
“I have trouble justifying it for children so unlikely to get the disease,” he said during debate on the measure.
But panel member Ofer Levy, MD, PhD, director of the Precision Vaccines Program at Boston Children’s Hospital, said the 16-years-and-up authorization would speed the vaccine’s testing in and approval for younger children. That is vital for the world’s protection from COVID-19, he said, since in the United States and most places “most vaccines are delivered early in life.”
While vaccines given to tens of thousands of people so far appear to be safe, the lack of understanding of the inflammatory syndrome means that children in any trials should be followed closely, said Emily Erbelding, MD, MPH, director of the division of microbiology and infectious diseases at the National Institute of Allergy and Infectious Diseases.
Under a 2003 law, vaccine companies are required eventually to test all their products on children. By late November, Pfizer had vaccinated approximately 100 children aged 12-15 years, said spokesperson Jerica Pitts.
Moderna has started enrolling 3,000 children aged 12 years and over in another clinical trial, and other companies have similar plans. Assuming the trials show the vaccines are safe and provide a good immune response, future tests could include progressively younger children, moving to, say, 6- to 12-year-olds next, then 2- to 6-year-olds. Eventually, trials could include younger toddlers and infants.
Similar step-down approaches were taken to test vaccines against human papillomavirus (HPV), influenza and other diseases in the past, Dr. Erbelding noted. Such trials are easiest to conduct when researchers know that a measurable immune response, like antibody levels in the blood, translates to effective protection against disease. Armed with such knowledge, they can see whether children were protected without them having to be exposed to the virus. Federal scientists hope to get that data from the Moderna and Pfizer adult vaccine trials, she said.
Vaccine trials geared to tweens or younger children may involve testing half-doses, which, if protective, would require less vaccine and might cause fewer incidents of sore arms and fevers that afflicted many who’ve received the Pfizer and Moderna vaccines, Dr. Campbell said.
But unless additional studies begin quickly, the window for having an FDA-authorized vaccine available before the next school year “will be closed even for our oldest children,” said Evan Anderson, MD, a pediatrics professor at Emory University, Atlanta. “Our younger children are almost certainly going into next school year without a vaccine option available for them.”
In the meantime, teachers are likely to be high on the priority list for vaccination. Protecting school staff could allow more schools to reopen even if most children can’t be vaccinated, Dr. Erbelding said.
Eventually, if the SARS-CoV-2 virus remains in circulation, governments may want to mandate childhood vaccination against the virus to protect them as they grow up and protect society as a whole, Dr. Plotkin said.
In the 1960s, Dr. Plotkin invented the rubella vaccine that has been given to hundreds of millions of children since. Like COVID-19, rubella – or German measles – is not usually a serious illness for children. But congenital rubella syndrome afflicted babies in the womb with blindness, deafness, developmental delays, and autism. Immunizing toddlers, which, in turn, protects their pregnant mothers, has indirectly prevented hundreds of thousands of such cases.
“We don’t want to use children to protect everyone in the community,” said Dr. Campbell. “But when you can protect both children and their community, that’s important.”
And while a coronavirus infection may not be bad for most children, missed school, absent friends, and distanced families have caused them immense suffering, he said.
“It’s a huge burden on a child to have their entire world flipped around,” Dr. Campbell said. “If vaccinating could help to flip it back, we should begin testing to see if that’s possible.”
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Teenage bone density declines following sleeve gastrectomy
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Vaccine-preventable infection risk high for pediatric hematopoietic cell transplantation recipients
Vaccine-preventable infections (VPIs) in pediatric hematopoietic cell transplantation (HCT) recipients cause significant morbidity, health care burden, and mortality.
Dana Danino, MD, and colleagues presented their evaluation of the prevalence and epidemiology of pediatric VPI-associated hospitalizations occurring within 5 years post HCT at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
“Pediatric HCT recipients are at increased risk of VPIs, and HCT recipients have poor outcomes from VPIs, compared with the general population,” explained Dr. Danino, of the department of pediatrics, and divisions of infectious diseases and host defense at the Ohio State University, Columbus. “However, the contemporary prevalence, risk factors, morbidity and mortality resulting from VPIs in children post HCT are not well known.”
Their epidemiological study, using the Pediatric Health Information System (PHIS) database, identified all children under 18 years that underwent allogeneic or autologous HCT in an 8-year period. A total of 9,591 unique HCT recipients were identified.
The researchers demonstrated that 7.1% of this cohort were hospitalized for a VPI in the first 5 years post HCT. Dr. Danino explained that 67% of VPI hospitalizations occurred during the first year, at a median of 222 days, and 22% of VPIs occurred during the initial HCT admission.
As to the type of infection, Dr. Danino and colleagues found that, the prevalence of VPI hospitalizations were highest for influenza, followed by varicella and invasive pneumococcal infections. They identified no hospitalizations due to measles or rubella during the study period.
The study findings revealed that the influenza infections occurred a median 231 days post HCT; varicella infections occurred a median 190 days; and invasive pneumococcal infections occurred a median 311 days post HCT.
“When we did a multivariate analysis by time post HCT, we found that age at transplantation, primary immune deficiency as an indication for transplantation, and graft versus host disease were independent predictors of VPIs during the initial HCT admission,” said Dr. Danino.
Children with a VPI who spent longer in hospital were more likely to be admitted to an ICU and have higher mortality, compared with children without a VPI diagnosis.
“VPIs led to longer duration of hospitalization, higher rates of ICU admission, and higher mortality, compared to HCT recipients without VPIs,” Dr. Danino explained. It was not possible in this retrospective study to determine whether increased mortality was VPI related.
These results underline the seriousness of infections in vulnerable children after HCT. Dr. Danino concluded by saying that “efforts to optimize vaccination strategies early post HCT are warranted to decrease VPIs.”
Dr. Danino had nothing to disclose.
Vaccine-preventable infections (VPIs) in pediatric hematopoietic cell transplantation (HCT) recipients cause significant morbidity, health care burden, and mortality.
Dana Danino, MD, and colleagues presented their evaluation of the prevalence and epidemiology of pediatric VPI-associated hospitalizations occurring within 5 years post HCT at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
“Pediatric HCT recipients are at increased risk of VPIs, and HCT recipients have poor outcomes from VPIs, compared with the general population,” explained Dr. Danino, of the department of pediatrics, and divisions of infectious diseases and host defense at the Ohio State University, Columbus. “However, the contemporary prevalence, risk factors, morbidity and mortality resulting from VPIs in children post HCT are not well known.”
Their epidemiological study, using the Pediatric Health Information System (PHIS) database, identified all children under 18 years that underwent allogeneic or autologous HCT in an 8-year period. A total of 9,591 unique HCT recipients were identified.
The researchers demonstrated that 7.1% of this cohort were hospitalized for a VPI in the first 5 years post HCT. Dr. Danino explained that 67% of VPI hospitalizations occurred during the first year, at a median of 222 days, and 22% of VPIs occurred during the initial HCT admission.
As to the type of infection, Dr. Danino and colleagues found that, the prevalence of VPI hospitalizations were highest for influenza, followed by varicella and invasive pneumococcal infections. They identified no hospitalizations due to measles or rubella during the study period.
The study findings revealed that the influenza infections occurred a median 231 days post HCT; varicella infections occurred a median 190 days; and invasive pneumococcal infections occurred a median 311 days post HCT.
“When we did a multivariate analysis by time post HCT, we found that age at transplantation, primary immune deficiency as an indication for transplantation, and graft versus host disease were independent predictors of VPIs during the initial HCT admission,” said Dr. Danino.
Children with a VPI who spent longer in hospital were more likely to be admitted to an ICU and have higher mortality, compared with children without a VPI diagnosis.
“VPIs led to longer duration of hospitalization, higher rates of ICU admission, and higher mortality, compared to HCT recipients without VPIs,” Dr. Danino explained. It was not possible in this retrospective study to determine whether increased mortality was VPI related.
These results underline the seriousness of infections in vulnerable children after HCT. Dr. Danino concluded by saying that “efforts to optimize vaccination strategies early post HCT are warranted to decrease VPIs.”
Dr. Danino had nothing to disclose.
Vaccine-preventable infections (VPIs) in pediatric hematopoietic cell transplantation (HCT) recipients cause significant morbidity, health care burden, and mortality.
Dana Danino, MD, and colleagues presented their evaluation of the prevalence and epidemiology of pediatric VPI-associated hospitalizations occurring within 5 years post HCT at the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year.
“Pediatric HCT recipients are at increased risk of VPIs, and HCT recipients have poor outcomes from VPIs, compared with the general population,” explained Dr. Danino, of the department of pediatrics, and divisions of infectious diseases and host defense at the Ohio State University, Columbus. “However, the contemporary prevalence, risk factors, morbidity and mortality resulting from VPIs in children post HCT are not well known.”
Their epidemiological study, using the Pediatric Health Information System (PHIS) database, identified all children under 18 years that underwent allogeneic or autologous HCT in an 8-year period. A total of 9,591 unique HCT recipients were identified.
The researchers demonstrated that 7.1% of this cohort were hospitalized for a VPI in the first 5 years post HCT. Dr. Danino explained that 67% of VPI hospitalizations occurred during the first year, at a median of 222 days, and 22% of VPIs occurred during the initial HCT admission.
As to the type of infection, Dr. Danino and colleagues found that, the prevalence of VPI hospitalizations were highest for influenza, followed by varicella and invasive pneumococcal infections. They identified no hospitalizations due to measles or rubella during the study period.
The study findings revealed that the influenza infections occurred a median 231 days post HCT; varicella infections occurred a median 190 days; and invasive pneumococcal infections occurred a median 311 days post HCT.
“When we did a multivariate analysis by time post HCT, we found that age at transplantation, primary immune deficiency as an indication for transplantation, and graft versus host disease were independent predictors of VPIs during the initial HCT admission,” said Dr. Danino.
Children with a VPI who spent longer in hospital were more likely to be admitted to an ICU and have higher mortality, compared with children without a VPI diagnosis.
“VPIs led to longer duration of hospitalization, higher rates of ICU admission, and higher mortality, compared to HCT recipients without VPIs,” Dr. Danino explained. It was not possible in this retrospective study to determine whether increased mortality was VPI related.
These results underline the seriousness of infections in vulnerable children after HCT. Dr. Danino concluded by saying that “efforts to optimize vaccination strategies early post HCT are warranted to decrease VPIs.”
Dr. Danino had nothing to disclose.
FROM ESPID 2020
COVID-19 vaccines: Safe for immunocompromised patients?
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.
Coronavirus vaccines have become a reality, as they are now being approved and authorized for use in a growing number of countries including the United States. The U.S. Food and Drug Administration has just issued emergency authorization for the use of the COVID-19 vaccine produced by Pfizer and BioNTech. Close behind is the vaccine developed by Moderna, which has also applied to the FDA for emergency authorization.
The efficacy of a two-dose administration of the vaccine has been pegged at 95.0%, and the FDA has said that the 95% credible interval for the vaccine efficacy was 90.3%-97.6%. But as with many initial clinical trials, whether for drugs or vaccines, not all populations were represented in the trial cohort, including individuals who are immunocompromised. At the current time, it is largely unknown how safe or effective the vaccine may be in this large population, many of whom are at high risk for serious COVID-19 complications.
At a special session held during the recent annual meeting of the American Society of Hematology, Anthony Fauci, MD, the nation’s leading infectious disease expert, said that individuals with compromised immune systems, whether because of chemotherapy or a bone marrow transplant, should plan to be vaccinated when the opportunity arises.
In response to a question from ASH President Stephanie J. Lee, MD, of the Fred Hutchinson Cancer Center, Seattle, Dr. Fauci emphasized that, despite being excluded from clinical trials, this population should get vaccinated. “I think we should recommend that they get vaccinated,” he said. “I mean, it is clear that, if you are on immunosuppressive agents, history tells us that you’re not going to have as robust a response as if you had an intact immune system that was not being compromised. But some degree of immunity is better than no degree of immunity.”
That does seem to be the consensus among experts who spoke in interviews: that as long as these are not live attenuated vaccines, they hold no specific risk to an immunocompromised patient, other than any factors specific to the individual that could be a contraindication.
“Patients, family members, friends, and work contacts should be encouraged to receive the vaccine,” said William Stohl, MD, PhD, chief of the division of rheumatology at the University of Southern California, Los Angeles. “Clinicians should advise patients to obtain the vaccine sooner rather than later.”
Kevin C. Wang, MD, PhD, of the department of dermatology at Stanford (Calif.) University, agreed. “I am 100% with Dr. Fauci. Everyone should get the vaccine, even if it may not be as effective,” he said. “I would treat it exactly like the flu vaccines that we recommend folks get every year.”
Dr. Wang noted that he couldn’t think of any contraindications unless the immunosuppressed patients have a history of severe allergic reactions to prior vaccinations. “But I would even say patients with history of cancer, upon recommendation of their oncologists, are likely to be suitable candidates for the vaccine,” he added. “I would say clinicians should approach counseling the same way they counsel patients for the flu vaccine, and as far as I know, there are no concerns for systemic drugs commonly used in dermatology patients.”
However, guidance has not yet been issued from either the FDA or the Centers for Disease Control and Prevention regarding the use of the vaccine in immunocompromised individuals. Given the lack of data, the FDA has said that “it will be something that providers will need to consider on an individual basis,” and that individuals should consult with physicians to weigh the potential benefits and potential risks.
The CDC’s Advisory Committee on Immunization Practices has said that clinicians need more guidance on whether to use the vaccine in pregnant or breastfeeding women, the immunocompromised, or those who have a history of allergies. The CDC itself has not yet released its formal guidance on vaccine use.
COVID-19 vaccines
Vaccines typically require years of research and testing before reaching the clinic, but this year researchers embarked on a global effort to develop safe and effective coronavirus vaccines in record time. Both the Pfizer/BioNTech and Moderna vaccines have only a few months of phase 3 clinical trial data, so much remains unknown about them, including their duration of effect and any long-term safety signals. In addition to excluding immunocompromised individuals, the clinical trials did not include children or pregnant women, so data are lacking for several population subgroups.
But these will not be the only vaccines available, as the pipeline is already becoming crowded. U.S. clinical trial data from a vaccine jointly being developed by Oxford-AstraZeneca, could potentially be ready, along with a request for FDA emergency use authorization, by late January 2021.
In addition, China and Russia have released vaccines, and there are currently 61 vaccines being investigated in clinical trials and at least 85 preclinical products under active investigation.
The vaccine candidates are using both conventional and novel mechanisms of action to elicit an immune response in patients. Conventional methods include attenuated inactivated (killed) virus and recombinant viral protein vaccines to develop immunity. Novel approaches include replication-deficient, adenovirus vector-based vaccines that contain the viral protein, and mRNA-based vaccines, such as the Pfizer and Moderna vaccines, that encode for a SARS-CoV-2 spike protein.
“The special vaccine concern for immunocompromised individuals is introduction of a live virus,” Dr. Stohl said. “Neither the Moderna nor Pfizer vaccines are live viruses, so there should be no special contraindication for such individuals.”
Live vaccine should be avoided in immunocompromised patients, and currently, live SARS-CoV-2 vaccines are only being developed in India and Turkey.
It is not unusual for vaccine trials to begin with cohorts that exclude participants with various health conditions, including those who are immunocompromised. These groups are generally then evaluated in phase 4 trials, or postmarketing surveillance. While the precise number of immunosuppressed adults in the United States is not known, the numbers are believed to be rising because of increased life expectancy among immunosuppressed adults as a result of advances in treatment and new and wider indications for therapies that can affect the immune system.
According to data from the 2013 National Health Interview Survey, an estimated 2.7% of U.S. adults are immunosuppressed. This population covers a broad array of health conditions and medical specialties; people living with inflammatory or autoimmune conditions, such as inflammatory rheumatic diseases (rheumatoid arthritis, axial spondyloarthritis, lupus); inflammatory bowel disease (Crohn’s disease and ulcerative colitis); psoriasis; multiple sclerosis; organ transplant recipients; patients undergoing chemotherapy; and life-long immunosuppression attributable to HIV infection.
As the vaccines begin to roll out and become available, how should clinicians advise their patients, in the absence of any clinical trial data?
Risk vs. benefit
Gilaad Kaplan, MD, MPH, a gastroenterologist and professor of medicine at the University of Calgary (Alta.), noted that the inflammatory bowel disease (IBD) community has dealt with tremendous anxiety during the pandemic because many are immunocompromised because of the medications they use to treat their disease.
“For example, many patients with IBD are on biologics like anti-TNF [tumor necrosis factor] therapies, which are also used in other immune-mediated inflammatory diseases such as rheumatoid arthritis,” he said. “Understandably, individuals with IBD on immunosuppressive medications are concerned about the risk of severe complications due to COVID-19.”
The entire IBD community, along with the world, celebrated the announcement that multiple vaccines are protective against SARS-CoV-2, he noted. “Vaccines offer the potential to reduce the spread of COVID-19, allowing society to revert back to normalcy,” Dr. Kaplan said. “Moreover, for vulnerable populations, including those who are immunocompromised, vaccines offer the potential to directly protect them from the morbidity and mortality associated with COVID-19.”
That said, even though the news of vaccines are extremely promising, some cautions must be raised regarding their use in immunocompromised populations, such as persons with IBD. “The current trials, to my knowledge, did not include immunocompromised individuals and thus, we can only extrapolate from what we know from other trials of different vaccines,” he explained. “We know from prior vaccines studies that the immune response following vaccination is less robust in those who are immunocompromised as compared to a healthy control population.”
Dr. Kaplan also pointed to recent reports of allergic reactions that have been reported in healthy individuals. “We don’t know whether side effects, like allergic reactions, may be different in unstudied populations,” he said. “Thus, the medical and scientific community should prioritize clinical studies of safety and effectiveness of COVID-19 vaccines in immunocompromised populations.”
So, what does this mean for an individual with an immune-mediated inflammatory disease like Crohn’s disease or ulcerative colitis who is immunocompromised? Dr. Kaplan explained that it is a balance between the potential harm of being infected with COVID-19 and the uncertainty of receiving a vaccine in an understudied population. For those who are highly susceptible to dying from COVID-19, such as an older adult with IBD, or someone who faces high exposure, such as a health care worker, the potential protection of the vaccine greatly outweighs the uncertainty.
“However, for individuals who are at otherwise lower risk – for example, young and able to work from home – then waiting a few extra months for postmarketing surveillance studies in immunocompromised populations may be a reasonable approach, as long as these individuals are taking great care to avoid infection,” he said.
No waiting needed
Joel M. Gelfand, MD, MSCE, professor of dermatology and epidemiology at the University of Pennsylvania, Philadelphia, feels that the newly approved vaccine should be safe for most of his patients.
“Patients with psoriatic disease should get the mRNA-based COVID-19 vaccine as soon as possible based on eligibility as determined by the CDC and local public health officials,” he said. “It is not a live vaccine, and therefore patients on biologics or other immune-modulating or immune-suppressing treatment can receive it.”
However, the impact of psoriasis treatment on immune response to the mRNA-based vaccines is not known. Dr. Gelfand noted that, extrapolating from the vaccine literature, there is some evidence that methotrexate reduces response to the influenza vaccine. “However, the clinical significance of this finding is not clear,” he said. “Since the mRNA vaccine needs to be taken twice, a few weeks apart, I do not recommend interrupting or delaying treatment for psoriatic disease while undergoing vaccination for COVID-19.”
Given the reports of allergic reactions, he added that it is advisable for patients with a history of life-threatening allergic reactions such as anaphylaxis or who have been advised to carry an epinephrine autoinjector, to talk with their health care provider to determine if COVID-19 vaccination is medically appropriate.
The National Psoriasis Foundation has issued guidance on COVID-19, explained Steven R. Feldman, MD, PhD, professor of dermatology, pathology, and social sciences & health policy at Wake Forest University, Winston-Salem, N.C., who is also a member of the committee that is working on those guidelines and keeping them up to date. “We are in the process of updating the guidelines with information on COVID vaccines,” he said.
He agreed that there are no contraindications for psoriasis patients to receive the vaccine, regardless of whether they are on immunosuppressive treatment, even though definitive data are lacking. “Fortunately, there’s a lot of good data coming out of Italy that patients with psoriasis on biologics do not appear to be at increased risk of getting COVID or of having worse outcomes from COVID,” he said.
Patients are going to ask about the vaccines, and when counseling them, clinicians should discuss the available data, the residual uncertainty, and patients’ concerns should be considered, Dr. Feldman explained. “There may be some concern that steroids and cyclosporine would reduce the effectiveness of vaccines, but there is no concern that any of the drugs would cause increased risk from nonlive vaccines.”
He added that there is evidence that “patients on biologics who receive nonlive vaccines do develop antibody responses and are immunized.”
Boosting efficacy
Even prior to making their announcement, the American College of Rheumatology had said that they would endorse the vaccine for all patients, explained rheumatologist Brett Smith, DO, from Blount Memorial Physicians Group and East Tennessee Children’s Hospital, Alcoa. “The vaccine is safe for all patients, but the problem may be that it’s not as effective,” he said. “But we don’t know that because it hasn’t been tested.”
With other vaccines, biologic medicines are held for 2 weeks before and afterwards, to get the best response. “But some patients don’t want to stop the medication,” Dr. Smith said. “They are afraid that their symptoms will return.”
As for counseling patients as to whether they should receive this vaccine, he explained that he typically doesn’t try to sway patients one way or another until they are really high risk. “When I counsel, it really depends on the individual situation. And for this vaccine, we have to be open to the fact that many people have already made up their mind.”
There are a lot of questions regarding the vaccine. One is the short time frame of development. “Vaccines typically take 6-10 years to come on the market, and this one is now available after a 3-month study,” Dr. Smith said. “Some have already decided that it’s too new for them.”
The process is also new, and patients need to understand that it doesn’t contain an active virus and “you can’t catch coronavirus from it.”
Dr. Smith also explained that, because the vaccine may be less effective in a person using biologic therapies, there is currently no information available on repeat vaccination. “These are all unanswered questions,” he said. “If the antibodies wane in a short time, can we be revaccinated and in what time frame? We just don’t know that yet.”
Marcelo Bonomi, MD, a medical oncologist from The Ohio State University Comprehensive Cancer Center, Columbus, explained that one way to ensure a more optimal response to the vaccine would be to wait until the patient has finished chemotherapy.* “The vaccine can be offered at that time, and in the meantime, they can take other steps to avoid infection,” he said. “If they are very immunosuppressed, it isn’t worth trying to give the vaccine.”
Cancer patients should be encouraged to stay as healthy as possible, and to wear masks and social distance. “It’s a comprehensive approach. Eat healthy, avoid alcohol and tobacco, and exercise. [These things] will help boost the immune system,” Dr. Bonomi said. “Family members should be encouraged to get vaccinated, which will help them avoid infection and exposing the patient.”
Jim Boonyaratanakornkit, MD, PhD, an infectious disease specialist who cares for cancer patients at the Fred Hutchinson Cancer Research Center, agreed. “Giving a vaccine right after a transplant is a futile endeavor,” he said. “We need to wait 6 months to have an immune response.”
He pointed out there may be a continuing higher number of cases, with high levels peaking in Washington in February and March. “Close friends and family should be vaccinated if possible,” he said, “which will help interrupt transmission.”
The vaccines are using new platforms that are totally different, and there is no clear data as to how long the antibodies will persist. “We know that they last for at least 4 months,” said Dr. Boonyaratanakornkit. “We don’t know what level of antibody will protect them from COVID-19 infection. Current studies are being conducted, but we don’t have that information for anyone yet.”
*Correction, 1/7/21: An earlier version of this article misattributed quotes from Dr. Marcelo Bonomi.