Vaccines

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

The newest version of the COVID-19 vaccine will be available by the end of September, according to the Centers for Disease Control and Prevention. 

The updated vaccine still needs final sign-offs from the Food and Drug Administration and the CDC.

“We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”

For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Dr. Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6-8 months since their last dose. For all other people, it’s OK to wait for the new version.

Analysts expect low demand for the updated vaccine. About 240 million people in the United States got at least one dose when vaccines first became available in 2021, Reuters reported, but that number dropped to less than 50 million getting the most updated shot in the fall of 2022.

“Take a look at what happened last winter. It was 50 million in the U.S., and it seems likely to be lower than that, given that there’s less concern about COVID this year than last year,” Michael Yee, a health care industry analyst for the firm Jefferies, told Reuters.

Dr. Cohen noted during the podcast that the recent uptick in virus activity should be taken in context. 

“What we’re seeing right now in August of 2023 are small increases of folks getting COVID. We are still at some of the lowest hospitalizations that we’ve been at in the past 3 years,” she said. “Even a 10% increase on a very, very small number is still very small. My level of concern continues to be low.”

A version of this article was first published on WebMD.com .

Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.

Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.

Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.

In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.

Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.

Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.

Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.

Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.

The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.

However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
 

More data are needed to tease out patterns

“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.

The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.

Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.

However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.

“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.

Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.

Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.

“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.

In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.

Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.

Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.

In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.

Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.

Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.

Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.

Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.

The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.

However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
 

More data are needed to tease out patterns

“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.

The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.

Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.

However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.

“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.

Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.

Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.

“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.

In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

Approximately one-quarter of adults who experience long COVID report activity limitations that do not change over time, based on data from national sample of nonhospitalized individuals.

Symptoms of long COVID, an ongoing medical condition that occurs in the wake of COVID-19 infection, include respiratory, neurologic, cardiovascular, or other complications that may last for weeks, months, or years after infection.

Current estimates of the incidence of long COVID in the United States range from 7.5% to 41%, according to Nicole D. Ford, PhD, of the Centers for Disease Control and Prevention, Atlanta, and colleagues. Long COVID has shown a significant effect on patients’ quality of life, functional status, and ability to work, but the impact on activity limitation in particular has not been examined, the researchers said.

In a study published in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report (MMWR), the researchers reviewed data from surveys conducted between June 1 and 13, 2022, and June 7 and 19, 2023. The data came from the Census Bureau’s Household Pulse Survey (HPS), a cross-sectional national survey designed to measure the social and economic effects of COVID-19 on U.S. households. Surveys were conducted in 2-week cycles (2 weeks on, 2 weeks off). Questions about long COVID were added to the survey beginning on June 1, 2022, and questions about activity limitations from long COVID were added on Sept. 14, 2022, including questions about participants’ abilities to perform daily activities before and after COVID-19 infection.

Overall, the prevalence of long COVID decreased from 7.5% to 6.0% in U.S. adults aged 18 years and older during the study period. However, when stratified by age group, the decline was significant only in adults older than 60 years, and 1 in 10 adults with a history of COVID-19 reported long COVID at the end of the study period.

Among respondents with long COVID, 26.4% of respondents for time period of June 7-19, 2023, reported significant activity limitations, which remained unchanged over time, with no clear pattern in activity limitations across age groups, the researchers said.

Prevalence of long COVID was highest for individuals in middle adulthood (aged 30-39 years, 40-49 years, and 50-59 years) and lowest for younger adults (18-29 years) and older adults (aged 60 years and older). The prevalence of long COVID decreased by 1.16% per survey cycle between the June 1-13 and Jan. 4-16 cycles, but then remained stable, with a decrease of 0.01% per cycle between June 1-13, 2022, and Jan. 4-16, 2023.

Previous studies have shown that activity limitations resulting from long COVID can significantly affect quality of life and functional status, as well as the ability to work or care for others. A recent study in the United Kingdom showed that quality of life scores among long COVID patients were similar to those of individuals with advanced cancer, and more than half of the long COVID patients reported moderately severe functional impairment. “The larger economic and societal impact of long COVID could be far-reaching if working-age adults are unable to maintain employment or care for children or aging parents,” the researchers said.

The current study findings were limited by several factors including potential coverage bias in the survey sample, the relatively low survey response rate, and the inability to collect data on duration of symptoms, COVID-19 vaccination status, treatment during acute infection, and time since COVID-19 illness; any of these factors could affect the reported prevalence of long COVID, the researchers noted.

However, the results suggest the need for continued attention to COVID-19 prevention efforts, including not only staying current with recommended COVID-19 vaccination, but also planning for symptom management and health care service needs of long COVID patients, they concluded.
 

More data are needed to tease out patterns

“Physicians and patients are still trying to understand long COVID and its implications for the health of affected individuals,” said Noel Deep, MD, in an interview.

The current study shows a prevalence of long COVID in approximately 11% of COVID patients, which is a significant number, said Dr. Deep, a general internist in private practice in Antigo, Wisc., who was not involved in the study. Dr. Deep also serves as chief medical officer and a staff physician at Aspirus Langlade Hospital in Antigo.

The study also was useful to illustrate a decline in the incidence of people affected by long COVID symptoms in the United States and in other countries, he said.

Dr. Deep noted that despite the persistent prevalence of long COVID symptoms overall, he was encouraged by the findings that older adults “who tend to have other underlying health conditions that could put them at a higher risk for adverse health outcomes” reported fewer long COVID symptoms than younger adults.

However, he noted that the high incidence of long COVID symptoms in able-bodied individuals in their 30s and 40s may affect their the economic situations as well as their ability to care for elderly relatives and children who might be dependent on them.

“Physicians and other clinicians should be aware of the symptoms and impacts caused by long COVID,” Dr. Deep said in an interview. “These individuals usually present with a myriad of vague and varying symptoms. Physicians should be cognizant of this situation, ask about previous infection with COVID-19, and utilize the resources of long COVID clinics where available,” he said.

Several factors can affect the assessment and management of patients with long COVID symptoms in primary care practices, said Dr. Deep. First and foremost are the time constraints of detailed evaluation and testing, he said.

Second, primary care clinicians need to be aware of the different symptoms that may be indicative of long COVID including fatigue, neurocognitive symptoms such as brain fog or memory disturbance, respiratory symptoms, and cardiovascular symptoms, as well as olfactory and gustatory symptoms. “These symptoms can be confounded by underlying health conditions, especially in elderly individuals,” he noted.

“Recommendations and guidelines are evolving regarding the evaluation and management of patients with long COVID that should help physicians and other clinicians in the future,” said Dr. Deep.

In the meantime, having a high index of suspicion, paying attention to the symptoms described by the patient, and taking a proper history with regard to previous COVID-19 infection should help overcome some of these challenges, he said.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Deep had no financial conflicts to disclose and serves on the Editorial Advisory Board of Internal Medicine News.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

BALTIMORE – Receiving the first dose of the human papillomavirus (HPV) vaccine at age 9, rather than bundling it with the Tdap and meningitis vaccines, appears to increase the likelihood that children will complete the HPV vaccine series, according to a retrospective cohort study of commercially insured youth presented at the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists. The research was published ahead of print in Human Vaccines and Immunotherapeutics.

Changing attitudes

“These findings are novel because they emphasize starting at age 9, and that is different than prior studies that emphasize bundling of these vaccines,” Kevin Ault, MD, professor and chair of the department of obstetrics and gynecology at Western Michigan University Homer Stryker MD School of Medicine and a former member of the CDC’s Advisory Committee on Immunization Practices, said in an interview.

Dr. Ault was not involved in the study but noted that these findings support the AAP’s recommendation to start the HPV vaccine series at age 9. The Centers for Disease Control and Prevention currently recommends giving the first dose of the HPV vaccine at ages 11-12, at the same time as the Tdap and meningitis vaccines. This recommendation to “bundle” the HPV vaccine with the Tdap and meningitis vaccines aims to facilitate provider-family discussion about the HPV vaccine, ideally reducing parent hesitancy and concerns about the vaccines. Multiple studies have shown improved HPV vaccine uptake when providers offer the HPV vaccine at the same time as the Tdap and meningococcal vaccines.

However, shifts in parents’ attitudes have occurred toward the HPV vaccine since those studies on bundling: Concerns about sexual activity have receded while concerns about safety remain high. The American Academy of Pediatrics and the American Cancer Society both advise starting the HPV vaccine series at age 9, based on evidence showing that more children complete the series when they get the first shot before age 11 compared to getting it at 11 or 12.

“The bundling was really to vaccinate people by the age of 13, thinking that onset of sexual activity was after that,” study author Sidika Kajtezovic, MD, a resident at Boston Medical Center and Boston University Obstetrics and Gynecology, said in an interview. But Dr. Kajtezovic said she delivers babies for 13-year-old patients. “Kids are having sex sooner or sooner.” It’s also clear that using the bundling strategy is not making up the entire gap right now: Ninety percent of children are getting the meningococcal vaccine while only 49% are getting the HPV vaccine, Dr. Kajtezovic pointed out. “There’s a disconnect happening there, even with the bundling,” she said.
 

Debundling vaccines

Dr. Kajtezovic and her colleagues used a national database of employee-sponsored health insurance to analyze the records of 100,857 children who were continuously enrolled in a plan from age 9 in 2015 to age 13 in 2019. They calculated the odds of children completing the HPV vaccine series based on whether they started the series before, at the same time as, or after the Tdap vaccination.

Youth who received the HPV vaccine before their Tdap vaccine had 38% greater odds of completing the series – getting both doses – than did those who received the HPV vaccine at the same time as the Tdap vaccine. Meanwhile, in line with prior evidence, those who got the first HPV dose after their Tdap were less likely – 68% lower odds – to complete the two- or three-dose (if starting above age 14) series.

The researchers identified several other factors that were linked to completing the HPV vaccine series. Females had greater odds than did males of completing the series, as did those living in urban, rather than rural, areas. Other factors associated with completing the series included living in the Northeast United States and receiving primary care from a pediatrician rather than a family medicine physician.
 

Timing is important

“I am encouraged by the findings of this study,” Dr. Ault said in an interview. “However, I would have liked the authors to expand the age range a bit higher. There are data that continuing to discuss the HPV vaccine with parents and teens will increase uptake into the later teen years.”

One challenge is that research shows attendance at primary care visits declines in older adolescence. Since there is no second Tdap or meningitis shot, families need to return for the second HPV vaccine dose after those shots, though they could get the second dose at the same time as other two vaccines if they receive the first dose before age 11. There’s also evidence suggesting that providers find conversations about the HPV vaccine easier when sexual activity is not the focus.

“I often feel that, before a child reaches adolescence, they’re almost, in a way, not sexualized yet, so talking about cancer prevention for an 8- or 9-year-old sometimes sounds a little different to patients versus protecting your 12-year-old, who’s starting to go through adolescence and developing breasts” and other signs of puberty, Dr. Kajtezovic said. Keeping the focus of HPV vaccine discussions on cancer prevention also allows providers to point out the protection against anal cancer, vulvar cancer, vaginal cancer, and head and neck cancer. “They are horrible, and even if they’re treatable, they’re often very hard to treat at an advanced stage,” Dr. Kajtezovic said. “The surgery required is so life disabling and disfiguring.”

The HPV Roundtable advises continuing bundling at practices having success with it but encourages practices to consider earlier vaccination if their uptake is lagging. Quality improvement initiatives, such as earlier electronic medical record prompts and multi-level interventions in pediatric practices, have shown substantial increases in HPV vaccine uptake at 9 and 10 years old. One survey in 2021 found that one in five primary care providers already routinely recommend the HPV vaccine at ages 9-10, and nearly half of others would consider doing so.

“My hope is in the next few years, when [the CDC] refreshes their vaccine recommendations, that they will either unbundle it or move the bar a few years earlier so that you can initiate it to encourage earlier initiation,” Dr. Kajtezovic said.

Dr. Ault had no other disclosures besides prior service on ACIP. Dr. Kajtezovic had no disclosures.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

Family physicians receive less private insurer reimbursement for the human papillomavirus (HPV) vaccine than do pediatricians, according to a new analysis in Family Medicine.

HPV is the most expensive of all routine pediatric vaccines and the reimbursement by third-party payers varies widely. The concerns about HPV reimbursement often appear on clinician surveys.

This study, led by Yenan Zhu, PhD, who was with the department of public health sciences, college of medicine, Medical University of South Carolina, Charleston, at the time of the research, found that, on average, pediatricians received higher reimbursement ($216.07) for HPV vaccine cost when compared with family physicians ($211.33), internists ($212.97), nurse practitioners ($212.91), and “other” clinicians who administer the vaccine ($213.29) (P values for all comparisons were < .001).

The final sample for this study included 34,247 clinicians.

The net return from vaccine cost reimbursements was lowest for family physicians ($0.34 per HPV vaccine dose administered) and highest for pediatricians ($5.08 per HPV vaccine dose administered).

“Adequate cost reimbursement by third-party payers is a critical enabling factor for clinicians to continue offering vaccines,” the authors wrote.

The authors concluded that “reimbursement for HPV vaccine costs by private payers is adequate; however, return margins are small for nonpediatric specialties.”
 

CDC, AAP differ in recommendations

In the United States, private insurers use the Centers for Disease Control and Prevention vaccine list price as a benchmark.

Overall in this study, HPV vaccine cost reimbursement by private payers was at or above the CDC list price of $210.99 but below the American Academy of Pediatrics recommendations ($263.74). 

The study found that every $1 increment in return was associated with an increase in HPV vaccine doses administered. That was highest for family physicians at 0.08% per dollar.

The modeling showed that changing the HPV vaccine reimbursement to the AAP-recommended level could translate to “an estimated 18,643 additional HPV vaccine doses administrated by pediatricians, 4,041 additional doses by family physicians, and 433 doses by ‘other’ specialties in 2017-2018.”

The authors noted that U.S. vaccination coverage has improved in recent years but initiation and completion rates are lower among privately insured adolescents (4.6% lower for initiation and 2.0% points lower for completion in 2021), compared with adolescents covered under public insurance.

Why the difference among specialties?

Variation in reimbursements might be tied to the ability to negotiate reimbursements for adolescent vaccines, the authors said.

“For instance, pediatricians may be able to negotiate higher cost reimbursement, compared with nonpediatric specialties, given that adolescents constitute a large fraction of their patient volume,” they wrote.

Dr. Zhu and colleagues wrote that it should be noted that HPV vaccine cost reimbursement to family practitioners was considerably less than other specialties and they are barely breaking even though they have the second-highest volume of HPV vaccinations (after pediatricians).

The authors acknowledged that it may not be possible to raise reimbursement to the AAP level, but added that “a reasonable increase that can cover direct and indirect expenses (acquisition cost, storage cost, personnel cost for monitoring inventory, insurance, waste, and lost opportunity costs) will reduce the financial strain on nonpediatric clinicians.” That may encourage clinicians to stock and offer the vaccine.
 

Limitations

The researchers acknowledged several limitations. The models did not account for factors such as vaccination bundling, physicians’ recommendation style or differences in knowledge of the vaccination schedule.

The models were also not able to adjust for whether a clinic had reminder prompts in the electronic health records, the overhead costs of vaccines, or vaccine knowledge or hesitancy on the part of the adolescents’ parents.

Additionally, they used data from one private payer, which limits generalizability.

Researchers identified a sample of adolescents eligible for the HPV vaccine (9-14 years old) enrolled in a large private health insurance plan during 2017-2018. Data from states with universal or universal select vaccine purchasing were excluded. These states included Alaska, Hawaii, Idaho, Maine, Massachusetts, South Dakota, New Hampshire, New Mexico, Rhode Island, Vermont, Washington, Wisconsin, and Wyoming.

One coauthor reported receiving a consulting fee from Merck on unrelated projects. Another coauthor has provided consultancy to Value Analytics Labs on unrelated projects. All other authors declared no competing interests.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

At the new Walnut Creek Clinic in the East Bay of the San Francisco Bay area, kids get a “Comfort Promise.”

The clinic extends the work of the Stad Center for Pediatric Pain, Palliative & Integrative Medicine beyond the locations in University of California San Francisco Benioff Children’s Hospitals in San Francisco and Oakland.

At Walnut Creek, clinical acupuncturists, massage therapists, and specialists in hypnosis complement advanced medical care with integrative techniques.

The “Comfort Promise” program, which is being rolled out at that clinic and other UCSF pediatric clinics through the end of 2024, is the clinicians’ pledge to do everything in their power to make tests, infusions, and vaccinations “practically pain free.”

Needle sticks, for example, can be a common source of pain and anxiety for kids. Techniques to minimize pain vary by age. Among the ways the clinicians minimize needle pain for a child 6- to 12-years-old are:

• Giving the child control options to pick which arm; and watch the injection, pause it, or stop it with a communication sign.
• Introducing memory shaping by asking the child about the experience afterward and presenting it in a positive way by praising the acts of sitting still, breathing deeply, or being brave.
• Using distractors such as asking the child to hold a favorite item from home, storytelling, coloring, singing, or using breathing exercises.

Stefan Friedrichsdorf, MD, chief of the UCSF division of pediatric pain, palliative & integrative medicine, said in a statement: “For kids with chronic pain, complex pain medications can cause more harm than benefit. Our goal is to combine exercise and physical therapy with integrative medicine and skills-based psychotherapy to help them become pain free in their everyday life.”
 

Bundling appointments for early impact

At Lurie Children’s Hospital of Chicago, the chronic pain treatment program bundles visits with experts in several disciplines, include social workers, psychologists, and physical therapists, in addition to the medical team, so that patients can complete a first round of visits with multiple specialists in a short period, as opposed to several months.

Natalie Weatherred, APRN-NP, CPNP-PC, a pediatric nurse practitioner in anesthesiology and the pain clinic coordinator, said in an interview that the up-front visits involve between four and eight follow-up sessions in a short period with everybody in the multidisciplinary team “to really help jump-start their pain treatment.”

She pointed out that many families come from distant parts of the state or beyond so the bundled appointments are also important for easing burden on families.

Sarah Duggan, APRN-NP, CPNP-PC, also a pediatric nurse practitioner in anesthesiology at Lurie’s, pointed out that patients at their clinic often have other chronic conditions as well, such as such as postural orthostatic tachycardia syndrome so the care integration is particularly important.

“We can get them the appropriate care that they need and the resources they need, much sooner than we would have been able to do 5 or 10 years ago,” Ms. Duggan said.
 

Virtual reality distraction instead of sedation

Henry Huang, MD, anesthesiologist and pain physician at Texas Children’s Hospital, Houston, said a special team there collaborates with the Chariot Program at Stanford (Calif.) University and incorporates virtual reality to distract children from pain and anxiety and harness their imaginations during induction for anesthesia, intravenous placement, and vaccinations.

“At our institution we’ve been recruiting patients to do a proof of concept to do virtual reality distraction for pain procedures, such as nerve blocks or steroid injections,” Dr. Huang said.

Traditionally, kids would have received oral or intravenous sedation to help them cope with the fear and pain.

“We’ve been successful in several cases without relying on any sedation,” he said. “The next target is to expand that to the chronic pain population.”

The distraction techniques are promising for a wide range of ages, he said, and the programming is tailored to the child’s ability to interact with the technology.

He said he is also part of a group promoting use of ultrasound instead of x-rays to guide injections to the spine and chest to reduce children’s exposure to radiation. His group is helping teach these methods to other clinicians nationally.

Dr. Huang said the most important development in chronic pediatric pain has been the growth of rehab centers that include the medical team, and practitioners from psychology as well as occupational and physical therapy.

“More and more hospitals are recognizing the importance of these pain rehab centers,” he said.

The problem, Dr. Huang said, is that these programs have always been resource intensive and involve highly specialized clinicians. The cost and the limited number of specialists make it difficult for widespread rollout.

“That’s always been the challenge from the pediatric pain world,” he said.
 

Recognizing the complexity of kids’ chronic pain

Angela Garcia, MD, a consulting physician for pediatric rehabilitation medicine at UPMC Children’s Hospital of Pittsburgh said recognizing the validity and complexity of pediatric pain has led to multidisciplinary approaches and specialty clinics for chronic pain instead of primarily pharmaceutical solutions.

Techniques such as biofeedback and acupuncture are becoming more mainstream in pediatric chronic care, she said.

At the UPMC clinic, children and their families talk with a care team about their values and what they want to accomplish in managing the child’s pain. They ask what the pain is preventing the child from doing.

“Their goals really are our goals,” she said.

She said she also refers almost all patients to one of the center’s pain psychologists.

“Pain is biopsychosocial,” she said. “We want to make sure we’re addressing how to cope with pain.”

Dr. Garcia said she hopes nutritional therapy is one of the next approaches the clinic will incorporate, particularly surrounding how dietary changes can reduce inflammation “and heal the body from the inside out.”

She said the hospital is also looking at developing an inpatient pain program for kids whose functioning has changed so drastically that they need more intensive therapies.

Whatever the treatment approach, she said, addressing the pain early is critical.

“There is an increased risk of a child with chronic pain becoming an adult with chronic pain,” Dr. Garcia pointed out, “and that can lead to a decrease in the ability to participate in society.”

Ms. Weatherred, Ms. Duggan, Dr. Huang, and Dr. Garcia reported no relevant financial relationships.

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

TOPLINE

A new American Academy of Pediatrics study reveals that 17.2% of toddlers started but did not finish at least one recommended early childhood vaccine series.

METHODOLOGY

• Examined data collected in 2019 from the National Immunization Survey – Child.
• 16,365 children ages 19-35 months were included.
• Vaccines for diphtheria, tetanus, acellular pertussis, pneumococcal infections, Haemophilus influenzae type b, hepatitis B, polio, measles, mumps, rubella, and varicella were included.

TAKEAWAY

• 72.9% of toddlers completed the seven-vaccine series.
• 17.2% initiated but did not complete one or more of a multidose vaccine series.
• The strongest association with not completing the vaccine series was moving across state lines and not having insurance.
• Children with more siblings at home were less likely to complete a vaccine series.

IN PRACTICE

The study suggests that the “children experienced structural barriers to vaccination,” and the authors urge an “increased focus on strategies to encourage multidose series completion ... to optimize protection from preventable diseases and achieve vaccination coverage goals.”

SOURCE

The study was funded by the National Institutes of Health and published online July 25 in Pediatrics. Sarah Y. Michels, an epidemiology specialist from the University of Montana in Missoula, was the lead author.

LIMITATIONS

Though the researchers studied the risk factors for series noncompletion, they did not have information on the specific reasons why children were missing vaccine doses. Children whose parents chose to participate in the National Immunization Survey – Child may have had higher vaccination coverage than children whose parents declined participation.

DISCLOSURES

The authors have reported no relevant financial relationships.

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

Two newly approved respiratory syncytial virus (RSV) vaccines for adults aged 60 years and older may be able to prevent illness in those at risk for severe RSV disease.

Most adult RSV illness occurs among the older age group and results in an estimated 60,000-160,000 hospitalizations and 6,000-10,000 deaths per year among people aged at least 65 years.

Older adults deciding whether to get the vaccines should weigh risks and their own preferences and make the decision in consultation with their clinicians, said authors of a Centers for Disease Control and Prevention report.

Michael Melgar, MD, with the Coronavirus and Other Respiratory Viruses Division at the CDC, was lead author on the report, published in the Morbidity and Mortality Weekly Report.
 

Two new vaccines

In May, the Food and Drug Administration approved the first of two vaccines for preventing RSV lower respiratory tract disease for adults aged at least 60 years.

On June 21, the Advisory Committee on Immunization Practices (ACIP) recommended that people in that age group receive a single dose of RSV vaccine using shared decision-making.

The recommendation for shared decision-making makes the ACIP decision different from routine and risk-based vaccine recommendations. Rather than targeting all in a particular age group or risk group, the decision calls for consideration of a patients’ risk for disease and their characteristics, preferences, and values; the health care professional’s clinical discretion; and performance of the vaccine.

Dr. Melgar and colleagues reported that vaccination with one dose of the GSK or Pfizer RSV vaccines has proved moderately to highly effective in preventing symptomatic RSV-associated lower respiratory tract disease over two consecutive RSV seasons among people aged 60 and older.

The trials that led to approval weren’t powered to gauge efficacy against RSV-associated hospitalization and death. However, the authors wrote, the prevention of lower respiratory tract disease, including medically attended illness, suggests that the shots might prevent considerable morbidity from RSV disease among those aged 60 and older.

Both vaccines were generally well tolerated with a good safety profile. However, six cases of inflammatory neurologic events (including Guillain-Barré Syndrome, acute disseminated encephalomyelitis, and others) were reported in clinical trials after RSV vaccination.

“Whether these events occurred due to chance, or whether RSV vaccination increases the risk for inflammatory neurologic events, is currently unknown,” the authors wrote.

Postmarketing surveillance may help clarify the existence of any potential risk, but until those results are clearer, the CDC researchers said, RSV vaccinations should be targeted to older adults at highest risk for severe RSV and those most likely to benefit from the shots.
 

At higher risk

Some adults with certain medical conditions have a higher risk for RSV-associated hospitalization, according to the report.

Those conditions include chronic obstructive pulmonary disease, asthma, heart failure, coronary artery disease, cerebrovascular disease, diabetes mellitus, and chronic kidney disease.

People who are frail and of advanced age also are at higher risk for RSV hospitalization. That risk increases with age and the highest risk is for people aged at least 75 years.

The researchers added that RSV can cause severe disease in those with compromised immunity, including people who have received hematopoietic stem cell transplants and patients taking immunosuppressive drugs such as those used with solid organ transplants, cancer treatment, or other conditions.

As for when physicians should offer the vaccinations, shots are optimally given before the start of the RSV season.

However, the COVID-19 pandemic interrupted the seasonality and the timing has not yet returned to prepandemic patterns.

For the 2023-24 season, this report states, clinicians should offer RSV vaccination to adults aged at least 60 years using shared clinical decision-making as early as vaccine supply is available and should continue to offer vaccination to eligible adults who remain unvaccinated.

RSV vaccines can be administered with other adult vaccines during the same visit, the authors confirmed.
 

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

The Centers for Disease Control and Prevention (CDC) recently published new recommendations on screening for hepatitis B infection.¹ They recommend screening all adults (ages 18 years and older) at least once.

These recommendations differ in a few ways from those of the US Preventive Services­ Task Force (USPSTF).² This Practice Alert will highlight these differences but also point out areas of agreement between the 2 sets of ­recommendations—and discuss why 2 separate agencies in the US Department of Health and Human Services reached different conclusions on some issues.

First, some background on hepatitis B

An estimated 580,000 to 2.4 million people in the United States have chronic hepatitis B (CHB) infection—and as many as two-thirds are unaware of it.³ In 2020, the Department of Health and Human Services published the Viral Hepatitis National Strategic Plan for the United States with a stated goal of increasing awareness of infection status among those with hepatitis B virus (HBV) from 32% to 90% by 2030.⁴ People living in the United States but born outside the country are at highest risk for CHB; they account for 69% of those with the infection.⁵

The incidence of acute HBV infection has declined markedly since the HBV vaccine was recommended for high-risk adults in 1982 and universally for infants in 1991.^6,7 Overall rates of HBV infection declined fairly steadily starting around 1987—but in 2014, rates began to increase, especially in those ages 40 to 59 years.^8,9 In 2019, 3192 cases were reported; but when one factors in underreporting, the CDC estimates that the number is likely closer to 20,700.¹⁰ This uptick is one reason the Advisory Committee on Immunization Practices changed its HBV vaccination recommendation for adults from a risk-based to a universal recommendation for all unvaccinated adults through age 60 years.¹⁰

Chronic hepatitis B infection has serious consequences

The proportion of those infected with HBV who develop CHB differs by age at infection: 80% to 90% if infected during infancy, 30% if infected before age 6 years, and 1% to 12% if infected as an older child or adult.⁸

CHB infection can lead to chronic liver disease, including cirrhosis of the liver, liver cancer, and liver failure. About 25% of those who develop CHB infection during childhood and 15% of those who develop chronic infection after childhood will die prematurely from cirrhosis or liver cancer.⁸

The American Association for the Study of Liver Diseases (AASLD) classifies CHB into 4 phases that reflect the rate of viral replication and the patient’s immune response.¹¹ These phases are:

• immune-tolerant (minimal inflammation and fibrosis)
• hepatitis B e-antigen (HBeAg)-positive immune-active (moderate-to-severe inflammation or fibrosis)
• inactive CHB (minimal necroinflammation but variable fibrosis), and
• HBeAg-negative immune reactivation (moderate-to-severe inflammation or fibrosis).¹¹

Continue to: The progression from one phase...

The progression from one phase to the next varies by patient, and not all patients will progress through each phase. The AASLD recommends periodically monitoring the HBV DNA and alanine aminotransferase (ALT) levels in those with CHB to track the progression from one phase to the next and to guide treatment decisions.

Treatment can be beneficial for those who meet criteria

The evidence report prepared for USPSTF found that antiviral treatment of those with CHB infection resulted in improved intermediate outcomes (histologic improvement, loss of hepatitis B surface antigen [HBsAg], loss of HBeAg, HBeAg seroconversion, virologic suppression, and normalization of ALT levels). The magnitude of benefit varied by location and study design.¹²

In addition, the evidence review found that antiviral therapy was associated with a decreased risk for overall mortality (relative risk [RR] = 0.15; 95% CI, 0.03-0.69), cirrhosis (RR = 0.72; 95% CI, 0.29-1.77), and hepatocellular carcinoma (RR = 0.60; 95% CI, 0.16-2.33). However, these results came from studies that were “limited due to small numbers of trials, few events, and insufficient duration of follow-up.”¹²

The USPSTF and the CDC both judged that the intermediate outcome results, as well as findings that improved intermediate outcomes lead to decreases in chronic liver disease, are strong enough evidence for their recommendations.

However, not all patients with CHB infection require treatment; estimates of patients with HBV infection meeting AASLD criteria for treatment range from 24% to 48%.¹ The AASLD guideline on the treatment of CHB infection is an excellent resource that makes recommendations on the initial evaluation, ongoing monitoring, and treatment decisions for those with CHB.¹¹

Continue to: How CDC and USPSTF guidance on HBV screeinng differs

The CDC and USPSTF recommendations for HBV screening differ in 3 aspects: whom to screen, whom to classify as at high risk for HBV infection, and what tests to use for screening.

Who should be screened?

The USPSTF recommends screening adults and adolescents who are at high risk for HBV. The CDC recommends screening all adults at least once. Both entities agree that those who are at increased risk should be screened periodically, although the optimal frequency has not been established. The USPSTF does not recommend against screening for the general population, so universal screening (as advocated by the CDC) is not in direct conflict with the USPSTF’s recommendations.

Who is at increased risk for HBV infection?

The CDC and the USPSTF differ slightly on the factors they consider to constitute increased risk for HBV infection. These are listed in ­TABLE 1.^1,2

The CDC lists 6 categories that the ­USPSTF does not mention. However, 4 of these categories are mentioned indirectly in the USPSTF evidence report that accompanies the recommendations, via statements that certain settings have high proportions of people at risk for HBV infection: sexually transmitted infection clinics; HIV testing and treatment centers; health care settings that target services toward people who inject drugs and men who have sex with men; correctional facilities; hemodialysis facilities; and institutions and nonresidential daycare centers for developmentally disabled persons. People who are served at most of these facilities are also at risk for hepatitis C virus infection.

Three categories are listed by the CDC and not by the USPSTF, in either the recommendation or evidence report. These include a history of multiple sex partners; elevated ALT or aspartate aminotransferase levels of unknown origin; and patient request for testing (because they may not want to reveal risk factors).

Continue to: What test(s) should be ordered?

What test(s) should be ordered? 

The USPSTF recommends screening using HBsAg. The CDC recommends using triple-panel screening: HBsAg, anti-hepatitis B surface antigen (anti-HBs), and total antibody to hepatitis B core antigen (anti-HBc).

HBsAg indicates HBV infection, either acute or chronic, or a recent dose of HBV vaccine. Anti-HBs indicate recovery from HBV infection, response to HBV vaccine, or recent receipt of hepatitis B immune globulin. Total anti-HBc develops in all HBV infections, resolved or current, and usually persists for life. Vaccine-induced immunity does not cause anti-HBc to develop.

The USPSTF’s rationale is that testing for HBsAg is more than 98% sensitive and specific for detecting HBV infections.² The CDC recommends triple testing because it can detect those with asymptomatic active HBV infections (this would be a rare occurrence); those who have resolved infection and might be susceptible to reactivation (eg, those who are immunosuppressed); and those who are susceptible and need vaccination.

Interpretation of HBV test results and suggested actions are described in TABLE 2.^1,8,13

Why do the CDC and USPSTF differ?

While it would be optimal if the CDC and the USPSTF coordinated and harmonized recommendations, this is difficult to achieve given their different missions. The USPSTF is charged to make evidence-based recommendations about preventive services such as screenings, behavioral counseling, and preventive medications, which are provided by clinicians to individual patients. The Task Force uses a very strict evidence-based process and will not make recommendations unless there is adequate evidence of efficacy and safety. Members of the Task Force are primary care professionals, and their collaborating professional organizations are primary care focused.

Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use singleor triple-test screening.

The CDC takes a community-wide, public health perspective. The professionals that work there are not always clinicians. They strive to prevent as much illness as possible, using public health measures and making recommendations to clinicians. They collaborate with professional organizations; on topics such as hepatitis and other infectious diseases, they collaborate with specialty-oriented societies. Given the imperative to act with the best evidence available, their evidence assessment process is not as strict.

The result, at times, is slight differences in recommendations. However, the HBV screening recommendations from the CDC and the USPSTF agree more than they do not. Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use single- or triple-test screening.

The Centers for Disease Control and Prevention (CDC) recently published new recommendations on screening for hepatitis B infection.¹ They recommend screening all adults (ages 18 years and older) at least once.

These recommendations differ in a few ways from those of the US Preventive Services­ Task Force (USPSTF).² This Practice Alert will highlight these differences but also point out areas of agreement between the 2 sets of ­recommendations—and discuss why 2 separate agencies in the US Department of Health and Human Services reached different conclusions on some issues.

First, some background on hepatitis B

An estimated 580,000 to 2.4 million people in the United States have chronic hepatitis B (CHB) infection—and as many as two-thirds are unaware of it.³ In 2020, the Department of Health and Human Services published the Viral Hepatitis National Strategic Plan for the United States with a stated goal of increasing awareness of infection status among those with hepatitis B virus (HBV) from 32% to 90% by 2030.⁴ People living in the United States but born outside the country are at highest risk for CHB; they account for 69% of those with the infection.⁵

The incidence of acute HBV infection has declined markedly since the HBV vaccine was recommended for high-risk adults in 1982 and universally for infants in 1991.^6,7 Overall rates of HBV infection declined fairly steadily starting around 1987—but in 2014, rates began to increase, especially in those ages 40 to 59 years.^8,9 In 2019, 3192 cases were reported; but when one factors in underreporting, the CDC estimates that the number is likely closer to 20,700.¹⁰ This uptick is one reason the Advisory Committee on Immunization Practices changed its HBV vaccination recommendation for adults from a risk-based to a universal recommendation for all unvaccinated adults through age 60 years.¹⁰

Chronic hepatitis B infection has serious consequences

The proportion of those infected with HBV who develop CHB differs by age at infection: 80% to 90% if infected during infancy, 30% if infected before age 6 years, and 1% to 12% if infected as an older child or adult.⁸

CHB infection can lead to chronic liver disease, including cirrhosis of the liver, liver cancer, and liver failure. About 25% of those who develop CHB infection during childhood and 15% of those who develop chronic infection after childhood will die prematurely from cirrhosis or liver cancer.⁸

The American Association for the Study of Liver Diseases (AASLD) classifies CHB into 4 phases that reflect the rate of viral replication and the patient’s immune response.¹¹ These phases are:

• immune-tolerant (minimal inflammation and fibrosis)
• hepatitis B e-antigen (HBeAg)-positive immune-active (moderate-to-severe inflammation or fibrosis)
• inactive CHB (minimal necroinflammation but variable fibrosis), and
• HBeAg-negative immune reactivation (moderate-to-severe inflammation or fibrosis).¹¹

Continue to: The progression from one phase...

The progression from one phase to the next varies by patient, and not all patients will progress through each phase. The AASLD recommends periodically monitoring the HBV DNA and alanine aminotransferase (ALT) levels in those with CHB to track the progression from one phase to the next and to guide treatment decisions.

Treatment can be beneficial for those who meet criteria

The evidence report prepared for USPSTF found that antiviral treatment of those with CHB infection resulted in improved intermediate outcomes (histologic improvement, loss of hepatitis B surface antigen [HBsAg], loss of HBeAg, HBeAg seroconversion, virologic suppression, and normalization of ALT levels). The magnitude of benefit varied by location and study design.¹²

In addition, the evidence review found that antiviral therapy was associated with a decreased risk for overall mortality (relative risk [RR] = 0.15; 95% CI, 0.03-0.69), cirrhosis (RR = 0.72; 95% CI, 0.29-1.77), and hepatocellular carcinoma (RR = 0.60; 95% CI, 0.16-2.33). However, these results came from studies that were “limited due to small numbers of trials, few events, and insufficient duration of follow-up.”¹²

The USPSTF and the CDC both judged that the intermediate outcome results, as well as findings that improved intermediate outcomes lead to decreases in chronic liver disease, are strong enough evidence for their recommendations.

However, not all patients with CHB infection require treatment; estimates of patients with HBV infection meeting AASLD criteria for treatment range from 24% to 48%.¹ The AASLD guideline on the treatment of CHB infection is an excellent resource that makes recommendations on the initial evaluation, ongoing monitoring, and treatment decisions for those with CHB.¹¹

Continue to: How CDC and USPSTF guidance on HBV screeinng differs

The CDC and USPSTF recommendations for HBV screening differ in 3 aspects: whom to screen, whom to classify as at high risk for HBV infection, and what tests to use for screening.

Who should be screened?

The USPSTF recommends screening adults and adolescents who are at high risk for HBV. The CDC recommends screening all adults at least once. Both entities agree that those who are at increased risk should be screened periodically, although the optimal frequency has not been established. The USPSTF does not recommend against screening for the general population, so universal screening (as advocated by the CDC) is not in direct conflict with the USPSTF’s recommendations.

Who is at increased risk for HBV infection?

The CDC and the USPSTF differ slightly on the factors they consider to constitute increased risk for HBV infection. These are listed in ­TABLE 1.^1,2

The CDC lists 6 categories that the ­USPSTF does not mention. However, 4 of these categories are mentioned indirectly in the USPSTF evidence report that accompanies the recommendations, via statements that certain settings have high proportions of people at risk for HBV infection: sexually transmitted infection clinics; HIV testing and treatment centers; health care settings that target services toward people who inject drugs and men who have sex with men; correctional facilities; hemodialysis facilities; and institutions and nonresidential daycare centers for developmentally disabled persons. People who are served at most of these facilities are also at risk for hepatitis C virus infection.

Three categories are listed by the CDC and not by the USPSTF, in either the recommendation or evidence report. These include a history of multiple sex partners; elevated ALT or aspartate aminotransferase levels of unknown origin; and patient request for testing (because they may not want to reveal risk factors).

Continue to: What test(s) should be ordered?

What test(s) should be ordered? 

The USPSTF recommends screening using HBsAg. The CDC recommends using triple-panel screening: HBsAg, anti-hepatitis B surface antigen (anti-HBs), and total antibody to hepatitis B core antigen (anti-HBc).

HBsAg indicates HBV infection, either acute or chronic, or a recent dose of HBV vaccine. Anti-HBs indicate recovery from HBV infection, response to HBV vaccine, or recent receipt of hepatitis B immune globulin. Total anti-HBc develops in all HBV infections, resolved or current, and usually persists for life. Vaccine-induced immunity does not cause anti-HBc to develop.

The USPSTF’s rationale is that testing for HBsAg is more than 98% sensitive and specific for detecting HBV infections.² The CDC recommends triple testing because it can detect those with asymptomatic active HBV infections (this would be a rare occurrence); those who have resolved infection and might be susceptible to reactivation (eg, those who are immunosuppressed); and those who are susceptible and need vaccination.

Interpretation of HBV test results and suggested actions are described in TABLE 2.^1,8,13

Why do the CDC and USPSTF differ?

While it would be optimal if the CDC and the USPSTF coordinated and harmonized recommendations, this is difficult to achieve given their different missions. The USPSTF is charged to make evidence-based recommendations about preventive services such as screenings, behavioral counseling, and preventive medications, which are provided by clinicians to individual patients. The Task Force uses a very strict evidence-based process and will not make recommendations unless there is adequate evidence of efficacy and safety. Members of the Task Force are primary care professionals, and their collaborating professional organizations are primary care focused.

Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use singleor triple-test screening.

The CDC takes a community-wide, public health perspective. The professionals that work there are not always clinicians. They strive to prevent as much illness as possible, using public health measures and making recommendations to clinicians. They collaborate with professional organizations; on topics such as hepatitis and other infectious diseases, they collaborate with specialty-oriented societies. Given the imperative to act with the best evidence available, their evidence assessment process is not as strict.

The result, at times, is slight differences in recommendations. However, the HBV screening recommendations from the CDC and the USPSTF agree more than they do not. Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use single- or triple-test screening.

The Centers for Disease Control and Prevention (CDC) recently published new recommendations on screening for hepatitis B infection.¹ They recommend screening all adults (ages 18 years and older) at least once.

These recommendations differ in a few ways from those of the US Preventive Services­ Task Force (USPSTF).² This Practice Alert will highlight these differences but also point out areas of agreement between the 2 sets of ­recommendations—and discuss why 2 separate agencies in the US Department of Health and Human Services reached different conclusions on some issues.

First, some background on hepatitis B

An estimated 580,000 to 2.4 million people in the United States have chronic hepatitis B (CHB) infection—and as many as two-thirds are unaware of it.³ In 2020, the Department of Health and Human Services published the Viral Hepatitis National Strategic Plan for the United States with a stated goal of increasing awareness of infection status among those with hepatitis B virus (HBV) from 32% to 90% by 2030.⁴ People living in the United States but born outside the country are at highest risk for CHB; they account for 69% of those with the infection.⁵

The incidence of acute HBV infection has declined markedly since the HBV vaccine was recommended for high-risk adults in 1982 and universally for infants in 1991.^6,7 Overall rates of HBV infection declined fairly steadily starting around 1987—but in 2014, rates began to increase, especially in those ages 40 to 59 years.^8,9 In 2019, 3192 cases were reported; but when one factors in underreporting, the CDC estimates that the number is likely closer to 20,700.¹⁰ This uptick is one reason the Advisory Committee on Immunization Practices changed its HBV vaccination recommendation for adults from a risk-based to a universal recommendation for all unvaccinated adults through age 60 years.¹⁰

Chronic hepatitis B infection has serious consequences

The proportion of those infected with HBV who develop CHB differs by age at infection: 80% to 90% if infected during infancy, 30% if infected before age 6 years, and 1% to 12% if infected as an older child or adult.⁸

CHB infection can lead to chronic liver disease, including cirrhosis of the liver, liver cancer, and liver failure. About 25% of those who develop CHB infection during childhood and 15% of those who develop chronic infection after childhood will die prematurely from cirrhosis or liver cancer.⁸

The American Association for the Study of Liver Diseases (AASLD) classifies CHB into 4 phases that reflect the rate of viral replication and the patient’s immune response.¹¹ These phases are:

• immune-tolerant (minimal inflammation and fibrosis)
• hepatitis B e-antigen (HBeAg)-positive immune-active (moderate-to-severe inflammation or fibrosis)
• inactive CHB (minimal necroinflammation but variable fibrosis), and
• HBeAg-negative immune reactivation (moderate-to-severe inflammation or fibrosis).¹¹

Continue to: The progression from one phase...

The progression from one phase to the next varies by patient, and not all patients will progress through each phase. The AASLD recommends periodically monitoring the HBV DNA and alanine aminotransferase (ALT) levels in those with CHB to track the progression from one phase to the next and to guide treatment decisions.

Treatment can be beneficial for those who meet criteria

The evidence report prepared for USPSTF found that antiviral treatment of those with CHB infection resulted in improved intermediate outcomes (histologic improvement, loss of hepatitis B surface antigen [HBsAg], loss of HBeAg, HBeAg seroconversion, virologic suppression, and normalization of ALT levels). The magnitude of benefit varied by location and study design.¹²

In addition, the evidence review found that antiviral therapy was associated with a decreased risk for overall mortality (relative risk [RR] = 0.15; 95% CI, 0.03-0.69), cirrhosis (RR = 0.72; 95% CI, 0.29-1.77), and hepatocellular carcinoma (RR = 0.60; 95% CI, 0.16-2.33). However, these results came from studies that were “limited due to small numbers of trials, few events, and insufficient duration of follow-up.”¹²

The USPSTF and the CDC both judged that the intermediate outcome results, as well as findings that improved intermediate outcomes lead to decreases in chronic liver disease, are strong enough evidence for their recommendations.

However, not all patients with CHB infection require treatment; estimates of patients with HBV infection meeting AASLD criteria for treatment range from 24% to 48%.¹ The AASLD guideline on the treatment of CHB infection is an excellent resource that makes recommendations on the initial evaluation, ongoing monitoring, and treatment decisions for those with CHB.¹¹

Continue to: How CDC and USPSTF guidance on HBV screeinng differs

The CDC and USPSTF recommendations for HBV screening differ in 3 aspects: whom to screen, whom to classify as at high risk for HBV infection, and what tests to use for screening.

Who should be screened?

The USPSTF recommends screening adults and adolescents who are at high risk for HBV. The CDC recommends screening all adults at least once. Both entities agree that those who are at increased risk should be screened periodically, although the optimal frequency has not been established. The USPSTF does not recommend against screening for the general population, so universal screening (as advocated by the CDC) is not in direct conflict with the USPSTF’s recommendations.

Who is at increased risk for HBV infection?

The CDC and the USPSTF differ slightly on the factors they consider to constitute increased risk for HBV infection. These are listed in ­TABLE 1.^1,2

The CDC lists 6 categories that the ­USPSTF does not mention. However, 4 of these categories are mentioned indirectly in the USPSTF evidence report that accompanies the recommendations, via statements that certain settings have high proportions of people at risk for HBV infection: sexually transmitted infection clinics; HIV testing and treatment centers; health care settings that target services toward people who inject drugs and men who have sex with men; correctional facilities; hemodialysis facilities; and institutions and nonresidential daycare centers for developmentally disabled persons. People who are served at most of these facilities are also at risk for hepatitis C virus infection.

Three categories are listed by the CDC and not by the USPSTF, in either the recommendation or evidence report. These include a history of multiple sex partners; elevated ALT or aspartate aminotransferase levels of unknown origin; and patient request for testing (because they may not want to reveal risk factors).

Continue to: What test(s) should be ordered?

What test(s) should be ordered? 

The USPSTF recommends screening using HBsAg. The CDC recommends using triple-panel screening: HBsAg, anti-hepatitis B surface antigen (anti-HBs), and total antibody to hepatitis B core antigen (anti-HBc).

HBsAg indicates HBV infection, either acute or chronic, or a recent dose of HBV vaccine. Anti-HBs indicate recovery from HBV infection, response to HBV vaccine, or recent receipt of hepatitis B immune globulin. Total anti-HBc develops in all HBV infections, resolved or current, and usually persists for life. Vaccine-induced immunity does not cause anti-HBc to develop.

The USPSTF’s rationale is that testing for HBsAg is more than 98% sensitive and specific for detecting HBV infections.² The CDC recommends triple testing because it can detect those with asymptomatic active HBV infections (this would be a rare occurrence); those who have resolved infection and might be susceptible to reactivation (eg, those who are immunosuppressed); and those who are susceptible and need vaccination.

Interpretation of HBV test results and suggested actions are described in TABLE 2.^1,8,13

Why do the CDC and USPSTF differ?

While it would be optimal if the CDC and the USPSTF coordinated and harmonized recommendations, this is difficult to achieve given their different missions. The USPSTF is charged to make evidence-based recommendations about preventive services such as screenings, behavioral counseling, and preventive medications, which are provided by clinicians to individual patients. The Task Force uses a very strict evidence-based process and will not make recommendations unless there is adequate evidence of efficacy and safety. Members of the Task Force are primary care professionals, and their collaborating professional organizations are primary care focused.

Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use singleor triple-test screening.

The CDC takes a community-wide, public health perspective. The professionals that work there are not always clinicians. They strive to prevent as much illness as possible, using public health measures and making recommendations to clinicians. They collaborate with professional organizations; on topics such as hepatitis and other infectious diseases, they collaborate with specialty-oriented societies. Given the imperative to act with the best evidence available, their evidence assessment process is not as strict.

The result, at times, is slight differences in recommendations. However, the HBV screening recommendations from the CDC and the USPSTF agree more than they do not. Based on practice-specific characteristics, family physicians should decide if they want to screen all adults or only those at increased risk, and whether to use single- or triple-test screening.

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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

A U.S. Food and Drug Administration investigation of injection-site necrosis in some people who received the 23-valent pneumococcal vaccine has concluded that the benefits of the vaccine outweigh the risks.

No similar safety signal has been detected for the more recently approved 15-valent and 20-valent pneumococcal conjugate vaccines, explain the investigators, led by Brendan Day, MD, MPH, from the FDA’s Center for Biologics Evaluation and Research, in their report published online in JAMA Internal Medicine.

Reports of injection-site necrosis emerged after the vaccine (Pneumovax 23, Merck) had been approved by the FDA and was administered to a large, diverse, real-world population.

Rare safety events can emerge after FDA approval, as clinical trials may not be able to detect them in a study-group population.

Therefore, “postmarketing safety surveillance is critical to further characterize the safety profile of licensed vaccines,” the investigators point out.

The FDA and the Centers for Disease Control and Prevention monitor the postmarketing safety of licensed vaccines using the Vaccine Adverse Event Reporting System (VAERS), which relies on people who get the vaccines to report adverse events.
 

Real-world finding

After reports indicated a safety signal in 2020, the researchers conducted a case-series review, calculated the reporting rate, and did a PubMed search for similar reports.

They found that the reporting rate for injection-site necrosis was less than 0.2 cases per 1 million vaccine doses administered. The PubMed search yielded two cases of injection-site necrosis after the vaccine.

The 23-valent vaccine helps protect people from pneumococcus bacterial infection. The manufacturer reports that it is for people at least 50 years of age and for children who are at least 2 years of age with medical conditions that put them at elevated risk for infection.

The U.S. package insert has been updated, in the Post-Marketing Experience section, to include injection-site necrosis.

Of the 104 VAERS reports identified by the researchers, 48 met the case definition. Of those cases, most were for skin necrosis (n = 43), five of which also included fat necrosis. The remaining five cases of necrosis affected fascia (n = 2); fat and fascia (n = 1); fat, fascia, and muscle (n = 1); and muscle (n = 1).

In 23 of the 48 cases (47.9%), the reactions were serious and included one death (unrelated to vaccination).

Seventeen patients (35.4%) were hospitalized and 26 (54.2%) required surgery, most commonly debridement. Eight patients (16.7%) underwent multiple surgical procedures and three (6.3%) required a skin graft.

For patients with skin necrosis (n = 43), the median age was 67 years, and most patients were female (n = 36). Twelve patients were immunocompromised.

Concomitant vaccinations were reported in 10 patients, five of whom got the shot in the same arm as the 23-valent pneumococcal vaccine. A concurrent diagnosis of cellulitis was reported in 16 patients and an abscess was reported in three patients. There were too few cases of fat, fascia, or muscle necrosis to draw conclusions, the researchers report.

Often, skin necrosis was seen after a progression of symptoms, such as redness, pain, or swelling.

“These reports are consistent with published descriptions of injection-site necrosis, which has been reported as a rare complication for many vaccines and injectable drugs,” the investigators report.

Although the researchers couldn’t conclude from the VAERS reports alone that the vaccine injection caused the necrosis, “the timing and the location of reactions at the injection site suggest a possible causal association with the vaccine,” they explain. However, they add, patient comorbidities and poor injection technique may also be contributors.

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