MDedge Infectious Disease

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Advanced practice providers (APPs) such as nurse practitioners (NPs) and physician assistants (PAs) have long been at odds with doctor groups over scope of practice issues. But in a rare alliance, more than 500 physicians, NPs, and PAs at Allina Health primary care and urgent care clinics in Minneapolis recently filed a petition with the National Labor Relations Board to hold a union election in late September. If successful, the Allina group will join the Doctors Council SEIU, Local 10MD.

The Allina health care providers share concerns about their working conditions, such as understaffing and inadequate resources, limited decision-making authority, and health systems valuing productivity and profit over patient care.

Although doctors and APPs have said that they generally work well together, the relationship has been strained in recent years as APPs argue for greater scope of practice. Meanwhile, physician groups, such as the American Medical Association, believe that APPs need more oversight.

An Allina union organizer, Britta V. Kasmarik, CNP, acknowledges the tension between physicians and APPs. But she said in an interview that the union effort helped bond this group of health care providers. “We share common goals of providing high-quality care for patients in a safe way, and we see the same things day in and day out with our patients.”

Matt Hoffman, MD, a primary care physician at Allina, told this news organization that APPs in his specialty perform the same job as doctors “and the working conditions are really identical. In our view, that means we should be unionizing together.”

The decision to hold a union vote follows similar action by nearly 150 Allina Mercy Hospital physicians in March. Allina Health appealed the vote.

In response to a New York Times investigation, the Minnesota Attorney General’s office began reviewing reports of aggressive billing practices and denied care at Allina Health.

The Allina Health system, which reports $4 billion in annual revenue, cut off nonemergency services to patients, including children, if their medical debt exceeded $4,500, according to the New York Times article. For Allina’s physicians and APPs, that meant leaving patients’ illnesses untreated.

Less than a week after the attorney general announced its investigation, the health system ended this practice.

In a prepared statement to this news organization, Allina Health said that its providers are “critical members of our teams. … We deeply value and share their commitment to providing high-quality care to our patients.”

The health system said it planned to make operational improvements, implement new communication tools, and provide additional well-being resources and enhanced employee benefits “to improve the provider experience.” In addition, it hoped to continue to “foster a culture of collaboration with all our employees.”

Having a union will allow health care providers to advocate for their patients and give health care providers more decision-making power instead of corporate leaders maintaining full authority, Ms. Kasmarik told this news organization.

Union organizers are also concerned with changes to the daily practice of medicine. “We don’t want to be spending our time doing paperwork and calling insurance companies and filling out forms,” said Dr. Hoffman. “We want to be in the exam room with a patient.”

The Allina providers organized after multiple requests to corporate managers failed to address their concerns. Their demands include increased staffing and help with nonclinical work so that clinicians can spend more time with their patients.

“What I’m really excited about is that we will be able to work with the other unionized groups to make change ... by being involved in health care policy at a state or national level,” Dr. Hoffman said. For example, that involvement might include challenging insurance company decisions.

Doctors Council bills itself as the largest union for attending physicians in the country, with 3,500 members, according to Joe Crane, national organizing director.

Despite an increase in union efforts since the pandemic, health care workers – particularly doctors – have been slow to join unions. Mr. Crane estimated that only about 3% of U.S. physicians are currently union members. He cited union campaigns in Massachusetts, New York, and Washington, DC. For comparison, a minority of advanced practice registered nurses (APRNs) (9%) report union membership, according to Medscape’s APRN compensation report last year.

Dr. Hoffman is confident the Allina health care providers will have enough votes to win the election to join the union. “We should have done this years ago.”

A version of this article appeared on Medscape.com.

Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that nearly a third of men older than 15 years are infected with human papillomavirus (HPV), and one in five are carriers of high-risk HPV (HR-HPV). These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.

“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
 

Literature review

HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.

Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.

Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.

In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
 

Prevalent HPV genotype

Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).

HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.

This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.

The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
 

Preventive measures

“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.

“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”

In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.

The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.

Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that nearly a third of men older than 15 years are infected with human papillomavirus (HPV), and one in five are carriers of high-risk HPV (HR-HPV). These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.

“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
 

Literature review

HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.

Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.

Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.

In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
 

Prevalent HPV genotype

Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).

HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.

This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.

The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
 

Preventive measures

“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.

“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”

In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.

The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.

Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Findings from a meta-analysis of 65 studies conducted in 35 countries indicate that nearly a third of men older than 15 years are infected with human papillomavirus (HPV), and one in five are carriers of high-risk HPV (HR-HPV). These estimates provide further weight to arguments in favor of vaccinating boys against HPV to prevent certain types of cancer.

“Our results support that sexually active men, regardless of age, are an important reservoir of HPV genital infection,” wrote the authors in The Lancet Global Health . “These estimates emphasize the importance of incorporating men into comprehensive HPV prevention strategies to reduce HPV-related morbidity and mortality in men and ultimately achieve elimination of cervical cancer and other HPV-related diseases.”
 

Literature review

HPV infection is the most common sexually transmitted viral infection worldwide. More than 200 HPV types can be transmitted sexually, and at least 12 types are oncogenic. Previous studies have shown that most sexually active men and women acquire at least one genital HPV infection during their lifetime.

Although most HPV infections are asymptomatic, they can lead to cancer. Indeed, HPV is involved in the development of cervical, vulval, and vaginal cancers, as well as oropharyngeal and anal cancers, which also affect the male population. More than 25% of cancers caused by HPV occur in men.

Despite these observations, fewer epidemiologic studies have assessed HPV infection in men than in women. To determine the prevalence of HPV infection in the male population, Laia Bruni, MD, MPH, PhD, an epidemiologist at the Catalan Institute of Oncology in Barcelona, and her colleagues collated data from 65 studies conducted in 35 countries pertaining to males older than 15 years.

In this literature review, the researchers selected studies that reported infection rates in males without HPV-related symptoms. Studies conducted exclusively in populations that were considered at increased risk for sexually transmitted infections (STIs) were excluded. Overall, the analysis included close to 45,000 men.
 

Prevalent HPV genotype

Testing for HPV was conducted on samples collected from the anus and genitals. The results show a global pooled prevalence of HPV infection in males older than 15 years of 31% for any HPV and 21% for HR-HPV. One of these viruses, HPV-16, was the most prevalent HPV genotype (5% prevalence).

HPV prevalence was highest among young adults. It stabilized and decreased from age 50 years. Between ages 25 and 29 years, 35% of men are infected with HPV. It should be noted that prevalence is already high in the youngest group, reaching 28% in males between the ages of 15 and 19 years. The variations are similar for HR-HPV infections.

This age-related change is different from rates in women. Among the female population, HPV prevalence peaks soon after first sexual activity and declines with age, with a slight rebound after ages 50–55 years (i.e., often after or around the time of menopause), wrote the researchers.

The results also show country- and region-based disparities. The pooled prevalence for any HPV was highest in Sub-Saharan Africa (37%), followed by Europe and Northern America (36%). The lowest prevalence was in East and Southeast Asia (15%). Here again, the trends are similar with high-risk HPV.
 

Preventive measures

“Our study draws attention to the high prevalence, ranging from 20% to 30% for HR-HPV in men across most regions, and the need for strengthening HPV prevention within overall STI control efforts,” wrote the authors.

“Future epidemiological studies are needed to monitor trends in prevalence in men, especially considering the roll-out of HPV vaccination in girls and young women and that many countries are beginning to vaccinate boys.”

In France, the HPV vaccination program was extended in 2021 to include all boys between the ages of 11 and 14 years (two-dose schedule), with a catch-up course in males up to age 19 years (three-dose schedule). This is the same vaccine program as for girls. It is also recommended for men up to age 26 years who have sex with other men.

The 2023 return to school will see the launch of a general vaccination campaign aimed at seventh-grade students, both boys and girls, with parental consent, to increase vaccine coverage. In 2021, vaccine uptake was 43.6% in girls between the ages of 15 and 18 years and scarcely 6% in boys, according to Public Health France.

Two vaccines are in use: the bivalent Cervarix vaccine, which is effective against HPV-16 and HPV-18, and the nonavalent Gardasil 9, which is effective against types 16, 18, 31, 33, 45, 52, and 58. Both provide protection against HPV-16, the type most common in men, which is responsible for more than half of cases of cervical cancer.

This article was translated from the Medscape French Edition. A version appeared on Medscape.com.

Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

The study was published online in the Canadian Medical Association Journal.
 

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

The study was published online in the Canadian Medical Association Journal.
 

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Variability in antimicrobial prescribing among hospital-based physicians is not associated with patient characteristics or clinical outcomes, data suggest. The lowest level of such prescribing within each hospital could be considered a target for antimicrobial stewardship, according to the researchers.

In a multicenter study of 124 physicians responsible for more than 124,000 hospitalized patients, the difference in mean prescribing between the highest and lowest quartiles of prescription volume was 15.8 days of treatment per 100 patient-days.

Baseline patient characteristics were similar across the quartiles, and there were no differences in patient outcomes, including in-hospital deaths, hospital length of stay, intensive care unit transfer, and hospital readmission.

Although the investigators expected variation in prescribing, “what surprised us most was the limited association with any differences in clinical outcomes, particularly when it came to the amount of antimicrobials used,” study author Mark T. McIntyre, PharmD, pharmacotherapy specialist at the Sinai Health System in Toronto, told this news organization.

“Importantly, this is not a study that defines quality of care,” he said. “We looked at natural variation in practice and association with outcomes. So, I don’t want clinicians to think, ‘Well, I’m high, therefore I’m bad,’ or, ‘I’m low, therefore I’m good.’

“This is an early explanatory analysis that asks whether this is an opportunity to optimize prescribing in ways we hadn’t thought of before,” he said. “Now that we don’t have an association with higher or lower prescribing and outcomes, we can look at what else is driving that antimicrobial prescribing and what we can do about it. Comfort level, risk tolerance, and social, cultural, and contextual factors all likely play a role.”

The study was published online in the Canadian Medical Association Journal.
 

Antimicrobial reductions possible

The investigators conducted a retrospective cohort study using the General Medicine Inpatient Initiative database to assess physician-level volume and spectrum of antimicrobial prescribing in adult general medical wards. Four academic hospitals in Toronto were evaluated for the period 2010 to 2019.

The investigators stratified physicians into quartiles by hospital site on the basis of volume of antimicrobial prescribing (specifically, days of therapy per 100 patient-days and antimicrobial-free days) and antibacterial spectrum (modified spectrum score, which assigns a value to each antibacterial agent on the basis of its breadth of coverage).

They also examined potential differences between physician quartiles in patient characteristics, such as age, sex, the Laboratory-Based Acute Physiology Score, discharge diagnosis, and the Charlson Comorbidity Index.

Multilevel modeling allowed the investigators to evaluate the association between clinical outcomes and antimicrobial volume and spectrum.

The primary measure was days of therapy per 100 patient-days.

As noted, the cohort included 124 physicians who were responsible for 124,158 hospital admissions. The median physician-level volume of antimicrobial prescribing was 56.1 days of therapy per 100 patient-days. Patient characteristics were balanced across the quartiles of physician prescribing.

The difference in mean prescribing between physician quartile 4 and quartile 1 was 15.8 days of therapy per 100 patient-days, meaning the median physician in quartile 4 prescribed antimicrobials at a volume that was 30% higher than that of the median physician in quartile 1.

No significant differences were noted for any clinical outcome with regard to quartile of days of therapy, antimicrobial-free days, or modified spectrum score after adjustment for patient-level characteristics.

In addition, no significant differences in the case mix between quartile 4 and quartile 1 were found when the cohort was restricted to patients admitted and discharged by the same most responsible person, nor were differences found in an analysis that was restricted to those without a discharge diagnosis code of palliative care.

In-hospital mortality was higher among patients cared for by prescribers with higher modified spectrum scores (odds ratio, 1.13). “We still can’t fully explain this finding,” Dr. McIntyre acknowledged. “We only saw that in our primary analysis. When we did several sensitivity analyses, that finding didn’t appear.”

The authors concluded, “Ultimately, without discernible benefit in outcomes of patients of physicians who prescribe more frequently, less antimicrobial exposure may be possible, leading to lower risk of antimicrobial resistance.”
 

Decision-making support

Commenting on the study, Lawrence I. Kaplan, MD, section chief of general internal medicine and associate dean for interprofessional education at the Lewis Katz School of Medicine at Temple University in Philadelphia, said, “Trying to get to the lowest quartile would be a goal, and given that physician characteristics are involved, I think there needs to be much better training in clinical management decision-making: how you come about making a decision based on a diagnosis for a particular patient, in or out of the hospital.” Dr. Kaplan was not involved in the research.

“Clinical decision-making tools that can be plugged into the electronic health record can help,” he suggested. “The tools basically ask if a patient meets certain criteria and then might give a prompt that says, for example, ‘These symptoms are not consistent with bacterial sinusitis. The patient should be treated with decongestants, nasal steroids, et cetera, because antibiotics aren’t appropriate.’

“It’s a bit like checkbox medicine, which a lot of physicians bridle at,” he said. “But if it’s really based on evidence, I think that’s an appropriate use of evidence-based medicine.”

Dr. Kaplan said that more research is needed into the best way to get a physician or any provider to step back and say, “Is this the right decision?” or, “I’m doing this but I’m really on shaky ground. What am I missing?’” He noted that the Society for Medical Decision Making publishes research and resources in this area.

“I love the fact that the paper was authored by an interdisciplinary group,” Dr. Kaplan added. “A pharmacist embedded in the team can, for example, help with treatment decision-making and point out potential drug interactions that prescribers might not be aware of.

“We need to stop practicing medicine siloed, which is what we do a lot of ways, both in the hospital and out of the hospital, because it’s the path of least resistance,” Dr. Kaplan added. “But when we can say, ‘Hey, I have a question about this,’ be it to a computer or a colleague, I would argue that we come up with better care.”

No funding was provided for the study. Dr. McIntyre and Dr. Kaplan have disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

The understanding that human papillomavirus (HPV) causes oropharyngeal squamous cell carcinoma (OPSCC) has been linked with increased likelihood of adults having been vaccinated for HPV, new research indicates.

In a study published online in JAMA Otolaryngology–Head and Neck Surgery, most of the 288 adults surveyed with validated questions were not aware that HPV causes OPSCC and had not been told of the relationship by their health care provider.

Researchers found that when participants knew about the relationship between HPV infection and OPSCC they were more than three times as likely to be vaccinated (odds ratio, 3.7; 95% confidence interval, 1.8-7.6) as those without the knowledge.

The survey was paired with a novel point-of-care adult vaccination program within an otolaryngology clinic. 

“Targeted education aimed at unvaccinated adults establishing the relationship between HPV infection and OPSCC, paired with point-of-care vaccination, may be an innovative strategy for increasing HPV vaccination rates in adults,” write the authors, led by Jacob C. Bloom, MD, with the department of otolaryngology–head and neck surgery at Boston Medical Center.

Current HPV vaccination recommendations include three parts:

• Routine vaccination at age 11 or 12 years
• Catch-up vaccination at ages 13-26 years if not adequately vaccinated
• Shared clinical decision-making in adults aged 27-45 years if the vaccine series has not been completed.

Despite proven efficacy and safety of the HPV vaccine, vaccination rates are low for adults. Although 75% of adolescents aged 13-17 years have initiated the HPV vaccine, recent studies show only 16% of U.S. men aged 18-21 years have received at least 1 dose of the HPV vaccine, the authors write.

Christiana Zhang, MD, with the division of internal medicine at Johns Hopkins University in Baltimore, who was not part of the study, said she was not surprised by the lack of knowledge about the HPV-OPSCC link.

Patients are often counseled on the relationship between HPV and genital warts or anogenital cancers like cervical cancer, she says, but there is less patient education surrounding the relationship between HPV and oropharyngeal cancers.

She says she does counsel patients on the link with OPSCC, but not all providers do and provider knowledge in general surrounding HPV is low.

“Research has shown that knowledge and confidence among health care providers surrounding HPV vaccination is generally low, and this corresponds with a low vaccination recommendation rate,” she says.

She adds, “Patient education on HPV infection and its relationship with OPSCC, paired with point-of-care vaccination for qualifying patients, is a great approach.”

But the education needs to go beyond patients, she says.

“Given the important role that health care providers play in vaccine uptake, I think further efforts are needed to educate providers on HPV vaccination as well,” she says.

The study included patients aged 18-45 years who sought routine outpatient care at the otolaryngology clinic at Boston Medical Center from Sept. 1, 2020, to May 19, 2021.

Limitations of this study include studying a population from a single otolaryngology clinic in an urban, academic medical center. The population was more racially and ethnically diverse than the U.S. population with 60.3% identifying as racial and ethnic minorities. Gender and educational levels were also not reflective of U.S. demographics as half (50.8%) of the participants had a college degree or higher and 58.3% were women.

Dr. Bloom reports grants from the American Head and Neck Cancer Society during the conduct of the study. Coauthor Dr. Faden reports personal fees from Merck, Neotic, Focus, BMS, Chrystalis Biomedical Advisors, and Guidepoint; receiving nonfinancial support from BostonGene and Predicine; and receiving grants from Calico outside the submitted work. Dr. Zhang reports no relevant financial relationships.

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

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

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

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

A new strain of COVID-19 that was identified only a week ago in the United States has prompted the Centers for Disease Control and Prevention to take the rare step of issuing a formal message that it could evade vaccines or the protection of natural immunity. 

The strain is called BA.2.86 and is of particular concern because of its more than 30 mutations, which means it may behave very differently than previous versions of the virus. That number of mutations is on par with the difference between variants so serious that they were formally named, such as between Delta and Omicron, the CDC explained in the risk assessment issued Aug. 23.

Worldwide, health agencies are issuing a flurry of updates on BA.2.86. The strain only recently landed on the World Health Organization’s radar when it was named a “variant under monitoring” on Aug. 17. The CDC announced the same day that it had been detected in the United States.

Among the characteristics the CDC monitors for are how contagious a strain is, how well it responds to treatment, and how severely it affects people.

“BA.2.86 may be more capable of causing infection in people who have previously had COVID-19 or who have received COVID-19 vaccines,” the CDC risk assessment stated.

The agency is evaluating how well the forthcoming updated vaccine, due out in September, performs against BA.2.86.

A new forecast also released this week by the CDC predicts hospitalizations due to the virus will continue their upward trend through at least mid-September. Currently, about 1,800 people are hospitalized daily with COVID-19. The new prediction shows that number has a small potential to drop as low as 1,100 daily, but it could also increase by as many as 7,500 per day. The most likely scenario lands somewhere in the middle of that range, with daily hospital admissions of between 2,000 and 4,000 people by Sept. 18.

The CDC said there is “no evidence” that BA.2.86 is causing more severe illness but said that could change as more information becomes available. Health experts typically gauge severity by the rate of COVID hospitalizations.

The journal Nature reported that many scientists see similarities between the emergence of BA.2.86 and that of Omicron, which rapidly spread around the world in late 2021.

“There’s a little bit of déjà vu all over again,” University of Michigan virologist Adam Lauring, MD, PhD, whose lab detected one of the first U.S. cases of BA.2.86, told Nature.

Dr. Lauring, as well as the CDC and the WHO, all caution that more data is needed to truly understand the threat posed by BA.2.86.

“There’s good reason to think it won’t be like the Omicron wave, but it’s early days,” Dr. Lauring said.

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

The U.S. Preventive Services Task Force is expanding its recommendation for antiretrovirals in HIV now that more options are available on the market.

“With these new options we could potentially extend pre-exposure prophylaxis (PrEP) to a wider population,” says James Stevermer, MD, a member of the task force and a professor of family and community medicine at the University of Missouri–Columbia.

The guidance, published in JAMA, updates the group’s previous recommendation from 2019 to take into account the new options that have become available since the U.S. Food and Drug Administration approvals that included a long-acting injectable form.

In the original report, daily oral tenofovir disoproxil fumarate with emtricitabine was the only approved medication available and the task force recommended it. Since then, two new regimens have been approved: daily oral tenofovir alafenamide with emtricitabine and the long-acting injectable cabotegravir.

The task force is backing all three options and is recommending that clinicians use whichever formulation is most appropriate for their patients at risk for HIV infection.
 

Task force in primary and preventive care

The USPSTF is a volunteer group of experts in primary and preventive care who make recommendations on the best preventative interventions clinicians should take on everything from cancer screening, to preventive aspirin use, to behavioral counseling. The group is convened and supported by the Agency for Healthcare Research and Quality.

Recommendations from this group are particularly helpful for clinicians who may not see HIV as their area of expertise, says Carolyn Chu, MD, chief medical officer of the American Academy of HIV Medicine. “Hopefully, this will catch the eye of people who are not tracking all of the HIV updates,” she says.

A person’s risk for infection is mostly based on their behavior, Dr. Stevermer says. Those who use injectable drugs, particularly if they share needles, those who use condoms inconsistently and do not know their partner’s HIV status, and those who have recently had bacterial sexually transmitted infections like gonorrhea and syphilis are all at higher risk.

The efficacy of each of the three options is close enough to equal that it doesn’t usually matter which is prescribed, according to the task force. However, daily oral tenofovir alafenamide with emtricitabine is not approved for use by people engaging in receptive vaginal sex. For most people, the best medication option is the one they are most likely able to integrate into their routine. Cabotegravir, for example, which requires injections every 2 months, is an easier method for some people, particularly those who don’t think they could successfully take a daily pill.
 

Reducing risk

“The evidence is very clear that being able to adhere to taking the medication daily was very closely associated with the effectiveness of PrEP,” Dr. Stevermer says. “So, everything that we can do to make sure that the person who wants to prevent HIV is getting their PrEP as it is supposed to be taken makes it that much more effective.”

Expanding access to antiretrovirals among at-risk groups is an important part of the Ending the HIV Epidemic in the United States initiative that aims to reduce new HIV cases by 90% by 2030.

But an editorial published alongside the recommendation in JAMA notes that uptake of PrEP has been disproportionately low among populations most heavily affected by HIV.

In 2021, 78% of White people expected to benefit from PrEP received it, compared with just 11% of Black people and 21% of Hispanic people, despite both of those populations having a higher incidence of HIV than Whites. PrEP use is also substantially lower among cisgender and transgender women, youth, and people who inject drugs.

“We have an intervention that can markedly reduce people’s risk of getting HIV and so we want to make sure we get this out to all those populations at increased risk,” Dr. Stevermer says.

Having multiple options when it comes to PrEP is a big part of expanding access to the treatment for underserved groups, Dr. Chu says. “Even though oral tenofovir disoproxil fumarate with emtricitabine has been out for a while, we know it’s not getting to everyone, and there may be clinical circumstances that means it’s not the right option,” she says. “Making sure we are supporting choices so people can make the decision for themselves is important.”

But doctors also need to be willing to have an open conversation with their patients and bring up the topic of PrEP in a way that doesn’t feel judgmental or stigmatizing, Dr. Chu says.

It is also important not to make assumptions about who would want to talk about medication, she adds. “How can we change the narrative around PrEP?” she asks. “The evidence is there, these medications are effective and safe; weave PrEP into your preventive care portfolio to at least start the conversation.”

A version of this article appeared on Medscape.com.

The U.S. Preventive Services Task Force is expanding its recommendation for antiretrovirals in HIV now that more options are available on the market.

“With these new options we could potentially extend pre-exposure prophylaxis (PrEP) to a wider population,” says James Stevermer, MD, a member of the task force and a professor of family and community medicine at the University of Missouri–Columbia.

The guidance, published in JAMA, updates the group’s previous recommendation from 2019 to take into account the new options that have become available since the U.S. Food and Drug Administration approvals that included a long-acting injectable form.

In the original report, daily oral tenofovir disoproxil fumarate with emtricitabine was the only approved medication available and the task force recommended it. Since then, two new regimens have been approved: daily oral tenofovir alafenamide with emtricitabine and the long-acting injectable cabotegravir.

The task force is backing all three options and is recommending that clinicians use whichever formulation is most appropriate for their patients at risk for HIV infection.
 

Task force in primary and preventive care

The USPSTF is a volunteer group of experts in primary and preventive care who make recommendations on the best preventative interventions clinicians should take on everything from cancer screening, to preventive aspirin use, to behavioral counseling. The group is convened and supported by the Agency for Healthcare Research and Quality.

Recommendations from this group are particularly helpful for clinicians who may not see HIV as their area of expertise, says Carolyn Chu, MD, chief medical officer of the American Academy of HIV Medicine. “Hopefully, this will catch the eye of people who are not tracking all of the HIV updates,” she says.

A person’s risk for infection is mostly based on their behavior, Dr. Stevermer says. Those who use injectable drugs, particularly if they share needles, those who use condoms inconsistently and do not know their partner’s HIV status, and those who have recently had bacterial sexually transmitted infections like gonorrhea and syphilis are all at higher risk.

The efficacy of each of the three options is close enough to equal that it doesn’t usually matter which is prescribed, according to the task force. However, daily oral tenofovir alafenamide with emtricitabine is not approved for use by people engaging in receptive vaginal sex. For most people, the best medication option is the one they are most likely able to integrate into their routine. Cabotegravir, for example, which requires injections every 2 months, is an easier method for some people, particularly those who don’t think they could successfully take a daily pill.
 

Reducing risk

“The evidence is very clear that being able to adhere to taking the medication daily was very closely associated with the effectiveness of PrEP,” Dr. Stevermer says. “So, everything that we can do to make sure that the person who wants to prevent HIV is getting their PrEP as it is supposed to be taken makes it that much more effective.”

Expanding access to antiretrovirals among at-risk groups is an important part of the Ending the HIV Epidemic in the United States initiative that aims to reduce new HIV cases by 90% by 2030.

But an editorial published alongside the recommendation in JAMA notes that uptake of PrEP has been disproportionately low among populations most heavily affected by HIV.

In 2021, 78% of White people expected to benefit from PrEP received it, compared with just 11% of Black people and 21% of Hispanic people, despite both of those populations having a higher incidence of HIV than Whites. PrEP use is also substantially lower among cisgender and transgender women, youth, and people who inject drugs.

“We have an intervention that can markedly reduce people’s risk of getting HIV and so we want to make sure we get this out to all those populations at increased risk,” Dr. Stevermer says.

Having multiple options when it comes to PrEP is a big part of expanding access to the treatment for underserved groups, Dr. Chu says. “Even though oral tenofovir disoproxil fumarate with emtricitabine has been out for a while, we know it’s not getting to everyone, and there may be clinical circumstances that means it’s not the right option,” she says. “Making sure we are supporting choices so people can make the decision for themselves is important.”

But doctors also need to be willing to have an open conversation with their patients and bring up the topic of PrEP in a way that doesn’t feel judgmental or stigmatizing, Dr. Chu says.

It is also important not to make assumptions about who would want to talk about medication, she adds. “How can we change the narrative around PrEP?” she asks. “The evidence is there, these medications are effective and safe; weave PrEP into your preventive care portfolio to at least start the conversation.”

A version of this article appeared on Medscape.com.

The U.S. Preventive Services Task Force is expanding its recommendation for antiretrovirals in HIV now that more options are available on the market.

“With these new options we could potentially extend pre-exposure prophylaxis (PrEP) to a wider population,” says James Stevermer, MD, a member of the task force and a professor of family and community medicine at the University of Missouri–Columbia.

The guidance, published in JAMA, updates the group’s previous recommendation from 2019 to take into account the new options that have become available since the U.S. Food and Drug Administration approvals that included a long-acting injectable form.

In the original report, daily oral tenofovir disoproxil fumarate with emtricitabine was the only approved medication available and the task force recommended it. Since then, two new regimens have been approved: daily oral tenofovir alafenamide with emtricitabine and the long-acting injectable cabotegravir.

The task force is backing all three options and is recommending that clinicians use whichever formulation is most appropriate for their patients at risk for HIV infection.
 

Task force in primary and preventive care

The USPSTF is a volunteer group of experts in primary and preventive care who make recommendations on the best preventative interventions clinicians should take on everything from cancer screening, to preventive aspirin use, to behavioral counseling. The group is convened and supported by the Agency for Healthcare Research and Quality.

Recommendations from this group are particularly helpful for clinicians who may not see HIV as their area of expertise, says Carolyn Chu, MD, chief medical officer of the American Academy of HIV Medicine. “Hopefully, this will catch the eye of people who are not tracking all of the HIV updates,” she says.

A person’s risk for infection is mostly based on their behavior, Dr. Stevermer says. Those who use injectable drugs, particularly if they share needles, those who use condoms inconsistently and do not know their partner’s HIV status, and those who have recently had bacterial sexually transmitted infections like gonorrhea and syphilis are all at higher risk.

The efficacy of each of the three options is close enough to equal that it doesn’t usually matter which is prescribed, according to the task force. However, daily oral tenofovir alafenamide with emtricitabine is not approved for use by people engaging in receptive vaginal sex. For most people, the best medication option is the one they are most likely able to integrate into their routine. Cabotegravir, for example, which requires injections every 2 months, is an easier method for some people, particularly those who don’t think they could successfully take a daily pill.
 

Reducing risk

“The evidence is very clear that being able to adhere to taking the medication daily was very closely associated with the effectiveness of PrEP,” Dr. Stevermer says. “So, everything that we can do to make sure that the person who wants to prevent HIV is getting their PrEP as it is supposed to be taken makes it that much more effective.”

Expanding access to antiretrovirals among at-risk groups is an important part of the Ending the HIV Epidemic in the United States initiative that aims to reduce new HIV cases by 90% by 2030.

But an editorial published alongside the recommendation in JAMA notes that uptake of PrEP has been disproportionately low among populations most heavily affected by HIV.

In 2021, 78% of White people expected to benefit from PrEP received it, compared with just 11% of Black people and 21% of Hispanic people, despite both of those populations having a higher incidence of HIV than Whites. PrEP use is also substantially lower among cisgender and transgender women, youth, and people who inject drugs.

“We have an intervention that can markedly reduce people’s risk of getting HIV and so we want to make sure we get this out to all those populations at increased risk,” Dr. Stevermer says.

Having multiple options when it comes to PrEP is a big part of expanding access to the treatment for underserved groups, Dr. Chu says. “Even though oral tenofovir disoproxil fumarate with emtricitabine has been out for a while, we know it’s not getting to everyone, and there may be clinical circumstances that means it’s not the right option,” she says. “Making sure we are supporting choices so people can make the decision for themselves is important.”

But doctors also need to be willing to have an open conversation with their patients and bring up the topic of PrEP in a way that doesn’t feel judgmental or stigmatizing, Dr. Chu says.

It is also important not to make assumptions about who would want to talk about medication, she adds. “How can we change the narrative around PrEP?” she asks. “The evidence is there, these medications are effective and safe; weave PrEP into your preventive care portfolio to at least start the conversation.”

A version of this article appeared on Medscape.com.

People who have been infected with the COVID-19 virus have a greater risk of many long-term health conditions, including diabetes, lung problems, fatigue, blood clots, and disorders affecting the gastrointestinal and musculoskeletal systems.

That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.

“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”

The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.

“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”

Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.

“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”

People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.

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

People who have been infected with the COVID-19 virus have a greater risk of many long-term health conditions, including diabetes, lung problems, fatigue, blood clots, and disorders affecting the gastrointestinal and musculoskeletal systems.

That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.

“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”

The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.

“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”

Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.

“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”

People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.

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

People who have been infected with the COVID-19 virus have a greater risk of many long-term health conditions, including diabetes, lung problems, fatigue, blood clots, and disorders affecting the gastrointestinal and musculoskeletal systems.

That is the finding of a new study from Washington University in St. Louis. The school distributed a press release about the study, which was published in the journal Nature Medicine.

“Some estimates show more than 90% of the U.S. population has been infected with COVID-19,” Ziyad Al-Aly, chief of research and development at Veterans Affairs St. Louis Health Care System and clinical epidemiologist at Washington University, told the St. Louis Post–Dispatch. “Doctors need to realize that their patients could be at risk of these conditions, be it heart disease or lung problems or brain problems – they’re at risk.”

The researchers compared the health records for 138,000 patients who had been infected with those of 6 million who had not. They followed 80 health conditions associated with long COVID for 2 years. They used unnamed records from the VA.

“There was really nothing at all looking at what happens to people at two years after the infection,” Dr. Al-Aly said. “So we decided to take a look.”

Patients who hadn’t been hospitalized within 30 days of infection had a higher risk of death 6 months after recovery, and a higher risk of hospitalization within 18 months. They had higher risk of diabetes, fatigue, joint pain, and other problems compared with people who had not been infected.

“In the nonhospitalized group, risks remained elevated for several problems, for several organ systems,” Dr. Al-Aly said. “For the people who were hospitalized, the risk was ubiquitous across all organ systems. It really spans the gamut with respect to the organ systems that are affected.”

People who had been hospitalized had a 65% greater risk of illnesses after 2 years. Nonhospitalized patients had just a 35% greater risk.

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

For the first time in the fall of 2023, families will be offered season-long protection for infants and some children against respiratory syncytial virus (RSV).

The Food and Drug Administration in July approved a prevention called nirsevimab (Beyfortus, AstraZeneca/Sanofi) and it is expected to be widely rolled out in the coming weeks as the RSV season begins.

It’s not a vaccine, but a monoclonal antibody used for prevention. That may cause confusion because a vaccine for RSV was approved just 3 months ago for adults aged 60 and older. And monoclonal antibodies are often used for treatment rather than prevention.

Adding to potential confusion is the fact the Centers for Disease Control and Prevention has included nirsevimab in the Vaccines for Children program, which covers the costs for uninsured kids and makes it more accessible.

Nirsevimab is approved for infants (up to 8 months old) born during or entering their first RSV season, and in children up to 2 years of age who are still vulnerable to severe RSV through their second season.

It’s recommended that all infants get one injection in their first 8 months for prevention instead of the previous monthly shots used to help prevent kids at high risk from getting severe RSV.

If monoclonal antibodies can be used for preventing disease in infants, could they become a viable vaccine alternative for adults?

Specialists say no.

That’s partly because of the difference in body size. Although an injection is an option for a newborn, pediatricians suggest, it would take far too much of the treatment to work as a shot for adults.

Ruth Karron, MD, an expert in pediatric infectious diseases at Johns Hopkins Medicine, Baltimore, said that, while vaccines come in small amounts and activate immune cells, monoclonal antibodies are more like a drug, with the dose based on weight.

“You’d have to give it intravenously,” for larger doses, she explained, which has never been studied before and would also be very expensive. “It really couldn’t be an option for adults.”
 

What’s the difference between vaccines and antibodies?

Monoclonal antibodies are proteins made in a lab to mimic the immune system’s ability to fight pathogens such as viruses.

Dr. Karron explained that a wide variety of monoclonal antibodies have long been used to treat diseases such as cancers and autoimmune disease. In recent years, the antibodies have been used to treat COVID.

Monoclonal antibodies have also been used to treat RSV in children, but the effects don’t last long – they confer passive immunity and “when it’s gone, it’s gone,” Dr. Karron said.

That means kids at high risk for severe RSV have had to get monthly injections.

But with nirsevimab, the mutated antibodies stay in circulation longer so they can last 5 or 6 months, enough to cover the RSV season, Dr. Karron explained. “It’s highly, highly effective.”
 

Vaccines train the body

“The idea with vaccines is that you engage the individual’s immune system. You teach it to make antibodies,” Dr. Karron said. Conversely, “you give an antibody and it’s good for as long as the antibody lasts. It’s not teaching your body anything.”

Frank Esper, MD, a pediatric infectious disease specialist at Cleveland Clinic Children’s Hospital, said monoclonal antibody protection for RSV is particularly welcome. “We’ve been trying to make an RSV vaccine since the 1960s and have done nothing but fail miserably.”

“The best thing is always a vaccine,” Dr. Esper said, explaining that vaccines teach the body to make its own antibodies and confer long-term protection and are “probably more efficacious than anything that’s ever manmade.

“But since we’ve really not done very well for pediatric RSV vaccines, nirsevimab is certainly something I’m looking forward to,” he said.
 

Fast-acting monoclonal antibodies

An advantage for monoclonal antibodies is that they start working almost immediately.

Children can get sick with RSV in the first few months of life so the speed of the monoclonal antibodies to begin protection is important, Dr. Esper said, adding that RSV “is the worst during the first year of life.”

The peak age for babies getting infected enough to require hospitalization is about 2 months, he said.

By 14 months, he said, kids’ immune systems and airways have matured enough “that it’s not nearly as bad.”

To get protection from a vaccine, he added, “usually takes 2-4 weeks from the time you get your shot to the time you see some benefit. With an antibody, you’re bypassing the processing that the body has to do, and it goes straight to ‘protection’ mode,” Dr. Esper said. “You get protected pretty much as soon as you get the antibody.”

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

People may get more protection against COVID-19 if they get their vaccinations and boosters in the same arm, a new study says.

Scientists in Germany looked at health data for 303 people who got the mRNA vaccine and then a booster shot. Their antibody levels were measured two weeks after the second shot. None of the people had had COVID before the vaccinations.

Scientists found that the number of protective “killer T cells” was higher in the 147 study participants who got both shots in the same arm, said the study published in EBioMedicine.

The killer cells were found in 67% of cases in which both shots went into the same arm, compared with 43% of cases with different arms.

“That may suggest that that ipsilateral vaccination (in the same arm) is more likely to provide better protection should the vaccinated person become infected with the SARS-CoV-2 virus,” Laura Ziegler, a doctoral student at Saarland University, Germany, said in a news release.

William Schaffner, MD, a professor in the Division of Infectious Diseases at Vanderbilt University Medical Center, Nashville, Tenn., told CBS News that same-arm vaccinations may work better because the cells that provide the immune response are in local lymph nodes.

There’s greater immunological response if the immune cells in the lymph nodes are restimulated in the same place, said Dr. Schaffner, who was not involved in the German study.

The scientists from Saarland University said more research is needed before they can be certain that having vaccinations in the same arm is actually more effective for COVID shots and sequential vaccinations against diseases such as the flu.

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

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

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

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

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

The long-awaited vaccine for respiratory syncytial virus (RSV) that can be given during pregnancy has been approved by the Food and Drug Administration.

The vaccine, known as Abrysvo, can be given between weeks 32 and 36 of pregnancy and is designed to protect infants from the virus from birth to 6 months of age.

Administered as a single-dose, intramuscular injection, the FDA approved Abrysvo at the end of May for the prevention of lower respiratory tract illness caused by RSV in people aged 60 years and older.

However, “RSV is a common cause of illness in children, and infants are among those at highest risk for severe disease, which can lead to hospitalization,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, pointed out in a news release. “This approval provides an option for health care providers and pregnant individuals to protect infants from this potentially life-threatening disease.”

Most children are infected with the contagious virus at least once by the time they reach age 2 years. Very young children are at particular risk of severe complications, such as pneumonia or bronchitis, and in clinical trials, the new vaccine reduced that risk by up to 82%.

Before the vaccine became available, up to 3% of infants infected with RSV needed to be hospitalized, according to the Centers for Disease Control and Prevention. In the hospital, treatment typically includes oxygen, intravenous fluids, and mechanical ventilation.

RSV often causes common cold symptoms, but the virus poses the risk of severe complications that can lead to death among young children and older people. The CDC estimates 100-300 deaths of children younger than 5 years and 6,000-10,000 deaths of people aged 65 years and older are linked to RSV annually.

This is also the first year that an antibody shot is available to be given after birth to prevent severe RSV in infants younger than 1 year.

In its approval announcement, the FDA pointed out that preeclampsia occurred in 1.8% of pregnancies after Abrysvo, compared with 1.4% of those who received placebo. The FDA also reported that, in infants, low birth weight and jaundice occurred at a higher rate among the pregnant Abrysvo recipients, compared with the placebo group.

Studies have also shown that pregnant vaccine recipients experienced preterm birth at a rate of 5.7%, compared with a rate of 4.7% among those who received placebo. The FDA called the difference “a numerical imbalance” but said in the approval announcement that a “causal relationship” could not be established.

The FDA also noted that people already at high risk of preterm birth were excluded from clinical trials and that Pfizer must conduct ongoing studies to monitor the risk of preeclampsia as well as preterm birth.

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