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AI chatbot ‘hallucinates’ faulty medical intelligence
Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.
Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”
Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.
To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.
ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.
For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
Uncritical AI use risky
Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.
For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.
ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.
“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.
ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.
“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.
Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
Advancing fast
At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.
As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.
“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”
A version of this article first appeared on Medscape.com.
Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.
Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”
Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.
To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.
ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.
For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
Uncritical AI use risky
Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.
For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.
ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.
“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.
ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.
“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.
Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
Advancing fast
At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.
As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.
“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”
A version of this article first appeared on Medscape.com.
Artificial intelligence (AI) models are typically a year out of date and have this “charming problem of hallucinating made-up data and saying it with all the certainty of an attending on rounds,” Isaac Kohane, MD, PhD, Harvard Medical School, Boston, told a packed audience at plenary at an annual scientific meeting on infectious diseases.
Dr. Kohane, chair of the department of biomedical informatics, says the future intersection between AI and health care is “muddy.”
Echoing questions about the accuracy of new AI tools, researchers at the meeting presented the results of their new test of ChatGPT.
To test the accuracy of ChatGPT’s version 3.5, the researchers asked it if there are any boxed warnings on the U.S. Food and Drug Administration’s label for common antibiotics, and if so, what they are.
ChatGPT provided correct answers about FDA boxed warnings for only 12 of the 41 antibiotics queried – a matching rate of just 29%.
For the other 29 antibiotics, ChatGPT either “incorrectly reported that there was an FDA boxed warning when there was not, or inaccurately or incorrectly reported the boxed warning,” Rebecca Linfield, MD, infectious diseases fellow, Stanford (Calif.) University, said in an interview.
Uncritical AI use risky
Nine of the 41 antibiotics included in the query have boxed warnings. And ChatGPT correctly identified all nine, but only three were the matching adverse event (33%). For the 32 antibiotics without an FDA boxed warning, ChatGPT correctly reported that 28% (9 of 32) do not have a boxed warning.
For example, ChatGPT stated that the antibiotic fidaxomicin has a boxed warning for increased risk for Clostridioides difficile, “but it is the first-line antibiotic used to treat C. difficile,” Dr. Linfield pointed out.
ChatGPT also reported that cefepime increased the risk for death in those with pneumonia and fabricated a study supporting that assertion. “However, cefepime is a first-line drug for those with hospital-acquired pneumonia,” Dr. Linfield explained.
“I can imagine a worried family member finding this through ChatGPT, and needing to have extensive reassurances from the patient’s physicians about why this antibiotic was chosen,” she said.
ChatGPT also incorrectly stated that aztreonam has a boxed warning for increased mortality.
“The risk is that both physicians and the public uncritically use ChatGPT as an easily accessible, readable source of clinically validated information, when these large language models are meant to generate fluid text, and not necessarily accurate information,” Dr. Linfield told this news organization.
Dr. Linfield said that the next step is to compare the ChatGPT 3.5 used in this analysis with ChatGPT 4, as well as with Google’s Med-PaLM 2 after it is released to the public.
Advancing fast
At plenary, Dr. Kohane pointed out that AI is a quick learner and improvements in tools are coming fast.
As an example, just 3 years ago, the best AI tool could score about as well as the worst student taking the medical boards, he told the audience. “Three years later, the leading large language models are scoring better than 90% of all the candidates. What’s it going to be doing next year?” he asked.
“I don’t know,” Dr. Kohane said, “but it will be better than this year.” AI will “transform health care.”
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2023
Antibiotics ‘like gold’ for some, driving inappropriate use
Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.
Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.
Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.
“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.
To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.
Dr. Laytner said several prominent themes emerged.
Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
Ineffectively treating symptoms
Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.
They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.
A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.
Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.
She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
Access to care, education
Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”
said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.
“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.
The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.
Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.
Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.
“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.
To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.
Dr. Laytner said several prominent themes emerged.
Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
Ineffectively treating symptoms
Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.
They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.
A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.
Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.
She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
Access to care, education
Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”
said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.
“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.
The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
Personal beliefs and health care system barriers contribute to inappropriate antibiotic use by patients, report researchers presenting results at an annual scientific meeting on infectious diseases.
Nonprescription antibiotic use includes accessing medication left over from a prior prescribed course, obtained from social networks, and purchased over-the-counter in other countries or illegally in stores and markets in the United States.
Overuse and misuse of antibiotics contributes to a growing threat of antimicrobial resistance, and it is tough to say how common it is, Lindsey A. Laytner, PhD, MPH, with Baylor College of Medicine, Houston, pointed out in her presentation.
“This is an understudied area. We don’t routinely collect these data, so we don’t actually know what the true prevalence is. The factors that contribute to this unsafe practice in the U.S. are also underexplored,” Dr. Laytner said.
To investigate, the researchers conducted in-depth interviews with 86 adults (median age, 49 years; 62% women) to identify patients’ motivations to use antibiotics without a prescription. All of them answered “yes” when asked in a previous survey whether they would use antibiotics without contacting a doctor, nurse, dentist, or clinic.
Dr. Laytner said several prominent themes emerged.
Nearly all interviewees reported nonprescription antibiotic use for symptoms that mostly do not warrant antibiotics. These included symptoms of COVID-19, influenza, and the common cold, as well as for pain management, allergies, and even wounds.
Ineffectively treating symptoms
Many felt they “knew their body, knew what they had, and knew how to treat themselves” without a health care provider, Dr. Laytner said.
They also felt the over-the-counter medicines “don’t always work and that antibiotics are like gold or this cure-all and because they are difficult to get a prescription for, they should be kept on hand,” she explained.
A variety of health care system barriers also contribute to inappropriate antibiotic use, including long wait times to schedule appointments and to see the doctor while at their appointments; high costs for clinic visits and prescriptions; and transportation issues.
Many patients opted to use nonprescription antibiotics out of “convenience,” Laytner added.
She explains that the findings could help inform community-level education efforts on inappropriate use of antibiotics and help shape policies to promote antibiotic stewardship.
Access to care, education
Commenting on the study, Emily Sydnor Spivak, MD, associate professor of medicine at University of Utah, Salt Lake City, said she “wasn’t totally surprised by the results, but found it very interesting how there was a theme of autonomy, or ‘I know my body,’ that seemed to drive patients to get antibiotics for relief of symptoms.”
said Dr. Spivak, who is also medical director of antimicrobial stewardship programs at University of Utah Health and VA Salt Lake City Health Care System.
“Given the lack of access to health care as a reason some patients use nonprescription antibiotics, we need to think about access to the health care system and process changes and policy changes to allow better access. Without better access or interaction with the health care system, we can’t educate patients,” Dr. Spivak said.
The study had no commercial funding. Dr. Laytner and Dr. Spivak report no relevant financial disclosures.
A version of this article first appeared on Medscape.com.
IDWEEK 2023
New RSV vaccine will cut hospitalizations, study shows
, according to research presented at an annual scientific meeting on infectious diseases.
“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.
“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.
This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.
The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
Strong efficacy data
Most children are infected with RSV 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.
As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.
The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.
Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
New modeling study
Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.
According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.
With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.
Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.
Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.
Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.
Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”
In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.
A version of this article first appeared on Medscape.com.
, according to research presented at an annual scientific meeting on infectious diseases.
“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.
“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.
This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.
The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
Strong efficacy data
Most children are infected with RSV 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.
As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.
The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.
Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
New modeling study
Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.
According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.
With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.
Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.
Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.
Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.
Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”
In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.
A version of this article first appeared on Medscape.com.
, according to research presented at an annual scientific meeting on infectious diseases.
“With RSV maternal vaccination that is associated with clinical efficacy of 69% against severe RSV disease at 6 months, we estimated that up to 200,000 cases can be averted, and that is associated with almost $800 million in total,” presenting author Amy W. Law, PharmD, director of global value and evidence at Pfizer, pointed out during a news briefing.
“RSV is associated with a significant burden in the U.S. and this newly approved and recommended maternal RSV vaccine can have substantial impact in easing some of that burden,” Dr. Law explained.
This study is “particularly timely as we head into RSV peak season,” said briefing moderator Natasha Halasa, MD, MPH, professor of pediatrics, division of pediatric infectious diseases at Vanderbilt University, Nashville, Tenn.
The challenge, said Dr. Halasa, is that uptake of maternal vaccines and vaccines in general is “not optimal,” making increased awareness of this new maternal RSV vaccine important.
Strong efficacy data
Most children are infected with RSV 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.
As reported previously by this news organization, in the randomized, double-blind, placebo-controlled phase 3 study, Pfizer’s maternal RSV vaccine had an almost 82% efficacy against severe RSV infection in infants from birth through the first 90 days of life.
The vaccine also had a 69% efficacy against severe disease through the first 6 months of life. As part of the trial, a total of 7,400 women received a single dose of the vaccine in the late second or third trimester of their pregnancy. There were no signs of safety issues for the mothers or infants.
Based on the results, the U.S. Food and Drug Administration approved the vaccine, known as Abrysvo, in August, to be given between weeks 32 and 36 of pregnancy.
New modeling study
Dr. Law and colleagues modeled the potential public health impact – both clinical and economic – of the maternal RSV vaccine among the population of all pregnant women and their infants born during a 12-month period in the United States. The model focused on severe RSV disease in babies that required medical attention.
According to their model, without widespread use of the maternal RSV vaccine, 48,246 hospitalizations, 144,495 emergency department encounters, and 399,313 outpatient clinic visits related to RSV are projected to occur annually among the U.S. birth cohort of 3.7 million infants younger than 12 months.
With widespread use of the vaccine, annual hospitalizations resulting from infant RSV would fall by 51%, emergency department encounters would decline by 32%, and outpatient clinic visits by 32% – corresponding to a decrease in direct medical costs of about $692 million and indirect nonmedical costs of roughly $110 million.
Dr. Law highlighted two important caveats to the data. “The protections are based on the year-round administration of the vaccine to pregnant women at 32 to 36 weeks’ gestational age, and this is also assuming 100% uptake. Of course, in reality, that most likely is not the case,” she told the briefing.
Dr. Halasa noted that the peak age for severe RSV illness is 3 months and it’s tough to identify infants at highest risk for severe RSV.
Nearly 80% of infants with RSV who are hospitalized do not have an underlying medical condition, “so we don’t even know who those high-risk infants are. That’s why having this vaccine is so exciting,” she told the briefing.
Dr. Halasa said it’s also important to note that infants with severe RSV typically make not just one but multiple visits to the clinic or emergency department, leading to missed days of work for the parent, not to mention the “emotional burden of having your otherwise healthy newborn or young infant in the hospital.”
In addition to Pfizer’s maternal RSV vaccine, the FDA in July approved AstraZeneca’s monoclonal antibody nirsevimab (Beyfortus) for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season.
The study was funded by Pfizer. Dr. Law is employed by Pfizer. Dr. Halasa has received grant and research support from Merck.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2023
Wastewater can signal upswing in flu, RSV
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new research reported at an annual scientific meeting on infectious diseases.
The analysis of wastewater in Calgary (Alta.) found a “positive correlation” between positivity rates for these three viruses in wastewater and weekly laboratory-confirmed clinical cases and test positivity rates, study investigator Kristine Du, with Cumming School of Medicine, University of Calgary, told this news organization.
Wastewater monitoring of viral activity has become an established tool for COVID-19 pandemic monitoring, providing a leading indicator to cases and hospitalizations. However, less is known about its potential for monitoring endemic respiratory viruses.
The new study shows that wastewater-based surveillance is a “robust and adaptable” tool for community-level surveillance of seasonal respiratory viruses – “one that can complement health care clinical testing because it’s independent from testing biases, and we can actually correlate our cases very well with it,” Ms. Du said during a preconference media briefing.
Tracking community trends
For the study, Ms. Du and colleagues assessed the occurrence of influenza A, influenza B, and RSV RNA in all three wastewater treatment plants in Calgary between March 2022 and April 2023 and its correlation with clinical disease.
They found that viral signals in Calgary’s wastewater for influenza A and B and RSV correlated significantly with weekly confirmed clinical cases in Calgary residents.
Influenza A peaked in Calgary’s wastewater between November and December 2022; influenza B peaked between February and April 2023; and RSV between November 2022 and February 2023.
“Wastewater gives us unbiased, objective, and comprehensive data. It can be used in addition to other testing for assessing the community burden that disease may have, and it is complementary to clinical testing,” Ms. Du said.
Their team, Ms. Du said, is continuing to proactively monitor wastewater for influenza and RSV, as well as other agents of “pandemic potential to make sure we know what could affect humans – and make sure everyone is aware of that.”
Commenting on the research, briefing moderator Belinda Ostrowsky, MD, MPH, Albert Einstein College of Medicine, New York, said, “Wastewater surveillance illustrates how understanding community levels of viral trends can identify hotspots, inform local public health decision-making, and prepare clinicians and hospitals for potential outreach. This topic is particularly timely as we head into the flu and RSV season.”
The study had no commercial funding. Ms. Du and Dr. Ostrowsky report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM IDWEEK 2023