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Pelvic floor dysfunction imaging: New guidelines provide recommendations
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New consensus guidelines from a multispecialty working group of the Pelvic Floor Disorders Consortium (PFDC) clear up inconsistencies in the use of magnetic resonance defecography (MRD) and provide universal recommendations on MRD technique, interpretation, reporting, and other factors.
“The consensus language used to describe pelvic floor disorders is critical, so as to allow the various experts who treat these patients [to] communicate and collaborate effectively with each other,” coauthor Liliana Bordeianou, MD, MPH, an associate professor of surgery at Harvard Medical School and chair of the Massachusetts General Hospital Colorectal and Pelvic Floor Centers, told this news organization.
“These diseases do not choose an arbitrary side in the pelvis,” she noted. “Instead, these diseases affect the entire pelvis and require a multidisciplinary and collaborative solution.”
MRD is a key component in that solution, providing dynamic evaluation of pelvic floor function and visualization of the complex interaction in pelvic compartments among patients with defecatory pelvic floor disorders, such as vaginal or uterine prolapse, constipation, incontinence, or other pelvic floor dysfunctions.
However, a key shortcoming has been a lack of consistency in nomenclature and the reporting of MRD findings among institutions and subspecialties.
Clinicians may wind up using different definitions for the same condition and different thresholds for grading severity, resulting in inconsistent communication not only between clinicians across institutions but even within the same institution, the report notes.
To address the situation, radiologists with the Pelvic Floor Dysfunction Disease Focused Panel of the Society of Abdominal Radiology (SAR) published recommendations on MRD protocol and technique in April.
However, even with that guidance, there has been significant variability in the interpretation and utilization of MRD findings among specialties outside of radiology.
The new report was therefore developed to include input from the broad variety of specialists involved in the treatment of patients with pelvic floor disorders, including colorectal surgeons, urogynecologists, urologists, gynecologists, gastroenterologists, radiologists, physiotherapists, and other advanced care practitioners.
“The goal of this effort was to create a universal set of recommendations and language for MRD technique, interpretation, and reporting that can be utilized and carry the same significance across disciplines,” write the authors of the report, published in the American Journal of Roentgenology.
One key area addressed in the report is a recommendation that MRD can be performed in either the upright or supine position, which has been a topic of inconsistency, said Brooke Gurland, MD, medical director of the Pelvic Health Center at Stanford University, California, a co-author on the consensus statement.
“Supine versus upright position was a source of debate, but ultimately there was a consensus that supine position was acceptable,” she told said in an interview.
Regarding positioning, the recommendations conclude that “given the variable results from different studies, consortium members agreed that it is acceptable to perform MRD in the supine position when upright MRD is not available.”
“Importantly, consortium experts stressed that it is very important that this imaging be performed after proper patient education on the purpose of the examination,” they note.
Other recommendations delve into contrast medium considerations, such as the recommendation that MRD does not require the routine use of vaginal contrast medium for adequate imaging of pathology.
And guidance on the technique and grading of relevant pathology include a recommendation to use the pubococcygeal line (PCL) as a point of reference to quantify the prolapse of organs in all compartments of the pelvic floor.
“There is an increasing appreciation that most patients with pelvic organ prolapse experience dual or even triple compartment pathology, making it important to describe the observations in all three compartments to ensure the mobilization of the appropriate team of experts to treat the patient,” the authors note.
The consensus report features an interpretative template providing synopses of the recommendations, which can be adjusted and modified according to additional radiologic information, as well as individualized patient information or clinician preferences.
However, “the suggested verbiage and steps should be advocated as the minimum requirements when performing and interpreting MRD in patients with evacuation disorders of the pelvic floor,” the authors note.
Dr. Gurland added that, in addition to providing benefits in the present utilization of MRD, the clearer guidelines should help advance its use to improve patient care in the future.
“Standardizing imaging techniques, reporting, and language is critical to improving our understanding and then developing therapies for pelvic floor disorders,” she said.
“In the future, correlating MRD with surgical outcomes and identifying modifiable risk factors will improve patient care.”
In addition to being published in the AJR, the report was published concurrently in the journals Diseases of the Colon & Rectum, International Urogynecology Journal, and Female Pelvic Medicine and Reconstructive Surgery.
The authors of the guidelines have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Doctors preyed on homeless for slip-and-fall schemes; more
a story in the New York Daily News, among other news outlets, indicates.
In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.
These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.
In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.
Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.
According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.
If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.
This isn’t the first time such a scheme has been hatched and carried out in New York City.
In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)
Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”
Sales reps in the OR — helpful or harmful?
Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.
In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.
Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.
In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.
The defendants have each denied any wrongdoing.
The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”
The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.
A trial is scheduled for this November.
But was the Houston incident typical?
Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.
Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.
The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.
Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.
Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.
Device makers have denied these and other allegations. Many of their cases have been settled confidentially.
This high-risk specialty found a way to lower its claim rates
Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.
Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.
The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.
Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)
For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)
“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
a story in the New York Daily News, among other news outlets, indicates.
In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.
These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.
In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.
Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.
According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.
If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.
This isn’t the first time such a scheme has been hatched and carried out in New York City.
In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)
Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”
Sales reps in the OR — helpful or harmful?
Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.
In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.
Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.
In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.
The defendants have each denied any wrongdoing.
The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”
The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.
A trial is scheduled for this November.
But was the Houston incident typical?
Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.
Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.
The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.
Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.
Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.
Device makers have denied these and other allegations. Many of their cases have been settled confidentially.
This high-risk specialty found a way to lower its claim rates
Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.
Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.
The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.
Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)
For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)
“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
a story in the New York Daily News, among other news outlets, indicates.
In the latest iteration of this age-old practice, a team of attorneys and doctors allegedly recruited more than 400 New York City inhabitants, many of whom were homeless or addicted to drugs, over the course of 5 years to participate in their scam.
These people, who were often desperate for money, were coached to claim they’d tripped and fallen over one of the many obstacles pedestrians encounter in the city — sidewalk cracks, potholes, open or protruding cellar doors, and the like. The participant would be cajoled into signing his or her name to a fraudulent suit. Over the years, the scam netted the bosses more than $31 million from city businesses and their insurance companies.
In some cases, to add authenticity to the swindle, the scammers convinced the so-called victims to undergo an operation, promising them up to $1,500 to go under the knife.
Accused by the U.S. Attorney’s Office of masterminding the slip-and-fall operation were two attorneys, George Constantine and Marc Elefant, and a pair of doctors, Andrew Dowd, MD, an orthopedic surgeon, and Sady Ribeiro, MD, a pain management specialist and surgeon.
According to the charges, Mr. Constantine and Mr. Elefant filed lawsuits — either together or separately, though the report isn’t clear — on behalf of hundreds of people who took part in the scheme. Dr. Dowd and Dr. Ribeiro also profited handsomely, according to authorities. Dr. Dowd, they say, earned roughly $9,500 per surgery. Dr. Ribeiro is accused of treating nearly 200 participants during the con and of often paying kickbacks to them to drum up additional referrals.
If convicted on all charges, including mail and wire fraud, each of the defendants could face up to 20 years in prison.
This isn’t the first time such a scheme has been hatched and carried out in New York City.
In May 2020, three men were sentenced to prison for their involvement in a similar slip-and-fall operation that took place between 2013 and 2018. (Their sentencing followed an earlier conviction for conspiracy to commit mail and wire fraud.)
Like the most recent scheme, the one that began in 2013 preyed on the hopeless. “The whole essence of this conspiracy is to find the down-and-out, find the desperate, find the homeless,” the sentencing judge said at the time. “No person who has a job and education and can support his or her family even minimally is going to say, ‘Oh, I’ll undergo unnecessary back surgery for a thousand dollars.’ These people were vulnerable and desperate.”
Sales reps in the OR — helpful or harmful?
Although medical device makers insist that the practice of placing sales reps in operating rooms (ORs) has proven beneficial to surgeons over the years, others claim it has contributed to unwanted outcomes, according to a report published in Kaiser Health News.
In May 2018, for instance, Cristina Martinez underwent what was supposed to be a routine spinal implant procedure. In the course of the operation, her Houston-based spine surgeon discovered that the implant he was about to insert in her back was larger than the one he had intended to use. Under different circumstances, the device maker’s sales representative who was present in the OR that day might have been able to supply the smaller implant. But the rep didn’t have one available, so the surgeon proceeded with the operation using the larger plastic disk.
Four days later, in another procedure, the surgeon removed that disk and replaced it with one that was the correct size. Ms. Martinez has claimed that she awakened from the second procedure in pain, the result of nerve damage that she says led to loss of feeling in her left leg.
In a suit against the doctor, the device maker, and its distributor and sales reps, Ms. Martinez alleges that her injuries were the direct result of their negligence in not having the proper disk available during the initial operation.
The defendants have each denied any wrongdoing.
The accused spine surgeon submitted to the court his operating notes, which reportedly say that he had depended on a company distributor and its sales reps to provide “all lengths available” of the implant. In another filing, he contends that the “small area of leg numbness experienced by Ms. Martinez was a known complication of the first surgery...and was not the result of any alleged negligence.”
The device maker also denies any wrongdoing. In its filings, it claims that sales reps initially ordered a sterile kit that included implants ranging from 50 mm to 55 mm in length. The kit, says the manufacturer, was duly shipped to Houston, but the surgeon replaced the original implant with a 40-mm version during Ms. Martinez’ reoperation.
A trial is scheduled for this November.
But was the Houston incident typical?
Device makers argue that having sales reps in the OR makes sense: Well trained, they offer surgeons vital technical guidance in the use of products that are often complex.
Kaiser Health News says its investigation found otherwise. This practice and others “have been blamed for contributing to serious patient harm in thousands of medical malpractice, product liability, and whistleblower lawsuits filed over the past decade,” it reports.
The list of allegations is long: Some patients say they were injured because sales reps sold or delivered either the wrong-size implant or a defective one. Others say that in their communications with doctors, device makers were shown to have been less than truthful about the safety and durability of their products.
Currently, more than 28,000 suits have been consolidated into six multi-district federal cases. Most involve patients who claim injury after receiving hip implants. Some of the procedures required painful reoperations.
Other court actions cite device makers for other misdeeds, including keeping federal regulators in the dark about potentially dangerous product defects and plying surgeons with millions of dollars in illegal kickbacks.
Device makers have denied these and other allegations. Many of their cases have been settled confidentially.
This high-risk specialty found a way to lower its claim rates
Ob.gyns. who undergo training that simulates team interactions during a high-acuity clinical case face fewer malpractice claims afterward, according to a study published in August in Obstetrics and Gynecology.
Researchers examined the claim rates of 292 ob.gyns. who had undergone one or more such training simulations from 2002 to 2019. To gauge the effect of simulation training on the rate of medical malpractice claims, the researchers compared pretraining rates with posttraining rates. Because participants were insured by the same carrier, the team had access to the relevant claims data as well as the doctors’ durations of coverage.
The investigators assessed claim rates for the period 2002 to 2019 (the full study period), as well as rates for 2-year and 1-year participation.
Researchers found a nonsignificant drop in claim rates for doctors in the 1-year group. The drop was greater for those in the 2-year group; it decreased from 9.2 to 5.4 claims per 100 physician coverage years. (A coverage year is defined as 12 months of indemnity protection.)
For doctors who took part for the entire study period — and were therefore more likely to be among the nearly 20% of doctors who attended three or more training sessions — postsimulation claim rates dropped significantly, from 11.2 to 5.7 per 100 physician coverage years. (Attendance in more than one simulation session correlated with a greater reduction in claim rates.)
“We observed a significant reduction in malpractice claim rates after simulation training,” the researchers concluded. “Wider use of simulation training within obstetrics and gynecology should be considered.”
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
CDC chief overrules panel, OKs boosters for health care workers
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.
The CDC’s Advisory Committee on Immunization Practices earlier Thursday voted to allow several groups of Americans to get a booster shot, but voted not to recommend it for adults age 18 to 64 who live or work in a place where the risk of COVID-19 is high. That would have included health care workers and other frontline employees.
But CDC Director Rochelle Walensky, MD, decided to reverse that recommendation and include the 18-to-64-year-olds in her final decision.
“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” Dr. Walensky said in a statement late Thursday night, according to published reports. “At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good.”
Dr. Walensky agreed with the rest of the advisory committee's decisions, which included recommendations that the following groups also be eligible for a booster shot:
- Adults ages 65 and up and residents of long-term care facilities
- Adults ages 50 to 64 who have an underlying medical condition that may increase their risk from a COVID infection
- Adults ages 18 to 49 who may be at increased risk from a COVID-19 infection because of an underlying medical condition, if a person feels like they need one based on a consideration of their individual benefit and risks.
About 26 million Americans are at least 6 months past the last dose of the Pfizer vaccines, making them eligible to receive a third dose. About 13.6 million of them are over the age of 65. Another 5.3 million are ages 50 to 64.
In making the recommendations, the committee left out healthcare workers. This was a departure from the Food and Drug Administration’s authorization which included boosters for those 65 and over, and for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers – such as those in healthcare -- whose jobs increase their risk for infection.
This is the group Dr. Walensky added to the eligible list on her own.
Committee members “did not buy the need in occupational or institutional settings,” said William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville. Dr. Schaffner sits on the ACIP workgroup that considered the evidence behind boosters. He said that he would have voted yes to offer boosters to healthcare and other essential workers.
“There was a real split in the committee,” he said.
The vote on boosters for healthcare and other high-risk workers was rejected 9 to 6.
“I think that there is ample evidence that people such as healthcare workers do not have repeated exposure in the workplace,” said Beth Bell, MD, a clinical professor at the University of Washington. “They’re using PPE as they should and they’re following the other policies within the healthcare setting. There’s lots of evidence that suggest that health care workers who become infected become infected because of exposures in the community.”
She was not alone in feeling cautious.
“I think this is an extremely slippery slope,” said Sarah Long, MD, a pediatric infectious disease specialist at Drexel University in Philadelphia, before her vote to reject boosters for healthcare and other high-risk workers.
“We might as well just say, ‘Give it to everybody 18 and over.’ We have an extremely effective vaccine. It’s like saying it’s not working, and it is working.”
The committee saw data showing that all of the vaccines remain highly protective against hospitalization and death for all age groups, though protection against getting sick with COVID has waned slightly over time and with the dominance of the more contagious Delta variant. Those at highest risk for a severe breakthrough infection — those that cause hospitalization or death — are older adults.
How much will the U.S. benefit from boosters?
Some felt squeamish about broadly recommending boosters at all.
“We have too much hope on the line with these boosters,” said James Loehr, MD, who is a family physician in Ithaca, N.Y. Dr. Loehr said he felt the goal of giving boosters in the United States should be to decrease hospitalizations, and he felt they would, but that the impact would likely be smaller than appreciated.
Based on his calculations of the benefits of boosters for each age group, Dr. Loehr said if boosters were given to all 13 million seniors previously vaccinated with the Pfizer vaccine, we might prevent 200 hospitalizations a day, “which would be a lot,” he noted. But, he said, “considering that we have 10,000 hospitalizations a day now, it’s probably not that much.”
Others agreed.
“I really think this is a solution looking for a problem,” said Jason Goldman, MD, an associate professor at Florida Atlantic University who was representing the American College of Physicians. “You know, I don’t think it’s going to address the issue of the pandemic. I really think it’s just going to create more confusion on the provider from the position of implementation, and I really think it’s going really far afield of the data.”
ACIP Chair Grace Lee, MD, a pediatric infectious disease specialist at Stanford, said she had cared for children who had died of COVID.
“I can tell you that their family members really wished they had extra protection for their kids, because they weren’t symptomatic. Nobody else was sick at home,” she said.
Dr. Lee said for her, access was paramount, and she was in favor of expanding access to boosters for as many people as possible.
Next steps
People who were initially vaccinated with either Moderna or Johnson & Johnson vaccines are excluded from booster recommendations, something many on the committee were uncomfortable with.
The FDA is still considering Moderna’s application to market booster doses. Johnson & Johnson hasn’t yet applied to the FDA for permission to offer second doses in the United States.
While the ACIP’s recommendations are important, in this case, they may not have a huge practical effect, said Schaffner. The CDC has already approved third shots for people who are immunocompromised, and no proof of a medical condition is required to get one.
More than 2 million people have already gotten a third dose, he noted, and not all of them are immunocompromised.
“They have heard the president say that, you know, everybody should get a booster, and they’ve taken that at face value,” he said.
A version of this article first appeared on WebMD.com.
New COVID-19 strain has reached the U.S.
Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.
On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.
About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.
However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.
“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.
Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.
Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.
Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.
The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”
A version of this article first appeared on WebMD.com.
Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.
On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.
About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.
However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.
“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.
Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.
Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.
Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.
The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”
A version of this article first appeared on WebMD.com.
Deadline, citing a Centers for Disease Control and Prevention report, said 26 residents and 20 workers tested positive for COVID-19 at a skilled care nursing home. The facility has 83 residents and 116 employees.
On March 1, 28 specimens that had been subjected to whole genome sequencing were found to have “mutations aligning with the R.1 lineage,” Deadline said.
About 90% of the facility’s residents and 52% of the staff had received two COVID vaccine doses, the CDC said. Because of the high vaccination rate, the finding raises concerns about “reduced protective immunity” in relation to the R.1 variant, the CDC said.
However, the nursing home case appears to show that the vaccine keeps most people from getting extremely sick, the CDC said. The vaccine was 86.5% protective against symptomatic illness among residents and 87.1% protective for employees.
“Compared with unvaccinated persons, vaccinated persons had reduced risk for SARS-CoV-2 infection and symptomatic COVID-19,” the CDC said. The vaccination of nursing home residents and health care workers “is essential to reduce the risk for symptomatic COVID-19, as is continued focus on infection prevention and control practices,” the CDC said.
Since being reported in Kentucky, R.1 has been detected more than 10,000 times in the United States, Forbes reported, basing that number on entries in the GISAID SARS-CoV-2 database.
Overall, more than 42 million cases of COVID have been reported since the start of the pandemic.
Deadline reported that the R.1 strain was first detected in Japan in January among three members of one family. The family members had no history of traveling abroad, Deadline said, citing an National Institutes of Health report.
The CDC has not classified R.1 as a variant of concern yet but noted it has “several mutations of importance” and “demonstrates evidence of increasing virus transmissibility.”
A version of this article first appeared on WebMD.com.
Your bathroom towel rack has a dirty little secret
Bacteria get the rack ... the towel rack
Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.
Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.
According to research conducted by electric heating company Rointe in the United Kingdom, bathroom radiators and towel racks/bars are the most germy and dirty parts of the bathroom.
Company investigators examined five bathrooms using swabs that changed color on contact with bacteria and found that 60% of towel racks and radiators were “really dirty,” compared with 50% of sink drains and just 10% of toilets.
Most people probably pay more attention to the sink, floors, and toilets while cleaning, the company suggested, and dampness is a factor in bacteria growth, so it’s no surprise that towels that stay wet on a rack are prime spots for dust, mildew, and mold.
The toilet may be busier, but you don’t put your face in it.
Anti-vaxxers would like to be called ‘purebloods’
COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”
Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.
Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.
Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
Hated broccoli? Blame your DNA
Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.
Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.
These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.
The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.
Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.
Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.
Bacteria get the rack ... the towel rack
Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.
Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.
According to research conducted by electric heating company Rointe in the United Kingdom, bathroom radiators and towel racks/bars are the most germy and dirty parts of the bathroom.
Company investigators examined five bathrooms using swabs that changed color on contact with bacteria and found that 60% of towel racks and radiators were “really dirty,” compared with 50% of sink drains and just 10% of toilets.
Most people probably pay more attention to the sink, floors, and toilets while cleaning, the company suggested, and dampness is a factor in bacteria growth, so it’s no surprise that towels that stay wet on a rack are prime spots for dust, mildew, and mold.
The toilet may be busier, but you don’t put your face in it.
Anti-vaxxers would like to be called ‘purebloods’
COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”
Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.
Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.
Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
Hated broccoli? Blame your DNA
Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.
Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.
These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.
The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.
Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.
Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.
Bacteria get the rack ... the towel rack
Obviously, bathrooms have germs. Some people are cleaner about their bathrooms than others, but in general most people just try not to think about the microscopic critters crawling about.
Now you would probably think that the toilet is the dirtiest part of the bathroom because that’s where ... you know, most of the business takes place. Or maybe you’d guess the floor. Truth be told, though, the dirtiest part of the bathroom is where the towels are hung.
According to research conducted by electric heating company Rointe in the United Kingdom, bathroom radiators and towel racks/bars are the most germy and dirty parts of the bathroom.
Company investigators examined five bathrooms using swabs that changed color on contact with bacteria and found that 60% of towel racks and radiators were “really dirty,” compared with 50% of sink drains and just 10% of toilets.
Most people probably pay more attention to the sink, floors, and toilets while cleaning, the company suggested, and dampness is a factor in bacteria growth, so it’s no surprise that towels that stay wet on a rack are prime spots for dust, mildew, and mold.
The toilet may be busier, but you don’t put your face in it.
Anti-vaxxers would like to be called ‘purebloods’
COVID-19 anti-vaxxers are an interesting bunch, to be kind. And TikTok is a wacky place. So you can just imagine that anti-vaxxer TikTok is a very strange place. The citizens of anti-vax TikTok have decided that the real reason so many people dislike them is branding. They consider anti-vaccination to be a negative word (duh), so they now want to be referred to as “purebloods.”
Harry Potter doesn’t quite occupy the zeitgeist as it once did, so let’s give you a reminder: In the books, purebloods came from old wizarding families and claimed not to have any Muggle, or nonmagic, blood. While having pure wizard blood was no guarantee of being a villain, most of them were. In addition, it is made quite clear throughout the novels that having supposedly pure blood had no relevance on one’s wizarding ability. Pureblood was a meaningless title, and only the characters with small, cruel minds concerned themselves over it.
Perhaps the anti-vaxxers have decided that they want to be called the same thing. Maybe they just like the name. It does sound impressive and vaguely regal: Pureblood. Like something the nobles of medieval Europe might have used.
Critical-thinking skills may be in short supply here, or maybe the anti-vaxxers know exactly what they’re doing.
Hated broccoli? Blame your DNA
Were you that kid who would rather sit at the table for hours than eat your broccoli? Well, as much as your parents might have pushed you, new research suggests that it might be their fault you didn’t like it to begin with.
Investigators at Australia’s national science agency, CSIRO, recently reported that distaste for Brassica vegetables – broccoli, Brussels sprouts, cabbage, and cauliflower – can be traced to the oral microbiome.
These vegetables have a compound called S-methyl-L-cysteine sulfoxide that gives off sulfurous odors ... mmm, sulfurous ... when mixed with an enzyme in the plant, and that enzyme is also produced by bacteria in some people’s oral microbiomes. So why do adults tolerate these Brassica veggies more than children? It’s all about levels.
The researchers tested the idea by asking 98 child/parent pairs to rate the odors and by using gas chromatography-olfactometry-mass spectrometry to identify the odor-active compounds in both raw and steamed cauliflower and broccoli. The children whose saliva produced high levels of sulfur volatiles disliked Brassica vegetables the most, they reported, and the children with high levels of sulfur volatiles usually had parents who produced high levels.
Despite that connection, however, the distaste for raw Brassica seen in children wasn’t seen in adults.
Maybe it’s not that taste buds change as we age, maybe we just learn to tolerate the sulfurousness.
FDA OKs Pfizer COVID booster for 65 and over, those at high risk
The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.
The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.
“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.
The recommendations align with those from an FDA advisory panel Sept. 17.
The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
Other questions remain
So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.
The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.
“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”
Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.
Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision.
Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.
Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.
Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other.
He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
Correlates of immunity
The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.
Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.
But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.
Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure.
The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity.
The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.
Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot.
Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away.
The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.
Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.
After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.
Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
Essential workers
Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.
Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.
“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said.
“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.
Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.
“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.
The considerations of who should get an extra dose are not always straightforward.
New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission.
In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.
A version of this article first appeared on Medscape.com.
The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.
The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.
“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.
The recommendations align with those from an FDA advisory panel Sept. 17.
The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
Other questions remain
So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.
The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.
“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”
Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.
Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision.
Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.
Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.
Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other.
He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
Correlates of immunity
The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.
Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.
But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.
Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure.
The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity.
The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.
Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot.
Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away.
The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.
Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.
After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.
Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
Essential workers
Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.
Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.
“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said.
“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.
Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.
“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.
The considerations of who should get an extra dose are not always straightforward.
New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission.
In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.
A version of this article first appeared on Medscape.com.
The agency’s move comes as a Centers for Disease Control and Prevention (CDC) panel ended the first day of a 2-day meeting. That panel, the Advisory Committee on Immunization Practices (ACIP), is expected to vote Sept. 23 to instruct doctors on how to administer the boosters.
The FDA officially authorized the vaccine not only for individuals 65 and older, but also for people 18 through 64 years of age who are at high risk for severe illness from the coronavirus, including essential workers whose jobs increase their risk for infection.
“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as health care workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release.
The recommendations align with those from an FDA advisory panel Sept. 17.
The agency determined that the benefits of a booster dose outweigh the risks for people now authorized to receive it, according to the news release.
Other questions remain
So, how will this work? That was the main question weighing on the minds of the CDC’s ACIP during their first day of a 2-day meeting where they are expected to make recommendations on booster doses for Americans.
The panel discussed situations the FDA will still need to consider, such as what should be done for Americans who were originally vaccinated with a Moderna or Johnson and Johnson vaccine, but are not covered under the revised EUA, which is only for those people who received Pfizer’s two-dose vaccine regimen.
“That’s going to leave half of the people immunized in this age group having received the vaccine and being told that they’re at risk now for waning immunity and hospitalization unable to get a booster dose,” said committee member Sarah S. Long, MD, a professor of pediatrics at Drexel University College of Medicine in Philadelphia. “So that’s a big public health panic that we would like to avoid.”
Johnson and Johnson recently reported that second doses of its vaccine boosted its efficacy to almost 94% against COVID-19. A new study, published ahead of peer review, suggests that the efficacy of the single-dose Johnson and Johnson shot has fallen to about 78% against symptomatic infection during the Delta surge.
Moderna has applied for permission to market third doses of its vaccine in the United States, but the FDA has given no timeline on when it might make a decision.
Doran Fink, MD, PhD, deputy director of the FDA’s Division of Vaccines and Related Products Applications, a representative advising the committee Sept. 22, said the agency was working as rapidly as possible on Moderna’s submission.
Regarding the question of whether it was OK to mix vaccines, rather than match them, Dr. Fink said there are currently not enough data available to inform that decision.
Those answers are coming, though. John Beigel, MD, associate director of clinical research at the National Institute of Allergy and Infectious Diseases, revealed that the federal government has a study underway to see what happens when the vaccines are mixed with each other.
He said that data from the study would be available later this fall, and would certainly help physicians and other healthcare providers know whether it’s effective or safe to use them interchangeably.
Correlates of immunity
The ACIP left much of its schedule open Sept. 23 to discuss extra Pfizer doses and vote on how they should be used.
Pfizer had originally applied to the FDA for an amendment to its FDA approval, which would have given doctors a freer hand to prescribe third doses as they saw fit, in patients as young as 16.
But the FDA’s Vaccines and Related Biological Products Advisory Committee voted Sept. 17 against granting the amendment. The committee was particularly concerned about the lack of data in teens ages 16 and 17, who have the highest risk for a rare side effect that causes heart inflammation that requires hospital care.
Instead, they recommended — and the FDA agreed per their decision Sept. 22 — that third doses should be given to people at higher risk for severe breakthrough infections because of advanced age or because they work in an occupation that puts them at high risk for exposure.
The CDC panel heard important presentations on new science that is helping to identify the correlates of immunity.
The correlates of immunity are biomarkers that can be measured in blood that help doctors understand how protected a person may be against COVID-19. These markers of immunity are not yet known for the COVID-19 vaccines.
Emerging evidence shows that booster doses of the Pfizer vaccine cause front-line immune defenders — called binding antibodies — to roughly triple soon after a person gets the third shot.
Neutralizing antibodies also jump soon after two vaccine doses, but they fall over time, which is natural. The body doesn’t need these foot soldiers to be on guard all the time, so they go away.
The body retains its memory of how to make them, however, so they can quickly be marshaled again, if needed.
Early studies suggest that antibodies account for about two thirds of a person’s protection against COVID, while the longer-lasting T-cells and B-cells account for about one third.
After the antibody levels fall, it may take a few days to recreate this army. In the meantime, the virus can try to break in. This can cause symptoms, which can make a person feel terrible, but for the most part, vaccinated individuals don’t need hospital care and are nearly always protected from dying — even against the Delta variant.
Those most likely to be at risk for a breakthrough infection are older, because immune function wanes with age.
Essential workers
Essential workers, such as those who work in healthcare, may also benefit from high antibody levels, which can minimize symptoms and help them get back to work more quickly.
Helen Talbot, MD, MPH, an associate professor of medicine at Vanderbilt University Medical Center in Nashville, said that in her area staffing levels are critical right now.
“I’m actually sitting in one of the deepest red [states] with high rates of COVID. We don’t have enough health care workers currently to take care of the unvaccinated,” she said.
“When we have beds, we are often missing staff, and so the idea of vaccinating health care workers is to be a little bit different than our idea of using vaccines in the general population,” Dr. Talbot said.
Oliver Brooks, MD, chief medical officer of the Watts Healthcare Corporation in Los Angeles, said he was in favor of making a public statement about the temporary nature of the potential recommendations Sept. 23, because they probably won’t cover all who might need a third shot.
“We may want to go on record stating what it is that would allow us to broaden our recommendation or restrict our recommendation,” Dr. Brooks said.
The considerations of who should get an extra dose are not always straightforward.
New modeling by the Harvard TH Chan School of Public Health and the CDC to assist the government’s decisions on boosters had a surprise finding: in nursing homes, it’s more effective to vaccinate healthcare workers than it is to give booster doses to these residents. Nursing homes are at the mercy of community transmission.
In regions with high transmission, it’s easy for a caregiver to bring the virus into a facility — so the models found that the transmission from these workers is a more effective strategy than giving third doses to the already highly vaccinated group of seniors who live in them.
A version of this article first appeared on Medscape.com.
FDA approves Abbott’s Portico valve for TAVR
The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.
The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.
With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.
The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.
With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with “symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery,” the company has announced.
The approval indication is in line with the entry criteria of PORTICO IDE, the investigational device exemption trial from which the FDA largely made its decision.
With the self-expanding Portico valve, Abbott joins two other companies with TAVR valves on the U.S. market: Medtronic with the self-expanding Corevalve Evolut (Medtronic) line, and Edwards Lifesciences with its Sapien (Edwards Lifesciences) valves, both of which can be used in patients at low surgical risk.
A version of this article first appeared on Medscape.com.
Call for a move or boycott of big Texas cancer meeting
Docs won’t attend in person
Held annually in December, SABCS is the world’s largest breast cancer meeting and welcomes thousands of attendees every year.
The law banning abortions after 6 weeks, at which time a woman may not even realize that she is pregnant, has been described as the most restrictive in the United States. It also enables private citizens to bring civil lawsuits against people who assist a pregnant person seeking an abortion in violation of the ban.
If the meeting remains in Texas this year, then UCSF’s Laura Esserman, MD, director of the Carol Franc Buck Breast Cancer Center, has said that she and other university faculty and professionals from elsewhere will attend only online — a form of boycotting the in-person event.
Dr. Esserman and UCSF colleague Mary Helen Barcellos-Hoff, PhD, professor of radiation oncology, have emailed conference leaders encouraging them to move the meeting, according to a press statement issued by UCSF.
SABCS organizers told this news organization via email that they “are having serious discussions about this matter” and will update the public via their website and social media channels.
“It’s a terrible law, and it is absolutely not protective of women. I think that if Texas officials understood that when they pass laws inhospitable to women, we will not hold a major conference about women’s health in their state,” said Dr. Esserman.
Dr. Esserman received support for the idea to move the meeting earlier this month from peers on Twitter.
“In light of the Texas law that prohibits abortion past 6 weeks of pregnancy AND promotes vigilantism, directly harming women and their caregivers, the 2021 SABCS breast cancer meeting should be moved out of Texas to a place that supports Women’s rights and public health #sabcs,” tweeted Dr. Esserman on September 5.
The post generated more than 3,300 likes and retweets and 40-plus comments from readers, many of whom were healthcare professionals.
Supporters of the proposed move included Michael Feldman, MD, PhD, pathologist, University of Pennsylvania in Philadelphia; Sarah Sammons, MD, breast medical oncologist, Duke Cancer Center, Durham, N.C.; Anjali Thawani, MD, breast surgeon, Evanston, Ill.; Debora Barton, MD, Carisma Therapeutics, Philadelphia; Jane Hui, MD, surgical oncologist, University of Minnesota, Minneapolis; Erica Leith Mitchell, MD, surgeon, University of Tennessee, Memphis; and Rebecca Shatsky, MD, breast medical oncologist, University of California, San Diego.
Support for boycotting in-person attendance is growing nationally, Dr. Esserman said in the press statement, which also highlighted an “additional concern” about Texas laws prohibiting mandated masking and asking for vaccine status. Conference organizers said local ordinances will be used to require masking.
Notably, a Twitter search using #SABCS21, the meeting’s hashtag, indicates that COVID 19 — and not the restrictive abortion law — is the primary worry of would-be meeting attendees as of the last week or so.
Some said the combination of the two issues was influential in their decision not to attend in person.
Kelly Shanahan, MD, a former ob/gyn living with metastatic breast cancer in South Lake Tahoe, Calif., tweeted: “It’s a hybrid model this year. I was originally going in person but will not now because of their COVID behaviors and now this [the abortion law]. I will tune in virtually but I will not spend the $1500 on the hotel room, the hundreds of $$ on food and drink and Xmas presents. #SayNoToTX #SABCS21.”
Dr. Shanahan also replied to Dr. Esserman’s move-the-meeting-out-of-Texas tweet: “100% agree.”
UCSF’s Dr. Barcellos-Hoff believes moving the meeting would be a high-profile happening. “I think moving a meeting of that size would have an impact, largely because of the visibility of scientists who oppose the law.”
First organized in 1977, SABCS is jointly sponsored by the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine.
A version of this article first appeared on Medscape.com.
Docs won’t attend in person
Docs won’t attend in person
Held annually in December, SABCS is the world’s largest breast cancer meeting and welcomes thousands of attendees every year.
The law banning abortions after 6 weeks, at which time a woman may not even realize that she is pregnant, has been described as the most restrictive in the United States. It also enables private citizens to bring civil lawsuits against people who assist a pregnant person seeking an abortion in violation of the ban.
If the meeting remains in Texas this year, then UCSF’s Laura Esserman, MD, director of the Carol Franc Buck Breast Cancer Center, has said that she and other university faculty and professionals from elsewhere will attend only online — a form of boycotting the in-person event.
Dr. Esserman and UCSF colleague Mary Helen Barcellos-Hoff, PhD, professor of radiation oncology, have emailed conference leaders encouraging them to move the meeting, according to a press statement issued by UCSF.
SABCS organizers told this news organization via email that they “are having serious discussions about this matter” and will update the public via their website and social media channels.
“It’s a terrible law, and it is absolutely not protective of women. I think that if Texas officials understood that when they pass laws inhospitable to women, we will not hold a major conference about women’s health in their state,” said Dr. Esserman.
Dr. Esserman received support for the idea to move the meeting earlier this month from peers on Twitter.
“In light of the Texas law that prohibits abortion past 6 weeks of pregnancy AND promotes vigilantism, directly harming women and their caregivers, the 2021 SABCS breast cancer meeting should be moved out of Texas to a place that supports Women’s rights and public health #sabcs,” tweeted Dr. Esserman on September 5.
The post generated more than 3,300 likes and retweets and 40-plus comments from readers, many of whom were healthcare professionals.
Supporters of the proposed move included Michael Feldman, MD, PhD, pathologist, University of Pennsylvania in Philadelphia; Sarah Sammons, MD, breast medical oncologist, Duke Cancer Center, Durham, N.C.; Anjali Thawani, MD, breast surgeon, Evanston, Ill.; Debora Barton, MD, Carisma Therapeutics, Philadelphia; Jane Hui, MD, surgical oncologist, University of Minnesota, Minneapolis; Erica Leith Mitchell, MD, surgeon, University of Tennessee, Memphis; and Rebecca Shatsky, MD, breast medical oncologist, University of California, San Diego.
Support for boycotting in-person attendance is growing nationally, Dr. Esserman said in the press statement, which also highlighted an “additional concern” about Texas laws prohibiting mandated masking and asking for vaccine status. Conference organizers said local ordinances will be used to require masking.
Notably, a Twitter search using #SABCS21, the meeting’s hashtag, indicates that COVID 19 — and not the restrictive abortion law — is the primary worry of would-be meeting attendees as of the last week or so.
Some said the combination of the two issues was influential in their decision not to attend in person.
Kelly Shanahan, MD, a former ob/gyn living with metastatic breast cancer in South Lake Tahoe, Calif., tweeted: “It’s a hybrid model this year. I was originally going in person but will not now because of their COVID behaviors and now this [the abortion law]. I will tune in virtually but I will not spend the $1500 on the hotel room, the hundreds of $$ on food and drink and Xmas presents. #SayNoToTX #SABCS21.”
Dr. Shanahan also replied to Dr. Esserman’s move-the-meeting-out-of-Texas tweet: “100% agree.”
UCSF’s Dr. Barcellos-Hoff believes moving the meeting would be a high-profile happening. “I think moving a meeting of that size would have an impact, largely because of the visibility of scientists who oppose the law.”
First organized in 1977, SABCS is jointly sponsored by the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine.
A version of this article first appeared on Medscape.com.
Held annually in December, SABCS is the world’s largest breast cancer meeting and welcomes thousands of attendees every year.
The law banning abortions after 6 weeks, at which time a woman may not even realize that she is pregnant, has been described as the most restrictive in the United States. It also enables private citizens to bring civil lawsuits against people who assist a pregnant person seeking an abortion in violation of the ban.
If the meeting remains in Texas this year, then UCSF’s Laura Esserman, MD, director of the Carol Franc Buck Breast Cancer Center, has said that she and other university faculty and professionals from elsewhere will attend only online — a form of boycotting the in-person event.
Dr. Esserman and UCSF colleague Mary Helen Barcellos-Hoff, PhD, professor of radiation oncology, have emailed conference leaders encouraging them to move the meeting, according to a press statement issued by UCSF.
SABCS organizers told this news organization via email that they “are having serious discussions about this matter” and will update the public via their website and social media channels.
“It’s a terrible law, and it is absolutely not protective of women. I think that if Texas officials understood that when they pass laws inhospitable to women, we will not hold a major conference about women’s health in their state,” said Dr. Esserman.
Dr. Esserman received support for the idea to move the meeting earlier this month from peers on Twitter.
“In light of the Texas law that prohibits abortion past 6 weeks of pregnancy AND promotes vigilantism, directly harming women and their caregivers, the 2021 SABCS breast cancer meeting should be moved out of Texas to a place that supports Women’s rights and public health #sabcs,” tweeted Dr. Esserman on September 5.
The post generated more than 3,300 likes and retweets and 40-plus comments from readers, many of whom were healthcare professionals.
Supporters of the proposed move included Michael Feldman, MD, PhD, pathologist, University of Pennsylvania in Philadelphia; Sarah Sammons, MD, breast medical oncologist, Duke Cancer Center, Durham, N.C.; Anjali Thawani, MD, breast surgeon, Evanston, Ill.; Debora Barton, MD, Carisma Therapeutics, Philadelphia; Jane Hui, MD, surgical oncologist, University of Minnesota, Minneapolis; Erica Leith Mitchell, MD, surgeon, University of Tennessee, Memphis; and Rebecca Shatsky, MD, breast medical oncologist, University of California, San Diego.
Support for boycotting in-person attendance is growing nationally, Dr. Esserman said in the press statement, which also highlighted an “additional concern” about Texas laws prohibiting mandated masking and asking for vaccine status. Conference organizers said local ordinances will be used to require masking.
Notably, a Twitter search using #SABCS21, the meeting’s hashtag, indicates that COVID 19 — and not the restrictive abortion law — is the primary worry of would-be meeting attendees as of the last week or so.
Some said the combination of the two issues was influential in their decision not to attend in person.
Kelly Shanahan, MD, a former ob/gyn living with metastatic breast cancer in South Lake Tahoe, Calif., tweeted: “It’s a hybrid model this year. I was originally going in person but will not now because of their COVID behaviors and now this [the abortion law]. I will tune in virtually but I will not spend the $1500 on the hotel room, the hundreds of $$ on food and drink and Xmas presents. #SayNoToTX #SABCS21.”
Dr. Shanahan also replied to Dr. Esserman’s move-the-meeting-out-of-Texas tweet: “100% agree.”
UCSF’s Dr. Barcellos-Hoff believes moving the meeting would be a high-profile happening. “I think moving a meeting of that size would have an impact, largely because of the visibility of scientists who oppose the law.”
First organized in 1977, SABCS is jointly sponsored by the Cancer Therapy & Research Center at The University of Texas Health Science Center at San Antonio, the American Association for Cancer Research, and Baylor College of Medicine.
A version of this article first appeared on Medscape.com.
COVID-19 claims more than 675,000 U.S. lives, surpassing the 1918 flu
to data collected by Johns Hopkins University.
, accordingAlthough the raw numbers match, epidemiologists point out that 675,000 deaths in 1918 was a much greater proportion of the population. In 1918, the U.S. population was 105 million, less than one third of what it is today.
The AIDS pandemic of the 1980s remains the deadliest of the 20th Century, claiming the lives of 700,000 Americans. But at our current pace of 2,000 COVID deaths a day, we could quickly eclipse that death toll, too.
Even though the 1918 epidemic is often called the “Spanish Flu,” there is no universal consensus regarding where the virus originated, according to the Centers for Disease Control and Prevention.
Still, the almost incomprehensible loss harkens back to a time when medicine and technology were far less advanced than they are today.
In 1918, the United States didn’t have access to a vaccine, or near real-time tools to trace the spread and communicate the threat.
In some ways, the United States has failed to learn from the mistakes of the past.
There are many similarities between the two pandemics. In the spring of 1918, when the first wave of influenza hit, the United States and its allies were nearing victory in Europe in World War I. Just this summer the United States has ended its longest war, the conflict in Afghanistan, as COVID cases surge.
In both pandemics, hospitals and funeral homes were overrun and makeshift clinics were opened where space was available. Mask mandates were installed; schools, churches, and theaters closed; and social distancing was encouraged.
As is the case today, different jurisdictions took different steps to fight the pandemic and some were more successful than others.
According to History.com, in 1918, Philadelphia’s mayor said a popular annual parade could be held, and an estimated 200,000 people attended. In less than 2 weeks, more than 1,000 local residents were dead. But in St. Louis, public gatherings were banned, schools and theaters closed, and the death toll there was one eighth of Philadelphia’s.
Just as in 1918, America has at times continued to fan the flames of the epidemic by relaxing restrictions too quickly and relying on unproven treatments. Poor communication allowed younger people to feel that they wouldn’t necessarily face the worst consequences of the virus, contributing to a false sense of security in the age group that was fueling the spread.
“A lot of the mistakes that we definitely fell into in 1918, we hoped we wouldn’t fall into in 2020,” epidemiologist Stephen Kissler, PhD, of the Harvard T.H. Chan School of Public Health, told CNN. “We did.”
A version of this article first appeared on Medscape.com.
to data collected by Johns Hopkins University.
, accordingAlthough the raw numbers match, epidemiologists point out that 675,000 deaths in 1918 was a much greater proportion of the population. In 1918, the U.S. population was 105 million, less than one third of what it is today.
The AIDS pandemic of the 1980s remains the deadliest of the 20th Century, claiming the lives of 700,000 Americans. But at our current pace of 2,000 COVID deaths a day, we could quickly eclipse that death toll, too.
Even though the 1918 epidemic is often called the “Spanish Flu,” there is no universal consensus regarding where the virus originated, according to the Centers for Disease Control and Prevention.
Still, the almost incomprehensible loss harkens back to a time when medicine and technology were far less advanced than they are today.
In 1918, the United States didn’t have access to a vaccine, or near real-time tools to trace the spread and communicate the threat.
In some ways, the United States has failed to learn from the mistakes of the past.
There are many similarities between the two pandemics. In the spring of 1918, when the first wave of influenza hit, the United States and its allies were nearing victory in Europe in World War I. Just this summer the United States has ended its longest war, the conflict in Afghanistan, as COVID cases surge.
In both pandemics, hospitals and funeral homes were overrun and makeshift clinics were opened where space was available. Mask mandates were installed; schools, churches, and theaters closed; and social distancing was encouraged.
As is the case today, different jurisdictions took different steps to fight the pandemic and some were more successful than others.
According to History.com, in 1918, Philadelphia’s mayor said a popular annual parade could be held, and an estimated 200,000 people attended. In less than 2 weeks, more than 1,000 local residents were dead. But in St. Louis, public gatherings were banned, schools and theaters closed, and the death toll there was one eighth of Philadelphia’s.
Just as in 1918, America has at times continued to fan the flames of the epidemic by relaxing restrictions too quickly and relying on unproven treatments. Poor communication allowed younger people to feel that they wouldn’t necessarily face the worst consequences of the virus, contributing to a false sense of security in the age group that was fueling the spread.
“A lot of the mistakes that we definitely fell into in 1918, we hoped we wouldn’t fall into in 2020,” epidemiologist Stephen Kissler, PhD, of the Harvard T.H. Chan School of Public Health, told CNN. “We did.”
A version of this article first appeared on Medscape.com.
to data collected by Johns Hopkins University.
, accordingAlthough the raw numbers match, epidemiologists point out that 675,000 deaths in 1918 was a much greater proportion of the population. In 1918, the U.S. population was 105 million, less than one third of what it is today.
The AIDS pandemic of the 1980s remains the deadliest of the 20th Century, claiming the lives of 700,000 Americans. But at our current pace of 2,000 COVID deaths a day, we could quickly eclipse that death toll, too.
Even though the 1918 epidemic is often called the “Spanish Flu,” there is no universal consensus regarding where the virus originated, according to the Centers for Disease Control and Prevention.
Still, the almost incomprehensible loss harkens back to a time when medicine and technology were far less advanced than they are today.
In 1918, the United States didn’t have access to a vaccine, or near real-time tools to trace the spread and communicate the threat.
In some ways, the United States has failed to learn from the mistakes of the past.
There are many similarities between the two pandemics. In the spring of 1918, when the first wave of influenza hit, the United States and its allies were nearing victory in Europe in World War I. Just this summer the United States has ended its longest war, the conflict in Afghanistan, as COVID cases surge.
In both pandemics, hospitals and funeral homes were overrun and makeshift clinics were opened where space was available. Mask mandates were installed; schools, churches, and theaters closed; and social distancing was encouraged.
As is the case today, different jurisdictions took different steps to fight the pandemic and some were more successful than others.
According to History.com, in 1918, Philadelphia’s mayor said a popular annual parade could be held, and an estimated 200,000 people attended. In less than 2 weeks, more than 1,000 local residents were dead. But in St. Louis, public gatherings were banned, schools and theaters closed, and the death toll there was one eighth of Philadelphia’s.
Just as in 1918, America has at times continued to fan the flames of the epidemic by relaxing restrictions too quickly and relying on unproven treatments. Poor communication allowed younger people to feel that they wouldn’t necessarily face the worst consequences of the virus, contributing to a false sense of security in the age group that was fueling the spread.
“A lot of the mistakes that we definitely fell into in 1918, we hoped we wouldn’t fall into in 2020,” epidemiologist Stephen Kissler, PhD, of the Harvard T.H. Chan School of Public Health, told CNN. “We did.”
A version of this article first appeared on Medscape.com.
Moderna vaccine more effective than Pfizer and J&J
the Centers for Disease Control and Protection has said.
“Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–Aug. 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%),” the agency’s Morbidity and Mortality Weekly Report said. Janssen refers to the Johnson & Johnson vaccine.
The CDC said the data could help people make informed decisions.
“Understanding differences in VE [vaccine effectiveness] by vaccine product can guide individual choices and policy recommendations regarding vaccine boosters. All Food and Drug Administration–approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization,” the report said.
The study also broke down effectiveness for longer periods. Moderna came out on top again.
After 120 days, the Moderna vaccine provided 92% effectiveness against hospitalization, whereas the Pfizer vaccine’s effectiveness dropped to 77%, the CDC said. There was no similar calculation for the Johnson & Johnson vaccine.
The CDC studied 3,689 adults at 21 hospitals in 18 states who got the two-shot Pfizer or Moderna vaccine or the one-shot Johnson & Johnson vaccine between March and August.
The agency noted some factors that could have come into play.
“Differences in vaccine effectiveness between the Moderna and Pfizer-BioNTech vaccine might be due to higher mRNA content in the Moderna vaccine, differences in timing between doses (3 weeks for Pfizer-BioNTech vs. 4 weeks for Moderna), or possible differences between groups that received each vaccine that were not accounted for in the analysis,” the report said.
The CDC noted limitations in the findings. Children, immunocompromised adults, and vaccine effectiveness against COVID-19 that did not result in hospitalization were not studied.
Other studies have shown all three U.S. vaccines provide a high rate of protection against coronavirus.
A version of this article first appeared on WebMD.com.
the Centers for Disease Control and Protection has said.
“Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–Aug. 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%),” the agency’s Morbidity and Mortality Weekly Report said. Janssen refers to the Johnson & Johnson vaccine.
The CDC said the data could help people make informed decisions.
“Understanding differences in VE [vaccine effectiveness] by vaccine product can guide individual choices and policy recommendations regarding vaccine boosters. All Food and Drug Administration–approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization,” the report said.
The study also broke down effectiveness for longer periods. Moderna came out on top again.
After 120 days, the Moderna vaccine provided 92% effectiveness against hospitalization, whereas the Pfizer vaccine’s effectiveness dropped to 77%, the CDC said. There was no similar calculation for the Johnson & Johnson vaccine.
The CDC studied 3,689 adults at 21 hospitals in 18 states who got the two-shot Pfizer or Moderna vaccine or the one-shot Johnson & Johnson vaccine between March and August.
The agency noted some factors that could have come into play.
“Differences in vaccine effectiveness between the Moderna and Pfizer-BioNTech vaccine might be due to higher mRNA content in the Moderna vaccine, differences in timing between doses (3 weeks for Pfizer-BioNTech vs. 4 weeks for Moderna), or possible differences between groups that received each vaccine that were not accounted for in the analysis,” the report said.
The CDC noted limitations in the findings. Children, immunocompromised adults, and vaccine effectiveness against COVID-19 that did not result in hospitalization were not studied.
Other studies have shown all three U.S. vaccines provide a high rate of protection against coronavirus.
A version of this article first appeared on WebMD.com.
the Centers for Disease Control and Protection has said.
“Among U.S. adults without immunocompromising conditions, vaccine effectiveness against COVID-19 hospitalization during March 11–Aug. 15, 2021, was higher for the Moderna vaccine (93%) than the Pfizer-BioNTech vaccine (88%) and the Janssen vaccine (71%),” the agency’s Morbidity and Mortality Weekly Report said. Janssen refers to the Johnson & Johnson vaccine.
The CDC said the data could help people make informed decisions.
“Understanding differences in VE [vaccine effectiveness] by vaccine product can guide individual choices and policy recommendations regarding vaccine boosters. All Food and Drug Administration–approved or authorized COVID-19 vaccines provide substantial protection against COVID-19 hospitalization,” the report said.
The study also broke down effectiveness for longer periods. Moderna came out on top again.
After 120 days, the Moderna vaccine provided 92% effectiveness against hospitalization, whereas the Pfizer vaccine’s effectiveness dropped to 77%, the CDC said. There was no similar calculation for the Johnson & Johnson vaccine.
The CDC studied 3,689 adults at 21 hospitals in 18 states who got the two-shot Pfizer or Moderna vaccine or the one-shot Johnson & Johnson vaccine between March and August.
The agency noted some factors that could have come into play.
“Differences in vaccine effectiveness between the Moderna and Pfizer-BioNTech vaccine might be due to higher mRNA content in the Moderna vaccine, differences in timing between doses (3 weeks for Pfizer-BioNTech vs. 4 weeks for Moderna), or possible differences between groups that received each vaccine that were not accounted for in the analysis,” the report said.
The CDC noted limitations in the findings. Children, immunocompromised adults, and vaccine effectiveness against COVID-19 that did not result in hospitalization were not studied.
Other studies have shown all three U.S. vaccines provide a high rate of protection against coronavirus.
A version of this article first appeared on WebMD.com.