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Possible bivalent vaccine link to strokes in people over 65
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
who got the shot, the Centers for Disease Control and Prevention and the Food and Drug Administration said in a joint news release.
The release did not recommend people change their vaccine practices, saying the database finding probably did not represent a “true clinical risk.” The CDC said everybody, including people over 65, should stay up to date on their COVID vaccines, including the bivalent booster.
The news release said the Vaccine Safety Datalink (VSD), “a near real-time surveillance system,” raised a safety concern about the Pfizer/BioNTech booster.
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the news release said.
Ischemic strokes are blockages of blood to the brain, often caused by blood clots.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD (Vaccine Safety Datalink) represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal,” the release said.
No higher likelihood of strokes linked to the Pfizer bivalent vaccine had been found by Pfizer/BioNTech, the Department of Veterans Affairs, the Vaccine Adverse Event Reporting System maintained by the CDC and the FDA, or other agencies that monitor reactions of vaccines, the news release said. No safety issues about strokes have been identified with the Moderna bivalent vaccine.
CNN, citing a CDC official, reported that about 550,000 seniors who got Pfizer bivalent boosters were tracked by the VSD, and 130 of them had strokes within 3 weeks of getting the shot. None of those 130 people died, CNN said. The official spoke on the condition of anonymity because they weren’t authorized to share the data.
The issue will be discussed at the January meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.
In a joint statement, Pfizer and BioNTech said: “Neither Pfizer and BioNTech nor the CDC or FDA have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines.”
Bivalent boosters contain two strains of vaccine – one to protect against the original COVID-19 virus and another targeting Omicron subvariants.
A version of this article first appeared on WebMD.com.
CDC frets over further dip in kindergarten vaccination rates
The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.
Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.
Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.
The rate fell to 94% the following year.
For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.
The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.
“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
Exemptions steady
For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.
The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.
In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.
Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.
In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.
Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.
“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.
To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
Hundreds of thousands unprotected
MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.
Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.
The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.
Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.
A version of this article first appeared on Medscape.com.
The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.
Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.
Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.
The rate fell to 94% the following year.
For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.
The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.
“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
Exemptions steady
For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.
The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.
In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.
Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.
In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.
Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.
“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.
To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
Hundreds of thousands unprotected
MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.
Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.
The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.
Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.
A version of this article first appeared on Medscape.com.
The percentage of kindergarteners in the United States who have received routine vaccines to protect against illnesses such as measles, whooping cough, and polio has declined for 2 straight years, a new study has found.
Drops in vaccine coverage leave communities more susceptible to outbreaks of vaccine-preventable diseases, such as those that occurred in 2022, public health officials said.
Coverage for four vaccines – against measles, mumps, and rubella (MMR); diphtheria, tetanus, and acellular pertussis (DTaP); poliovirus; and varicella – among kindergarten students was about 95% in 2019-2020.
The rate fell to 94% the following year.
For the 2021-2022 school year, coverage dropped another point, to 93%, according to the report, published online in Morbidity and Mortality Weekly Report.
The rate of vaccination overall remains high, but about 250,000 kindergarten students may not be protected against measles, the researchers estimate. Measles, which is highly infectious, can lead to serious illness and even death in children who have not been vaccinated against the virus.
“In 2022, two communities in the United States responded to outbreaks of measles where children have been hospitalized,” Georgina Peacock, MD, MPH, director of the immunization services division of the Centers for Disease Control and Prevention, said in a media briefing about the report. “One community reported a case of paralytic polio in an unvaccinated person. These outbreaks were preventable. The best way to prevent these diseases and their devastating impact on children is through vaccination.”
Exemptions steady
For the new study, Ranee Seither, MPH, with the CDC’s National Center for Immunization and Respiratory Diseases and her colleagues analyzed data reported by states to estimate nationwide coverage for the four routine vaccines.
The number of students with exemptions remained low, at 2.6%, but another 3.9% who were without exemptions were not up to date with the MMR vaccine, the investigators report.
In a separate study, researchers found that vaccination coverage for 2-year-olds has increased. Approximately 70% of children were up to date with a seven-vaccine series by age 24 months. The coverage rate was higher for children born during 2018-2019 than for those born during 2016-2017.
Although the COVID-19 pandemic was not associated with decreased vaccination rates in this younger age group overall, coverage fell by 4-5 percentage points for children living below the poverty level or in rural areas, according to the study.
In addition, uninsured children were eight times more likely than those with private insurance to not be vaccinated by their second birthday, the researchers found.
Strategies to increase vaccination coverage include enforcing school vaccination requirements and holding vaccination clinics at schools, the CDC said.
“Providers should review children’s histories and recommend needed vaccinations during every clinical encounter and address parental hesitancy to help reduce disparities and ensure that all children are protected from vaccine-preventable diseases,” the agency said.
To that end, the agency launched an initiative this week called Let’s RISE (Routine Immunizations on Schedule for Everyone) to provide clinicians with resources to help patients get on track with their immunizations.
Hundreds of thousands unprotected
MMR vaccination coverage for kindergartners is the lowest it has been in over a decade, Dr. Peacock noted. Decreased coverage for kindergarten students might be tied to pandemic-related disruptions in health care systems and schools, she said. School administrators and parents may have been less focused on routine vaccination paperwork amid the return to in-person learning, for instance.
Hesitancy about COVID vaccines could be affecting routine vaccinations. “That’s something that we are watching very closely,” Dr. Peacock said.
The 2-point decrease in vaccination coverage “translates to hundreds of thousands of children starting school without being fully protected” against preventable diseases that can spread easily in classrooms, Sean O’Leary, MD, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said.
Despite the drop in coverage, Dr. O’Leary said he saw some encouraging signs in the data: Nonmedical exemptions for kindergarten students have not increased. And the vast majority of parents are still having their children vaccinated. At the same time, the reports highlight a need to address child poverty and improve vaccine access in rural areas, he said.
A version of this article first appeared on Medscape.com.
FROM THE MMWR
Children and COVID: ED visits and hospitalizations start to fall again
Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.
. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.
The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.
The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.
The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.
The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.
Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.
. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.
The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.
The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.
The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.
The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.
Emergency department visits and hospitalizations for COVID-19 in children appear to be following the declining trend set by weekly cases since early December, based on data from the Centers for Disease Control and Prevention.
. New cases took a different path that had the weekly total falling through November before taking a big jump during the week of Nov. 27 to Dec. 3 – the count doubled from 30,000 the previous week to 63,000 – and then decreased again, the CDC reported.
The proportion of ED visits with COVID, which was down to 1.0% of all ED visits (7-day average) for children aged 0-4 years on Nov. 4, was up to 3.2% on Jan. 3 but slipped to 2.5% as of Jan. 10. The patterns for older children are similar, with some differences in timing and lower peaks (1.7% for 12- to 15-year-olds and 1.9% for those aged 16-17), according to the CDC’s COVID Data Tracker.
The trend for new hospital admissions of children with confirmed COVID showed a similar rise through December, and the latest data for the very beginning of January suggest an even faster drop, although there is more of a reporting lag with hospitalization data, compared with ED visits, the CDC noted.
The most current data (Dec. 30 to Jan. 5) available from the American Academy of Pediatrics and the Children’s Hospital Association show less volatility in the number of weekly cases through November and December, with the peak being about 48,000 in mid-December. The AAP/CHA totals for the last 2 weeks, however, were both higher than the CDC’s corresponding counts, which are more preliminary and subject to revision.
The CDC puts the total number of COVID cases in children at 16.7 million – about 17.2% of all cases – as of Jan. 11, with 1,981 deaths reported so far. The AAP and CHA are not tracking deaths, but their case total as of Jan. 5 was 15.2 million, which represents 18.1% of cases in all ages. The AAP/CHA report is based on data reported publicly by an ever-decreasing number of states and territories.
Manicure gone wrong leads to cancer diagnosis
. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.
“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.
Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.
She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it.
Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.
Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.
“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”
Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.
“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”
. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.
“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.
Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.
She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it.
Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.
Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.
“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”
Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.
“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”
. Now, she and her doctor are spreading the word about her ordeal as a lesson that speed and persistence in seeking treatment are the keys that make her type of cancer – squamous cell carcinoma – completely curable.
“She cut me, and the cut wasn’t just a regular cuticle cut. She cut me deep, and that was one of the first times that happened to me,” Grace Garcia, 50, told TODAY.com, recalling the November 2021 incident.
Ms. Garcia had been getting her nails done regularly for 20 years, she said, but happened to go to a different salon than her usual spot because she couldn’t get an appointment during the busy pre-Thanksgiving season. She doesn’t recall whether the technician opened packaging that signals unused tools.
She put antibiotic ointment on the cut, but it didn’t heal after a few days. Eventually, the skin closed and a darkened bump formed. It was painful. She went to her doctor, who said it was a “callus from writing,” she told TODAY.com. But it was on her ring finger, which didn’t seem connected to writing. Her doctor said to keep an eye on it.
Five months after the cut occurred, she mentioned it during a gynecology appointment and was referred to a dermatologist, who also advised keeping an eye on it. A wart developed. She went back to her primary care physician and then to another dermatologist. The spot was biopsied.
Squamous cell carcinoma is a common type of skin cancer, according to the American Academy of Dermatology. It can have many causes, but the cause in Ms. Garcia’s case was both very common and very rare: human papillomavirus, or HPV. HPV is a virus that infects millions of people every year, but it’s not a typical cause of skin cancer.
“It’s pretty rare for several reasons. Generally speaking, the strains that cause cancer from an HPV standpoint tend to be more sexually transmitted,” dermatologist Teo Soleymani told TODAY.com. “In Grace’s case, she had an injury, which became the portal of entry. So that thick skin that we have on our hands and feet that acts as a natural barrier against infections and things like that was no longer the case, and the virus was able to infect her skin.”
Dr. Soleymani said Ms. Garcia’s persistence to get answers likely saved her from losing a finger.
“Your outcomes are entirely dictated by how early you catch them, and very often they’re completely curable,” he said. “Her persistence – not only was she able to have a great outcome, she probably saved herself from having her finger amputated.”
Add this to the list of long COVID symptoms: Stigma
Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.
The U.K. team found that more than three-quarters of people studied had experienced stigma often or always.
In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.
Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.
“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”
Even some doctors argue that the growing attention paid to long COVID is excessive.
“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.
Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.
“Putting that spin on things, it’s just hurting people,” she says.
One example is people who cannot return to work.
“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”
Some experts say the U.K. study represents a landmark.
“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.
She recalls her first patient with long COVID.
“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.
Another one of her patients is working at her job from home but facing doubt about her condition from her employers.
“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.
Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.
Half of them said they had a clinical diagnosis of long COVID.
More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.
That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.
“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.
Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.
He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”
The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:
- Enacted stigma: People were directly treated unfairly because of their condition.
- Internalized stigma: People felt embarrassed by that condition.
- Anticipated stigma: People expected they would be treated poorly because of their diagnosis.
Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.
“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.
Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.
Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.
Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.
The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.
“Stigma within medicine or health care is nothing new,” she says.
In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”
Dr. Pantelic says she and her colleagues are continuing their research.
“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.
A version of this article first appeared on WebMD.com.
Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.
The U.K. team found that more than three-quarters of people studied had experienced stigma often or always.
In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.
Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.
“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”
Even some doctors argue that the growing attention paid to long COVID is excessive.
“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.
Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.
“Putting that spin on things, it’s just hurting people,” she says.
One example is people who cannot return to work.
“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”
Some experts say the U.K. study represents a landmark.
“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.
She recalls her first patient with long COVID.
“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.
Another one of her patients is working at her job from home but facing doubt about her condition from her employers.
“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.
Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.
Half of them said they had a clinical diagnosis of long COVID.
More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.
That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.
“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.
Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.
He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”
The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:
- Enacted stigma: People were directly treated unfairly because of their condition.
- Internalized stigma: People felt embarrassed by that condition.
- Anticipated stigma: People expected they would be treated poorly because of their diagnosis.
Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.
“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.
Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.
Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.
Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.
The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.
“Stigma within medicine or health care is nothing new,” she says.
In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”
Dr. Pantelic says she and her colleagues are continuing their research.
“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.
A version of this article first appeared on WebMD.com.
Most people with long COVID find they’re facing stigma due to their condition, according to a new report from researchers in the United Kingdom. In short: Relatives and friends may not believe they’re truly sick.
The U.K. team found that more than three-quarters of people studied had experienced stigma often or always.
In fact, 95% of people with long COVID faced at least one type of stigma at least sometimes, according to the study, published in November in the journal PLOS One.
Those conclusions had surprised the study’s lead researcher, Marija Pantelic, PhD, a public health lecturer at Brighton and Sussex Medical School, England.
“After years of working on HIV-related stigma, I was shocked to see how many people were turning a blind eye to and dismissing the difficulties experienced by people with long COVID,” Dr. Pantelic says. “It has also been clear to me from the start that this stigma is detrimental not just for people’s dignity, but also public health.”
Even some doctors argue that the growing attention paid to long COVID is excessive.
“It’s often normal to experience mild fatigue or weaknesses for weeks after being sick and inactive and not eating well. Calling these cases long COVID is the medicalization of modern life,” Marty Makary, MD, a surgeon and public policy researcher at Johns Hopkins University, Baltimore, wrote in a commentary in the Wall Street Journal.
Other doctors strongly disagree, including Alba Azola, MD, codirector of the Johns Hopkins Post-Acute COVID-19 Team and an expert in the stigma surrounding long COVID.
“Putting that spin on things, it’s just hurting people,” she says.
One example is people who cannot return to work.
“A lot of their family members tell me that they’re being lazy,” Dr. Azola says. “That’s part of the public stigma, that these are people just trying to get out of work.”
Some experts say the U.K. study represents a landmark.
“When you have data like this on long COVID stigma, it becomes more difficult to deny its existence or address it,” says Naomi Torres-Mackie, PhD, a clinical psychologist at Lenox Hill Hospital in New York. She also is head of research at the New York–based Mental Health Coalition, a group of experts working to end the stigma surrounding mental health.
She recalls her first patient with long COVID.
“She experienced the discomfort and pain itself, and then she had this crushing feeling that it wasn’t valid, or real. She felt very alone in it,” Dr. Torres-Mackie says.
Another one of her patients is working at her job from home but facing doubt about her condition from her employers.
“Every month, her medical doctor has to produce a letter confirming her medical condition,” Dr. Torres-Mackie says.
Taking part in the British stigma survey were 1,166 people, including 966 residents of the United Kingdom, with the average age of 48. Nearly 85% were female, and more than three-quarters were educated at the university level or higher.
Half of them said they had a clinical diagnosis of long COVID.
More than 60% of them said that at least some of the time, they were cautious about who they talked to about their condition. And fully 34% of those who did disclose their diagnosis said that they regretted having done so.
That’s a difficult experience for those with long COVID, says Leonard Jason, PhD, a professor of psychology at DePaul University in Chicago.
“It’s like they’re traumatized by the initial experience of being sick, and retraumatized by the response of others to them,” he says.
Unexplained illnesses are not well-regarded by the general public, Dr. Jason says.
He gave the example of multiple sclerosis. Before the 1980s, those with MS were considered to have a psychological illness, he says. “Then, in the 1980s, there were biomarkers that said, ‘Here’s the evidence.’ ”
The British study described three types of stigma stemming from the long COVID diagnosis of those questioned:
- Enacted stigma: People were directly treated unfairly because of their condition.
- Internalized stigma: People felt embarrassed by that condition.
- Anticipated stigma: People expected they would be treated poorly because of their diagnosis.
Dr. Azola calls the medical community a major problem when it comes to dealing with long COVID.
“What I see with my patients is medical trauma,” she says. They may have symptoms that send them to the emergency room, and then the tests come back negative. “Instead of tracking the patients’ symptoms, patients get told, ‘Everything looks good, you can go home, this is a panic attack,’ ” she says.
Some people go online to search for treatments, sometimes launching GoFundMe campaigns to raise money for unreliable treatments.
Long COVID patients may have gone through 5 to 10 doctors before they arrive for treatment with the Johns Hopkins Post-Acute COVID-19 Team. The clinic began in April 2020 remotely and in August of that year in person.
Today, the clinic staff spends an hour with a first-time long COVID patient, hearing their stories and helping relieve anxiety, Dr. Azola says.
The phenomenon of long COVID is similar to what patients have had with chronic fatigue syndrome, lupus, or fibromyalgia, where people have symptoms that are hard to explain, says Jennifer Chevinsky, MD, deputy public health officer for Riverside County, Calif.
“Stigma within medicine or health care is nothing new,” she says.
In Chicago, Dr. Jason notes that the federal government’s decision to invest hundreds of millions of dollars in long COVID research “shows the government is helping destigmatize it.”
Dr. Pantelic says she and her colleagues are continuing their research.
“We are interested in understanding the impacts of this stigma, and how to mitigate any adverse outcomes for patients and services,” she says.
A version of this article first appeared on WebMD.com.
PLOS ONE
The Safety and Efficacy of AUC/MIC-Guided vs Trough-Guided Vancomycin Monitoring Among Veterans
Vancomycin is a commonly used glycopeptide antibiotic used to treat infections caused by gram-positive organisms. Vancomycin is most often used as a parenteral agent for empiric or definitive treatment of methicillin-resistant Staphylococcus aureus (MRSA). It can also be used for the treatment of other susceptible Staphylococcus or Enterococcus species. Adverse effects of parenteral vancomycin include infusion-related reactions, ototoxicity, and nephrotoxicity.1 Higher vancomycin trough levels have been associated with an increased risk of nephrotoxicity.1-4 The major safety concern with vancomycin is acute kidney injury (AKI). Even mild AKI can prolong hospitalizations, increase the cost of health care, and increase morbidity.2
In March 2020, the American Society of Health-System Pharmacists, the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Disease Society, and the Society of Infectious Diseases Pharmacists released a consensus statement and guidelines regarding the optimization of vancomycin dosing and monitoring for patients with suspected or definitive serious MRSA infections. Based on these guidelines, it is recommended to target an individualized area under the curve/minimum inhibitory concentration (AUC/MIC) ratio of 400 to 600 mg × h/L to maximize clinical efficacy and minimize the risk of AKI.2
Before March 2020, the vancomycin monitoring recommendation was to target trough levels of 10 to 20 mg/L. A goal trough of 15 to 20 mg/L was recommended for severe infections, including sepsis, endocarditis, hospital-acquired pneumonia, meningitis, and osteomyelitis, caused by MRSA. A goal trough of 10 to 15 mg/L was recommended for noninvasive infections, such as skin and soft tissue infections and urinary tract infections, caused by MRSA. Targeting these trough levels was thought to achieve an AUC/MIC ≥ 400 mg × h/L.5 Evidence has since shown that trough values may not be an optimal marker for AUC/MIC values.2
The updated vancomycin therapeutic drug monitoring (TDM) guidelines recommend that health systems transition to AUC/MIC-guided monitoring for suspected or confirmed infections caused by MRSA. There is not enough evidence to recommend AUC/MIC-guided monitoring in patients with noninvasive infections or infections caused by other microbes.2
AUC/MIC-guided monitoring can be achieved in 2 ways. The first method is collecting Cmax (peak level) and Cmin (trough level) serum concentrations, preferably during the same dosing interval. Ideally, Cmax should be drawn 1 to 2 hours after the vancomycin infusion and Cmin should be drawn at the end of the dosing interval. First-order pharmacokinetic equations are used to estimate the AUC/MIC with this method. Bayesian software pharmacokinetic modeling based on 1 or 2 vancomycin concentrations with 1 trough level also can be used for monitoring. Preferably, 2 levels would be obtained to estimate the AUC/MIC when using Bayesian modeling.2
The bactericidal activity of vancomycin was achieved with AUC/MIC ratios of ≥ 400 mg × h/L. AUC/MIC ratios of < 400 mg × h/L increase the incidence of resistant and intermediate strains of S aureus. AUC/MIC-guided monitoring assumes an MIC of 1 mg/L. When the MIC is > 1 mg/L, it is less likely that an AUC/MIC ≥ 400 mg × h/L is achievable. Regardless of the TDM method used, AUC/MIC ratios ≥ 400 mg × h/L are not achievable with conventional dosing methods if the vancomycin MIC is > 2 mg/L in patients with normal renal function. Alternative therapy is recommended to be used for these patients.2
There are multiple studies investigating the therapeutic dosing of vancomycin and the associated incidence of AKI. Previous studies have correlated vancomycin AUC/MICs of 400 mg to 600 mg × h/L with clinical effectiveness.2,6 In 2017, Neely and colleagues looked at the therapeutic dosing of vancomycin in 252 adults with ≥ 1 vancomycin level.7 During this prospective trial, they evaluated patients for 1 year and targeted trough concentrations of 10 to 20 mg/L with infection-specific goal ranges of 10 to 15 mg/L and 15 to 20 mg/L for noninvasive and invasive infections, respectively. They also targeted AUC/MIC ratios ≥ 400 mg × h/L regardless of trough concentration using Bayesian estimated AUC/MICs for 2 years. They found only 19% of trough concentrations to be therapeutic compared with 70% of AUC/MICs. A secondary outcome assessed by Neely and colleagues was nephrotoxicity, which was identified in 8% of patients with trough targets and 2% of patients with AUC/MIC targets.8
Previous studies evaluating the use of vancomycin in the veteran population have focused on AKI incidence, general nephrotoxicity, and 30-day readmission rates.4,7,9,10 Poston-Blahnik and colleagues investigated the rates of AKI in 200 veterans using AUC/MIC-guided vancomycin TDM.5 They found an AKI incidence of 42% of patients with AUC/MICs ≥ 550 mg × h/L and 2% of patients with AUC/MICs < 550 mg × h/L.5 Gyamlani and colleagues investigated the rates of AKI in 33,527 veterans and found that serum vancomycin trough levels ≥ 20 mg/L were associated with a higher risk of AKI.8 Prabaker and colleagues investigated the association between vancomycin trough levels and nephrotoxicity, defined as 0.5 mg/L or a 50% increase in serum creatinine (sCr) in 348 veterans. They found nephrotoxicity in 8.9% of patients.10 Patel and colleagues investigated the effect of AKI on 30-day readmission rates in 216 veterans.10 AKI occurred in 8.8% of patients and of those 19.4% were readmitted within 30 days.10 Current literature lacks evidence regarding the comparison of the safety and efficacy of vancomycin trough-guided vs AUC/MIC-guided TDM in the veteran population. Therefore, the objective of this study was to investigate the differences in the safety and efficacy of vancomycin TDM in the veteran population based on the different monitoring methods used.
METHODS
This study was a retrospective, single-center, quasi-experimental chart review conducted at the Sioux Falls Veterans Affairs Health Care System (SFVAHCS) in South Dakota. Data were collected from the Computerized Patient Record System (CPRS). The SFVAHCS transitioned from trough-guided to AUC/MIC-guided TDM in November 2020.
Patients included in this study were veterans aged ≥ 18 years with orders for parenteral vancomycin between February 1, 2020, and October 31, 2020, for the trough-guided TDM group and between December 1, 2020, and August 31, 2021, for the AUC/MIC-guided TDM group. Patients with vancomycin courses initiated during November 2020 were excluded as both TDM methods were being used at that time. Patients were excluded if their vancomycin course began before February 1, 2020, for the trough-guided TDM group or began during November 2020 for the AUC/MIC-guided TDM group. Patients were excluded if their vancomycin course extended past October 31, 2020, for the trough group or past August 31, 2021, for the AUC/MIC group. Patients on dialysis or missing Cmax, Cmin, or sCr levels were excluded.
This study evaluated both safety (AKI incidence) and effectiveness (time spent in therapeutic range and time to therapeutic range). The primary endpoint was presence of vancomycin-induced AKI, which was based on the most recent Kidney Disease: Improving Global Outcomes (KDIGO) AKI definition: increased sCr of ≥ 0.3 mg/dL or by 50% from baseline sustained over 48 hours without any other explanation for the change.11 A secondary endpoint was the absence or presence of AKI.
Additional secondary endpoints included the presence of the initial trough or AUC/MIC of each vancomycin course within the therapeutic range and the percentage of all trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges. The therapeutic range for AUC/MIC-guided TDM was 400 to 600 mg × h/L and 10 to 20 mg/L depending on indication for trough-guided TDM (15-20 mg/L for severe infections and 10-15 mg/L for less invasive infections). The percentage of trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges were calculated as a ratio of levels within each range to total levels taken for each patient.
For AUC/MIC-guided TDM the Cmax levels were ideally drawn 1 to 2 hours after vancomycin infusion and Cmin levels were ideally drawn 30 minutes before the next dose. First-order pharmacokinetic equations were used to estimate the AUC/MIC.12 If the timing of a vancomycin level was inappropriate, actual levels were extrapolated based on the timing of the blood draw compared with the ideal Cmin or Cmax time. Extrapolated levels were used for both trough-guided and AUC/MIC-guided TDM groups when appropriate. Vancomycin levels were excluded if they were drawn during the vancomycin infusion.
Study participant age, sex, race, weight, baseline estimated glomerular filtration (eGFR) rate, baseline sCr, concomitant nephrotoxic medications, duration of vancomycin course, indication of vancomycin, and acuity of illness based on indication were collected. sCr levels were collected from the initial day vancomycin was ordered through 72 hours following completion of a vancomycin course to evaluate for AKI. Patients’ charts were reviewed for the use of the following nephrotoxic medications: nonsteroidal anti-inflammatories, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, aminoglycosides, piperacillin/tazobactam, loop diuretics, amphotericin B, acyclovir, intravenous contrast, and nephrotoxic chemotherapy (cisplatin). The category of concomitant nephrotoxic medications was also collected including the continuation of a home nephrotoxic medication vs the initiation of a new nephrotoxic medication.
Statistical Analysis
The primary endpoint of the incidence of vancomycin-induced AKI was compared using a Fisher exact test. The secondary endpoint of the percentage of trough levels or AUC/MICs in the therapeutic, subtherapeutic, and supratherapeutic range were compared using a student t test. The secondary endpoint of first level or AUC/MIC within goal range was compared using a χ2 test. Continuous baseline characteristics were reported as a mean and compared using a student t test. Nominal baseline characteristics were reported as a percentage and compared using the χ2 test. P values < .05 were considered statistically significant.
RESULTS
This study included 97 patients, 43 in the AUC/MIC group and 54 in the trough group. 
One (2%) patient in the AUC/MIC group and 2 (4%) patients in the trough group experienced vancomycin-induced AKI (P = .10) (Table 2).
DISCUSSION
There was no statistically significant difference between the 2 groups for the vancomycin-induced AKI (P = .10), the primary endpoint, or overall AKI (P = .29), the secondary endpoint. It should be noted that there was more overall AKI in the AUC/MIC group. Veterans in the AUC/MIC group were found to have their first AUC/MIC within the therapeutic range statistically significantly more often than the first trough level in the trough group (P = .04). The percentage of time spent within therapeutic range was statistically significantly higher in the AUC/MIC-guided TDM group (P = .02). The percentage of time spent subtherapeutic of goal range was statistically significantly higher in the trough-guided TDM group (P < .001). There was no statistically significant difference found in the percent of time spent supratherapeutic of goal range (P = .25). However, the observed percentage of time spent supratherapeutic of goal range was higher in the AUC/MIC group. These results indicate that AUC/MIC-guided TDM may be more efficacious with regard to time in therapeutic range and time to therapeutic range.
The finding of increased AKI with AUC/MIC-guided TDM does not align with previous studies.8 The prospective study by Neely and colleagues found that AUC/MIC-guided TDM resulted in more time in the therapeutic range as well as less nephrotoxicity compared with trough-guided TDM, although it was limited by its lack of randomization and did not account for other causes of nephrotoxicity.8 They found that only 19% of trough concentrations were therapeutic compared with 70% of AUC/MICs and found nephrotoxicity in 8% of trough-guided TDM patients compared with 2% of AUC/MIC-guided TDM patients.8
Unlike Nealy and colleagues, our study did not find lower nephrotoxicity associated with AUC/MIC-guided TDM. Multiple factors may have influenced our results. Our AUC/MIC group had significantly more newly started concomitant nephrotoxins and other nephrotoxic medications used during the vancomycin courses compared with the trough-guided group, which may have influenced AKI outcomes. It also should be noted that there was significantly more time spent subtherapeutic of the goal range and significantly less time in the goal range in the trough group compared with the AUC/MIC group. In our study, the trough-guided group had significantly more patients with acute illness compared with the AUC/MIC group (skin, soft tissue, and joint infections were similar between the groups). The group with more acutely ill patients would have been expected to have more nephrotoxicity. However, despite the acute illnesses, patients in the trough-guided group spent more time in the subtherapeutic range. This may explain the increased nephrotoxicity in the AUC/MIC group since those patients spent more time in the therapeutic range.
This study used the most recent KDIGO AKI definition: either an increase in sCr of ≥ 0.3 mg/dL or a 50% increase in sCr from baseline sustained over 48 hours without any other explanation for the change in renal function.11 This AKI definition is stricter than the previous definition, which was used by earlier studies, including Neely and colleagues, to evaluate rates of vancomycin-induced AKI.2,3 Therefore, the rates of overall AKI found in this study may be higher than in previous studies due to the definition of AKI used.
Limitations
This study was limited by its retrospective nature, lack of randomization, and small sample size. To decrease the potential for error in this study, analysis of power and a larger study sample would have been beneficial. During the COVID-19 pandemic, increased pneumonia cases may have hidden bacterial causes and caused an undercount. Nephrotoxicity may also be related to volume depletion, severe systemic illness, dehydration, or hypotension. Screening was completed via chart review for these alternative causes of nephrotoxicity in this study but may not be completely accounted for due to lack of documentation and the retrospective nature of this study.
CONCLUSIONS
This study did not find a significant difference in the rates of vancomycin-induced or overall AKI between AUC/MIC-guided and trough-guided TDM. However, this study may not have been powered to detect a significant difference in the primary endpoint. This study indicated that AUC/MIC-guided TDM of vancomycin resulted in a quicker time to the therapeutic range and a higher percentage of overall time in the therapeutic range as compared with trough-guided TDM. The results of this study indicated that trough-guided monitoring resulted in a higher percentage of time in a subtherapeutic range. This study also found that the first AUC/MIC calculated was within therapeutic range more often than the first trough level collected.
These results indicate that AUC/MIC-guided TDM may be more effective than trough-guided TDM in the veteran population. However, while AUC/MIC-guided TDM may be more effective with regards to time in therapeutic range and time to therapeutic range, this study did not indicate any safety benefit of AUC/MIC-guided over trough-guided TDM with regards to AKI incidence. Our data indicate that AUC/MIC-guided TDM increases the amount of time in the therapeutic range compared with trough-guided TDM and is not more nephrotoxic. The findings of this study support the recommendation to transition to the use of AUC/MIC-guided TDM of vancomycin in the veteran population.
Acknowledgments
This material is the result of work supported with the use of facilities and resources from the Sioux Falls Veterans Affairs Health Care System.
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2. Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
3. Hermsen ED, Hanson M, Sankaranarayanan J, Stoner JA, Florescu MC, Rupp ME. Clinical outcomes and nephrotoxicity associated with vancomycin trough concentrations during treatment of deep-seated infections. Expert Opin Drug Saf. 2010;9(1):9-14. doi:10.1517/14740330903413514
4. Poston-Blahnik A, Moenster R. Association between vancomycin area under the curve and nephrotoxicity: a single center, retrospective cohort study in a veteran population. Open Forum Infect Dis. 2021;8(5):ofab094. Published 2021 Mar 12. doi:10.1093/ofid/ofab094
5. Rybak M, Lomaestro B, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009;66(1):82-98. doi:10.2146/ajhp080434
6. Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004;43(13):925-942. doi:10.2165/00003088-200443130-00005
7. Gyamlani G, Potukuchi PK, Thomas F, et al. Vancomycin-Associated Acute Kidney Injury in a Large Veteran Population. Am J Nephrol. 2019;49(2):133-142. doi:10.1159/000496484
8. Neely MN, Kato L, Youn G, et al. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018;62(2):e02042-17. Published 2018 Jan 25. doi:10.1128/AAC.02042-17
9. Prabaker KK, Tran TP, Pratummas T, Goetz MB, Graber CJ. Elevated vancomycin trough is not associated with nephrotoxicity among inpatient veterans. J Hosp Med. 2012;7(2):91-97. doi:10.1002/jhm.946
10. Patel N, Stornelli N, Sangiovanni RJ, Huang DB, Lodise TP. Effect of vancomycin-associated acute kidney injury on incidence of 30-day readmissions among hospitalized Veterans Affairs patients with skin and skin structure infections. Antimicrob Agents Chemother. 2020;64(10):e01268-20. Published 2020 Sep 21. doi:10.1128/AAC.01268-20
11. Acute Kidney Injury Work Group. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney Int. 2012;2(suppl 1):1-138.
12. Pai MP, Neely M, Rodvold KA, Lodise TP. Innovative approaches to optimizing the delivery of vancomycin in individual patients. Adv Drug Deliv Rev. 2014;77:50-57. doi:10.1016/j.addr.2014.05.016
Vancomycin is a commonly used glycopeptide antibiotic used to treat infections caused by gram-positive organisms. Vancomycin is most often used as a parenteral agent for empiric or definitive treatment of methicillin-resistant Staphylococcus aureus (MRSA). It can also be used for the treatment of other susceptible Staphylococcus or Enterococcus species. Adverse effects of parenteral vancomycin include infusion-related reactions, ototoxicity, and nephrotoxicity.1 Higher vancomycin trough levels have been associated with an increased risk of nephrotoxicity.1-4 The major safety concern with vancomycin is acute kidney injury (AKI). Even mild AKI can prolong hospitalizations, increase the cost of health care, and increase morbidity.2
In March 2020, the American Society of Health-System Pharmacists, the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Disease Society, and the Society of Infectious Diseases Pharmacists released a consensus statement and guidelines regarding the optimization of vancomycin dosing and monitoring for patients with suspected or definitive serious MRSA infections. Based on these guidelines, it is recommended to target an individualized area under the curve/minimum inhibitory concentration (AUC/MIC) ratio of 400 to 600 mg × h/L to maximize clinical efficacy and minimize the risk of AKI.2
Before March 2020, the vancomycin monitoring recommendation was to target trough levels of 10 to 20 mg/L. A goal trough of 15 to 20 mg/L was recommended for severe infections, including sepsis, endocarditis, hospital-acquired pneumonia, meningitis, and osteomyelitis, caused by MRSA. A goal trough of 10 to 15 mg/L was recommended for noninvasive infections, such as skin and soft tissue infections and urinary tract infections, caused by MRSA. Targeting these trough levels was thought to achieve an AUC/MIC ≥ 400 mg × h/L.5 Evidence has since shown that trough values may not be an optimal marker for AUC/MIC values.2
The updated vancomycin therapeutic drug monitoring (TDM) guidelines recommend that health systems transition to AUC/MIC-guided monitoring for suspected or confirmed infections caused by MRSA. There is not enough evidence to recommend AUC/MIC-guided monitoring in patients with noninvasive infections or infections caused by other microbes.2
AUC/MIC-guided monitoring can be achieved in 2 ways. The first method is collecting Cmax (peak level) and Cmin (trough level) serum concentrations, preferably during the same dosing interval. Ideally, Cmax should be drawn 1 to 2 hours after the vancomycin infusion and Cmin should be drawn at the end of the dosing interval. First-order pharmacokinetic equations are used to estimate the AUC/MIC with this method. Bayesian software pharmacokinetic modeling based on 1 or 2 vancomycin concentrations with 1 trough level also can be used for monitoring. Preferably, 2 levels would be obtained to estimate the AUC/MIC when using Bayesian modeling.2
The bactericidal activity of vancomycin was achieved with AUC/MIC ratios of ≥ 400 mg × h/L. AUC/MIC ratios of < 400 mg × h/L increase the incidence of resistant and intermediate strains of S aureus. AUC/MIC-guided monitoring assumes an MIC of 1 mg/L. When the MIC is > 1 mg/L, it is less likely that an AUC/MIC ≥ 400 mg × h/L is achievable. Regardless of the TDM method used, AUC/MIC ratios ≥ 400 mg × h/L are not achievable with conventional dosing methods if the vancomycin MIC is > 2 mg/L in patients with normal renal function. Alternative therapy is recommended to be used for these patients.2
There are multiple studies investigating the therapeutic dosing of vancomycin and the associated incidence of AKI. Previous studies have correlated vancomycin AUC/MICs of 400 mg to 600 mg × h/L with clinical effectiveness.2,6 In 2017, Neely and colleagues looked at the therapeutic dosing of vancomycin in 252 adults with ≥ 1 vancomycin level.7 During this prospective trial, they evaluated patients for 1 year and targeted trough concentrations of 10 to 20 mg/L with infection-specific goal ranges of 10 to 15 mg/L and 15 to 20 mg/L for noninvasive and invasive infections, respectively. They also targeted AUC/MIC ratios ≥ 400 mg × h/L regardless of trough concentration using Bayesian estimated AUC/MICs for 2 years. They found only 19% of trough concentrations to be therapeutic compared with 70% of AUC/MICs. A secondary outcome assessed by Neely and colleagues was nephrotoxicity, which was identified in 8% of patients with trough targets and 2% of patients with AUC/MIC targets.8
Previous studies evaluating the use of vancomycin in the veteran population have focused on AKI incidence, general nephrotoxicity, and 30-day readmission rates.4,7,9,10 Poston-Blahnik and colleagues investigated the rates of AKI in 200 veterans using AUC/MIC-guided vancomycin TDM.5 They found an AKI incidence of 42% of patients with AUC/MICs ≥ 550 mg × h/L and 2% of patients with AUC/MICs < 550 mg × h/L.5 Gyamlani and colleagues investigated the rates of AKI in 33,527 veterans and found that serum vancomycin trough levels ≥ 20 mg/L were associated with a higher risk of AKI.8 Prabaker and colleagues investigated the association between vancomycin trough levels and nephrotoxicity, defined as 0.5 mg/L or a 50% increase in serum creatinine (sCr) in 348 veterans. They found nephrotoxicity in 8.9% of patients.10 Patel and colleagues investigated the effect of AKI on 30-day readmission rates in 216 veterans.10 AKI occurred in 8.8% of patients and of those 19.4% were readmitted within 30 days.10 Current literature lacks evidence regarding the comparison of the safety and efficacy of vancomycin trough-guided vs AUC/MIC-guided TDM in the veteran population. Therefore, the objective of this study was to investigate the differences in the safety and efficacy of vancomycin TDM in the veteran population based on the different monitoring methods used.
METHODS
This study was a retrospective, single-center, quasi-experimental chart review conducted at the Sioux Falls Veterans Affairs Health Care System (SFVAHCS) in South Dakota. Data were collected from the Computerized Patient Record System (CPRS). The SFVAHCS transitioned from trough-guided to AUC/MIC-guided TDM in November 2020.
Patients included in this study were veterans aged ≥ 18 years with orders for parenteral vancomycin between February 1, 2020, and October 31, 2020, for the trough-guided TDM group and between December 1, 2020, and August 31, 2021, for the AUC/MIC-guided TDM group. Patients with vancomycin courses initiated during November 2020 were excluded as both TDM methods were being used at that time. Patients were excluded if their vancomycin course began before February 1, 2020, for the trough-guided TDM group or began during November 2020 for the AUC/MIC-guided TDM group. Patients were excluded if their vancomycin course extended past October 31, 2020, for the trough group or past August 31, 2021, for the AUC/MIC group. Patients on dialysis or missing Cmax, Cmin, or sCr levels were excluded.
This study evaluated both safety (AKI incidence) and effectiveness (time spent in therapeutic range and time to therapeutic range). The primary endpoint was presence of vancomycin-induced AKI, which was based on the most recent Kidney Disease: Improving Global Outcomes (KDIGO) AKI definition: increased sCr of ≥ 0.3 mg/dL or by 50% from baseline sustained over 48 hours without any other explanation for the change.11 A secondary endpoint was the absence or presence of AKI.
Additional secondary endpoints included the presence of the initial trough or AUC/MIC of each vancomycin course within the therapeutic range and the percentage of all trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges. The therapeutic range for AUC/MIC-guided TDM was 400 to 600 mg × h/L and 10 to 20 mg/L depending on indication for trough-guided TDM (15-20 mg/L for severe infections and 10-15 mg/L for less invasive infections). The percentage of trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges were calculated as a ratio of levels within each range to total levels taken for each patient.
For AUC/MIC-guided TDM the Cmax levels were ideally drawn 1 to 2 hours after vancomycin infusion and Cmin levels were ideally drawn 30 minutes before the next dose. First-order pharmacokinetic equations were used to estimate the AUC/MIC.12 If the timing of a vancomycin level was inappropriate, actual levels were extrapolated based on the timing of the blood draw compared with the ideal Cmin or Cmax time. Extrapolated levels were used for both trough-guided and AUC/MIC-guided TDM groups when appropriate. Vancomycin levels were excluded if they were drawn during the vancomycin infusion.
Study participant age, sex, race, weight, baseline estimated glomerular filtration (eGFR) rate, baseline sCr, concomitant nephrotoxic medications, duration of vancomycin course, indication of vancomycin, and acuity of illness based on indication were collected. sCr levels were collected from the initial day vancomycin was ordered through 72 hours following completion of a vancomycin course to evaluate for AKI. Patients’ charts were reviewed for the use of the following nephrotoxic medications: nonsteroidal anti-inflammatories, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, aminoglycosides, piperacillin/tazobactam, loop diuretics, amphotericin B, acyclovir, intravenous contrast, and nephrotoxic chemotherapy (cisplatin). The category of concomitant nephrotoxic medications was also collected including the continuation of a home nephrotoxic medication vs the initiation of a new nephrotoxic medication.
Statistical Analysis
The primary endpoint of the incidence of vancomycin-induced AKI was compared using a Fisher exact test. The secondary endpoint of the percentage of trough levels or AUC/MICs in the therapeutic, subtherapeutic, and supratherapeutic range were compared using a student t test. The secondary endpoint of first level or AUC/MIC within goal range was compared using a χ2 test. Continuous baseline characteristics were reported as a mean and compared using a student t test. Nominal baseline characteristics were reported as a percentage and compared using the χ2 test. P values < .05 were considered statistically significant.
RESULTS
This study included 97 patients, 43 in the AUC/MIC group and 54 in the trough group.
One (2%) patient in the AUC/MIC group and 2 (4%) patients in the trough group experienced vancomycin-induced AKI (P = .10) (Table 2).
DISCUSSION
There was no statistically significant difference between the 2 groups for the vancomycin-induced AKI (P = .10), the primary endpoint, or overall AKI (P = .29), the secondary endpoint. It should be noted that there was more overall AKI in the AUC/MIC group. Veterans in the AUC/MIC group were found to have their first AUC/MIC within the therapeutic range statistically significantly more often than the first trough level in the trough group (P = .04). The percentage of time spent within therapeutic range was statistically significantly higher in the AUC/MIC-guided TDM group (P = .02). The percentage of time spent subtherapeutic of goal range was statistically significantly higher in the trough-guided TDM group (P < .001). There was no statistically significant difference found in the percent of time spent supratherapeutic of goal range (P = .25). However, the observed percentage of time spent supratherapeutic of goal range was higher in the AUC/MIC group. These results indicate that AUC/MIC-guided TDM may be more efficacious with regard to time in therapeutic range and time to therapeutic range.
The finding of increased AKI with AUC/MIC-guided TDM does not align with previous studies.8 The prospective study by Neely and colleagues found that AUC/MIC-guided TDM resulted in more time in the therapeutic range as well as less nephrotoxicity compared with trough-guided TDM, although it was limited by its lack of randomization and did not account for other causes of nephrotoxicity.8 They found that only 19% of trough concentrations were therapeutic compared with 70% of AUC/MICs and found nephrotoxicity in 8% of trough-guided TDM patients compared with 2% of AUC/MIC-guided TDM patients.8
Unlike Nealy and colleagues, our study did not find lower nephrotoxicity associated with AUC/MIC-guided TDM. Multiple factors may have influenced our results. Our AUC/MIC group had significantly more newly started concomitant nephrotoxins and other nephrotoxic medications used during the vancomycin courses compared with the trough-guided group, which may have influenced AKI outcomes. It also should be noted that there was significantly more time spent subtherapeutic of the goal range and significantly less time in the goal range in the trough group compared with the AUC/MIC group. In our study, the trough-guided group had significantly more patients with acute illness compared with the AUC/MIC group (skin, soft tissue, and joint infections were similar between the groups). The group with more acutely ill patients would have been expected to have more nephrotoxicity. However, despite the acute illnesses, patients in the trough-guided group spent more time in the subtherapeutic range. This may explain the increased nephrotoxicity in the AUC/MIC group since those patients spent more time in the therapeutic range.
This study used the most recent KDIGO AKI definition: either an increase in sCr of ≥ 0.3 mg/dL or a 50% increase in sCr from baseline sustained over 48 hours without any other explanation for the change in renal function.11 This AKI definition is stricter than the previous definition, which was used by earlier studies, including Neely and colleagues, to evaluate rates of vancomycin-induced AKI.2,3 Therefore, the rates of overall AKI found in this study may be higher than in previous studies due to the definition of AKI used.
Limitations
This study was limited by its retrospective nature, lack of randomization, and small sample size. To decrease the potential for error in this study, analysis of power and a larger study sample would have been beneficial. During the COVID-19 pandemic, increased pneumonia cases may have hidden bacterial causes and caused an undercount. Nephrotoxicity may also be related to volume depletion, severe systemic illness, dehydration, or hypotension. Screening was completed via chart review for these alternative causes of nephrotoxicity in this study but may not be completely accounted for due to lack of documentation and the retrospective nature of this study.
CONCLUSIONS
This study did not find a significant difference in the rates of vancomycin-induced or overall AKI between AUC/MIC-guided and trough-guided TDM. However, this study may not have been powered to detect a significant difference in the primary endpoint. This study indicated that AUC/MIC-guided TDM of vancomycin resulted in a quicker time to the therapeutic range and a higher percentage of overall time in the therapeutic range as compared with trough-guided TDM. The results of this study indicated that trough-guided monitoring resulted in a higher percentage of time in a subtherapeutic range. This study also found that the first AUC/MIC calculated was within therapeutic range more often than the first trough level collected.
These results indicate that AUC/MIC-guided TDM may be more effective than trough-guided TDM in the veteran population. However, while AUC/MIC-guided TDM may be more effective with regards to time in therapeutic range and time to therapeutic range, this study did not indicate any safety benefit of AUC/MIC-guided over trough-guided TDM with regards to AKI incidence. Our data indicate that AUC/MIC-guided TDM increases the amount of time in the therapeutic range compared with trough-guided TDM and is not more nephrotoxic. The findings of this study support the recommendation to transition to the use of AUC/MIC-guided TDM of vancomycin in the veteran population.
Acknowledgments
This material is the result of work supported with the use of facilities and resources from the Sioux Falls Veterans Affairs Health Care System.
Vancomycin is a commonly used glycopeptide antibiotic used to treat infections caused by gram-positive organisms. Vancomycin is most often used as a parenteral agent for empiric or definitive treatment of methicillin-resistant Staphylococcus aureus (MRSA). It can also be used for the treatment of other susceptible Staphylococcus or Enterococcus species. Adverse effects of parenteral vancomycin include infusion-related reactions, ototoxicity, and nephrotoxicity.1 Higher vancomycin trough levels have been associated with an increased risk of nephrotoxicity.1-4 The major safety concern with vancomycin is acute kidney injury (AKI). Even mild AKI can prolong hospitalizations, increase the cost of health care, and increase morbidity.2
In March 2020, the American Society of Health-System Pharmacists, the Infectious Diseases Society of America (IDSA), the Pediatric Infectious Disease Society, and the Society of Infectious Diseases Pharmacists released a consensus statement and guidelines regarding the optimization of vancomycin dosing and monitoring for patients with suspected or definitive serious MRSA infections. Based on these guidelines, it is recommended to target an individualized area under the curve/minimum inhibitory concentration (AUC/MIC) ratio of 400 to 600 mg × h/L to maximize clinical efficacy and minimize the risk of AKI.2
Before March 2020, the vancomycin monitoring recommendation was to target trough levels of 10 to 20 mg/L. A goal trough of 15 to 20 mg/L was recommended for severe infections, including sepsis, endocarditis, hospital-acquired pneumonia, meningitis, and osteomyelitis, caused by MRSA. A goal trough of 10 to 15 mg/L was recommended for noninvasive infections, such as skin and soft tissue infections and urinary tract infections, caused by MRSA. Targeting these trough levels was thought to achieve an AUC/MIC ≥ 400 mg × h/L.5 Evidence has since shown that trough values may not be an optimal marker for AUC/MIC values.2
The updated vancomycin therapeutic drug monitoring (TDM) guidelines recommend that health systems transition to AUC/MIC-guided monitoring for suspected or confirmed infections caused by MRSA. There is not enough evidence to recommend AUC/MIC-guided monitoring in patients with noninvasive infections or infections caused by other microbes.2
AUC/MIC-guided monitoring can be achieved in 2 ways. The first method is collecting Cmax (peak level) and Cmin (trough level) serum concentrations, preferably during the same dosing interval. Ideally, Cmax should be drawn 1 to 2 hours after the vancomycin infusion and Cmin should be drawn at the end of the dosing interval. First-order pharmacokinetic equations are used to estimate the AUC/MIC with this method. Bayesian software pharmacokinetic modeling based on 1 or 2 vancomycin concentrations with 1 trough level also can be used for monitoring. Preferably, 2 levels would be obtained to estimate the AUC/MIC when using Bayesian modeling.2
The bactericidal activity of vancomycin was achieved with AUC/MIC ratios of ≥ 400 mg × h/L. AUC/MIC ratios of < 400 mg × h/L increase the incidence of resistant and intermediate strains of S aureus. AUC/MIC-guided monitoring assumes an MIC of 1 mg/L. When the MIC is > 1 mg/L, it is less likely that an AUC/MIC ≥ 400 mg × h/L is achievable. Regardless of the TDM method used, AUC/MIC ratios ≥ 400 mg × h/L are not achievable with conventional dosing methods if the vancomycin MIC is > 2 mg/L in patients with normal renal function. Alternative therapy is recommended to be used for these patients.2
There are multiple studies investigating the therapeutic dosing of vancomycin and the associated incidence of AKI. Previous studies have correlated vancomycin AUC/MICs of 400 mg to 600 mg × h/L with clinical effectiveness.2,6 In 2017, Neely and colleagues looked at the therapeutic dosing of vancomycin in 252 adults with ≥ 1 vancomycin level.7 During this prospective trial, they evaluated patients for 1 year and targeted trough concentrations of 10 to 20 mg/L with infection-specific goal ranges of 10 to 15 mg/L and 15 to 20 mg/L for noninvasive and invasive infections, respectively. They also targeted AUC/MIC ratios ≥ 400 mg × h/L regardless of trough concentration using Bayesian estimated AUC/MICs for 2 years. They found only 19% of trough concentrations to be therapeutic compared with 70% of AUC/MICs. A secondary outcome assessed by Neely and colleagues was nephrotoxicity, which was identified in 8% of patients with trough targets and 2% of patients with AUC/MIC targets.8
Previous studies evaluating the use of vancomycin in the veteran population have focused on AKI incidence, general nephrotoxicity, and 30-day readmission rates.4,7,9,10 Poston-Blahnik and colleagues investigated the rates of AKI in 200 veterans using AUC/MIC-guided vancomycin TDM.5 They found an AKI incidence of 42% of patients with AUC/MICs ≥ 550 mg × h/L and 2% of patients with AUC/MICs < 550 mg × h/L.5 Gyamlani and colleagues investigated the rates of AKI in 33,527 veterans and found that serum vancomycin trough levels ≥ 20 mg/L were associated with a higher risk of AKI.8 Prabaker and colleagues investigated the association between vancomycin trough levels and nephrotoxicity, defined as 0.5 mg/L or a 50% increase in serum creatinine (sCr) in 348 veterans. They found nephrotoxicity in 8.9% of patients.10 Patel and colleagues investigated the effect of AKI on 30-day readmission rates in 216 veterans.10 AKI occurred in 8.8% of patients and of those 19.4% were readmitted within 30 days.10 Current literature lacks evidence regarding the comparison of the safety and efficacy of vancomycin trough-guided vs AUC/MIC-guided TDM in the veteran population. Therefore, the objective of this study was to investigate the differences in the safety and efficacy of vancomycin TDM in the veteran population based on the different monitoring methods used.
METHODS
This study was a retrospective, single-center, quasi-experimental chart review conducted at the Sioux Falls Veterans Affairs Health Care System (SFVAHCS) in South Dakota. Data were collected from the Computerized Patient Record System (CPRS). The SFVAHCS transitioned from trough-guided to AUC/MIC-guided TDM in November 2020.
Patients included in this study were veterans aged ≥ 18 years with orders for parenteral vancomycin between February 1, 2020, and October 31, 2020, for the trough-guided TDM group and between December 1, 2020, and August 31, 2021, for the AUC/MIC-guided TDM group. Patients with vancomycin courses initiated during November 2020 were excluded as both TDM methods were being used at that time. Patients were excluded if their vancomycin course began before February 1, 2020, for the trough-guided TDM group or began during November 2020 for the AUC/MIC-guided TDM group. Patients were excluded if their vancomycin course extended past October 31, 2020, for the trough group or past August 31, 2021, for the AUC/MIC group. Patients on dialysis or missing Cmax, Cmin, or sCr levels were excluded.
This study evaluated both safety (AKI incidence) and effectiveness (time spent in therapeutic range and time to therapeutic range). The primary endpoint was presence of vancomycin-induced AKI, which was based on the most recent Kidney Disease: Improving Global Outcomes (KDIGO) AKI definition: increased sCr of ≥ 0.3 mg/dL or by 50% from baseline sustained over 48 hours without any other explanation for the change.11 A secondary endpoint was the absence or presence of AKI.
Additional secondary endpoints included the presence of the initial trough or AUC/MIC of each vancomycin course within the therapeutic range and the percentage of all trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges. The therapeutic range for AUC/MIC-guided TDM was 400 to 600 mg × h/L and 10 to 20 mg/L depending on indication for trough-guided TDM (15-20 mg/L for severe infections and 10-15 mg/L for less invasive infections). The percentage of trough levels or AUC/MICs within therapeutic, subtherapeutic, and supratherapeutic ranges were calculated as a ratio of levels within each range to total levels taken for each patient.
For AUC/MIC-guided TDM the Cmax levels were ideally drawn 1 to 2 hours after vancomycin infusion and Cmin levels were ideally drawn 30 minutes before the next dose. First-order pharmacokinetic equations were used to estimate the AUC/MIC.12 If the timing of a vancomycin level was inappropriate, actual levels were extrapolated based on the timing of the blood draw compared with the ideal Cmin or Cmax time. Extrapolated levels were used for both trough-guided and AUC/MIC-guided TDM groups when appropriate. Vancomycin levels were excluded if they were drawn during the vancomycin infusion.
Study participant age, sex, race, weight, baseline estimated glomerular filtration (eGFR) rate, baseline sCr, concomitant nephrotoxic medications, duration of vancomycin course, indication of vancomycin, and acuity of illness based on indication were collected. sCr levels were collected from the initial day vancomycin was ordered through 72 hours following completion of a vancomycin course to evaluate for AKI. Patients’ charts were reviewed for the use of the following nephrotoxic medications: nonsteroidal anti-inflammatories, angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, aminoglycosides, piperacillin/tazobactam, loop diuretics, amphotericin B, acyclovir, intravenous contrast, and nephrotoxic chemotherapy (cisplatin). The category of concomitant nephrotoxic medications was also collected including the continuation of a home nephrotoxic medication vs the initiation of a new nephrotoxic medication.
Statistical Analysis
The primary endpoint of the incidence of vancomycin-induced AKI was compared using a Fisher exact test. The secondary endpoint of the percentage of trough levels or AUC/MICs in the therapeutic, subtherapeutic, and supratherapeutic range were compared using a student t test. The secondary endpoint of first level or AUC/MIC within goal range was compared using a χ2 test. Continuous baseline characteristics were reported as a mean and compared using a student t test. Nominal baseline characteristics were reported as a percentage and compared using the χ2 test. P values < .05 were considered statistically significant.
RESULTS
This study included 97 patients, 43 in the AUC/MIC group and 54 in the trough group.
One (2%) patient in the AUC/MIC group and 2 (4%) patients in the trough group experienced vancomycin-induced AKI (P = .10) (Table 2).
DISCUSSION
There was no statistically significant difference between the 2 groups for the vancomycin-induced AKI (P = .10), the primary endpoint, or overall AKI (P = .29), the secondary endpoint. It should be noted that there was more overall AKI in the AUC/MIC group. Veterans in the AUC/MIC group were found to have their first AUC/MIC within the therapeutic range statistically significantly more often than the first trough level in the trough group (P = .04). The percentage of time spent within therapeutic range was statistically significantly higher in the AUC/MIC-guided TDM group (P = .02). The percentage of time spent subtherapeutic of goal range was statistically significantly higher in the trough-guided TDM group (P < .001). There was no statistically significant difference found in the percent of time spent supratherapeutic of goal range (P = .25). However, the observed percentage of time spent supratherapeutic of goal range was higher in the AUC/MIC group. These results indicate that AUC/MIC-guided TDM may be more efficacious with regard to time in therapeutic range and time to therapeutic range.
The finding of increased AKI with AUC/MIC-guided TDM does not align with previous studies.8 The prospective study by Neely and colleagues found that AUC/MIC-guided TDM resulted in more time in the therapeutic range as well as less nephrotoxicity compared with trough-guided TDM, although it was limited by its lack of randomization and did not account for other causes of nephrotoxicity.8 They found that only 19% of trough concentrations were therapeutic compared with 70% of AUC/MICs and found nephrotoxicity in 8% of trough-guided TDM patients compared with 2% of AUC/MIC-guided TDM patients.8
Unlike Nealy and colleagues, our study did not find lower nephrotoxicity associated with AUC/MIC-guided TDM. Multiple factors may have influenced our results. Our AUC/MIC group had significantly more newly started concomitant nephrotoxins and other nephrotoxic medications used during the vancomycin courses compared with the trough-guided group, which may have influenced AKI outcomes. It also should be noted that there was significantly more time spent subtherapeutic of the goal range and significantly less time in the goal range in the trough group compared with the AUC/MIC group. In our study, the trough-guided group had significantly more patients with acute illness compared with the AUC/MIC group (skin, soft tissue, and joint infections were similar between the groups). The group with more acutely ill patients would have been expected to have more nephrotoxicity. However, despite the acute illnesses, patients in the trough-guided group spent more time in the subtherapeutic range. This may explain the increased nephrotoxicity in the AUC/MIC group since those patients spent more time in the therapeutic range.
This study used the most recent KDIGO AKI definition: either an increase in sCr of ≥ 0.3 mg/dL or a 50% increase in sCr from baseline sustained over 48 hours without any other explanation for the change in renal function.11 This AKI definition is stricter than the previous definition, which was used by earlier studies, including Neely and colleagues, to evaluate rates of vancomycin-induced AKI.2,3 Therefore, the rates of overall AKI found in this study may be higher than in previous studies due to the definition of AKI used.
Limitations
This study was limited by its retrospective nature, lack of randomization, and small sample size. To decrease the potential for error in this study, analysis of power and a larger study sample would have been beneficial. During the COVID-19 pandemic, increased pneumonia cases may have hidden bacterial causes and caused an undercount. Nephrotoxicity may also be related to volume depletion, severe systemic illness, dehydration, or hypotension. Screening was completed via chart review for these alternative causes of nephrotoxicity in this study but may not be completely accounted for due to lack of documentation and the retrospective nature of this study.
CONCLUSIONS
This study did not find a significant difference in the rates of vancomycin-induced or overall AKI between AUC/MIC-guided and trough-guided TDM. However, this study may not have been powered to detect a significant difference in the primary endpoint. This study indicated that AUC/MIC-guided TDM of vancomycin resulted in a quicker time to the therapeutic range and a higher percentage of overall time in the therapeutic range as compared with trough-guided TDM. The results of this study indicated that trough-guided monitoring resulted in a higher percentage of time in a subtherapeutic range. This study also found that the first AUC/MIC calculated was within therapeutic range more often than the first trough level collected.
These results indicate that AUC/MIC-guided TDM may be more effective than trough-guided TDM in the veteran population. However, while AUC/MIC-guided TDM may be more effective with regards to time in therapeutic range and time to therapeutic range, this study did not indicate any safety benefit of AUC/MIC-guided over trough-guided TDM with regards to AKI incidence. Our data indicate that AUC/MIC-guided TDM increases the amount of time in the therapeutic range compared with trough-guided TDM and is not more nephrotoxic. The findings of this study support the recommendation to transition to the use of AUC/MIC-guided TDM of vancomycin in the veteran population.
Acknowledgments
This material is the result of work supported with the use of facilities and resources from the Sioux Falls Veterans Affairs Health Care System.
1. Gallagher J, MacDougall C. Glycopeptides and short-acting lipoglycopeptides In: Antibiotics Simplified. Jones & Bartlett Learning; 2018.
2. Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
3. Hermsen ED, Hanson M, Sankaranarayanan J, Stoner JA, Florescu MC, Rupp ME. Clinical outcomes and nephrotoxicity associated with vancomycin trough concentrations during treatment of deep-seated infections. Expert Opin Drug Saf. 2010;9(1):9-14. doi:10.1517/14740330903413514
4. Poston-Blahnik A, Moenster R. Association between vancomycin area under the curve and nephrotoxicity: a single center, retrospective cohort study in a veteran population. Open Forum Infect Dis. 2021;8(5):ofab094. Published 2021 Mar 12. doi:10.1093/ofid/ofab094
5. Rybak M, Lomaestro B, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009;66(1):82-98. doi:10.2146/ajhp080434
6. Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004;43(13):925-942. doi:10.2165/00003088-200443130-00005
7. Gyamlani G, Potukuchi PK, Thomas F, et al. Vancomycin-Associated Acute Kidney Injury in a Large Veteran Population. Am J Nephrol. 2019;49(2):133-142. doi:10.1159/000496484
8. Neely MN, Kato L, Youn G, et al. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018;62(2):e02042-17. Published 2018 Jan 25. doi:10.1128/AAC.02042-17
9. Prabaker KK, Tran TP, Pratummas T, Goetz MB, Graber CJ. Elevated vancomycin trough is not associated with nephrotoxicity among inpatient veterans. J Hosp Med. 2012;7(2):91-97. doi:10.1002/jhm.946
10. Patel N, Stornelli N, Sangiovanni RJ, Huang DB, Lodise TP. Effect of vancomycin-associated acute kidney injury on incidence of 30-day readmissions among hospitalized Veterans Affairs patients with skin and skin structure infections. Antimicrob Agents Chemother. 2020;64(10):e01268-20. Published 2020 Sep 21. doi:10.1128/AAC.01268-20
11. Acute Kidney Injury Work Group. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney Int. 2012;2(suppl 1):1-138.
12. Pai MP, Neely M, Rodvold KA, Lodise TP. Innovative approaches to optimizing the delivery of vancomycin in individual patients. Adv Drug Deliv Rev. 2014;77:50-57. doi:10.1016/j.addr.2014.05.016
1. Gallagher J, MacDougall C. Glycopeptides and short-acting lipoglycopeptides In: Antibiotics Simplified. Jones & Bartlett Learning; 2018.
2. Rybak MJ, Le J, Lodise TP, et al. Therapeutic monitoring of vancomycin for serious methicillin-resistant Staphylococcus aureus infections: a revised consensus guideline and review by the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2020;77(11):835-864. doi:10.1093/ajhp/zxaa036
3. Hermsen ED, Hanson M, Sankaranarayanan J, Stoner JA, Florescu MC, Rupp ME. Clinical outcomes and nephrotoxicity associated with vancomycin trough concentrations during treatment of deep-seated infections. Expert Opin Drug Saf. 2010;9(1):9-14. doi:10.1517/14740330903413514
4. Poston-Blahnik A, Moenster R. Association between vancomycin area under the curve and nephrotoxicity: a single center, retrospective cohort study in a veteran population. Open Forum Infect Dis. 2021;8(5):ofab094. Published 2021 Mar 12. doi:10.1093/ofid/ofab094
5. Rybak M, Lomaestro B, Rotschafer JC, et al. Therapeutic monitoring of vancomycin in adult patients: a consensus review of the American Society of Health-System Pharmacists, the Infectious Diseases Society of America, and the Society of Infectious Diseases Pharmacists. Am J Health Syst Pharm. 2009;66(1):82-98. doi:10.2146/ajhp080434
6. Moise-Broder PA, Forrest A, Birmingham MC, Schentag JJ. Pharmacodynamics of vancomycin and other antimicrobials in patients with Staphylococcus aureus lower respiratory tract infections. Clin Pharmacokinet. 2004;43(13):925-942. doi:10.2165/00003088-200443130-00005
7. Gyamlani G, Potukuchi PK, Thomas F, et al. Vancomycin-Associated Acute Kidney Injury in a Large Veteran Population. Am J Nephrol. 2019;49(2):133-142. doi:10.1159/000496484
8. Neely MN, Kato L, Youn G, et al. Prospective Trial on the Use of Trough Concentration versus Area under the Curve To Determine Therapeutic Vancomycin Dosing. Antimicrob Agents Chemother. 2018;62(2):e02042-17. Published 2018 Jan 25. doi:10.1128/AAC.02042-17
9. Prabaker KK, Tran TP, Pratummas T, Goetz MB, Graber CJ. Elevated vancomycin trough is not associated with nephrotoxicity among inpatient veterans. J Hosp Med. 2012;7(2):91-97. doi:10.1002/jhm.946
10. Patel N, Stornelli N, Sangiovanni RJ, Huang DB, Lodise TP. Effect of vancomycin-associated acute kidney injury on incidence of 30-day readmissions among hospitalized Veterans Affairs patients with skin and skin structure infections. Antimicrob Agents Chemother. 2020;64(10):e01268-20. Published 2020 Sep 21. doi:10.1128/AAC.01268-20
11. Acute Kidney Injury Work Group. Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Acute Kidney Injury. Kidney Int. 2012;2(suppl 1):1-138.
12. Pai MP, Neely M, Rodvold KA, Lodise TP. Innovative approaches to optimizing the delivery of vancomycin in individual patients. Adv Drug Deliv Rev. 2014;77:50-57. doi:10.1016/j.addr.2014.05.016
COVID leading cause of death among law enforcement for third year
A new report says 70 officers died of COVID-related causes after getting the virus while on the job. The number is down dramatically from 2021, when 405 officer deaths were attributed to COVID.
The annual count was published Wednesday by the National Law Enforcement Officers Memorial Fund.
In total, 226 officers died in the line of duty in 2022, which is a decrease of 61% from 2021.
The decrease “is almost entirely related to the significant reduction in COVID-19 deaths,” the report stated. The authors said the decline was likely due to “reduced infection rates and the broad availability and use of vaccinations.”
Reported deaths included federal, state, tribal, and local law enforcement officers.
Firearms-related fatalities were the second-leading cause of death among officers, with 64 in 2022. That count sustains a 21% increase seen in 2021, up from the decade-long average of 53 firearms-related deaths annually from 2010 to 2020.
Traffic-related causes ranked third for cause of death in 2022, accounting for 56 deaths.
“While overall line-of-duty deaths are trending down, the continuing trend of greater-than-average firearms-related deaths continues to be a serious concern,” Marcia Ferranto, the organization’s chief executive officer, said in a news release. “Using and reporting on this data allows us to highlight the continuing cost of maintaining our democracy, regrettably measured in the lives of the many law enforcement professionals who sacrifice everything fulfilling their promise to serve and protect.”
A version of this article first appeared on WebMD.com.
A new report says 70 officers died of COVID-related causes after getting the virus while on the job. The number is down dramatically from 2021, when 405 officer deaths were attributed to COVID.
The annual count was published Wednesday by the National Law Enforcement Officers Memorial Fund.
In total, 226 officers died in the line of duty in 2022, which is a decrease of 61% from 2021.
The decrease “is almost entirely related to the significant reduction in COVID-19 deaths,” the report stated. The authors said the decline was likely due to “reduced infection rates and the broad availability and use of vaccinations.”
Reported deaths included federal, state, tribal, and local law enforcement officers.
Firearms-related fatalities were the second-leading cause of death among officers, with 64 in 2022. That count sustains a 21% increase seen in 2021, up from the decade-long average of 53 firearms-related deaths annually from 2010 to 2020.
Traffic-related causes ranked third for cause of death in 2022, accounting for 56 deaths.
“While overall line-of-duty deaths are trending down, the continuing trend of greater-than-average firearms-related deaths continues to be a serious concern,” Marcia Ferranto, the organization’s chief executive officer, said in a news release. “Using and reporting on this data allows us to highlight the continuing cost of maintaining our democracy, regrettably measured in the lives of the many law enforcement professionals who sacrifice everything fulfilling their promise to serve and protect.”
A version of this article first appeared on WebMD.com.
A new report says 70 officers died of COVID-related causes after getting the virus while on the job. The number is down dramatically from 2021, when 405 officer deaths were attributed to COVID.
The annual count was published Wednesday by the National Law Enforcement Officers Memorial Fund.
In total, 226 officers died in the line of duty in 2022, which is a decrease of 61% from 2021.
The decrease “is almost entirely related to the significant reduction in COVID-19 deaths,” the report stated. The authors said the decline was likely due to “reduced infection rates and the broad availability and use of vaccinations.”
Reported deaths included federal, state, tribal, and local law enforcement officers.
Firearms-related fatalities were the second-leading cause of death among officers, with 64 in 2022. That count sustains a 21% increase seen in 2021, up from the decade-long average of 53 firearms-related deaths annually from 2010 to 2020.
Traffic-related causes ranked third for cause of death in 2022, accounting for 56 deaths.
“While overall line-of-duty deaths are trending down, the continuing trend of greater-than-average firearms-related deaths continues to be a serious concern,” Marcia Ferranto, the organization’s chief executive officer, said in a news release. “Using and reporting on this data allows us to highlight the continuing cost of maintaining our democracy, regrettably measured in the lives of the many law enforcement professionals who sacrifice everything fulfilling their promise to serve and protect.”
A version of this article first appeared on WebMD.com.
Long COVID comes into focus, showing older patients fare worse
These findings help define long COVID, guiding providers and patients through the recovery process, Barak Mizrahi, MSc, of KI Research Institute, Kfar Malal, Israel, and colleagues reported.
“To provide efficient continuous treatment and prevent adverse events related to potential long term effects and delayed symptoms of COVID-19, determining the magnitude and severity of this phenomenon and distinguishing it from similar clinical manifestations that occur normally or following infections with other pathogens is essential,” the investigators wrote in The BMJ.
To this end, they conducted a retrospective, nationwide cohort study involving 1,913,234 people who took a polymerase chain reaction test for SARS-CoV-2 between March 1, 2020, and Oct. 1, 2021. They compared a range of long-term outcomes at different intervals post infection, and compared these trends across subgroups sorted by age, sex, and variant. Outcomes ranged broadly, including respiratory disorders, cough, arthralgia, weakness, hair loss, and others.
The investigators compared hazard ratios for each of these outcomes among patients who tested positive versus those who tested negative at three intervals after testing: 30-90 days, 30-180 days, and 180-360 days. Statistically significant differences in the risks of these outcomes between infected versus uninfected groups suggested that COVID was playing a role.
“The health outcomes that represent long COVID showed a significant increase in both early and late phases,” the investigators wrote. These outcomes included anosmia and dysgeusia, cognitive impairment, dyspnea, weakness, and palpitations. In contrast, chest pain, myalgia, arthralgia, cough, and dizziness were associated with patients who were in the early phase, but not the late phase of long COVID.
“Vaccinated patients with a breakthrough SARS-CoV-2 infection had a lower risk for dyspnea and similar risk for other outcomes compared with unvaccinated infected patients,” the investigators noted.
For the long COVID outcomes, plots of risk differences over time showed that symptoms tended to get milder or resolve within a few months to a year. Patients 41-60 years were most likely to be impacted by long COVID outcomes, and show least improvement at 1 year, compared with other age groups.
“We believe that these findings will shed light on what is ‘long COVID’, support patients and doctors, and facilitate better and more efficient care,” Mr. Mizrahi and coauthor Maytal Bivas-Benita, PhD said in a joint written comment. “Primary care physicians (and patients) will now more clearly understand what are the symptoms that might be related to COVID and for how long they might linger. This would help physicians monitor the patients efficiently, ease their patients’ concerns and navigate a more efficient disease management.”
They suggested that the findings should hold consistent for future variants, although they could not “rule out the possibility of the emergence of new and more severe variants which will be more virulent and cause a more severe illness.”
One “major limitation” of the study, according to Monica Verduzco-Gutierrez, MD, a physiatrist and professor and chair of rehabilitation medicine at the University of Texas Health Science Center, San Antonio, is the lack of data for fatigue and dysautonomia, which are “the major presentations” that she sees in her long COVID clinic.
“The authors of the article focus on the primary damage being related to the lungs, though we know this is a systemic disease beyond the respiratory system, with endothelial dysfunction and immune dysregulation,” Dr. Verduzco-Gutierrez, who is also director of COVID recovery at the University of Texas Health Science Center, said in an interview.
Although it was reassuring to see that younger adults with long COVID trended toward improvement, she noted that patients 41-60 years “still had pretty significant symptoms” after 12 months.
“That [age group comprises] probably the majority of my patients that I’m seeing in the long COVID clinic,” Dr. Verduzco-Gutierrez said. “If you look at the whole thing, it looks better, but then when you drill down to that age group where you’re seeing patients, then it’s not.”
Dr. Verduzco-Gutierrez is so busy managing patients with long COVID that new appointments in her clinic are now delayed until May 31, so most patients will remain under the care of their primary care providers. She recommended that these physicians follow guidance from the American Academy of Physical Medicine and Rehabilitation, who offer consensus statements based on clinical characteristics, with separate recommendations for pediatric patients.
Our understanding of long COVID will continue to improve, and with it, available recommendations, she predicted, but further advances will require persistent effort.
“I think no matter what this [study] shows us, more research is needed,” Dr. Verduzco-Gutierrez said. “We can’t just forget about it, just because there is a population of people who get better. What about the ones who don’t?”
The investigators and Dr. Verduzco-Gutierrez disclosed no conflicts of interest.
These findings help define long COVID, guiding providers and patients through the recovery process, Barak Mizrahi, MSc, of KI Research Institute, Kfar Malal, Israel, and colleagues reported.
“To provide efficient continuous treatment and prevent adverse events related to potential long term effects and delayed symptoms of COVID-19, determining the magnitude and severity of this phenomenon and distinguishing it from similar clinical manifestations that occur normally or following infections with other pathogens is essential,” the investigators wrote in The BMJ.
To this end, they conducted a retrospective, nationwide cohort study involving 1,913,234 people who took a polymerase chain reaction test for SARS-CoV-2 between March 1, 2020, and Oct. 1, 2021. They compared a range of long-term outcomes at different intervals post infection, and compared these trends across subgroups sorted by age, sex, and variant. Outcomes ranged broadly, including respiratory disorders, cough, arthralgia, weakness, hair loss, and others.
The investigators compared hazard ratios for each of these outcomes among patients who tested positive versus those who tested negative at three intervals after testing: 30-90 days, 30-180 days, and 180-360 days. Statistically significant differences in the risks of these outcomes between infected versus uninfected groups suggested that COVID was playing a role.
“The health outcomes that represent long COVID showed a significant increase in both early and late phases,” the investigators wrote. These outcomes included anosmia and dysgeusia, cognitive impairment, dyspnea, weakness, and palpitations. In contrast, chest pain, myalgia, arthralgia, cough, and dizziness were associated with patients who were in the early phase, but not the late phase of long COVID.
“Vaccinated patients with a breakthrough SARS-CoV-2 infection had a lower risk for dyspnea and similar risk for other outcomes compared with unvaccinated infected patients,” the investigators noted.
For the long COVID outcomes, plots of risk differences over time showed that symptoms tended to get milder or resolve within a few months to a year. Patients 41-60 years were most likely to be impacted by long COVID outcomes, and show least improvement at 1 year, compared with other age groups.
“We believe that these findings will shed light on what is ‘long COVID’, support patients and doctors, and facilitate better and more efficient care,” Mr. Mizrahi and coauthor Maytal Bivas-Benita, PhD said in a joint written comment. “Primary care physicians (and patients) will now more clearly understand what are the symptoms that might be related to COVID and for how long they might linger. This would help physicians monitor the patients efficiently, ease their patients’ concerns and navigate a more efficient disease management.”
They suggested that the findings should hold consistent for future variants, although they could not “rule out the possibility of the emergence of new and more severe variants which will be more virulent and cause a more severe illness.”
One “major limitation” of the study, according to Monica Verduzco-Gutierrez, MD, a physiatrist and professor and chair of rehabilitation medicine at the University of Texas Health Science Center, San Antonio, is the lack of data for fatigue and dysautonomia, which are “the major presentations” that she sees in her long COVID clinic.
“The authors of the article focus on the primary damage being related to the lungs, though we know this is a systemic disease beyond the respiratory system, with endothelial dysfunction and immune dysregulation,” Dr. Verduzco-Gutierrez, who is also director of COVID recovery at the University of Texas Health Science Center, said in an interview.
Although it was reassuring to see that younger adults with long COVID trended toward improvement, she noted that patients 41-60 years “still had pretty significant symptoms” after 12 months.
“That [age group comprises] probably the majority of my patients that I’m seeing in the long COVID clinic,” Dr. Verduzco-Gutierrez said. “If you look at the whole thing, it looks better, but then when you drill down to that age group where you’re seeing patients, then it’s not.”
Dr. Verduzco-Gutierrez is so busy managing patients with long COVID that new appointments in her clinic are now delayed until May 31, so most patients will remain under the care of their primary care providers. She recommended that these physicians follow guidance from the American Academy of Physical Medicine and Rehabilitation, who offer consensus statements based on clinical characteristics, with separate recommendations for pediatric patients.
Our understanding of long COVID will continue to improve, and with it, available recommendations, she predicted, but further advances will require persistent effort.
“I think no matter what this [study] shows us, more research is needed,” Dr. Verduzco-Gutierrez said. “We can’t just forget about it, just because there is a population of people who get better. What about the ones who don’t?”
The investigators and Dr. Verduzco-Gutierrez disclosed no conflicts of interest.
These findings help define long COVID, guiding providers and patients through the recovery process, Barak Mizrahi, MSc, of KI Research Institute, Kfar Malal, Israel, and colleagues reported.
“To provide efficient continuous treatment and prevent adverse events related to potential long term effects and delayed symptoms of COVID-19, determining the magnitude and severity of this phenomenon and distinguishing it from similar clinical manifestations that occur normally or following infections with other pathogens is essential,” the investigators wrote in The BMJ.
To this end, they conducted a retrospective, nationwide cohort study involving 1,913,234 people who took a polymerase chain reaction test for SARS-CoV-2 between March 1, 2020, and Oct. 1, 2021. They compared a range of long-term outcomes at different intervals post infection, and compared these trends across subgroups sorted by age, sex, and variant. Outcomes ranged broadly, including respiratory disorders, cough, arthralgia, weakness, hair loss, and others.
The investigators compared hazard ratios for each of these outcomes among patients who tested positive versus those who tested negative at three intervals after testing: 30-90 days, 30-180 days, and 180-360 days. Statistically significant differences in the risks of these outcomes between infected versus uninfected groups suggested that COVID was playing a role.
“The health outcomes that represent long COVID showed a significant increase in both early and late phases,” the investigators wrote. These outcomes included anosmia and dysgeusia, cognitive impairment, dyspnea, weakness, and palpitations. In contrast, chest pain, myalgia, arthralgia, cough, and dizziness were associated with patients who were in the early phase, but not the late phase of long COVID.
“Vaccinated patients with a breakthrough SARS-CoV-2 infection had a lower risk for dyspnea and similar risk for other outcomes compared with unvaccinated infected patients,” the investigators noted.
For the long COVID outcomes, plots of risk differences over time showed that symptoms tended to get milder or resolve within a few months to a year. Patients 41-60 years were most likely to be impacted by long COVID outcomes, and show least improvement at 1 year, compared with other age groups.
“We believe that these findings will shed light on what is ‘long COVID’, support patients and doctors, and facilitate better and more efficient care,” Mr. Mizrahi and coauthor Maytal Bivas-Benita, PhD said in a joint written comment. “Primary care physicians (and patients) will now more clearly understand what are the symptoms that might be related to COVID and for how long they might linger. This would help physicians monitor the patients efficiently, ease their patients’ concerns and navigate a more efficient disease management.”
They suggested that the findings should hold consistent for future variants, although they could not “rule out the possibility of the emergence of new and more severe variants which will be more virulent and cause a more severe illness.”
One “major limitation” of the study, according to Monica Verduzco-Gutierrez, MD, a physiatrist and professor and chair of rehabilitation medicine at the University of Texas Health Science Center, San Antonio, is the lack of data for fatigue and dysautonomia, which are “the major presentations” that she sees in her long COVID clinic.
“The authors of the article focus on the primary damage being related to the lungs, though we know this is a systemic disease beyond the respiratory system, with endothelial dysfunction and immune dysregulation,” Dr. Verduzco-Gutierrez, who is also director of COVID recovery at the University of Texas Health Science Center, said in an interview.
Although it was reassuring to see that younger adults with long COVID trended toward improvement, she noted that patients 41-60 years “still had pretty significant symptoms” after 12 months.
“That [age group comprises] probably the majority of my patients that I’m seeing in the long COVID clinic,” Dr. Verduzco-Gutierrez said. “If you look at the whole thing, it looks better, but then when you drill down to that age group where you’re seeing patients, then it’s not.”
Dr. Verduzco-Gutierrez is so busy managing patients with long COVID that new appointments in her clinic are now delayed until May 31, so most patients will remain under the care of their primary care providers. She recommended that these physicians follow guidance from the American Academy of Physical Medicine and Rehabilitation, who offer consensus statements based on clinical characteristics, with separate recommendations for pediatric patients.
Our understanding of long COVID will continue to improve, and with it, available recommendations, she predicted, but further advances will require persistent effort.
“I think no matter what this [study] shows us, more research is needed,” Dr. Verduzco-Gutierrez said. “We can’t just forget about it, just because there is a population of people who get better. What about the ones who don’t?”
The investigators and Dr. Verduzco-Gutierrez disclosed no conflicts of interest.
FROM THE BMJ
Strong support to provide DAA therapy to all patients with HCV
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
, a large, real-world analysis finds.
Improved outcomes were seen among patients without cirrhosis, those with compensated cirrhosis, and those with existing liver decompensation, the authors noted.
The findings highlight a “substantial need to provide DAA therapy to all patients with HCV, regardless of disease stage or financial status,” wrote Mindie Nguyen, MD, of Stanford University Medical Center, Palo Alto, Calif., and coinvestigators.
“Additional national efforts are needed to reach and treat U.S. population groups that are underinsured or not insured, incarcerated and otherwise marginalized, such as users of illicit drugs, who are also at higher risk of disease complication and reinfection,” they said.
The study was published online in JAMA Internal Medicine.
CHC and its complications are associated with high rates of illness and death. However, large-scale data on long-term liver and nonliver effects of DAA treatment are limited.
For their study, Dr. Nguyen and colleagues analyzed administrative claims data from 2010 to 2021 for 245,596 adults with CHC, of whom 40,654 had received one or more DAA therapies (without interferon) and 204,942 had not received treatment.
DAA-treated patients were slightly older than their untreated peers (mean age, 59.9 years, vs. 58.5 years) and were more likely to be male (62% vs. 58%) and White (59% vs. 57%), and to have diabetes (26% vs. 25%) and cirrhosis (44% vs. 29%).
For liver outcomes, DAA therapy was associated with a lower incidence of decompensation (28.2 vs. 40.8 per 1,000 person-years; P < .001) and hepatocellular carcinoma (HCC) in compensated cirrhosis (20.1 vs. 41.8; P < .001).
For nonliver outcomes, DAA treatment was associated with a lower incidence of diabetes (30.2 vs. 37.2 per 1,000 person-years; P < .001) and chronic kidney disease (31.1 vs. 34.1; P < .001).
The all-cause mortality rate per 1,000 person-years was 36.5 in the DAA-treated group, vs. 64.7 in the untreated group (P < .001).
In multivariable regression analysis, DAA treatment was independently associated with a significant decrease in the risk for HCC (adjusted hazard ratio [aHR], 0.73), decompensation (aHR, 0.36), diabetes (aHR, 0.74), chronic kidney disease (aHR, 0.81), cardiovascular disease (aHR, 0.90), nonliver cancer (aHR, 0.89), and mortality (aHR, 0.43).
The 57% lower mortality rate observed among DAA-treated vs. untreated patients aligns with a large French study of adults with CHC.
“Because HCV treatment with a DAA regimen is well tolerated for nearly all patients, we believe these findings provide further support for universal HCV treatment coverage for all patients affected by HCV,” Dr. Nguyen and colleagues wrote.
The strengths of this study are its large sample of DAA-treated and untreated patients from diverse racial and ethnic groups from across the United States and from diverse practice settings (not just tertiary centers).
One limitation is that the study cohort included only patients covered by private insurance; therefore, the findings may not be generalizable to individuals who are underinsured or not insured. Miscoding and misclassification are also possible with large claims databases.
Support for the study was provided by Stanford University and the Stanford Center for Population Health Sciences. Dr. Nguyen has received institutional grants and advisory board fees from Gilead Sciences outside the submitted work.
A version of this article first appeared on Medscape.com.
FROM JAMA INTERNAL MEDICINE
FDA OKs Tdap shot in pregnancy to protect newborns from pertussis
The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.
The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.
The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.
The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.
Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.
One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”
The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.
The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.
The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.
The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.
Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.
One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”
The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.
The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.
The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.
The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.
Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.
One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.
“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”