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Children and COVID: Vaccinations, new cases both rising
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
COVID-19 vaccine initiations rose in U.S. children for the second consecutive week, but new pediatric cases jumped by 64% in just 1 week, according to new data.
the American Academy of Pediatrics and the Children’s Hospital Association said in their weekly COVID-19 report.
“After decreases in weekly reported cases over the past couple of months, in July we have seen steady increases in cases added to the cumulative total,” the AAP noted. In this latest reversal of COVID fortunes, the steady increase in new cases is in its fourth consecutive week since hitting a low of 8,447 in late June.
As of July 22, the total number of reported cases was over 4.12 million in 49 states, the District of Columbia, New York City, Puerto Rico, and Guam, and there have been 349 deaths in children in the 46 jurisdictions reporting age distributions of COVID-19 deaths, the AAP and CHA said in their report.
Meanwhile, over 9.3 million children received at least one dose of COVID vaccine as of July 26, according to the Centers for Disease Control and Prevention.
Vaccine initiation rose for the second week in a row after falling for several weeks as 301,000 children aged 12-15 years and almost 115,000 children aged 16-17 got their first dose during the week ending July 26. Children aged 12-15 represented 14.1% (up from 13.5% a week before) of all first vaccinations and 16- to 17-year-olds were 5.4% (up from 5.1%) of all vaccine initiators, according to the CDC’s COVID Data Tracker.
Just over 37% of all 12- to 15-year-olds have received at least one dose of the Pfizer-BioNTech vaccine since the CDC approved its use for children under age 16 in May, and almost 28% are fully vaccinated. Use in children aged 16-17 started earlier (December 2020), and 48% of that age group have received a first dose and over 39% have completed the vaccine regimen, the CDC said.
Mayo, Cleveland Clinics top latest U.S. News & World Report hospital rankings
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.
This year’s expanded report debuts new ratings for seven “important procedures and conditions to help patients, in consultation with their doctors, narrow down their choice of hospital based on the specific type of care they need,” Ben Harder, managing editor and chief of health analysis, said in a news release.
With new ratings for myocardial infarction, stroke, hip fracture, and back surgery (spinal fusion), the report now ranks 17 procedures and conditions.
Also new to the 2021 report, which marks the 32nd edition, is a look at racial disparities in health care and the inclusion of health equity measures alongside the hospital rankings.
The new measures examine whether the patients each hospital has treated reflect the racial and ethnic diversity of the surrounding community, among other aspects of health equity.
“At roughly four out of five hospitals, we found that the community’s minority residents were underrepresented among patients receiving services such as joint replacement, cancer surgery and common heart procedures,” Mr. Harder said.
“Against this backdrop, however, we found important exceptions – hospitals that provide care to a disproportionate share of their community’s minority residents. These metrics are just a beginning; we aim to expand on our measurement of health equity in the future,” Mr. Harder added.
Mayo and Cleveland Clinic remain tops
Following the Mayo Clinic, the Cleveland Clinic once again takes the No. 2 spot in the magazine’s latest annual honor roll of best hospitals, which highlights hospitals that deliver exceptional treatment across multiple areas of care.
UCLA Medical Center, Los Angeles, holds the No. 3 spot in 2021. In 2020, UCLA Medical Center and New York–Presbyterian Hospital–Columbia and Cornell, New York, sat in a tie at No. 4.
In 2021, Johns Hopkins Hospital, Baltimore, which held the No. 3 spot in 2020, drops to No. 4, while Massachusetts General Hospital in Boston takes the No. 5 spot, up from No. 6 in 2020.
Rounding out the top 10 (in order) are Cedars-Sinai Medical Center, Los Angeles; New York–Presbyterian Hospital–Columbia and Cornell, New York; NYU Langone Hospitals, New York; UCSF Medical Center, San Francisco; and Northwestern Memorial Hospital, Chicago.
2021-2022 Best Hospitals honor roll
1. Mayo Clinic, Rochester, Minn.
2. Cleveland Clinic, Cleveland
3. UCLA Medical Center, Los Angeles
4. Johns Hopkins Hospital, Baltimore
5. Massachusetts General Hospital, Boston
6. Cedars-Sinai Medical Center, San Francisco
7. New York–Presbyterian Hospital–Columbia and Cornell, New York
8. NYU Langone Hospitals, New York
9. UCSF Medical Center, San Francisco
10. Northwestern Memorial Hospital, Chicago
11. University of Michigan Hospitals–Michigan Medicine, Ann Arbor.
12. Stanford Health Care–Stanford Hospital, Palo Alto, Calif.
13. Hospitals of the University of Pennsylvania–Penn Presbyterian, Philadelphia
14. Brigham and Women’s Hospital, Boston
15. Mayo Clinic–Phoenix, Phoenix
16. Houston Methodist Hospital, Houston
17. (tie) Barnes-Jewish Hospital, St. Louis
17. (tie) Mount Sinai Hospital, New York Rush University Medical Center, Chicago
19. Rush University Medical Center, Chicago
20. Vanderbilt University Medical Center, Nashville, Tenn.
For the 2021-2022 rankings and ratings, the magazine compared more than 4,750 hospitals nationwide in 15 specialties and 17 procedures and conditions.
At least 2,039 hospitals received a high performance rating in at least one of the services rated; 11 hospitals received high performance in all 17. A total of 175 hospitals were nationally ranked in at least one specialty
For specialty rankings, the University of Texas MD Anderson Cancer Center continues to hold the No. 1 spot in cancer care, the Hospital for Special Surgery continues to be No. 1 in orthopedics, and the Cleveland Clinic continues to be No. 1 in cardiology and heart surgery.
Top five for cancer
1. University of Texas MD Anderson Cancer Center, Houston
2. Memorial Sloan Kettering Cancer Center, New York
3. Mayo Clinic, Rochester, Minn.
4. Dana-Farber/Brigham & Women’s Cancer Center, Boston
5. Cleveland Clinic, Cleveland
Top five for cardiology and heart surgery
1. Cleveland Clinic, Cleveland
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. New York–Presbyterian Hospital–Columbia and Cornell, New York
5. NYU Langone Hospitals, New York
Top five for orthopedics
1. Hospital for Special Surgery, New York
2. Mayo Clinic, Rochester, Minn.
3. Cedars-Sinai Medical Center, Los Angeles
4. NYU Langone Orthopedic Hospital, New York
5. UCLA Medical Center, Los Angeles
The magazine noted that data for the 2021-2022 Best Hospitals rankings and ratings were not affected by the COVID-19 pandemic, which began after the end of the data collection period.
The methodologies used in determining the rankings are based largely on objective measures, such as risk-adjusted survival, discharge-to-home rates, volume, and quality of nursing, among other care-related indicators.
The full report is available online.
A version of this article first appeared on Medscape.com.
AMA, 55 other groups urge health care vax mandate
As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other
This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.
That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.
The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.
The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.
A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.
More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.
The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
Ethical commitment
The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”
In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.
The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.
Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.
While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”
There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.
But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.
“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.
“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.
A version of this article first appeared on Medscape.com.
As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other
This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.
That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.
The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.
The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.
A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.
More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.
The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
Ethical commitment
The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”
In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.
The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.
Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.
While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”
There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.
But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.
“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.
“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.
A version of this article first appeared on Medscape.com.
As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other
This injunction, issued July 26, covers everyone in healthcare, Emanuel Ezekiel, MD, PhD, chair of the department of medical ethics and health policy at the University of Pennsylvania, Philadelphia, and the organizer of the joint statement, said in an interview.
That includes not only hospitals, but also physician offices, ambulatory surgery centers, home care agencies, skilled nursing facilities, pharmacies, laboratories, and imaging centers, he said.
The exhortation to get vaccinated also extends to federal and state healthcare facilities, including those of the military health system — TRICARE and the Department of Veterans Affairs — which instituted a mandate the same day.
The American Hospital Association (AHA) and other hospital groups recently said they supported hospitals and health systems that required their personnel to get vaccinated. Several dozen healthcare organizations have already done so, including some of the nation’s largest health systems.
A substantial fraction of U.S. healthcare workers have not yet gotten vaccinated, although how many are unvaccinated is unclear. An analysis by WebMD and Medscape Medical News estimated that 25% of hospital workers who had contact with patients were unvaccinated at the end of May.
More than 38% of nursing workers were not fully vaccinated by July 11, according to an analysis of Centers for Medicare & Medicaid Services data by LeadingAge, which was cited by the Washington Post. And more than 40% of nursing home employees have not been fully vaccinated, according to the Centers for Disease Control and Prevention.
The joint statement did not give any indication of how many employees of physician practices have failed to get COVID shots. However, a recent AMA survey shows that 96% of physicians have been fully vaccinated.
Ethical commitment
The main reason for vaccine mandates, according to the healthcare associations’ statement, is “the ethical commitment to put patients as well as residents of long-term care facilities first and take all steps necessary to ensure their health and well-being.”
In addition, the statement noted, vaccination can protect healthcare workers and their families from getting COVID-19.
The statement also pointed out that many healthcare and long-term care organizations already require vaccinations for influenza, hepatitis B, and pertussis.
Workers who have certain medical conditions should be exempt from the vaccination mandates, the statement added.
While recognizing the “historical mistrust of health care institutions” among some healthcare workers, the statement said, “We must continue to address workers’ concerns, engage with marginalized populations, and work with trusted messengers to improve vaccine acceptance.”
There has been some skepticism about the legality of requiring healthcare workers to get vaccinated as a condition of employment, partly because the U.S. Food and Drug Administration has not yet fully authorized any of the COVID-19 vaccines.
But in June, a federal judge turned down a legal challenge to Houston Methodist’s vaccination mandate.
“It is critical that all people in the health care workforce get vaccinated against COVID-19 for the safety of our patients and our colleagues. With more than 300 million doses administered in the United States and nearly 4 billion doses administered worldwide, we know the vaccines are safe and highly effective at preventing severe illness and death from COVID-19.
“Increased vaccinations among health care personnel will not only reduce the spread of COVID-19 but also reduce the harmful toll this virus is taking within the health care workforce and those we are striving to serve,” Susan Bailey, MD, immediate past president of the AMA, said in a news release.
A version of this article first appeared on Medscape.com.
Vaccine breakthrough cases rising with Delta: Here’s what that means
At a recent town hall meeting in Cincinnati, President Joe Biden was asked about COVID-19 cases, hospitalizations, and deaths rising in response to the Delta variant.
Touting the importance of vaccination, “We have a pandemic for those who haven’t gotten a vaccination. It’s that basic, that simple,” President Biden said at the event, which was broadcast live on CNN.
“If you’re vaccinated, you’re not going to be hospitalized, not going to the ICU unit, and not going to die,” he said, adding “you’re not going to get COVID if you have these vaccinations.”
Unfortunately, it’s not so simple. Fully vaccinated people continue to be well protected against severe disease and death, even with Delta, Because of that, many experts continue to advise caution, even if fully vaccinated.
“I was disappointed,” Leana Wen, MD, MSc, an emergency physician and visiting professor of health policy and management at George Washington University’s Milken School of Public Health in Washington, told CNN in response to the president’s statement.
“I actually thought he was answering questions as if it were a month ago. He’s not really meeting the realities of what’s happening on the ground,” she said. “I think he may have led people astray.”
Vaccines still work
Recent cases support Dr. Wen’s claim. Fully vaccinated Olympic athletes, wedding guests, healthcare workers, and even White House staff have recently tested positive. So what gives?
The vast majority of these illnesses are mild, and public health officials say they are to be expected.
“The vaccines were designed to keep us out of the hospital and to keep us from dying. That was the whole purpose of the vaccine and they’re even more successful than we anticipated,” says William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville.
As good as they are, these shots aren’t perfect. Their protection differs from person to person depending on age and underlying health. People with immune function that’s weakened because of age or a health condition can still become seriously ill, and, in very rare cases, die after vaccination.
When people are infected with Delta, they carry approximately 1,000 times more virus compared with previous versions of the virus, according to a recent study. All that virus can overwhelm even the strong protection from the vaccines.
“Three months ago, breakthroughs didn’t occur nearly at this rate because there was just so much less virus exposure in the community,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis.
Breakthroughs by the numbers
In Los Angeles County, where 69% of residents over age 12 have been fully vaccinated, COVID-19 cases are rising, and so, too, are cases that break through the protection of the vaccine.
In June, fully vaccinated people accounted for 20%, or 1 in 5, COVID cases in the county, which is the most populous in the United States. The increase mirrors Delta’s rise. The proportion of breakthrough cases is up from 11% in May, 5% in April, and 2% in March, according to the Los Angeles County Department of Public Health.
In the United Kingdom, which is collecting the best information on infections caused by variants, the estimated effectiveness of the vaccines to prevent an illness that causes symptoms dropped by about 10 points against Delta compared with Alpha (or B.1.1.7).
After two doses, vaccines prevent symptomatic infection about 79% of the time against Delta, according to data compiled by Public Health England. They are still highly effective at preventing hospitalization, 96% after two doses.
Out of 229,218 COVID infections in the United Kingdom between February and July 19, 28,773 — or 12.5% — were in fully vaccinated people. Of those breakthrough infections, 1,101, or 3.8%, required a visit to an emergency room, according to Public Health England. Just 474, or 2.9%, of fully vaccinated people required hospital admission, and 229, or less than 1%, died.
Unanswered questions
One of the biggest questions about breakthrough cases is how often people who have it may pass the virus to others.
“We know the vaccine reduces the likelihood of carrying the virus and the amount of virus you would carry,” Dr. Wen told CNN. But we don’t yet know whether a vaccinated person with a breakthrough infection may still be contagious to others.
For that reason, the Centers for Disease Control and Prevention says that fully vaccinated people still need to be tested if they have symptoms and shouldn’t be out in public for at least 10 days after a positive test.
How should fully vaccinated people behave? That depends a lot on their underlying health and whether or not they have vulnerable people around them.
If you’re older or immunocompromised, Dr. Schaffner recommends what he calls the “belt-and-suspenders approach,” in other words, do everything you can to stay safe.
“Get vaccinated for sure, but since we can’t be absolutely certain that the vaccines are going to be optimally protective and you are particularly susceptible to serious disease, you would be well advised to adopt at least one and perhaps more of the other mitigation measures,” he said.
These include wearing a mask, social distancing, making sure your spaces are well ventilated, and not spending prolonged periods of time indoors in crowded places.
Taking young children to visit vaccinated, elderly grandparents demands extra caution, again, with Delta circulating, particularly as they go back to school and start mixing with other kids.
Dr. Schaffner recommends explaining the ground rules before the visit: Hugs around the waist. No kissing. Wearing a mask while indoors with them.
Other important unanswered questions are whether breakthrough infections can lead to prolonged symptoms, or “long covid.” Most experts think that’s less likely in vaccinated people.
And Dr. Osterholm said it will be important to see whether there’s anything unusual about the breakthrough cases happening in the community.
“I think some of us have been challenged by the number of clusters that we’ve seen,” he said. “I think that really needs to be examined more.”
A version of this article first appeared on Medscape.com.
At a recent town hall meeting in Cincinnati, President Joe Biden was asked about COVID-19 cases, hospitalizations, and deaths rising in response to the Delta variant.
Touting the importance of vaccination, “We have a pandemic for those who haven’t gotten a vaccination. It’s that basic, that simple,” President Biden said at the event, which was broadcast live on CNN.
“If you’re vaccinated, you’re not going to be hospitalized, not going to the ICU unit, and not going to die,” he said, adding “you’re not going to get COVID if you have these vaccinations.”
Unfortunately, it’s not so simple. Fully vaccinated people continue to be well protected against severe disease and death, even with Delta, Because of that, many experts continue to advise caution, even if fully vaccinated.
“I was disappointed,” Leana Wen, MD, MSc, an emergency physician and visiting professor of health policy and management at George Washington University’s Milken School of Public Health in Washington, told CNN in response to the president’s statement.
“I actually thought he was answering questions as if it were a month ago. He’s not really meeting the realities of what’s happening on the ground,” she said. “I think he may have led people astray.”
Vaccines still work
Recent cases support Dr. Wen’s claim. Fully vaccinated Olympic athletes, wedding guests, healthcare workers, and even White House staff have recently tested positive. So what gives?
The vast majority of these illnesses are mild, and public health officials say they are to be expected.
“The vaccines were designed to keep us out of the hospital and to keep us from dying. That was the whole purpose of the vaccine and they’re even more successful than we anticipated,” says William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville.
As good as they are, these shots aren’t perfect. Their protection differs from person to person depending on age and underlying health. People with immune function that’s weakened because of age or a health condition can still become seriously ill, and, in very rare cases, die after vaccination.
When people are infected with Delta, they carry approximately 1,000 times more virus compared with previous versions of the virus, according to a recent study. All that virus can overwhelm even the strong protection from the vaccines.
“Three months ago, breakthroughs didn’t occur nearly at this rate because there was just so much less virus exposure in the community,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis.
Breakthroughs by the numbers
In Los Angeles County, where 69% of residents over age 12 have been fully vaccinated, COVID-19 cases are rising, and so, too, are cases that break through the protection of the vaccine.
In June, fully vaccinated people accounted for 20%, or 1 in 5, COVID cases in the county, which is the most populous in the United States. The increase mirrors Delta’s rise. The proportion of breakthrough cases is up from 11% in May, 5% in April, and 2% in March, according to the Los Angeles County Department of Public Health.
In the United Kingdom, which is collecting the best information on infections caused by variants, the estimated effectiveness of the vaccines to prevent an illness that causes symptoms dropped by about 10 points against Delta compared with Alpha (or B.1.1.7).
After two doses, vaccines prevent symptomatic infection about 79% of the time against Delta, according to data compiled by Public Health England. They are still highly effective at preventing hospitalization, 96% after two doses.
Out of 229,218 COVID infections in the United Kingdom between February and July 19, 28,773 — or 12.5% — were in fully vaccinated people. Of those breakthrough infections, 1,101, or 3.8%, required a visit to an emergency room, according to Public Health England. Just 474, or 2.9%, of fully vaccinated people required hospital admission, and 229, or less than 1%, died.
Unanswered questions
One of the biggest questions about breakthrough cases is how often people who have it may pass the virus to others.
“We know the vaccine reduces the likelihood of carrying the virus and the amount of virus you would carry,” Dr. Wen told CNN. But we don’t yet know whether a vaccinated person with a breakthrough infection may still be contagious to others.
For that reason, the Centers for Disease Control and Prevention says that fully vaccinated people still need to be tested if they have symptoms and shouldn’t be out in public for at least 10 days after a positive test.
How should fully vaccinated people behave? That depends a lot on their underlying health and whether or not they have vulnerable people around them.
If you’re older or immunocompromised, Dr. Schaffner recommends what he calls the “belt-and-suspenders approach,” in other words, do everything you can to stay safe.
“Get vaccinated for sure, but since we can’t be absolutely certain that the vaccines are going to be optimally protective and you are particularly susceptible to serious disease, you would be well advised to adopt at least one and perhaps more of the other mitigation measures,” he said.
These include wearing a mask, social distancing, making sure your spaces are well ventilated, and not spending prolonged periods of time indoors in crowded places.
Taking young children to visit vaccinated, elderly grandparents demands extra caution, again, with Delta circulating, particularly as they go back to school and start mixing with other kids.
Dr. Schaffner recommends explaining the ground rules before the visit: Hugs around the waist. No kissing. Wearing a mask while indoors with them.
Other important unanswered questions are whether breakthrough infections can lead to prolonged symptoms, or “long covid.” Most experts think that’s less likely in vaccinated people.
And Dr. Osterholm said it will be important to see whether there’s anything unusual about the breakthrough cases happening in the community.
“I think some of us have been challenged by the number of clusters that we’ve seen,” he said. “I think that really needs to be examined more.”
A version of this article first appeared on Medscape.com.
At a recent town hall meeting in Cincinnati, President Joe Biden was asked about COVID-19 cases, hospitalizations, and deaths rising in response to the Delta variant.
Touting the importance of vaccination, “We have a pandemic for those who haven’t gotten a vaccination. It’s that basic, that simple,” President Biden said at the event, which was broadcast live on CNN.
“If you’re vaccinated, you’re not going to be hospitalized, not going to the ICU unit, and not going to die,” he said, adding “you’re not going to get COVID if you have these vaccinations.”
Unfortunately, it’s not so simple. Fully vaccinated people continue to be well protected against severe disease and death, even with Delta, Because of that, many experts continue to advise caution, even if fully vaccinated.
“I was disappointed,” Leana Wen, MD, MSc, an emergency physician and visiting professor of health policy and management at George Washington University’s Milken School of Public Health in Washington, told CNN in response to the president’s statement.
“I actually thought he was answering questions as if it were a month ago. He’s not really meeting the realities of what’s happening on the ground,” she said. “I think he may have led people astray.”
Vaccines still work
Recent cases support Dr. Wen’s claim. Fully vaccinated Olympic athletes, wedding guests, healthcare workers, and even White House staff have recently tested positive. So what gives?
The vast majority of these illnesses are mild, and public health officials say they are to be expected.
“The vaccines were designed to keep us out of the hospital and to keep us from dying. That was the whole purpose of the vaccine and they’re even more successful than we anticipated,” says William Schaffner, MD, an infectious disease expert at Vanderbilt University in Nashville.
As good as they are, these shots aren’t perfect. Their protection differs from person to person depending on age and underlying health. People with immune function that’s weakened because of age or a health condition can still become seriously ill, and, in very rare cases, die after vaccination.
When people are infected with Delta, they carry approximately 1,000 times more virus compared with previous versions of the virus, according to a recent study. All that virus can overwhelm even the strong protection from the vaccines.
“Three months ago, breakthroughs didn’t occur nearly at this rate because there was just so much less virus exposure in the community,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota in Minneapolis.
Breakthroughs by the numbers
In Los Angeles County, where 69% of residents over age 12 have been fully vaccinated, COVID-19 cases are rising, and so, too, are cases that break through the protection of the vaccine.
In June, fully vaccinated people accounted for 20%, or 1 in 5, COVID cases in the county, which is the most populous in the United States. The increase mirrors Delta’s rise. The proportion of breakthrough cases is up from 11% in May, 5% in April, and 2% in March, according to the Los Angeles County Department of Public Health.
In the United Kingdom, which is collecting the best information on infections caused by variants, the estimated effectiveness of the vaccines to prevent an illness that causes symptoms dropped by about 10 points against Delta compared with Alpha (or B.1.1.7).
After two doses, vaccines prevent symptomatic infection about 79% of the time against Delta, according to data compiled by Public Health England. They are still highly effective at preventing hospitalization, 96% after two doses.
Out of 229,218 COVID infections in the United Kingdom between February and July 19, 28,773 — or 12.5% — were in fully vaccinated people. Of those breakthrough infections, 1,101, or 3.8%, required a visit to an emergency room, according to Public Health England. Just 474, or 2.9%, of fully vaccinated people required hospital admission, and 229, or less than 1%, died.
Unanswered questions
One of the biggest questions about breakthrough cases is how often people who have it may pass the virus to others.
“We know the vaccine reduces the likelihood of carrying the virus and the amount of virus you would carry,” Dr. Wen told CNN. But we don’t yet know whether a vaccinated person with a breakthrough infection may still be contagious to others.
For that reason, the Centers for Disease Control and Prevention says that fully vaccinated people still need to be tested if they have symptoms and shouldn’t be out in public for at least 10 days after a positive test.
How should fully vaccinated people behave? That depends a lot on their underlying health and whether or not they have vulnerable people around them.
If you’re older or immunocompromised, Dr. Schaffner recommends what he calls the “belt-and-suspenders approach,” in other words, do everything you can to stay safe.
“Get vaccinated for sure, but since we can’t be absolutely certain that the vaccines are going to be optimally protective and you are particularly susceptible to serious disease, you would be well advised to adopt at least one and perhaps more of the other mitigation measures,” he said.
These include wearing a mask, social distancing, making sure your spaces are well ventilated, and not spending prolonged periods of time indoors in crowded places.
Taking young children to visit vaccinated, elderly grandparents demands extra caution, again, with Delta circulating, particularly as they go back to school and start mixing with other kids.
Dr. Schaffner recommends explaining the ground rules before the visit: Hugs around the waist. No kissing. Wearing a mask while indoors with them.
Other important unanswered questions are whether breakthrough infections can lead to prolonged symptoms, or “long covid.” Most experts think that’s less likely in vaccinated people.
And Dr. Osterholm said it will be important to see whether there’s anything unusual about the breakthrough cases happening in the community.
“I think some of us have been challenged by the number of clusters that we’ve seen,” he said. “I think that really needs to be examined more.”
A version of this article first appeared on Medscape.com.
CDC panel updates info on rare side effect after J&J vaccine
Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine,
The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.
Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.
The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.
The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.
To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.
Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group.
So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot. Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.
Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men.
Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.
The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.
Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
Good against variants
Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.
“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.
The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.
Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection.
It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.
Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.
“We will have a better view of the clinical efficacy in the coming weeks,” he said.
A version of this article first appeared on Medscape.com.
Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine,
The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.
Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.
The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.
The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.
To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.
Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group.
So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot. Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.
Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men.
Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.
The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.
Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
Good against variants
Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.
“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.
The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.
Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection.
It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.
Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.
“We will have a better view of the clinical efficacy in the coming weeks,” he said.
A version of this article first appeared on Medscape.com.
Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine,
The company also presented new data suggesting that the shots generate strong immune responses against circulating variants and that antibodies generated by the vaccine stay elevated for at least 8 months.
Members of the Advisory Committee on Immunization Practices (ACIP) did not vote, but discussed and affirmed their support for recent decisions by the Food and Drug Administration and CDC to update patient information about the very low risk of GBS that appears to be associated with the vaccine, but to continue offering the vaccine to people in the United States.
The Johnson & Johnson shot has been a minor player in the U.S. vaccination campaign, accounting for less than 4% of all vaccine doses given in this country. Still, the single-dose inoculation, which doesn’t require ultra-cold storage, has been important for reaching people in rural areas, through mobile clinics, at colleges and primary care offices, and in vulnerable populations – those who are incarcerated or homeless.
The FDA says it has received reports of 100 cases of GBS after the Johnson & Johnson vaccine in its Vaccine Adverse Event Reporting System database through the end of June. The cases are still under investigation.
To date, more than 12 million doses of the vaccine have been administered, making the rate of GBS 8.1 cases for every million doses administered.
Although it is still extremely rare, that’s above the expected background rate of GBS of 1.6 cases for every million people, said Grace Lee, MD, a Stanford, Calif., pediatrician who chairs the ACIP’s Vaccine Safety Technical Work Group.
So far, most GBS cases (61%) have been among men. The midpoint age of the cases was 57 years. The average time to onset was 14 days, and 98% of cases occurred within 42 days of the shot. Facial paralysis has been associated with an estimated 30%-50% of cases. One person, who had heart failure, high blood pressure, and diabetes, has died.
Still, the benefits of the vaccine far outweigh its risks. For every million doses given to people over age 50, the vaccine prevents nearly 7,500 COVID-19 hospitalizations and nearly 100 deaths in women, and more than 13,000 COVID-19 hospitalizations and more than 2,400 deaths in men.
Rates of GBS after the mRNA vaccines made by Pfizer and Moderna were around 1 case for every 1 million doses given, which is not above the rate that would be expected without vaccination.
The link to the Johnson & Johnson vaccine prompted the FDA to add a warning to the vaccine’s patient safety information on July 12.
Also in July, the European Medicines Agency recommended a similar warning for the product information of the AstraZeneca vaccine Vaxzevria, which relies on similar technology.
Good against variants
Johnson & Johnson also presented new information showing its vaccine maintained high levels of neutralizing antibodies against four of the so-called “variants of concern” – Alpha, Gamma, Beta, and Delta. The protection generated by the vaccine lasted for at least 8 months after the shot, the company said.
“We’re still learning about the duration of protection and the breadth of coverage against this evolving variant landscape for each of the authorized vaccines,” said Mathai Mammen, MD, PhD, global head of research and development at Janssen, the company that makes the vaccine for J&J.
The company also said that its vaccine generated very strong T-cell responses. T cells destroy infected cells and, along with antibodies, are an important part of the body’s immune response.
Antibody levels and T-cell responses are markers for immunity. Measuring these levels isn’t the same as proving that shots can fend off an infection.
It’s still unclear exactly which component of the immune response is most important for fighting off COVID-19.
Dr. Mammen said the companies are still gathering that clinical data, and would present it soon.
“We will have a better view of the clinical efficacy in the coming weeks,” he said.
A version of this article first appeared on Medscape.com.
Sharp decrease in opioid access for dying U.S. cancer patients
There has been a sharp decrease in access to opioids during the past decade, and many patients are going to emergency departments for pain treatment.
Overall, during the study period (2007-2017), there was a 34% reduction in the number of opioid prescriptions filled per patient and a 38% reduction in the total dose of opioids filled near the end of life.
There was a dramatic drop in the use of long-acting opioids, which can provide patients with more consistent pain relief and are important for managing severe cancer pain. The investigators’ results show that during the study period, the number of long-acting opioid prescriptions filled per patient fell by 50%.
“We do believe that the decline in cancer patients’ access to opioids near the end of life is likely attributable to the efforts to curtail opioid misuse,” commented lead author Andrea Enzinger, MD, a medical oncologist at Dana-Farber Cancer Institute, Boston.
The study was published online July 22 in the Journal of Clinical Oncology.
“The study provides fascinating data that support our clinical observations,” said Marcin Chwistek, MD, FAAHPM, director of the supportive oncology and palliative care program at Fox Chase Cancer Center, Philadelphia, who was asked for comment. “Primarily, we have noticed a heightened reluctance on the parts of patients with cancer, including those with advanced cancer, to take opioids in general.”
Many factors involved
The crisis of opioid misuse and abuse led to the implementation of regulations to curb inappropriate prescribing. But these restrictions on opioid prescribing may have unintended consequences for patients with advanced, incurable malignancies who are experiencing pain.
“Many but not all opioid regulations specifically exclude cancer patients,” said Dr. Enzinger. “However, the cumulative effect of these regulations may have had a chilling effect on providers’ comfort or willingness to prescribe opioids, even for cancer pain.”
She said in an interview that the prescribing of opioids has become much more difficult. Prescribers are often required to sign an opioid agreement with patients prior to providing them with opioids. Health care professionals may need to use a two-factor authentication to prescribe, and prescribers in 49 of 50 U.S. states are required to check electronic prescription drug monitoring programs prior to providing the prescription.
“After the medications are prescribed, insurance companies require prior-authorization paperwork before filling the medications, particularly for long-acting opioids or high-dose opioids,” Dr. Enzinger said. “These barriers pile up and make the whole process onerous and time consuming.”
Patient factors may also have contributed to the decline in use.
“Cancer patients are often very hesitant to use opioids to treat their pain, as they worry about becoming addicted or being labeled a ‘pill seeker,’” she explained. “Also, the added regulations, such as requirements for prior authorization paperwork, signing opioid agreements, and so on, may add to the stigma of opioid therapy and send a message to patients that these medications are inherently dangerous.”
Dr. Enzinger added that there are legitimate reasons why patients may not want to use opioids and that these should be respected. “But addiction risk should really not weigh into the decisions about pain management for patients who are dying from cancer,” she said.
Decline in opioid dose and prescriptions
Dr. Enzinger and colleagues used administrative data from the Centers for Medicare & Medicaid Services to identify 270,632 Medicare fee-for-service patients who had cancers that were associated with poor prognoses and who died from 2007 to 2017. During this period, the opioid crisis was first recognized. There followed legislative reforms and subsequent declines in population-based opioid prescribing.
Among the patients in the study, the most common cancers were lung, colorectal, pancreatic, prostate, and breast cancers; 166,962 patients (61.7%) were enrolled in hospice before death. This percentage increased from 57.1% in 2007 to 66.2% in 2017 (P for trend < .001).
From 2007 to 2017, the proportion of patients filling greater than or equal to 1 opioid prescriptions declined from 42.0% to 35.5%. The proportion declined faster from 2012-2017 than from 2007-2011.
The proportion of patients who filled prescriptions for long-acting opioids dropped from 18.1% to 11.5%. Here again, the decline was faster from 2012-2017 than from 2007-2011. Prescriptions for strong short-acting opioids declined from 31.7% to 28.5%. Prescribing was initially stable from 2007-2011 and began to decline in 2012. Conversely, prescriptions for weak short-acting opioids dropped from 8.4% to 6.5% from 2007-2011 and then stabilized after 2012.
The mean daily dose fell 24.5%, from 85.6 morphine milligram equivalents per day (MMED) to 64.6 MMED. Overall, the total amount of opioids prescribed per decedent fell 38.0%, from 1,075 MMEs per person to 666 MMEs.
At the same time, the proportion of patients who visited EDs increased 50.8%, from 13.2% to 19.9%.
Experts weigh in
Approached for an independent comment, Amit Barochia, MD, a hematologist/oncologist with Health First Medical Group, Titusville, Fla., commented that the decline could be due, in part, to greater vigilance and awareness by physicians in light of more stringent requirements and of federal and state regulations. “Some physicians are avoiding prescribing opioids due to more regulations and requirements as well, which is routing patients to the ER for pain relief,” he said.
Dr. Barochia agreed that some of the decline could be due to patient factors. “I do think that some of the patients are hesitant about considering opioid use for better pain relief, in part due to fear of addiction as well as complications arising from their use,” he said. “This is likely resulting from more awareness in the community about their adverse effects.
“That awareness could come from aggressive media coverage as well as social media,” he continued. “It is also true that there is a difficulty in getting authorization for certain opioid products, which is delaying the onset of a proper pain regimen that would help to provide adequate pain relief early on.”
For patients with advanced cancer, earlier referral to palliative care would be beneficial, Dr. Barochia pointed out, because this would allow for a more in-depth discussion about pain in addition to addressing the physical and mental symptoms associated with cancer.
Fox Chase Cancer Center’s Dr. Chwistek noted that patients and their caregivers are often apprehensive about the potential adverse effects of opioids, because they often hear about community-based opioid overdoses and are fearful of taking the medications. “Additionally, it has become increasingly challenging to fill opioid prescriptions at local pharmacies, due to quantity limitations, ubiquitous need for prior authorizations, and stigma,” he said.
The fear of addiction is often brought up by the patients during clinic visits, and insurers and pharmacies have imposed many limits on opioid prescribing. “Most of these can be overcome with prior authorizations, but not always, and prior authorizations are time consuming, confusing, and very frustrating for patients,” he said in an interview.
These findings suggest that not enough patients are getting optimal palliative care. “One of the primary tenets of palliative care is optimal symptom control, including pain,” said Dr. Chwistek. “Palliative care teams have the experience and insight needed to help patients overcome the barriers to appropriate pain control. Education, support, and advocacy are critical to ensure that patients’ pain is appropriately addressed.”
The study was funded by a grant from the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services.
A version of this article first appeared on Medscape.com.
There has been a sharp decrease in access to opioids during the past decade, and many patients are going to emergency departments for pain treatment.
Overall, during the study period (2007-2017), there was a 34% reduction in the number of opioid prescriptions filled per patient and a 38% reduction in the total dose of opioids filled near the end of life.
There was a dramatic drop in the use of long-acting opioids, which can provide patients with more consistent pain relief and are important for managing severe cancer pain. The investigators’ results show that during the study period, the number of long-acting opioid prescriptions filled per patient fell by 50%.
“We do believe that the decline in cancer patients’ access to opioids near the end of life is likely attributable to the efforts to curtail opioid misuse,” commented lead author Andrea Enzinger, MD, a medical oncologist at Dana-Farber Cancer Institute, Boston.
The study was published online July 22 in the Journal of Clinical Oncology.
“The study provides fascinating data that support our clinical observations,” said Marcin Chwistek, MD, FAAHPM, director of the supportive oncology and palliative care program at Fox Chase Cancer Center, Philadelphia, who was asked for comment. “Primarily, we have noticed a heightened reluctance on the parts of patients with cancer, including those with advanced cancer, to take opioids in general.”
Many factors involved
The crisis of opioid misuse and abuse led to the implementation of regulations to curb inappropriate prescribing. But these restrictions on opioid prescribing may have unintended consequences for patients with advanced, incurable malignancies who are experiencing pain.
“Many but not all opioid regulations specifically exclude cancer patients,” said Dr. Enzinger. “However, the cumulative effect of these regulations may have had a chilling effect on providers’ comfort or willingness to prescribe opioids, even for cancer pain.”
She said in an interview that the prescribing of opioids has become much more difficult. Prescribers are often required to sign an opioid agreement with patients prior to providing them with opioids. Health care professionals may need to use a two-factor authentication to prescribe, and prescribers in 49 of 50 U.S. states are required to check electronic prescription drug monitoring programs prior to providing the prescription.
“After the medications are prescribed, insurance companies require prior-authorization paperwork before filling the medications, particularly for long-acting opioids or high-dose opioids,” Dr. Enzinger said. “These barriers pile up and make the whole process onerous and time consuming.”
Patient factors may also have contributed to the decline in use.
“Cancer patients are often very hesitant to use opioids to treat their pain, as they worry about becoming addicted or being labeled a ‘pill seeker,’” she explained. “Also, the added regulations, such as requirements for prior authorization paperwork, signing opioid agreements, and so on, may add to the stigma of opioid therapy and send a message to patients that these medications are inherently dangerous.”
Dr. Enzinger added that there are legitimate reasons why patients may not want to use opioids and that these should be respected. “But addiction risk should really not weigh into the decisions about pain management for patients who are dying from cancer,” she said.
Decline in opioid dose and prescriptions
Dr. Enzinger and colleagues used administrative data from the Centers for Medicare & Medicaid Services to identify 270,632 Medicare fee-for-service patients who had cancers that were associated with poor prognoses and who died from 2007 to 2017. During this period, the opioid crisis was first recognized. There followed legislative reforms and subsequent declines in population-based opioid prescribing.
Among the patients in the study, the most common cancers were lung, colorectal, pancreatic, prostate, and breast cancers; 166,962 patients (61.7%) were enrolled in hospice before death. This percentage increased from 57.1% in 2007 to 66.2% in 2017 (P for trend < .001).
From 2007 to 2017, the proportion of patients filling greater than or equal to 1 opioid prescriptions declined from 42.0% to 35.5%. The proportion declined faster from 2012-2017 than from 2007-2011.
The proportion of patients who filled prescriptions for long-acting opioids dropped from 18.1% to 11.5%. Here again, the decline was faster from 2012-2017 than from 2007-2011. Prescriptions for strong short-acting opioids declined from 31.7% to 28.5%. Prescribing was initially stable from 2007-2011 and began to decline in 2012. Conversely, prescriptions for weak short-acting opioids dropped from 8.4% to 6.5% from 2007-2011 and then stabilized after 2012.
The mean daily dose fell 24.5%, from 85.6 morphine milligram equivalents per day (MMED) to 64.6 MMED. Overall, the total amount of opioids prescribed per decedent fell 38.0%, from 1,075 MMEs per person to 666 MMEs.
At the same time, the proportion of patients who visited EDs increased 50.8%, from 13.2% to 19.9%.
Experts weigh in
Approached for an independent comment, Amit Barochia, MD, a hematologist/oncologist with Health First Medical Group, Titusville, Fla., commented that the decline could be due, in part, to greater vigilance and awareness by physicians in light of more stringent requirements and of federal and state regulations. “Some physicians are avoiding prescribing opioids due to more regulations and requirements as well, which is routing patients to the ER for pain relief,” he said.
Dr. Barochia agreed that some of the decline could be due to patient factors. “I do think that some of the patients are hesitant about considering opioid use for better pain relief, in part due to fear of addiction as well as complications arising from their use,” he said. “This is likely resulting from more awareness in the community about their adverse effects.
“That awareness could come from aggressive media coverage as well as social media,” he continued. “It is also true that there is a difficulty in getting authorization for certain opioid products, which is delaying the onset of a proper pain regimen that would help to provide adequate pain relief early on.”
For patients with advanced cancer, earlier referral to palliative care would be beneficial, Dr. Barochia pointed out, because this would allow for a more in-depth discussion about pain in addition to addressing the physical and mental symptoms associated with cancer.
Fox Chase Cancer Center’s Dr. Chwistek noted that patients and their caregivers are often apprehensive about the potential adverse effects of opioids, because they often hear about community-based opioid overdoses and are fearful of taking the medications. “Additionally, it has become increasingly challenging to fill opioid prescriptions at local pharmacies, due to quantity limitations, ubiquitous need for prior authorizations, and stigma,” he said.
The fear of addiction is often brought up by the patients during clinic visits, and insurers and pharmacies have imposed many limits on opioid prescribing. “Most of these can be overcome with prior authorizations, but not always, and prior authorizations are time consuming, confusing, and very frustrating for patients,” he said in an interview.
These findings suggest that not enough patients are getting optimal palliative care. “One of the primary tenets of palliative care is optimal symptom control, including pain,” said Dr. Chwistek. “Palliative care teams have the experience and insight needed to help patients overcome the barriers to appropriate pain control. Education, support, and advocacy are critical to ensure that patients’ pain is appropriately addressed.”
The study was funded by a grant from the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services.
A version of this article first appeared on Medscape.com.
There has been a sharp decrease in access to opioids during the past decade, and many patients are going to emergency departments for pain treatment.
Overall, during the study period (2007-2017), there was a 34% reduction in the number of opioid prescriptions filled per patient and a 38% reduction in the total dose of opioids filled near the end of life.
There was a dramatic drop in the use of long-acting opioids, which can provide patients with more consistent pain relief and are important for managing severe cancer pain. The investigators’ results show that during the study period, the number of long-acting opioid prescriptions filled per patient fell by 50%.
“We do believe that the decline in cancer patients’ access to opioids near the end of life is likely attributable to the efforts to curtail opioid misuse,” commented lead author Andrea Enzinger, MD, a medical oncologist at Dana-Farber Cancer Institute, Boston.
The study was published online July 22 in the Journal of Clinical Oncology.
“The study provides fascinating data that support our clinical observations,” said Marcin Chwistek, MD, FAAHPM, director of the supportive oncology and palliative care program at Fox Chase Cancer Center, Philadelphia, who was asked for comment. “Primarily, we have noticed a heightened reluctance on the parts of patients with cancer, including those with advanced cancer, to take opioids in general.”
Many factors involved
The crisis of opioid misuse and abuse led to the implementation of regulations to curb inappropriate prescribing. But these restrictions on opioid prescribing may have unintended consequences for patients with advanced, incurable malignancies who are experiencing pain.
“Many but not all opioid regulations specifically exclude cancer patients,” said Dr. Enzinger. “However, the cumulative effect of these regulations may have had a chilling effect on providers’ comfort or willingness to prescribe opioids, even for cancer pain.”
She said in an interview that the prescribing of opioids has become much more difficult. Prescribers are often required to sign an opioid agreement with patients prior to providing them with opioids. Health care professionals may need to use a two-factor authentication to prescribe, and prescribers in 49 of 50 U.S. states are required to check electronic prescription drug monitoring programs prior to providing the prescription.
“After the medications are prescribed, insurance companies require prior-authorization paperwork before filling the medications, particularly for long-acting opioids or high-dose opioids,” Dr. Enzinger said. “These barriers pile up and make the whole process onerous and time consuming.”
Patient factors may also have contributed to the decline in use.
“Cancer patients are often very hesitant to use opioids to treat their pain, as they worry about becoming addicted or being labeled a ‘pill seeker,’” she explained. “Also, the added regulations, such as requirements for prior authorization paperwork, signing opioid agreements, and so on, may add to the stigma of opioid therapy and send a message to patients that these medications are inherently dangerous.”
Dr. Enzinger added that there are legitimate reasons why patients may not want to use opioids and that these should be respected. “But addiction risk should really not weigh into the decisions about pain management for patients who are dying from cancer,” she said.
Decline in opioid dose and prescriptions
Dr. Enzinger and colleagues used administrative data from the Centers for Medicare & Medicaid Services to identify 270,632 Medicare fee-for-service patients who had cancers that were associated with poor prognoses and who died from 2007 to 2017. During this period, the opioid crisis was first recognized. There followed legislative reforms and subsequent declines in population-based opioid prescribing.
Among the patients in the study, the most common cancers were lung, colorectal, pancreatic, prostate, and breast cancers; 166,962 patients (61.7%) were enrolled in hospice before death. This percentage increased from 57.1% in 2007 to 66.2% in 2017 (P for trend < .001).
From 2007 to 2017, the proportion of patients filling greater than or equal to 1 opioid prescriptions declined from 42.0% to 35.5%. The proportion declined faster from 2012-2017 than from 2007-2011.
The proportion of patients who filled prescriptions for long-acting opioids dropped from 18.1% to 11.5%. Here again, the decline was faster from 2012-2017 than from 2007-2011. Prescriptions for strong short-acting opioids declined from 31.7% to 28.5%. Prescribing was initially stable from 2007-2011 and began to decline in 2012. Conversely, prescriptions for weak short-acting opioids dropped from 8.4% to 6.5% from 2007-2011 and then stabilized after 2012.
The mean daily dose fell 24.5%, from 85.6 morphine milligram equivalents per day (MMED) to 64.6 MMED. Overall, the total amount of opioids prescribed per decedent fell 38.0%, from 1,075 MMEs per person to 666 MMEs.
At the same time, the proportion of patients who visited EDs increased 50.8%, from 13.2% to 19.9%.
Experts weigh in
Approached for an independent comment, Amit Barochia, MD, a hematologist/oncologist with Health First Medical Group, Titusville, Fla., commented that the decline could be due, in part, to greater vigilance and awareness by physicians in light of more stringent requirements and of federal and state regulations. “Some physicians are avoiding prescribing opioids due to more regulations and requirements as well, which is routing patients to the ER for pain relief,” he said.
Dr. Barochia agreed that some of the decline could be due to patient factors. “I do think that some of the patients are hesitant about considering opioid use for better pain relief, in part due to fear of addiction as well as complications arising from their use,” he said. “This is likely resulting from more awareness in the community about their adverse effects.
“That awareness could come from aggressive media coverage as well as social media,” he continued. “It is also true that there is a difficulty in getting authorization for certain opioid products, which is delaying the onset of a proper pain regimen that would help to provide adequate pain relief early on.”
For patients with advanced cancer, earlier referral to palliative care would be beneficial, Dr. Barochia pointed out, because this would allow for a more in-depth discussion about pain in addition to addressing the physical and mental symptoms associated with cancer.
Fox Chase Cancer Center’s Dr. Chwistek noted that patients and their caregivers are often apprehensive about the potential adverse effects of opioids, because they often hear about community-based opioid overdoses and are fearful of taking the medications. “Additionally, it has become increasingly challenging to fill opioid prescriptions at local pharmacies, due to quantity limitations, ubiquitous need for prior authorizations, and stigma,” he said.
The fear of addiction is often brought up by the patients during clinic visits, and insurers and pharmacies have imposed many limits on opioid prescribing. “Most of these can be overcome with prior authorizations, but not always, and prior authorizations are time consuming, confusing, and very frustrating for patients,” he said in an interview.
These findings suggest that not enough patients are getting optimal palliative care. “One of the primary tenets of palliative care is optimal symptom control, including pain,” said Dr. Chwistek. “Palliative care teams have the experience and insight needed to help patients overcome the barriers to appropriate pain control. Education, support, and advocacy are critical to ensure that patients’ pain is appropriately addressed.”
The study was funded by a grant from the Agency for Healthcare Research and Quality of the U.S. Department of Health and Human Services.
A version of this article first appeared on Medscape.com.
Common parasite now tied to impaired cognitive function
Investigators reviewed and conducted a meta-analysis of 13 studies that encompassed more than 13,000 healthy adults and found a modest but significant association between T. gondii seropositivity and impaired performance on cognitive tests of processing speed, working memory, short-term verbal memory, and executive function. The average age of the persons in the studies was close to 50 years.
“Our findings show that T. gondii could have a negative but small effect on cognition,” study investigator Arjen Sutterland, MD, of the Amsterdam Neuroscience Research Institute and the Amsterdam Institute for Infection and Immunity, University of Amsterdam, said in an interview.
The study was published online July 14, 2021, in JAMA Psychiatry.
Mental illness link
T. gondii is “an intracellular parasite that produces quiescent infection in approximately 30% of humans worldwide,” the authors wrote. The parasite that causes the infection not only settles in muscle and liver tissue but also can cross the blood-brain barrier and settle quiescently in brain tissue. It can be spread through contact with cat feces or by consuming contaminated meat.
Previous research has shown that neurocognitive changes associated with toxoplasmosis can occur in humans, and meta-analyses suggest an association with neuropsychiatric disorders. Some research has also tied T. gondii infection to increased motor vehicle crashes and suicide attempts.
Dr. Sutterland said he had been inspired by the work of E. Fuller Torrey and Bob Yolken, who proposed the connection between T. gondii and schizophrenia.
Some years ago, Dr. Sutterland and his group analyzed the mental health consequences of T. gondii infection and found “several interesting associations,” but they were unable to “rule out reverse causation – i.e., people with mental health disorders more often get these infections – as well as determine the impact on the population of this common infection.”
For the current study, the investigators analyzed studies that examined specifically cognitive functioning in otherwise healthy individuals in relation to T. gondii infection, “because reverse causation would be less likely in this population and a grasp of global impact would become more clear.”
The researchers conducted a literature search of studies conducted through June 7, 2019, that analyzed cognitive function among healthy participants for whom data on T. gondii seropositivity were available.
A total of 13 studies (n = 13,289 participants; mean age, 46.7 years; 49.6% male) were used in the review and meta-analysis. Some of the studies enrolled a healthy population sample; other studies compared participants with and those without psychiatric disorders. From these, the researchers extracted only the data concerning healthy participants.
The studies analyzed four cognitive domains: processing speed, working memory, short-term verbal memory, and executive functioning.
All cognitive domains affected
Of all the participants, 22.6% had antibodies against T. gondii.
Participants who were seropositive for T. gondii had less favorable functioning in all cognitive domains, with “small but significant” differences. 
The researchers conducted a meta-regression analysis of mean age in the analysis of executive functioning and found greater effect sizes as age increased (Q = 6.17; R2 = 81%; P = .01).
The studies were of “high quality,” and there was “little suggestion of publication bias was detected,” the authors noted.
“Although the extent of the associations was modest, the ubiquitous prevalence of the quiescent infection worldwide ... suggests that the consequences for cognitive function of the population as a whole may be substantial, although it is difficult to quantify the global impact,” they wrote.
They note that because the studies were cross-sectional in nature, causality cannot be established.
Nevertheless, Dr. Sutterland suggested several possible mechanisms through which T. gondii might affect neurocognition.
“We know the parasite forms cysts in the brain and can influence dopaminergic neurotransmission, which, in turn, affects neurocognition. Alternatively, it is also possible that the immune response to the infection in the brain causes cognitive impairment. This remains an important question to explore further,” he said.
He noted that clinicians can reassure patients who test positive for T. gondii that although the infection can have a negative impact on cognition, the effect is “small.”
Prevention programs warranted
Commenting on the study in an interview, Shawn D. Gale, PhD, associate professor, department of psychology and neuroscience center, Brigham Young University, Provo, Utah, called it a “great meta-analysis.” He noted that his group is researching the subject and has obtained similar findings. A big plus is that the researchers assessed several cognitive domains, not just one.
Although the data showed “mild effects,” the findings could be important on a population level. Because 30% of the world’s population are seropositive for T. gondii, a potentially large number of people are at risk for cognitive impairment, noted Dr. Gale, who was not involved with the study.
“If you look at the United States, perhaps 10%-15% of people might test positive [for T. gondii], but in Germany and France, the number comes closer to 50%, and in other places in the world – especially countries that have a harder time economically – the rates are even higher. So if it can affect cognition, even a small effect is a big deal,” Dr. Gale said.
“I think prevention will be the most important thing, and perhaps down the road, I hope that a vaccine will be considered,” Dr. Gale added.
“These findings indicate that primary prevention of the infection could have substantial global impact on mental health” and that public health programs to prevent T. gondii “are warranted.”
These programs might consist of hygienic measures, especially after human contact with contaminated sources, as well as research into vaccine development.
No source of funding for the study was listed. The authors and Dr. Gale reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators reviewed and conducted a meta-analysis of 13 studies that encompassed more than 13,000 healthy adults and found a modest but significant association between T. gondii seropositivity and impaired performance on cognitive tests of processing speed, working memory, short-term verbal memory, and executive function. The average age of the persons in the studies was close to 50 years.
“Our findings show that T. gondii could have a negative but small effect on cognition,” study investigator Arjen Sutterland, MD, of the Amsterdam Neuroscience Research Institute and the Amsterdam Institute for Infection and Immunity, University of Amsterdam, said in an interview.
The study was published online July 14, 2021, in JAMA Psychiatry.
Mental illness link
T. gondii is “an intracellular parasite that produces quiescent infection in approximately 30% of humans worldwide,” the authors wrote. The parasite that causes the infection not only settles in muscle and liver tissue but also can cross the blood-brain barrier and settle quiescently in brain tissue. It can be spread through contact with cat feces or by consuming contaminated meat.
Previous research has shown that neurocognitive changes associated with toxoplasmosis can occur in humans, and meta-analyses suggest an association with neuropsychiatric disorders. Some research has also tied T. gondii infection to increased motor vehicle crashes and suicide attempts.
Dr. Sutterland said he had been inspired by the work of E. Fuller Torrey and Bob Yolken, who proposed the connection between T. gondii and schizophrenia.
Some years ago, Dr. Sutterland and his group analyzed the mental health consequences of T. gondii infection and found “several interesting associations,” but they were unable to “rule out reverse causation – i.e., people with mental health disorders more often get these infections – as well as determine the impact on the population of this common infection.”
For the current study, the investigators analyzed studies that examined specifically cognitive functioning in otherwise healthy individuals in relation to T. gondii infection, “because reverse causation would be less likely in this population and a grasp of global impact would become more clear.”
The researchers conducted a literature search of studies conducted through June 7, 2019, that analyzed cognitive function among healthy participants for whom data on T. gondii seropositivity were available.
A total of 13 studies (n = 13,289 participants; mean age, 46.7 years; 49.6% male) were used in the review and meta-analysis. Some of the studies enrolled a healthy population sample; other studies compared participants with and those without psychiatric disorders. From these, the researchers extracted only the data concerning healthy participants.
The studies analyzed four cognitive domains: processing speed, working memory, short-term verbal memory, and executive functioning.
All cognitive domains affected
Of all the participants, 22.6% had antibodies against T. gondii.
Participants who were seropositive for T. gondii had less favorable functioning in all cognitive domains, with “small but significant” differences.
The researchers conducted a meta-regression analysis of mean age in the analysis of executive functioning and found greater effect sizes as age increased (Q = 6.17; R2 = 81%; P = .01).
The studies were of “high quality,” and there was “little suggestion of publication bias was detected,” the authors noted.
“Although the extent of the associations was modest, the ubiquitous prevalence of the quiescent infection worldwide ... suggests that the consequences for cognitive function of the population as a whole may be substantial, although it is difficult to quantify the global impact,” they wrote.
They note that because the studies were cross-sectional in nature, causality cannot be established.
Nevertheless, Dr. Sutterland suggested several possible mechanisms through which T. gondii might affect neurocognition.
“We know the parasite forms cysts in the brain and can influence dopaminergic neurotransmission, which, in turn, affects neurocognition. Alternatively, it is also possible that the immune response to the infection in the brain causes cognitive impairment. This remains an important question to explore further,” he said.
He noted that clinicians can reassure patients who test positive for T. gondii that although the infection can have a negative impact on cognition, the effect is “small.”
Prevention programs warranted
Commenting on the study in an interview, Shawn D. Gale, PhD, associate professor, department of psychology and neuroscience center, Brigham Young University, Provo, Utah, called it a “great meta-analysis.” He noted that his group is researching the subject and has obtained similar findings. A big plus is that the researchers assessed several cognitive domains, not just one.
Although the data showed “mild effects,” the findings could be important on a population level. Because 30% of the world’s population are seropositive for T. gondii, a potentially large number of people are at risk for cognitive impairment, noted Dr. Gale, who was not involved with the study.
“If you look at the United States, perhaps 10%-15% of people might test positive [for T. gondii], but in Germany and France, the number comes closer to 50%, and in other places in the world – especially countries that have a harder time economically – the rates are even higher. So if it can affect cognition, even a small effect is a big deal,” Dr. Gale said.
“I think prevention will be the most important thing, and perhaps down the road, I hope that a vaccine will be considered,” Dr. Gale added.
“These findings indicate that primary prevention of the infection could have substantial global impact on mental health” and that public health programs to prevent T. gondii “are warranted.”
These programs might consist of hygienic measures, especially after human contact with contaminated sources, as well as research into vaccine development.
No source of funding for the study was listed. The authors and Dr. Gale reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Investigators reviewed and conducted a meta-analysis of 13 studies that encompassed more than 13,000 healthy adults and found a modest but significant association between T. gondii seropositivity and impaired performance on cognitive tests of processing speed, working memory, short-term verbal memory, and executive function. The average age of the persons in the studies was close to 50 years.
“Our findings show that T. gondii could have a negative but small effect on cognition,” study investigator Arjen Sutterland, MD, of the Amsterdam Neuroscience Research Institute and the Amsterdam Institute for Infection and Immunity, University of Amsterdam, said in an interview.
The study was published online July 14, 2021, in JAMA Psychiatry.
Mental illness link
T. gondii is “an intracellular parasite that produces quiescent infection in approximately 30% of humans worldwide,” the authors wrote. The parasite that causes the infection not only settles in muscle and liver tissue but also can cross the blood-brain barrier and settle quiescently in brain tissue. It can be spread through contact with cat feces or by consuming contaminated meat.
Previous research has shown that neurocognitive changes associated with toxoplasmosis can occur in humans, and meta-analyses suggest an association with neuropsychiatric disorders. Some research has also tied T. gondii infection to increased motor vehicle crashes and suicide attempts.
Dr. Sutterland said he had been inspired by the work of E. Fuller Torrey and Bob Yolken, who proposed the connection between T. gondii and schizophrenia.
Some years ago, Dr. Sutterland and his group analyzed the mental health consequences of T. gondii infection and found “several interesting associations,” but they were unable to “rule out reverse causation – i.e., people with mental health disorders more often get these infections – as well as determine the impact on the population of this common infection.”
For the current study, the investigators analyzed studies that examined specifically cognitive functioning in otherwise healthy individuals in relation to T. gondii infection, “because reverse causation would be less likely in this population and a grasp of global impact would become more clear.”
The researchers conducted a literature search of studies conducted through June 7, 2019, that analyzed cognitive function among healthy participants for whom data on T. gondii seropositivity were available.
A total of 13 studies (n = 13,289 participants; mean age, 46.7 years; 49.6% male) were used in the review and meta-analysis. Some of the studies enrolled a healthy population sample; other studies compared participants with and those without psychiatric disorders. From these, the researchers extracted only the data concerning healthy participants.
The studies analyzed four cognitive domains: processing speed, working memory, short-term verbal memory, and executive functioning.
All cognitive domains affected
Of all the participants, 22.6% had antibodies against T. gondii.
Participants who were seropositive for T. gondii had less favorable functioning in all cognitive domains, with “small but significant” differences.
The researchers conducted a meta-regression analysis of mean age in the analysis of executive functioning and found greater effect sizes as age increased (Q = 6.17; R2 = 81%; P = .01).
The studies were of “high quality,” and there was “little suggestion of publication bias was detected,” the authors noted.
“Although the extent of the associations was modest, the ubiquitous prevalence of the quiescent infection worldwide ... suggests that the consequences for cognitive function of the population as a whole may be substantial, although it is difficult to quantify the global impact,” they wrote.
They note that because the studies were cross-sectional in nature, causality cannot be established.
Nevertheless, Dr. Sutterland suggested several possible mechanisms through which T. gondii might affect neurocognition.
“We know the parasite forms cysts in the brain and can influence dopaminergic neurotransmission, which, in turn, affects neurocognition. Alternatively, it is also possible that the immune response to the infection in the brain causes cognitive impairment. This remains an important question to explore further,” he said.
He noted that clinicians can reassure patients who test positive for T. gondii that although the infection can have a negative impact on cognition, the effect is “small.”
Prevention programs warranted
Commenting on the study in an interview, Shawn D. Gale, PhD, associate professor, department of psychology and neuroscience center, Brigham Young University, Provo, Utah, called it a “great meta-analysis.” He noted that his group is researching the subject and has obtained similar findings. A big plus is that the researchers assessed several cognitive domains, not just one.
Although the data showed “mild effects,” the findings could be important on a population level. Because 30% of the world’s population are seropositive for T. gondii, a potentially large number of people are at risk for cognitive impairment, noted Dr. Gale, who was not involved with the study.
“If you look at the United States, perhaps 10%-15% of people might test positive [for T. gondii], but in Germany and France, the number comes closer to 50%, and in other places in the world – especially countries that have a harder time economically – the rates are even higher. So if it can affect cognition, even a small effect is a big deal,” Dr. Gale said.
“I think prevention will be the most important thing, and perhaps down the road, I hope that a vaccine will be considered,” Dr. Gale added.
“These findings indicate that primary prevention of the infection could have substantial global impact on mental health” and that public health programs to prevent T. gondii “are warranted.”
These programs might consist of hygienic measures, especially after human contact with contaminated sources, as well as research into vaccine development.
No source of funding for the study was listed. The authors and Dr. Gale reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Trauma, psychiatric comorbidities tied to functional motor disorders
Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.
“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.
FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.
In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.
The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.
More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.
In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “ and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”
No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.
The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.
However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.
The study received no outside funding. Lead author Dr. Garcin had no disclosures.
Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.
“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.
FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.
In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.
The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.
More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.
In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “ and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”
No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.
The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.
However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.
The study received no outside funding. Lead author Dr. Garcin had no disclosures.
Most adults with functional motor disorders (FMDs) report a history of psychological or physical trauma 6 months before the onset of symptoms, a retrospective study of 482 individuals suggests. Those challenges prevent more than half of those patients – most of whom are women – from working, the researchers found.
“This finding points to the huge socioeconomical burden of FMD and emphasizes the need for better diagnostic procedure and active management,” wrote Béatrice Garcin, MD, of Sorbonne Université, Paris, and associates.
FMDs are a common presentation of functional neurologic disorders, but clinical characteristics of FMDs are not well understood because large series of consecutive patients are limited, Dr. Garcin and associates said.
In the study, published in the Journal of Psychosomatic Research, the investigators reviewed data from consecutive patients with FMD who were seen at a single hospital in France between 2008 and 2016. Half of the patients had functional motor weakness (241) and half had functional movement disorders (241). All of the patients had been referred for transcranial magnetic stimulation (TMS) as treatment for FMD.
The median age of the patients was 40 years, the median age at the onset of symptoms was 35.5 years, and 74% were women. The most common clinical presentations were tremor and dystonia (83.4%), and no demographic differences were observed between patients with functional motor weakness and functional movement disorders. Symptoms were bilateral in about half of the patients (51.7%), with left- and right-sided symptoms in 28.2% and 20.1%, respectively.
More than 80% of the patients reported a history of trauma within 6 months of the onset of their symptoms, mainly psychological trauma (50.6%). Another 20.1% reported a physical trauma, and 8.7% reported trauma from surgical procedures.
In addition, about two-thirds (66.4%) had psychiatric comorbidities; 52.7% of these were mood disorders: 49.3% depression and 3.3% bipolar disorder. “However, these results about psychiatric comorbidities should be taken with caution,” the researchers emphasized. “ and psychiatric diagnosis may lack precision because of the absence of systematic psychiatric interviews and psychiatric questionnaires in the present study.”
No significant differences appeared between the motor weakness and movement disorders groups in terms of occupation, level of education, medical somatic history, symptom onset, psychiatric comorbidities, or self-reported history of trauma. Patients in the motor weakness group were significantly younger at the time of TMS treatment and had a shorter disease duration prior to that treatment. No differences were noted between the groups with regard to clinical FMD phenotypes.
The study findings were limited by several factors, including the potential selection bias because of enrollment at a neurology referral center, lack of a control group, and underrepresentation of children and older adults, the researchers noted. Also, symptom severity was not assessed and could not be compared among phenotypes or demographic groups.
However, the results contribute to the characterization of FMD patients. “Future studies are needed to clarify the characteristics of FMD patients and the consequences of their symptoms on disability and work status,” they said.
The study received no outside funding. Lead author Dr. Garcin had no disclosures.
FROM THE JOURNAL OF PSYCHOSOMATIC RESEARCH
Necessary or not, COVID booster shots are probably on the horizon
The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.
This has led to confusion. Is the protection that has allowed them to see loved ones and go out to dinner fading?
Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”
The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.
But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.
What if a booster is safe and effective in one sense but simply not needed – at least for now?
Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.
The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”
In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.
The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.
It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.
In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?
For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?
In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.
When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.
To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.
But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.
This has led to confusion. Is the protection that has allowed them to see loved ones and go out to dinner fading?
Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”
The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.
But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.
What if a booster is safe and effective in one sense but simply not needed – at least for now?
Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.
The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”
In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.
The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.
It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.
In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?
For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?
In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.
When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.
To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.
But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
The drug maker Pfizer recently announced that vaccinated people are likely to need a booster shot to be effectively protected against new variants of COVID-19 and that the company would apply for Food and Drug Administration emergency use authorization for the shot. Top government health officials immediately and emphatically announced that the booster isn’t needed right now – and held firm to that position even after Pfizer’s top scientist made his case and shared preliminary data with them on July 12.
This has led to confusion. Is the protection that has allowed them to see loved ones and go out to dinner fading?
Ultimately, the question of whether a booster is needed is unlikely to determine the FDA’s decision. If recent history is predictive, booster shots will be here before long. That’s because of the outdated, 60-year-old basic standard the FDA uses to authorize medicines for sale: Is a new drug “safe and effective?”
The FDA, using that standard, will very likely have to authorize Pfizer’s booster for emergency use, as it did the company’s prior COVID shot. The booster is likely to be safe – hundreds of millions have taken the earlier shots – and Pfizer reported that it dramatically increases a vaccinated person’s antibodies against SARS-CoV-2. From that perspective, it may also be considered very effective.
But does that kind of efficacy matter? Is a higher level of antibodies needed to protect vaccinated Americans? Though antibody levels may wane some over time, the current vaccines deliver perfectly good immunity so far.
What if a booster is safe and effective in one sense but simply not needed – at least for now?
Reliance on the simple “safe and effective” standard – which certainly sounds reasonable – is a relic of a time when there were far fewer and simpler medicines available to treat diseases and before pharmaceutical manufacturing became one of the world’s biggest businesses.
The FDA’s 1938 landmark legislation focused primarily on safety after more than 100 Americans died from a raspberry-flavored liquid form of an early antibiotic because one of its ingredients was used as antifreeze. The 1962 Kefauver-Harris Amendments to the Federal Food, Drug, and Cosmetic Act set out more specific requirements for drug approval: Companies must scientifically prove a drug’s effectiveness through “adequate and well-controlled studies.”
In today’s pharmaceutical universe, a simple “safe and effective” determination is not always an adequate bar, and it can be manipulated to sell drugs of questionable value. There’s also big money involved: Pfizer is already projecting $26 billion in COVID revenue in 2021.
The United States’ continued use of this standard to let drugs into the market has led to the approval of expensive, not necessarily very effective drugs. In 2014, for example, the FDA approved a toenail fungus drug that can cost up to $1,500 a month and that studies showed cured fewer than 10% of patients after a year of treatment. That’s more effective than doing nothing but less effective and more costly than a number of other treatments for this bothersome malady.
It has also led to a plethora of high-priced drugs to treat diseases like cancers, multiple sclerosis and type 2 diabetes that are all more effective than a placebo but have often not been tested very much against one another to determine which are most effective.
In today’s complex world, clarification is needed to determine just what kind of effectiveness the FDA should demand. And should that be the job of the FDA alone?
For example, should drugmakers prove a drug is significantly more effective than products already on the market? Or demonstrate cost-effectiveness – the health value of a product relative to its price – a metric used by Britain’s health system? And in which cases is effectiveness against a surrogate marker – like an antibody level – a good enough stand-in for whether a drug will have a significant impact on a patient’s health?
In most industrialized countries, broad access to the national market is a two-step process, said Aaron Kesselheim, a professor of medicine at Harvard Medical School, Boston, who studies drug development, marketing and law and recently served on an FDA advisory committee. The first part certifies that a drug is sufficiently safe and effective. That is immediately followed by an independent health technology assessment to see where it fits in the treatment armamentarium, including, in some countries, whether it is useful enough to be sold at all at the stated price. But there’s no such automatic process in the United States.
When Pfizer applies for authorization, the FDA may well clear a booster for the U.S. market. The Centers for Disease Control and Prevention, likely with advice from National Institutes of Health experts, will then have to decide whether to recommend it and for whom. This judgment call usually determines whether insurers will cover it. Pfizer is likely to profit handsomely from a government authorization, and the company will gain some revenue even if only the worried well, who can pay out of pocket, decide to get the shot.
To make any recommendation on a booster, government experts say they need more data. They could, for example, as Anthony S. Fauci, MD, has suggested, eventually green-light the additional vaccine shot only for a small group of patients at high risk for a deadly infection, such as the very old or transplant recipients who take immunosuppressant drugs, as some other countries have done.
But until the United States refines the FDA’s “safe and effective” standard or adds a second layer of vetting, when new products hit the market and manufacturers promote them, Americans will be left to decipher whose version of effective and necessary matters to them.
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
Delta variant among the most infectious respiratory viruses, CDC says
.
“Today, I want to speak about our need to come together against a common enemy. SARS-CoV-2 and the Delta variant is spreading with incredible efficiency, and now represents more than 83% of the virus circulating in the U.S.,” Dr. Walensky said at a news briefing July 22. “It is one of the most infectious respiratory viruses we know of and that I have seen in my 20-year career.”
Dr. Walensky said there were 46,318 cases of COVID-19 reported July 21, with a 7-day average of 37,700 cases per day -- up 53% from the previous week. Hospital admissions average about 3,500 per day, an increase of 32%. The 7-day average of deaths is 237 -- a 19% increase from the previous week.
Meanwhile, there are now 162 million Americans who are fully vaccinated against COVID-19.
Areas with low vaccination coverage continue to have the highest case numbers, she reported, with unvaccinated people accounting for 97% of hospitalizations and deaths.
But there may be early signs of progress. The four states with the highest case rates -- Arkansas, Florida, Louisiana, and Nevada -- had a higher rate of new vaccinations, compared with the national average over the past week, White House COVID-19 Response Coordinator Jeff Zients said.
He also announced that the administration will send $100 million to nearly 2,000 rural health clinics to support vaccine education and outreach efforts.
Dr. Walensky said despite the rising numbers, the CDC mask guidance remains the same, but she encouraged vaccinated people to wear masks if they choose.
“Whether you are vaccinated or not, please know we together are not out of the woods yet,” she said. “We are yet at another pivotal moment in this pandemic, with cases rising again and hospitals reaching their capacity in some areas.”
A version of this article first appeared on WebMD.com.
.
“Today, I want to speak about our need to come together against a common enemy. SARS-CoV-2 and the Delta variant is spreading with incredible efficiency, and now represents more than 83% of the virus circulating in the U.S.,” Dr. Walensky said at a news briefing July 22. “It is one of the most infectious respiratory viruses we know of and that I have seen in my 20-year career.”
Dr. Walensky said there were 46,318 cases of COVID-19 reported July 21, with a 7-day average of 37,700 cases per day -- up 53% from the previous week. Hospital admissions average about 3,500 per day, an increase of 32%. The 7-day average of deaths is 237 -- a 19% increase from the previous week.
Meanwhile, there are now 162 million Americans who are fully vaccinated against COVID-19.
Areas with low vaccination coverage continue to have the highest case numbers, she reported, with unvaccinated people accounting for 97% of hospitalizations and deaths.
But there may be early signs of progress. The four states with the highest case rates -- Arkansas, Florida, Louisiana, and Nevada -- had a higher rate of new vaccinations, compared with the national average over the past week, White House COVID-19 Response Coordinator Jeff Zients said.
He also announced that the administration will send $100 million to nearly 2,000 rural health clinics to support vaccine education and outreach efforts.
Dr. Walensky said despite the rising numbers, the CDC mask guidance remains the same, but she encouraged vaccinated people to wear masks if they choose.
“Whether you are vaccinated or not, please know we together are not out of the woods yet,” she said. “We are yet at another pivotal moment in this pandemic, with cases rising again and hospitals reaching their capacity in some areas.”
A version of this article first appeared on WebMD.com.
.
“Today, I want to speak about our need to come together against a common enemy. SARS-CoV-2 and the Delta variant is spreading with incredible efficiency, and now represents more than 83% of the virus circulating in the U.S.,” Dr. Walensky said at a news briefing July 22. “It is one of the most infectious respiratory viruses we know of and that I have seen in my 20-year career.”
Dr. Walensky said there were 46,318 cases of COVID-19 reported July 21, with a 7-day average of 37,700 cases per day -- up 53% from the previous week. Hospital admissions average about 3,500 per day, an increase of 32%. The 7-day average of deaths is 237 -- a 19% increase from the previous week.
Meanwhile, there are now 162 million Americans who are fully vaccinated against COVID-19.
Areas with low vaccination coverage continue to have the highest case numbers, she reported, with unvaccinated people accounting for 97% of hospitalizations and deaths.
But there may be early signs of progress. The four states with the highest case rates -- Arkansas, Florida, Louisiana, and Nevada -- had a higher rate of new vaccinations, compared with the national average over the past week, White House COVID-19 Response Coordinator Jeff Zients said.
He also announced that the administration will send $100 million to nearly 2,000 rural health clinics to support vaccine education and outreach efforts.
Dr. Walensky said despite the rising numbers, the CDC mask guidance remains the same, but she encouraged vaccinated people to wear masks if they choose.
“Whether you are vaccinated or not, please know we together are not out of the woods yet,” she said. “We are yet at another pivotal moment in this pandemic, with cases rising again and hospitals reaching their capacity in some areas.”
A version of this article first appeared on WebMD.com.