Infectious Disease Practitioner

A body mass index (BMI) of at least 30 kg/m², rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

A body mass index (BMI) of at least 30 kg/m², rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

A body mass index (BMI) of at least 30 kg/m², rilpivirine resistance–associated mutations, and the HIV-1 subtype A6/A1 can raise a person’s risk for confirmed virologic failure (CVF) of long-acting cabotegravir (CAB) and rilpivirine (RPV) therapy, new research suggests. A combination of at least two of these factors was necessary to increase risk.

Long-acting CAB/RPV (Cabenuva) is a Food and Drug Administration–approved antiretroviral therapy that is administered intramuscularly on a monthly basis. Although CVF was rare in all three clinical trials of the drug regimen, understanding the factors that may predispose patients to this outcome is necessary, the authors wrote. “This information will help inform clinicians and patients, allowing them to assess the potential benefits and risks of this novel long-acting therapy.” The results were published July 15, 2021, in AIDS.

In the study, researchers pooled the clinical data from the FLAIR, ATLAS, and ATLAS-2M trials for long-acting CAB/RPV. Using these data, they examined whether participant factors such as sex, body weight, resistance mutations, and dosing regimen influenced risk for CVF using a multivariable analysis.

Of the 1,039 participants included in the analysis, 13 (1.3%) experienced CVF; 272 participants (26%) in the study population had at least one of the three risk factors, but no single variable raised risk on its own.

“When we looked at the presence of only one baseline factor, it was no different than having no baseline factors,” Bill Spreen, PharmD, an author of the study, said in an interview. Dr. Spreen is the medicine development leader for cabotegravir at ViiV Healthcare, in Research Triangle Park, N.C. CVF rates for participants with no risk factors and those with only one risk factor were 0.4%.

In comparison, CVF occurred in 9 of the 35 participants (25.7%) who had at least two risk factors, and the 1 participant who had all three risk factors also experienced CVF. The HIV subtype A1/A6, a subtype largely limited to Russia, together with a BMI greater than 30 was the most common combination, occurring in 21 individuals. Ten participants had both RPV resistance mutations and a BMI greater than 30, and only three had HIV subtype A1/A6 and RPV resistance mutations.

“The higher the BMI, typically, the lower the absorption rate of the drug, so it was not surprising to see that come out,” Dr. Spreen said. Previous research has associated subtype A1/A6 with L74I polymorphism, which may lower the barrier to resistance to integrase strand transfer inhibitors such as CAB. In the current study, researchers found that the L74I polymorphism mutation was not associated with CVF, in particular among those individuals with non-A1/A6 subtypes.

Although A1/A6 was the most common risk factor in the study, testing patients for the subtype prior to initiating CAB/RPV is likely unnecessary in the United States, where the subtype is very rare, Susan Swindells, MBBS, an expert in HIV/AIDS therapeutics from the University of Nebraska Medical Center, Omaha, said in an interview. Dr. Swindells was not an author of this study but was involved in all three CAB/RPV clinical trials. The most common risk factors health care professionals will likely encounter are high BMI and resistance mutations.

In cases in which a patient may have both a high BMI and resistance mutations, Dr. Swindells would not recommend starting a CAB/RPV regimen “unless there was a very pressing reason to do it,” as, for example, in rare cases in which a patient can’t take medications orally. “It’s all a question of balancing the risk and benefit.”

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

It’s not necessary to completely eradicate all Clostridioides difficile to successfully treat recurrent C. difficile infections with fecal microbiota transplant (FMT), according to a study presented online July 12 at the European Congress of Clinical Microbiology & Infectious Diseases.

C. difficile colonization persisted for 3 weeks after FMT in about one-quarter of patients, but it’s not clear whether this is a persistent infection, a newly acquired infection, or partial persistence of a mixed infection, said Elisabeth Terveer, MD, a medical microbiologist at Leiden (the Netherlands) University Medical Center. In addition, “82% of patients with detectable C. diff do not relapse, so it’s absolutely not necessary for a cure,” she said.

Several mechanisms explain why FMT is a highly effective therapy for recurrent C. difficile infections, including restoration of bacterial metabolism in the gut, immune modulation, and direct competition between bacteria, Dr. Terveer said, but it’s less clear whether eradication of C. difficile spores is among these mechanisms. 

Between May 2016 and April 2020, the researchers analyzed fecal samples from 84 patients who took vancomycin for at least 4 days before undergoing FMT. The researchers took fecal samples from patients before FMT and 3 weeks after FMT to culture them and the donor samples for presence of C. difficile, and they assessed clinical outcomes at 3 weeks and 6 months after FMT.

After antibiotic treatment but prior to FMT, 19% of patients (n = 16) still had a toxigenic C. difficile culture while the other 81% had a negative culture. None of the donor samples had a positive C. difficile culture. After FMT treatment, five patients who had a positive pre-FMT culture remained positive, and the other 11 were negative. Among the 81% of patients (n = 68) who had a negative culture just before FMT, 22 had a positive culture and 46 had a negative culture after FMT. Overall, 26% of patients post FMT had a positive C. difficile culture, a finding that was 10-fold higher than another study that assessed C. difficile with PCR testing, Dr. Terveer said.

The clinical cure rate after FMT was 94%, and five patients had relapses within 2 months of their FMT. These relapses were more prevalent in patients with a positive C. difficile culture prior to FMT (odds ratio [OR], 7.6; P = .045) and a positive C. difficile culture after FMT (OR, 13.6; P = .016). Still, 82% of patients who had a positive C. difficile culture post FMT remained clinically cured 2 months later.

It’s unclear why 19% of patients had a positive culture after their antibiotic pretreatment prior to FMT, Dr. Terveer said, but it may be because the pretreatment was of such a short duration.

“I think the advice should be: Give a full anti–C. diff antibiotic course to treat the C. diff infection, and then give FMT afterward to restore the microbiota and prevent further relapses,” Dr. Terveer told attendees.

Dimitri Drekonja, MD, chief of the Minneapolis VA Infectious Disease Section, said the findings were not necessarily surprising, but it would have been interesting for the researchers to have conducted DNA sequencing of the patients’ fecal samples post FMT to see what the biological diversity looked like.

“One school of thought has been that you have to repopulate the normal diverse microbiota of the colon” with FMT, and the other “is that you need to get rid of the C. diff that›s there,” Dr. Drekonja, who was not involved in the study, said in an interview. “I think more people think it’s the diverse microbiota because if it’s just getting rid of C. diff, we can get do that with antibiotics – but that gets rid of the other organisms.”

As long as you have a diverse microbiota post FMT, Dr. Drekonja said, then “having a few residual organisms, even if they get magnified in the culture process, is probably not that big a deal.”

But there’s a third school of thought that Dr. Drekonja said he himself falls into: “I don’t really care how it works, just that in well-done trials, it does work.” As long as large, robust, well-blinded trials show that FMT works, “I’m open to all sorts of ideas of what the mechanism is,” he said. “The main thing is that it does or doesn’t work.”

These findings basically reinforce current guidance not to test patients’ stools if they are asymptomatic, Dr. Drekonja said. In the past, clinicians sometimes tested patients’ stool after therapy to ensure the C. difficile was eradicated, regardless of whether the patient had symptoms of infection, he said.

“We’ve since become much more attuned that there are lots of people who have detectable C. diff in their stool without any symptoms,” whether detectable by culture or PCR, Dr. Drekonja said. “Generally, if you’re doing well and you’re not having diarrhea, don’t test, and if someone does test and finds it, pretend you didn’t see the test,” he advised. “This is a big part of diagnostic stewardship, which is: You don’t go testing people who are doing well.”

The Netherlands Donor Feces Bank used in the research is funded by a grant from Vedanta Biosciences. Dr. Drekonja had no disclosures.

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

It’s not necessary to completely eradicate all Clostridioides difficile to successfully treat recurrent C. difficile infections with fecal microbiota transplant (FMT), according to a study presented online July 12 at the European Congress of Clinical Microbiology & Infectious Diseases.

C. difficile colonization persisted for 3 weeks after FMT in about one-quarter of patients, but it’s not clear whether this is a persistent infection, a newly acquired infection, or partial persistence of a mixed infection, said Elisabeth Terveer, MD, a medical microbiologist at Leiden (the Netherlands) University Medical Center. In addition, “82% of patients with detectable C. diff do not relapse, so it’s absolutely not necessary for a cure,” she said.

Several mechanisms explain why FMT is a highly effective therapy for recurrent C. difficile infections, including restoration of bacterial metabolism in the gut, immune modulation, and direct competition between bacteria, Dr. Terveer said, but it’s less clear whether eradication of C. difficile spores is among these mechanisms. 

Between May 2016 and April 2020, the researchers analyzed fecal samples from 84 patients who took vancomycin for at least 4 days before undergoing FMT. The researchers took fecal samples from patients before FMT and 3 weeks after FMT to culture them and the donor samples for presence of C. difficile, and they assessed clinical outcomes at 3 weeks and 6 months after FMT.

After antibiotic treatment but prior to FMT, 19% of patients (n = 16) still had a toxigenic C. difficile culture while the other 81% had a negative culture. None of the donor samples had a positive C. difficile culture. After FMT treatment, five patients who had a positive pre-FMT culture remained positive, and the other 11 were negative. Among the 81% of patients (n = 68) who had a negative culture just before FMT, 22 had a positive culture and 46 had a negative culture after FMT. Overall, 26% of patients post FMT had a positive C. difficile culture, a finding that was 10-fold higher than another study that assessed C. difficile with PCR testing, Dr. Terveer said.

The clinical cure rate after FMT was 94%, and five patients had relapses within 2 months of their FMT. These relapses were more prevalent in patients with a positive C. difficile culture prior to FMT (odds ratio [OR], 7.6; P = .045) and a positive C. difficile culture after FMT (OR, 13.6; P = .016). Still, 82% of patients who had a positive C. difficile culture post FMT remained clinically cured 2 months later.

It’s unclear why 19% of patients had a positive culture after their antibiotic pretreatment prior to FMT, Dr. Terveer said, but it may be because the pretreatment was of such a short duration.

“I think the advice should be: Give a full anti–C. diff antibiotic course to treat the C. diff infection, and then give FMT afterward to restore the microbiota and prevent further relapses,” Dr. Terveer told attendees.

Dimitri Drekonja, MD, chief of the Minneapolis VA Infectious Disease Section, said the findings were not necessarily surprising, but it would have been interesting for the researchers to have conducted DNA sequencing of the patients’ fecal samples post FMT to see what the biological diversity looked like.

“One school of thought has been that you have to repopulate the normal diverse microbiota of the colon” with FMT, and the other “is that you need to get rid of the C. diff that›s there,” Dr. Drekonja, who was not involved in the study, said in an interview. “I think more people think it’s the diverse microbiota because if it’s just getting rid of C. diff, we can get do that with antibiotics – but that gets rid of the other organisms.”

As long as you have a diverse microbiota post FMT, Dr. Drekonja said, then “having a few residual organisms, even if they get magnified in the culture process, is probably not that big a deal.”

But there’s a third school of thought that Dr. Drekonja said he himself falls into: “I don’t really care how it works, just that in well-done trials, it does work.” As long as large, robust, well-blinded trials show that FMT works, “I’m open to all sorts of ideas of what the mechanism is,” he said. “The main thing is that it does or doesn’t work.”

These findings basically reinforce current guidance not to test patients’ stools if they are asymptomatic, Dr. Drekonja said. In the past, clinicians sometimes tested patients’ stool after therapy to ensure the C. difficile was eradicated, regardless of whether the patient had symptoms of infection, he said.

“We’ve since become much more attuned that there are lots of people who have detectable C. diff in their stool without any symptoms,” whether detectable by culture or PCR, Dr. Drekonja said. “Generally, if you’re doing well and you’re not having diarrhea, don’t test, and if someone does test and finds it, pretend you didn’t see the test,” he advised. “This is a big part of diagnostic stewardship, which is: You don’t go testing people who are doing well.”

The Netherlands Donor Feces Bank used in the research is funded by a grant from Vedanta Biosciences. Dr. Drekonja had no disclosures.

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

It’s not necessary to completely eradicate all Clostridioides difficile to successfully treat recurrent C. difficile infections with fecal microbiota transplant (FMT), according to a study presented online July 12 at the European Congress of Clinical Microbiology & Infectious Diseases.

C. difficile colonization persisted for 3 weeks after FMT in about one-quarter of patients, but it’s not clear whether this is a persistent infection, a newly acquired infection, or partial persistence of a mixed infection, said Elisabeth Terveer, MD, a medical microbiologist at Leiden (the Netherlands) University Medical Center. In addition, “82% of patients with detectable C. diff do not relapse, so it’s absolutely not necessary for a cure,” she said.

Several mechanisms explain why FMT is a highly effective therapy for recurrent C. difficile infections, including restoration of bacterial metabolism in the gut, immune modulation, and direct competition between bacteria, Dr. Terveer said, but it’s less clear whether eradication of C. difficile spores is among these mechanisms. 

Between May 2016 and April 2020, the researchers analyzed fecal samples from 84 patients who took vancomycin for at least 4 days before undergoing FMT. The researchers took fecal samples from patients before FMT and 3 weeks after FMT to culture them and the donor samples for presence of C. difficile, and they assessed clinical outcomes at 3 weeks and 6 months after FMT.

After antibiotic treatment but prior to FMT, 19% of patients (n = 16) still had a toxigenic C. difficile culture while the other 81% had a negative culture. None of the donor samples had a positive C. difficile culture. After FMT treatment, five patients who had a positive pre-FMT culture remained positive, and the other 11 were negative. Among the 81% of patients (n = 68) who had a negative culture just before FMT, 22 had a positive culture and 46 had a negative culture after FMT. Overall, 26% of patients post FMT had a positive C. difficile culture, a finding that was 10-fold higher than another study that assessed C. difficile with PCR testing, Dr. Terveer said.

The clinical cure rate after FMT was 94%, and five patients had relapses within 2 months of their FMT. These relapses were more prevalent in patients with a positive C. difficile culture prior to FMT (odds ratio [OR], 7.6; P = .045) and a positive C. difficile culture after FMT (OR, 13.6; P = .016). Still, 82% of patients who had a positive C. difficile culture post FMT remained clinically cured 2 months later.

It’s unclear why 19% of patients had a positive culture after their antibiotic pretreatment prior to FMT, Dr. Terveer said, but it may be because the pretreatment was of such a short duration.

“I think the advice should be: Give a full anti–C. diff antibiotic course to treat the C. diff infection, and then give FMT afterward to restore the microbiota and prevent further relapses,” Dr. Terveer told attendees.

Dimitri Drekonja, MD, chief of the Minneapolis VA Infectious Disease Section, said the findings were not necessarily surprising, but it would have been interesting for the researchers to have conducted DNA sequencing of the patients’ fecal samples post FMT to see what the biological diversity looked like.

“One school of thought has been that you have to repopulate the normal diverse microbiota of the colon” with FMT, and the other “is that you need to get rid of the C. diff that›s there,” Dr. Drekonja, who was not involved in the study, said in an interview. “I think more people think it’s the diverse microbiota because if it’s just getting rid of C. diff, we can get do that with antibiotics – but that gets rid of the other organisms.”

As long as you have a diverse microbiota post FMT, Dr. Drekonja said, then “having a few residual organisms, even if they get magnified in the culture process, is probably not that big a deal.”

But there’s a third school of thought that Dr. Drekonja said he himself falls into: “I don’t really care how it works, just that in well-done trials, it does work.” As long as large, robust, well-blinded trials show that FMT works, “I’m open to all sorts of ideas of what the mechanism is,” he said. “The main thing is that it does or doesn’t work.”

These findings basically reinforce current guidance not to test patients’ stools if they are asymptomatic, Dr. Drekonja said. In the past, clinicians sometimes tested patients’ stool after therapy to ensure the C. difficile was eradicated, regardless of whether the patient had symptoms of infection, he said.

“We’ve since become much more attuned that there are lots of people who have detectable C. diff in their stool without any symptoms,” whether detectable by culture or PCR, Dr. Drekonja said. “Generally, if you’re doing well and you’re not having diarrhea, don’t test, and if someone does test and finds it, pretend you didn’t see the test,” he advised. “This is a big part of diagnostic stewardship, which is: You don’t go testing people who are doing well.”

The Netherlands Donor Feces Bank used in the research is funded by a grant from Vedanta Biosciences. Dr. Drekonja had no disclosures.

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

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

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.

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

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.

For the sixth consecutive year, the Mayo Clinic in Rochester, Minn., claimed the No. 1 spot in the annual honor roll of best hospitals published July 27 by U.S. News & World Report.
 

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.

As COVID-19 cases, hospitalizations, and deaths mount again across the country, the American Medical Association (AMA), the American Nursing Association, and 54 other medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

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 medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

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 medical and allied healthcare associations released a joint statement calling on “all health care and long-term care employers” to require their workers to receive the COVID-19 vaccine.

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.

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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.

Andriy Onufriyenko

“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, but so-called breakthrough cases, where a person gets infected despite being fully vaccinated, are on the rise. 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.

Andriy Onufriyenko

“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, but so-called breakthrough cases, where a person gets infected despite being fully vaccinated, are on the rise. 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.

Andriy Onufriyenko

“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, but so-called breakthrough cases, where a person gets infected despite being fully vaccinated, are on the rise. 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.

A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

A meta-analysis by Australian researchers found no link between childhood vaccinations and an increase in allergies and asthma. In fact, children who received the BCG vaccine actually had a lesser incidence of eczema than other children, but there was no difference shown in any of the allergies or asthma.

The researchers, in a report published in the journal Allergy, write, “We found no evidence that childhood vaccination with commonly administered vaccines was associated with increased risk of later allergic disease.”

“Allergies have increased worldwide in the last 50 years, and in developed countries, earlier,” said study author Caroline J. Lodge, PhD, principal research fellow at the University of Melbourne, in an interview. “In developing countries, it is still a crisis.” No one knows why, she said. That was the reason for the recent study.

Allergic diseases such as allergic rhinitis (hay fever) and food allergies have a serious influence on quality of life, and the incidence is growing. According to the Global Asthma Network, there are 334 million people living with asthma. Between 2%-10% of adults have atopic eczema, and more than a 250,000 people have food allergies. This coincides temporally with an increase in mass vaccination of children.

Unlike the controversy surrounding vaccinations and autism, which has long been debunked as baseless, a hygiene hypothesis postulates that when children acquire immunity from many diseases, they become vulnerable to allergic reactions. Thanks to vaccinations, children in the developed world now are routinely immune to dozens of diseases.

That immunity leads to suppression of a major antibody response, increasing sensitivity to allergens and allergic disease. Suspicion of a link with childhood vaccinations has been used by opponents of vaccines in lobbying campaigns jeopardizing the sustainability of vaccine programs. In recent days, for example, the state of Tennessee has halted a program to encourage vaccination for COVID-19 as well as all other vaccinations, the result of pressure on the state by anti-vaccination lobbying.

But the Melbourne researchers reported that the meta-analysis of 42 published research studies doesn’t support the vaccine–allergy hypothesis. Using PubMed and EMBASE records between January 1946 and January 2018, researchers selected studies to be included in the analysis, looking for allergic outcomes in children given BCG or vaccines for measles or pertussis. Thirty-five publications reported cohort studies, and seven were based on randomized controlled trials.

The Australian study is not the only one showing the same lack of linkage between vaccination and allergy. The International Study of Asthma and Allergies in Childhood (ISAAC) found no association between mass vaccination and atopic disease. A 1998 Swedish study of 669 children found no differences in the incidence of allergic diseases between those who received pertussis vaccine and those who did not.

“The bottom line is that vaccines prevent infectious diseases,” said Matthew B. Laurens, associate professor of pediatrics at the University of Maryland, Baltimore, in an interview. Dr. Laurens was not part of the Australian study.

“Large-scale epidemiological studies do not support the theory that vaccines are associated with an increased risk of allergy or asthma,” he stressed. “Parents should not be deterred from vaccinating their children because of fears that this would increase risks of allergy and/or asthma.”

Dr. Lodge and Dr. Laurens have disclosed no relevant financial relationships.

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

Despite recent reports of Guillain-Barré Syndrome (GBS) after the Johnson & Johnson vaccine, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

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, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

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, independent experts who advise the Centers for Disease Control and Prevention on the use of vaccines agree that the benefits of the one-dose shot still outweigh its risks.

Johnson & Johnson

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.

The increased use of masks caused by the COVID-19 pandemic was accompanied by a “dramatic increase in face mask–related injuries” reported to a national surveillance system.

How dramatic? The number of mask-related injuries treated in U.S. emergency departments averaged about 200 per year from 2016 to 2019. In 2020, that figure soared to 4,976 – an increase of almost 2,400%, Gerald McGwin Jr., PhD, and associates said in a research letter published in the Journal to the American Academy of Dermatology.

“Prior to the COVID-19 pandemic the use of respiratory protection equipment was largely limited to healthcare and industrial settings. As [face mask] use by the general population increased, so too have reports of dermatologic reactions,” said Dr. McGwin and associates of the department of epidemiology at the University of Alabama at Birmingham.

Dermatitis was the most common mask-related injury treated last year, affecting 28.3% of those presenting to EDs, followed by lacerations at 10.1%. Injuries were more common in women than men, but while and black patients “were equally represented,” they noted, based on data from the National Electronic Injury Surveillance System, which includes about 100 hospitals and EDs.

Most injuries were caused by rashes/allergic reactions (38%) from prolonged use, poorly fitting masks (19%), and obscured vision (14%). “There was a small (5%) but meaningful number of injuries, all among children, attributable to consuming pieces of a mask or inserting dismantled pieces of a mask into body orifices,” the investigators said.

Guidance from the Centers for Disease Control and Prevention is available “to aid in the choice and proper fit of face masks,” they wrote, and “increased awareness of these resources [could] minimize the future occurrence of mask-related injuries.”

There was no funding source for the study, and the investigators did not declare any conflicts of interest.

[email protected]

The increased use of masks caused by the COVID-19 pandemic was accompanied by a “dramatic increase in face mask–related injuries” reported to a national surveillance system.

How dramatic? The number of mask-related injuries treated in U.S. emergency departments averaged about 200 per year from 2016 to 2019. In 2020, that figure soared to 4,976 – an increase of almost 2,400%, Gerald McGwin Jr., PhD, and associates said in a research letter published in the Journal to the American Academy of Dermatology.

“Prior to the COVID-19 pandemic the use of respiratory protection equipment was largely limited to healthcare and industrial settings. As [face mask] use by the general population increased, so too have reports of dermatologic reactions,” said Dr. McGwin and associates of the department of epidemiology at the University of Alabama at Birmingham.

Dermatitis was the most common mask-related injury treated last year, affecting 28.3% of those presenting to EDs, followed by lacerations at 10.1%. Injuries were more common in women than men, but while and black patients “were equally represented,” they noted, based on data from the National Electronic Injury Surveillance System, which includes about 100 hospitals and EDs.

Most injuries were caused by rashes/allergic reactions (38%) from prolonged use, poorly fitting masks (19%), and obscured vision (14%). “There was a small (5%) but meaningful number of injuries, all among children, attributable to consuming pieces of a mask or inserting dismantled pieces of a mask into body orifices,” the investigators said.

Guidance from the Centers for Disease Control and Prevention is available “to aid in the choice and proper fit of face masks,” they wrote, and “increased awareness of these resources [could] minimize the future occurrence of mask-related injuries.”

There was no funding source for the study, and the investigators did not declare any conflicts of interest.

[email protected]

The increased use of masks caused by the COVID-19 pandemic was accompanied by a “dramatic increase in face mask–related injuries” reported to a national surveillance system.

How dramatic? The number of mask-related injuries treated in U.S. emergency departments averaged about 200 per year from 2016 to 2019. In 2020, that figure soared to 4,976 – an increase of almost 2,400%, Gerald McGwin Jr., PhD, and associates said in a research letter published in the Journal to the American Academy of Dermatology.

“Prior to the COVID-19 pandemic the use of respiratory protection equipment was largely limited to healthcare and industrial settings. As [face mask] use by the general population increased, so too have reports of dermatologic reactions,” said Dr. McGwin and associates of the department of epidemiology at the University of Alabama at Birmingham.

Dermatitis was the most common mask-related injury treated last year, affecting 28.3% of those presenting to EDs, followed by lacerations at 10.1%. Injuries were more common in women than men, but while and black patients “were equally represented,” they noted, based on data from the National Electronic Injury Surveillance System, which includes about 100 hospitals and EDs.

Most injuries were caused by rashes/allergic reactions (38%) from prolonged use, poorly fitting masks (19%), and obscured vision (14%). “There was a small (5%) but meaningful number of injuries, all among children, attributable to consuming pieces of a mask or inserting dismantled pieces of a mask into body orifices,” the investigators said.

Guidance from the Centers for Disease Control and Prevention is available “to aid in the choice and proper fit of face masks,” they wrote, and “increased awareness of these resources [could] minimize the future occurrence of mask-related injuries.”

There was no funding source for the study, and the investigators did not declare any conflicts of interest.

[email protected]

Patients with a mental illness, particularly a psychotic or mood disorder, are twice as likely to die after infection with SARS-CoV-2, compared with those without a psychiatric diagnosis, according to the results of the largest study of its kind to date.

These findings, the investigators noted, highlight the need to prioritize vaccination in patients with preexisting mental health disorders.

“We have proven beyond a shadow of a doubt that there are increased risks” among psychiatric patients who get COVID-19, study investigator Livia De Picker, MD, PhD, psychiatrist and postdoctoral researcher, University Psychiatric Hospital Campus Duffel and University of Antwerp (Belgium), told this news organization.

“Doctors need to look at these patients the same way they would other high-risk people, for example those with diabetes or chronic obstructive pulmonary disease,” all of whom should be protected against COVID-19, Dr. De Picker added.

The study was published online July 15, 2021, in Lancet Psychiatry.
 

Risk by mental illness type

The systematic review included 33 studies from 22 countries that reported risk estimates for mortality, hospitalization, and ICU admission in patients with confirmed SARS-CoV-2 infection. The meta-analysis included 23 of these studies with a total of 1.47 million participants. Of these, 43,938 had a psychiatric disorder.

The primary outcome was mortality after COVID-19. Secondary outcomes included hospitalization and ICU admission after COVID-19. Researchers adjusted for age, sex, and other covariates.

Results showed the presence of any comorbid mental illness was associated with an increased risk for death after SARS-CoV-2 infection (odds ratio, 2.00; 95% confidence interval, 1.58-2.54; P < .0001).

When researchers stratified mortality risk by psychiatric disorder type, the most robust associations were for psychotic and mood disorders. Substance use disorders, intellectual disabilities, and developmental disorders were associated with higher mortality only in crude estimates. There was no increased death risk associated with anxiety disorders.

“That there are differences between the various types of disorders was an interesting finding,” said Dr. De Picker, adding that previous research “just lumped together all diagnostic categories.”
 

Potential mechanisms

The study did not explore why psychiatric illness raise the risk for death in the setting of COVID-19, so potential mechanisms are purely speculative. However, the investigators believe it may reflect biological processes such as immune-inflammatory alterations.

Psychotic disorders and mood disorders in particular, are associated with immune changes, including immunogenetic abnormalities, raised cytokine concentrations, autoantibodies, acute-phase proteins, and aberrant counts of leukocyte cell types, said Dr. De Picker.

She likened this to elderly people being at increased risk following COVID-19 because their immune system is compromised and less able to fight infection.

There are likely other factors at play, said Dr. De Picker. These could include social isolation and lifestyle factors like poor diet, physical inactivity, high alcohol and tobacco use, and sleep disturbances.

In addition, psychiatric patients have a higher prevalence of comorbidities including diabetes, cardiovascular disease, and respiratory disease, which could also play a role.

The increased mortality might also reflect reduced access to care. “Some of these patients may be living in difficult socioeconomic conditions,” said Dr. De Picker.

She noted that, while the in-hospital mortality was not increased, the risk was significantly increased in samples that were outside of the hospital. This reinforces the need for providing close monitoring and early referral to hospital for psychiatric patients with COVID-19.

Mortality varied significantly among countries, with the lowest risk in Europe and the United States. This difference might be attributable to differences in health care systems and access to care, said Dr. De Picker.

Overall, the risk for hospitalization was about double for COVID patients with a mental illness, but when stratified by disorder, there was only a significantly increased risk for substance use and mood disorders. “But mood disorders were not even significant any more after adjusting for age, sex, and comorbid conditions, and we don’t see an increased risk for psychotic disorders whereas they had the highest mortality risks,” said Dr. De Picker.
 

Psych meds a risk factor?

The studies were primarily based on electronic medical records, so investigators were unable to carry out “a fine grain analysis” into clinical factors affecting outcomes, she noted.

Antipsychotics were consistently associated with an increased risk for mortality (adjusted OR, 2.43; 95% CI, 1.81-3.25), as were anxiolytics (aOR, 1.47; 95% CI, 1.15-1.88).

“There are some theoretical reasons why we believe there could be a risk associated with these drugs,” said Dr. De Picker. For example, antipsychotics can increase the risk for cardiac arrhythmias and thromboembolic events, and cause interactions with drugs used to treat COVID-19.

As for anxiolytics, especially benzodiazepines, these drugs are associated with respiratory risk and with all-cause mortality. “So you could imagine that someone who is infected with a respiratory virus and [is] then using these drugs on top of that would have a worse outcome,” said Dr. De Picker.

In contrast to antipsychotics and anxiolytics, antidepressants did not increase mortality risk.

Dr. De Picker noted a new study by French researchers showing a protective effect of certain serotonergic antidepressants on COVID outcomes, including mortality.

There was no robust evidence of an increased risk for ICU admission for patients with mental disorders. However, the authors noted some studies included small samples of patients with psychiatric disorders, “contributing to a low certainty of evidence for ICU admission.”

Dr. De Picker criticized COVID vaccine policies that don’t prioritize patients with psychiatric disorders. In many countries, groups that were initially green-lighted for the vaccine included health care workers, the elderly, and those with underlying conditions such as diabetes, obesity and even mild hypertension – but not mental illness, which is also an underlying risk.
 

‘Outstanding’ research

Commenting on the study for this news organization, Jonathan E. Alpert, MD, PhD, department of psychiatry and behavioral sciences, Montefiore Medical Center, New York, and chair of the American Psychiatric Association Council on Research, called it “outstanding” and the largest of its kind.

“There have been a number of studies that have come to similar conclusions, that people with psychiatric illness are at greater risk for poorer outcomes, but because any given study had a relatively limited sample, perhaps from one health system or one country, there were some inconsistencies,” said Dr. Alpert.

“This is the strongest report so far that has made the point that people with psychiatric illness are a vulnerable population for a negative outcome from COVID, including the most worrisome – mortality.”

The study helps drive home a “very important public health lesson” that applies to COVID-19 but goes “beyond,” said Dr. Alpert.

“As a society, we need to keep in mind that people with serious mental disorders are a vulnerable population for poorer outcomes in most general medical conditions,” he stressed, “whether it’s cancer or heart disease or diabetes, and special efforts need to be made to reach out to those populations.”

Dr. Alpert agreed that, at the start of the pandemic, psychiatric patients in the United States were not prioritized for vaccination, and although psychiatric patients may initially have found it difficult to navigate the health care system to learn where and how to get a COVID shot, today that barrier has mostly been removed.

“Our patients are at least as willing as any other subgroup to get the vaccine, and that includes people with psychotic disorders,” he said.

The study was supported by the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry network and Fondazione Centro San Raffaele (Milan). Dr. De Picker reported receiving grants from Boehringer Ingelheim and Janssen outside the submitted work. She is a member of the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry Thematic Working Group.

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

Patients with a mental illness, particularly a psychotic or mood disorder, are twice as likely to die after infection with SARS-CoV-2, compared with those without a psychiatric diagnosis, according to the results of the largest study of its kind to date.

These findings, the investigators noted, highlight the need to prioritize vaccination in patients with preexisting mental health disorders.

“We have proven beyond a shadow of a doubt that there are increased risks” among psychiatric patients who get COVID-19, study investigator Livia De Picker, MD, PhD, psychiatrist and postdoctoral researcher, University Psychiatric Hospital Campus Duffel and University of Antwerp (Belgium), told this news organization.

“Doctors need to look at these patients the same way they would other high-risk people, for example those with diabetes or chronic obstructive pulmonary disease,” all of whom should be protected against COVID-19, Dr. De Picker added.

The study was published online July 15, 2021, in Lancet Psychiatry.
 

Risk by mental illness type

The systematic review included 33 studies from 22 countries that reported risk estimates for mortality, hospitalization, and ICU admission in patients with confirmed SARS-CoV-2 infection. The meta-analysis included 23 of these studies with a total of 1.47 million participants. Of these, 43,938 had a psychiatric disorder.

The primary outcome was mortality after COVID-19. Secondary outcomes included hospitalization and ICU admission after COVID-19. Researchers adjusted for age, sex, and other covariates.

Results showed the presence of any comorbid mental illness was associated with an increased risk for death after SARS-CoV-2 infection (odds ratio, 2.00; 95% confidence interval, 1.58-2.54; P < .0001).

When researchers stratified mortality risk by psychiatric disorder type, the most robust associations were for psychotic and mood disorders. Substance use disorders, intellectual disabilities, and developmental disorders were associated with higher mortality only in crude estimates. There was no increased death risk associated with anxiety disorders.

“That there are differences between the various types of disorders was an interesting finding,” said Dr. De Picker, adding that previous research “just lumped together all diagnostic categories.”
 

Potential mechanisms

The study did not explore why psychiatric illness raise the risk for death in the setting of COVID-19, so potential mechanisms are purely speculative. However, the investigators believe it may reflect biological processes such as immune-inflammatory alterations.

Psychotic disorders and mood disorders in particular, are associated with immune changes, including immunogenetic abnormalities, raised cytokine concentrations, autoantibodies, acute-phase proteins, and aberrant counts of leukocyte cell types, said Dr. De Picker.

She likened this to elderly people being at increased risk following COVID-19 because their immune system is compromised and less able to fight infection.

There are likely other factors at play, said Dr. De Picker. These could include social isolation and lifestyle factors like poor diet, physical inactivity, high alcohol and tobacco use, and sleep disturbances.

In addition, psychiatric patients have a higher prevalence of comorbidities including diabetes, cardiovascular disease, and respiratory disease, which could also play a role.

The increased mortality might also reflect reduced access to care. “Some of these patients may be living in difficult socioeconomic conditions,” said Dr. De Picker.

She noted that, while the in-hospital mortality was not increased, the risk was significantly increased in samples that were outside of the hospital. This reinforces the need for providing close monitoring and early referral to hospital for psychiatric patients with COVID-19.

Mortality varied significantly among countries, with the lowest risk in Europe and the United States. This difference might be attributable to differences in health care systems and access to care, said Dr. De Picker.

Overall, the risk for hospitalization was about double for COVID patients with a mental illness, but when stratified by disorder, there was only a significantly increased risk for substance use and mood disorders. “But mood disorders were not even significant any more after adjusting for age, sex, and comorbid conditions, and we don’t see an increased risk for psychotic disorders whereas they had the highest mortality risks,” said Dr. De Picker.
 

Psych meds a risk factor?

The studies were primarily based on electronic medical records, so investigators were unable to carry out “a fine grain analysis” into clinical factors affecting outcomes, she noted.

Antipsychotics were consistently associated with an increased risk for mortality (adjusted OR, 2.43; 95% CI, 1.81-3.25), as were anxiolytics (aOR, 1.47; 95% CI, 1.15-1.88).

“There are some theoretical reasons why we believe there could be a risk associated with these drugs,” said Dr. De Picker. For example, antipsychotics can increase the risk for cardiac arrhythmias and thromboembolic events, and cause interactions with drugs used to treat COVID-19.

As for anxiolytics, especially benzodiazepines, these drugs are associated with respiratory risk and with all-cause mortality. “So you could imagine that someone who is infected with a respiratory virus and [is] then using these drugs on top of that would have a worse outcome,” said Dr. De Picker.

In contrast to antipsychotics and anxiolytics, antidepressants did not increase mortality risk.

Dr. De Picker noted a new study by French researchers showing a protective effect of certain serotonergic antidepressants on COVID outcomes, including mortality.

There was no robust evidence of an increased risk for ICU admission for patients with mental disorders. However, the authors noted some studies included small samples of patients with psychiatric disorders, “contributing to a low certainty of evidence for ICU admission.”

Dr. De Picker criticized COVID vaccine policies that don’t prioritize patients with psychiatric disorders. In many countries, groups that were initially green-lighted for the vaccine included health care workers, the elderly, and those with underlying conditions such as diabetes, obesity and even mild hypertension – but not mental illness, which is also an underlying risk.
 

‘Outstanding’ research

Commenting on the study for this news organization, Jonathan E. Alpert, MD, PhD, department of psychiatry and behavioral sciences, Montefiore Medical Center, New York, and chair of the American Psychiatric Association Council on Research, called it “outstanding” and the largest of its kind.

“There have been a number of studies that have come to similar conclusions, that people with psychiatric illness are at greater risk for poorer outcomes, but because any given study had a relatively limited sample, perhaps from one health system or one country, there were some inconsistencies,” said Dr. Alpert.

“This is the strongest report so far that has made the point that people with psychiatric illness are a vulnerable population for a negative outcome from COVID, including the most worrisome – mortality.”

The study helps drive home a “very important public health lesson” that applies to COVID-19 but goes “beyond,” said Dr. Alpert.

“As a society, we need to keep in mind that people with serious mental disorders are a vulnerable population for poorer outcomes in most general medical conditions,” he stressed, “whether it’s cancer or heart disease or diabetes, and special efforts need to be made to reach out to those populations.”

Dr. Alpert agreed that, at the start of the pandemic, psychiatric patients in the United States were not prioritized for vaccination, and although psychiatric patients may initially have found it difficult to navigate the health care system to learn where and how to get a COVID shot, today that barrier has mostly been removed.

“Our patients are at least as willing as any other subgroup to get the vaccine, and that includes people with psychotic disorders,” he said.

The study was supported by the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry network and Fondazione Centro San Raffaele (Milan). Dr. De Picker reported receiving grants from Boehringer Ingelheim and Janssen outside the submitted work. She is a member of the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry Thematic Working Group.

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

Patients with a mental illness, particularly a psychotic or mood disorder, are twice as likely to die after infection with SARS-CoV-2, compared with those without a psychiatric diagnosis, according to the results of the largest study of its kind to date.

These findings, the investigators noted, highlight the need to prioritize vaccination in patients with preexisting mental health disorders.

“We have proven beyond a shadow of a doubt that there are increased risks” among psychiatric patients who get COVID-19, study investigator Livia De Picker, MD, PhD, psychiatrist and postdoctoral researcher, University Psychiatric Hospital Campus Duffel and University of Antwerp (Belgium), told this news organization.

“Doctors need to look at these patients the same way they would other high-risk people, for example those with diabetes or chronic obstructive pulmonary disease,” all of whom should be protected against COVID-19, Dr. De Picker added.

The study was published online July 15, 2021, in Lancet Psychiatry.
 

Risk by mental illness type

The systematic review included 33 studies from 22 countries that reported risk estimates for mortality, hospitalization, and ICU admission in patients with confirmed SARS-CoV-2 infection. The meta-analysis included 23 of these studies with a total of 1.47 million participants. Of these, 43,938 had a psychiatric disorder.

The primary outcome was mortality after COVID-19. Secondary outcomes included hospitalization and ICU admission after COVID-19. Researchers adjusted for age, sex, and other covariates.

Results showed the presence of any comorbid mental illness was associated with an increased risk for death after SARS-CoV-2 infection (odds ratio, 2.00; 95% confidence interval, 1.58-2.54; P < .0001).

When researchers stratified mortality risk by psychiatric disorder type, the most robust associations were for psychotic and mood disorders. Substance use disorders, intellectual disabilities, and developmental disorders were associated with higher mortality only in crude estimates. There was no increased death risk associated with anxiety disorders.

“That there are differences between the various types of disorders was an interesting finding,” said Dr. De Picker, adding that previous research “just lumped together all diagnostic categories.”
 

Potential mechanisms

The study did not explore why psychiatric illness raise the risk for death in the setting of COVID-19, so potential mechanisms are purely speculative. However, the investigators believe it may reflect biological processes such as immune-inflammatory alterations.

Psychotic disorders and mood disorders in particular, are associated with immune changes, including immunogenetic abnormalities, raised cytokine concentrations, autoantibodies, acute-phase proteins, and aberrant counts of leukocyte cell types, said Dr. De Picker.

She likened this to elderly people being at increased risk following COVID-19 because their immune system is compromised and less able to fight infection.

There are likely other factors at play, said Dr. De Picker. These could include social isolation and lifestyle factors like poor diet, physical inactivity, high alcohol and tobacco use, and sleep disturbances.

In addition, psychiatric patients have a higher prevalence of comorbidities including diabetes, cardiovascular disease, and respiratory disease, which could also play a role.

The increased mortality might also reflect reduced access to care. “Some of these patients may be living in difficult socioeconomic conditions,” said Dr. De Picker.

She noted that, while the in-hospital mortality was not increased, the risk was significantly increased in samples that were outside of the hospital. This reinforces the need for providing close monitoring and early referral to hospital for psychiatric patients with COVID-19.

Mortality varied significantly among countries, with the lowest risk in Europe and the United States. This difference might be attributable to differences in health care systems and access to care, said Dr. De Picker.

Overall, the risk for hospitalization was about double for COVID patients with a mental illness, but when stratified by disorder, there was only a significantly increased risk for substance use and mood disorders. “But mood disorders were not even significant any more after adjusting for age, sex, and comorbid conditions, and we don’t see an increased risk for psychotic disorders whereas they had the highest mortality risks,” said Dr. De Picker.
 

Psych meds a risk factor?

The studies were primarily based on electronic medical records, so investigators were unable to carry out “a fine grain analysis” into clinical factors affecting outcomes, she noted.

Antipsychotics were consistently associated with an increased risk for mortality (adjusted OR, 2.43; 95% CI, 1.81-3.25), as were anxiolytics (aOR, 1.47; 95% CI, 1.15-1.88).

“There are some theoretical reasons why we believe there could be a risk associated with these drugs,” said Dr. De Picker. For example, antipsychotics can increase the risk for cardiac arrhythmias and thromboembolic events, and cause interactions with drugs used to treat COVID-19.

As for anxiolytics, especially benzodiazepines, these drugs are associated with respiratory risk and with all-cause mortality. “So you could imagine that someone who is infected with a respiratory virus and [is] then using these drugs on top of that would have a worse outcome,” said Dr. De Picker.

In contrast to antipsychotics and anxiolytics, antidepressants did not increase mortality risk.

Dr. De Picker noted a new study by French researchers showing a protective effect of certain serotonergic antidepressants on COVID outcomes, including mortality.

There was no robust evidence of an increased risk for ICU admission for patients with mental disorders. However, the authors noted some studies included small samples of patients with psychiatric disorders, “contributing to a low certainty of evidence for ICU admission.”

Dr. De Picker criticized COVID vaccine policies that don’t prioritize patients with psychiatric disorders. In many countries, groups that were initially green-lighted for the vaccine included health care workers, the elderly, and those with underlying conditions such as diabetes, obesity and even mild hypertension – but not mental illness, which is also an underlying risk.
 

‘Outstanding’ research

Commenting on the study for this news organization, Jonathan E. Alpert, MD, PhD, department of psychiatry and behavioral sciences, Montefiore Medical Center, New York, and chair of the American Psychiatric Association Council on Research, called it “outstanding” and the largest of its kind.

“There have been a number of studies that have come to similar conclusions, that people with psychiatric illness are at greater risk for poorer outcomes, but because any given study had a relatively limited sample, perhaps from one health system or one country, there were some inconsistencies,” said Dr. Alpert.

“This is the strongest report so far that has made the point that people with psychiatric illness are a vulnerable population for a negative outcome from COVID, including the most worrisome – mortality.”

The study helps drive home a “very important public health lesson” that applies to COVID-19 but goes “beyond,” said Dr. Alpert.

“As a society, we need to keep in mind that people with serious mental disorders are a vulnerable population for poorer outcomes in most general medical conditions,” he stressed, “whether it’s cancer or heart disease or diabetes, and special efforts need to be made to reach out to those populations.”

Dr. Alpert agreed that, at the start of the pandemic, psychiatric patients in the United States were not prioritized for vaccination, and although psychiatric patients may initially have found it difficult to navigate the health care system to learn where and how to get a COVID shot, today that barrier has mostly been removed.

“Our patients are at least as willing as any other subgroup to get the vaccine, and that includes people with psychotic disorders,” he said.

The study was supported by the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry network and Fondazione Centro San Raffaele (Milan). Dr. De Picker reported receiving grants from Boehringer Ingelheim and Janssen outside the submitted work. She is a member of the European College of Neuropsychopharmacology Immuno-NeuroPsychiatry Thematic Working Group.

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