MDedge Rheumatology

Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

Key clinical point: Female vs. male patients with psoriatic arthritis (PsA) and a prior inadequate response to treatment exhibited significantly higher disease activity at baseline and a worse response to ixekizumab.

Major finding: At baseline, female vs. male patients had significantly higher Health Assessment Questionnaire Disability Index scores (P ≤ .003), with a significantly higher proportion of male vs. female patients in the ixekizumab every 4 weeks (53.8% vs. 38.3%) and ixekizumab every 2 weeks (41.2% vs. 28.1%) treatment arms achieving ≥50% and ≥70% improvement in the American College of Rheumatology criteria, respectively (both P < .05).

Study details: This post hoc analysis of two phase 3 trials included 679 patients with active PsA who were either biologic-naive (SPIRIT-P1) or showed an inadequate response to 1 or 2 tumor necrosis factor inhibitors (SPIRIT-P2) and were randomly assigned to receive ixekizumab or placebo.

Disclosures: This study was supported by Eli Lilly and Company. Five authors declared being employees and shareholders of Eli Lilly and Company and other authors reported ties with various sources, including Eli Lilly.

Source: Eder L et al. Responses to ixekizumab in male and female patients with psoriatic arthritis: Results from two randomized, phase 3 clinical trials. Rheumatol Ther. 2022 (Apr 9). Doi: 10.1007/s40744-022-00445-w

Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

Key clinical point: Dermatological symptoms are substantially associated with the quality of life (QoL) in patients with active psoriatic arthritis (PsA) and improvements in dermatology measures could translate to clinically meaningful improvements in their QoL.

Major finding: Itch severity item (ISI) scores of 7-10, Physician’s Global Assessment of Psoriasis (PGA-PsO) scores of 4, and Patient’s Global Joint and Skin Assessment-Visual Analog Scale (PGJS-VAS) scores of 90-100 mm corresponded with Dermatology Life Quality Index (DLQI) scores categorized as having a very large effect on a patient’s life. An improvement of ≥3 points in ISI, ≥2 points in PGA-PsO, and ≥40 mm in PGJS-VAS translated to a clinically meaningful improvement in DLQI scores.

Study details: This post hoc analysis of two phase 3 studies, OPAL Broaden and OPAL Beyond, included 816 patients with active PsA and an inadequate response to previous therapies who received tofacitinib, adalimumab, or placebo.

Disclosures: This study was funded by Pfizer. Four authors reported being employees or stockholders of Pfizer. The other authors reported ties with several sources, including Pfizer.

Source: Taylor PC et al. Relationships of dermatologic symptoms and quality of life in patients with psoriatic arthritis: analysis of two tofacitinib phase III studies. J Dermatol Treat. 2022 (Apr 11). Doi: 10.1080/09546634.2022.2060924

Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

Key clinical point: Upadacitinib led to early, clinically meaningful, and sustained improvements in pain in patients with psoriatic arthritis (PsA) and an inadequate response to prior biological or nonbiological disease-modifying antirheumatic drugs (b/nbDMARD).

Major finding: A significantly higher proportion of patients receiving 15 mg upadacitinib vs. placebo achieved ≥30%, ≥50%, and ≥70% reductions in pain as early as at 2 weeks (P < .05), with improvements sustained till week 56.

Study details: Findings are from an analysis of 2 phase 3 trials, SELECT-PsA 1 and SELECT-PsA 2 , including 1113 patients with active PsA and an inadequate response to ≥1 nb/bDMARD who were randomly assigned to receive 15 mg upadacitinib once daily, placebo, or adalimumab (only in the SELECT-PsA 1 study).

Disclosures: This study was sponsored by AbbVie. Eight authors declared serving as employees or owning stock/stock options in AbbVie and other authors reported ties with several sources, including AbbVie.

Source: McInnes IB et al. Effect of upadacitinib on reducing pain in patients with active psoriatic arthritis or ankylosing spondylitis: Post hoc analysis of three randomised clinical trials. RMD Open. 2022;8:e002049 (Mar 24). Doi: 10.1136/rmdopen-2021-002049

Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

Key clinical point: A dose of 100 mg guselkumab every 4 weeks (Q4W) or 8 weeks (Q8W) effectively improved the signs and symptoms of psoriatic arthritis (PsA) at week 24, with effects sustained till week 52, in subgroups of patients with diverse baseline characteristics.

Major finding: At week 24, a higher proportion of patients receiving guselkumab Q4W/Q8W (62%/60%) vs. placebo (29%) achieved ≥20% improvement in the American College of Rheumatology (ACR20) criteria, with guselkumab demonstrating superior efficacy over placebo regardless of baseline patient demographics, disease characteristics, or medication use, with effects sustained till week 52.

Study details: This post hoc analysis of two phase 3 trials, DISCOVER-1, and DISCOVER-2, and included 1120 patients with active PsA with an inadequate response to standard therapies who were randomly assigned to receive subcutaneous 100 mg guselkumab Q4W, 100 mg guselkumab Q8W, or placebo.

Disclosures: This study was funded by Janssen Research & Development, LLC. Six authors declared being employees of Janssen and owned stocks in Johnson & Johnson, the parent of Janssen. The other authors reported ties with several sources, including Janssen.

Source: Ritchlin CT et al. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: Pooled results through week 52 of two phase III, randomised, placebo-controlled studies.  RMD Open. 2022;8:e002195 (Mar 16). Doi: 10.1136/rmdopen-2022-002195

Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

Key clinical point: Interleukin-17 (IL-17) inhibitors were associated with higher treatment persistence than tumor necrosis factor (TNF) inhibitors or IL-12/23 inhibitors in patients with psoriatic arthritis (PsA) who initiated treatment with biologics.

Major finding: Treatment persistence was higher with IL-17 inhibitors than TNF inhibitors (weighted hazard ratio [HR] 0.70; P < .001) or IL-12/23 inhibitor (weighted HR 0.69; P < .001); however, IL-12/23 and TNF inhibitors showed similar persistence (P = .70).

Study details: This nationwide cohort study included 16,892 adults with psoriasis and 6531 adults with PsA who initiated first-line treatment with TNF, IL-12/23, or IL-17 inhibitors.

Disclosures: The study did not report any source of funding. P Claudepierre reported receiving consulting fees and serving as an investigator for several pharmaceutical companies.

Source: Vegas LP et al. Long-term persistence of first-line biologics for patients with psoriasis and psoriatic arthritis in the french health insurance database. JAMA Dermatol. 2022 (Mar 23). Doi: 10.1001/jamadermatol.2022.0364

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

One of the largest studies to date on myocarditis after COVID-19 vaccination confirms an increased risk with both the Pfizer and Moderna vaccines in young men and shows that the risk is higher with the Moderna than with the Pfizer vaccine.

The study also suggests for the first time that in young men 16 to 24 years of age, the risk for myocarditis after vaccination with either the Pfizer or Moderna vaccine is higher than the risk for myocarditis after COVID-19 infection.

The population-based study involved data on 23.1 million residents across four Scandinavian countries – Denmark, Finland, Norway, and Sweden – 74% of whom had received two vaccine doses and 7% of whom had received one dose.

By linking data from high-quality nationwide health registers on COVID-19 vaccination, infection rates, and myocarditis diagnoses, the researchers were able to evaluate the risk for myocarditis by vaccine product, vaccination dose number, sex, and age.

The study was published online in JAMA Cardiology.

The results confirm that the risk for myocarditis after COVID-19 mRNA vaccines is highest in young men 16 to 24 years of age after the second dose.

For men in this age group who received two doses of the same vaccine, data were compatible, with between four and seven excess myocarditis events in 28 days per 100,000 individuals after the second dose of the Pfizer vaccine, and between nine and 28 per 100,000 individuals after the second dose of the Moderna vaccine.

“This is one of the largest studies on this topic to date. The first population studies were in Israel, with 5 million individuals, and looked at just the Pfizer vaccine. We have data on 23 million people from Scandinavia that include both the Pfizer and Moderna vaccines,” senior author Rickard Ljung, MD, Swedish Medical Products Agency, told this news organization.

“We show a clearly higher risk of myocarditis after the Moderna vaccine than after the Pfizer vaccine. This has been suggested before, but our data confirm definitively that the Moderna vaccine has a higher risk of myocarditis than the Pfizer vaccine,” he added.

“In the group at highest risk of myocarditis after COVID vaccination – young men aged 16 to 24 – the Pfizer vaccine shows a five times higher risk of myocarditis versus the unvaccinated cohort, while the Moderna vaccine shows a 15 times higher risk,” Dr. Ljung noted.

After seeing these data, the Swedish regulatory authority is no longer recommending use of the Moderna vaccine for people younger than 30 years, Dr. Ljung said. Similar recommendations have been made in Norway and Finland.

The researchers report that their finding of a higher risk for myocarditis after the Moderna vaccine than after the Pfizer vaccine in young men is in line with data from the Canada, France, the United Kingdom, and the United States. But they point out that, compared with previous studies, the current study had the advantage of data analyzed according to a common protocol from four different countries and that showed similar directions of associations, despite considerable differences in previous COVID-19 infection levels and lockdown policies.

Risk higher with vaccination than infection?

For what is believed to be the first time, the Scandinavian data also suggest a higher risk for myocarditis after COVID-19 vaccination with both the Pfizer and Moderna vaccines than after COVID-19 infection in young men 16 to 24 years.

Although previous studies have shown that males in this age group have the highest risk for myocarditis after vaccination, it has always been suggested that the risk after vaccination is lower than the risk after infection. The Scandinavian data suggest otherwise for this age group.

Dr. Ljung explained that the myocarditis risk after COVID infection is very hard to study.

“It is highly dependent on the testing strategy,” he said. “For example, in the first half of 2020, the only people being tested were those admitted to hospital, so studies would have included the sickest patients and would therefore likely have found a higher rate of myocarditis. But this current Scandinavian dataset only included individuals with a positive COVID test after August 2020, reflecting a broader range of people.”

The researchers found an excess rate of myocarditis of 3.26 per 100,000 individuals within 28 days of a positive COVID-19 test among all males, and 1.37 per 100,000 individuals among males 16 to 24 years of age.

“We show that the risk of myocarditis after COVID infection is lower in younger people and higher in older people, but the opposite is true after COVID vaccination, where the risk of myocarditis is higher in younger people and lower in older people,” Dr. Ljung said.

The study was not able to look at severity of myocarditis but did record length of hospital stay, which was similar in patients who developed myocarditis after vaccination and those in the unvaccinated cohort (4 to 5 days). Deaths were rare, with no deaths in people younger than 40 years.

“I think we can say that in people aged over 40, the risk of myocarditis is greater with infection than with vaccination, but in those under 40, it is not so clear. And our data suggest that for young men aged 16 to 24 years, the risk of myocarditis after COVID vaccination with either the Pfizer or Moderna vaccine is higher than after COVID infection,” Dr. Ljung commented.

Although the Swedish regulatory agency has already stopped recommending use of Moderna vaccine in those younger than 30 years on the basis of these data, Dr. Ljung was reluctant to make any recommendations regarding the use of the Pfizer vaccine in young males, saying it was up to individual public-health agencies to makes these decisions. 

But he pointed out that the current study only looked at myocarditis, and COVID infection can result in many other complications that can lead to hospitalization and death, which needs to be taken into account when assessing the risk and benefit of vaccination.

Dr. Ljung noted that the current data only applied to the first two doses of the vaccines; data after booster injections have not been included, although the researchers are looking at that now.

What to advise patients?

In an accompanying Editor’s Note, Ann Marie Navar, MD, University of Texas Southwestern Medical Center, Dallas, who is editor of JAMA Cardiology, and Robert Bonow, MD, Northwestern University Feinberg School of Medicine, Chicago, who is deputy editor of JAMA Cardiology, try to explain how these data can inform the way health care professionals communicate with their patients about vaccination.

They point out the “good news,” that older adults who are at highest risk for COVID-19 complications appear to be at extremely low risk for vaccine-associated myocarditis.

They note that for both men and women older than 40 years, the excess number of cases of myocarditis after vaccination was fewer than two in 100,000 vaccinees across all vaccines studied, and the death toll from COVID-19 in the United States as of March was more than 200 per 100,000 population.

“Given the high rates of morbidity and mortality from COVID-19 infection in older adults and the efficacy of the vaccine in preventing severe infection and death, the benefits of immunization in those older than 40 years clearly outweigh the risks,” the editors say.

But given these data in young men, they suggest that health care professionals consider recommending the Pfizer vaccine over the Moderna vaccine for certain populations, including young men and other individuals for whom concerns about myocarditis present a barrier to immunization.

The editors also point out that although the risk for myocarditis after COVID-19 immunization is real, this low risk must be considered in the context of the overall benefit of the vaccine.

“At the individual level, immunization prevents not only COVID-19-related myocarditis but also severe disease, hospitalization, long-term complications after COVID-19 infection, and death. At the population level, immunization helps to decrease community spread, decrease the chances of new variants emerging, protect people who are immunocompromised, and ensure our health care system can continue to provide for our communities,” they conclude.

Dr. Ljung reports grants from Sanofi Aventis paid to his institution outside the submitted work and personal fees from Pfizer outside the submitted work. Dr. Navar reports personal fees from Pfizer and AstraZeneca, outside the scope of this work.

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

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

A small new study of women suggests that adopting a low-fat vegan diet and then eliminating remaining trigger foods may dramatically reduce symptoms of rheumatoid arthritis (RA) within months. After 16 weeks, the mean Disease Activity Score in 28 joints (DAS28) decreased from 4.5 to 2.5 (P < .001), and the mean number of swollen joints dipped from 7.0 to 3.3 (P = .03).

The study was published in the American Journal of Lifestyle Medicine. It’s not clear whether the vegan diet or the restriction of trigger foods – or both or neither – was helpful. Significant weight loss in the diet group could have played a role in reducing symptoms.

galitskaya / iStock / Getty Images

Still, the dietary strategy is “a life-changing experience for people,” lead author Neal D. Barnard, MD, an internal medicine specialist and adjunct professor of medicine at George Washington University, Washington, D.C, and president of the Physicians Committee for Responsible Medicine, said in an interview. “Doctors should know about it, and they should try it themselves.”

The researchers launched the study to determine the feasibility of a “practical and easy-to-prescribe diet” without caloric limits, Dr. Barnard said. “People have done a variety of studies where they’ve looked at diet changes, often with fasting, and the quality has been variable.”

There’s no consensus in the medical literature on which dietary approach is best for patients with RA. A 2021 systematic review by Philippa and colleagues found positive results for the Mediterranean diet, high doses of omega-3 fatty acids, vitamin D supplementation, and sodium restriction. Fasting had significant but temporary effects, and the reviewers noted “outcomes from vegetarian, elimination, peptide, or elemental diets suggested that responses are very individualized.”

For the new randomized, crossover study, researchers assigned 44 women to one of two diet phases. After 16 weeks, they had a 4-week washout period, then began the other 16-week phase. A total of 32 patients completed the study, and they had a mean age of 57 years. Overall, 66% were White, 16% were Black, and 79% held a college degree or graduate degree.

In the 16-week intervention phase, participants went on a low-fat vegan diet. After 4 weeks, they eliminated common RA trigger foods such as grains with gluten, nuts, citrus fruits, and chocolate. After week 7, the subjects added back the trigger foods one by one, keeping them in their diet if they didn’t seem to cause pain.

In the 16-week placebo phase, the women took a supplement that they were told contained omega-3 oils and vitamin E. However, the amounts of omega-3 and vitamin E were very low and had no apparent effect.

Participants in the diet phase attended weekly 1-hour dietary support-group sessions. Thirty-two women completed the full study.

Average DAS28 scores fell in the diet phase, compared with the supplement phase (treatment effect, 1.8 [95% confidence interval [CI], 3.2 to 0.4]; P = .01), as did swollen joints (treatment effect, –4.2 [95% CI, –8.3 to –0.1], P = .047).

While the researchers reported dips in the DAS28 score and swollen joints, “the reductions in the number of painful and tender joints did not reach statistical significance (treatment effects, –4.1 [95% CI, –8.7 to +0.5]; P = .08; and –1.8 [95% CI, –5.5 to +1.9]; P = .41, respectively).”

Mean body weight fell by 6.5 kg among those in the diet group, while those in the placebo group gained 0.8 kg (treatment effect, –7.3 kg [95% CI, –9.4 to –5.1]; P < .001).

The researchers noted “the presumed mechanisms by which diets such [as this intervention strategy] reduce joint symptoms relate to the removal of inflammatory elements of an omnivorous diet, the presence of anti-inflammatory constituents in a plant-based diet, and diet-induced reductions in gut permeability that may, in turn, reduce the passage of antigens into circulation.”

Patients tolerate the diet well, Dr. Barnard said. “It’s practical for day-to-day life, and you don’t have to check into a fasting hospital.”

Elliott O’Donovan Photography

The message for physicians, he said, is to encourage patients to try changing their eating patterns before turning to medication. “It’s a good idea for anyone to have a chance to try a diet change,” he said. “You’ll know within a matter of weeks whether it will work.”

Vegan diets are also cheaper than diets with meat and dairy, he added.

The study has various limitations. It began with 44 participants, but 12 failed to complete it for various reasons. Four participants who were assigned to the diet phase first refused to resume their regular diets during the next phase. It’s not clear if the lost weight is most responsible for the diet’s benefits, Harvard Medical School rheumatologist Daniel H. Solomon, MD, MPH, said in an interview. In his review of the study findings, Dr. Solomon said that another possibility is that certain aspects of the diet – and not the full diet – were responsible.

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

In their heyday, drug reps had big expense budgets and would wine and dine physicians, golf with them, and give gifts to their potential physician clients.

But in 2002, pressure from Congress and increased scrutiny from the American Medical Association prompted the Pharmaceutical Research and Manufacturers of America to adopt a set of voluntary ethical codes to regulate the gifts given to physicians. Now, physicians must report even small gifts or meals to the National Practitioner Data Bank.

Before the restrictions, physician/pharmaceutical rep relationships relied on face-to-face meetings. These included lunches with a limited budget or sharing a cup of coffee during a morning visit to a practice. The parties got to know each other, which led to trust and long-term relationships.

During the COVID-19 pandemic, everything changed. “It was culture shock for us,” admitted Craig F, a career pharmaceutical rep. “We didn’t know what we were going to do.”

The pharmaceutical industry pivoted and quickly got up to speed with Zoom, Microsoft Teams, and the like. “We began by reaching out to doctors via email and cell phones to set up virtual meetings,” Craig said. “Most of the doctors were working from home, doing telehealth whenever possible. For new sales reps, this was particularly difficult, because they couldn’t visit offices and get to know doctors.”

Many physicians didn’t want to devote time to Zoom meetings with pharma reps. “We worked around their schedules, and sometimes this even looked like Sunday calls,” he said.

As vaccination levels increased and medical offices began to reopen, so too did some of the old-school, face-to-face pharma rep/doctor meetings. But most proceeded with caution. “Some pharmaceutical companies didn’t put reps back into the field until the fall of 2020,” said Craig. “If we weren’t welcome in an office, we didn’t push it.”

Once much of the population was vaccinated, the thaw began in earnest, although the drug reps continued to tread cautiously, mask up, and respect the wishes of physicians. Today, Craig estimated that about two-thirds of his appointments are in person.

Still, it’s unlikely that the drug rep–supplied “free staff lunch” will ever regain its former popularity. Medical office staff are still keeping distance, owing to COVID; office schedules may be more crowded and may not allow the time; and many physicians are still nervous about having to report “gifts” or “paid lunches” from pharma. A new paradigm has emerged in the physician/pharma rep relationship, and it’s unlikely things will ever be the same.
 

The post-COVID paradigm shift

The pandemic put a dent in the pharma rep/doctor relationship, said Suzy Jackson, managing director of life sciences at Accenture and an author of The “New” Rules of Healthcare Provider Engagement . “COVID started moving power away from reps because they lost the ability to simply wander into a building and have a conversation with a health care provider. We’re seeing the pandemic evolve the meeting model into a hybrid in-person and virtual.”

“Many doctors are operating in a slower fashion because they’re balancing a hybrid model with patients, as well,” said Craig. “Some of my visits now involve talking to nurses or front-office staff, not getting in to see the doctors.”

The push from some doctors to see reps virtually as opposed to in person is a challenge for the pharma companies. “We get more done in person, so virtual is not our favorite way to do business,” said Craig. “But we’re thankful for any time we can get with doctors, so when they ask to do virtual, we agree.”

Still, the Accenture survey offered good news for pharma reps: Only 4% of respondents didn’t want to continue with in-person meetings at all. “I think of this as a positive,” Ms. Jackson said. “It shows that physicians value these relationships, if they’re done in the right way.”

But a survey by Boston Consulting Group confirms that virtual visits are likely to continue. BCG’s Doctors’ Changing Expectations of Pharma Are Here to Stay revealed that three-quarters of respondent physicians prefer to maintain or increase the amount of virtual engagements with pharma reps after becoming accustomed to the practice during the pandemic.

Under these changing scenarios, said Ms. Jackson, pharma reps have to think about more meaningful ways to engage with doctors.

“I feel that doctors are more crunched for time now, managing hybrid environments,” Craig said. “They have less time and want more patient-specific information that leads to fewer calls back to their offices.”

More physicians now value webinars, virtual training, and speaker programs. Virtual channels, the survey found, “give physicians access to the information they need in an easy and convenient manner.”

Still, physicians have noted that the survey indicated that email communications from pharma reps had increased. Often, physicians found the useful information buried in irrelevant “clutter.”
 

Restrictions on drug reps became tighter

In the 20 years since the guidelines came into existence, PhRMA has continued to strengthen the codes. In 2009, PhRMA issued new recommendations surrounding noneducational gifts and placed a cap of $100 for meals, drug samples, and other items. In 2022, they added layers to the code that focus on speaker programs. For instance, while companies can provide “modest” meals to attendees as an incidental courtesy, pharma reps can no longer pay for or provide alcohol in conjunction with these programs.

The rules vary from state to state. In Minnesota, for instance, gifts from pharma companies cannot exceed $50 per year. Some institutions – such as the Cleveland Clinic – have even stricter rules. “When we have conventions, we put up signage reminding doctors from the strictest states that they can’t even accept a cup of coffee from a rep,” said Craig.

However, COVID hasn’t completely changed doctor/pharma relationships. In Ms. Jackson’s words, “In spite of the shift to a more hybrid model, this is a very human relationship yielding real human results.”

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.

The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.

In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.

Instead, the experts talked about the potential timing of additional COVID-19 vaccines for those who already have had three shots, and challenges for vaccination efforts that likely will arise as the pandemic persists.

ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”

“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.

The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.

Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.

The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.

It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.

Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
 

Reasons to get a second booster

Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:

• Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
• Being moderately or severely immunocompromised.
• Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
• Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
• Living or working in an area where there is a medium or high level of COVID-19 in the community.

In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.

The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.

Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.

Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.

In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
 

Kids younger than 5

During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.

“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.

He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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

About 30% of COVID-19 patients developed the condition known as long COVID, University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.

The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.

A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.

The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.

Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.

Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.

People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.

“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”

Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.

Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.

“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.

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