All COVID-19 vaccines authorized for emergency use in the U.S. are effective in people with obesity, according to a new position statement issued by the Obesity Society.
In a review of data available on the Pfizer-BioNTech, Moderna, and Johnson & Johnson vaccines, efficacy was not significantly different between people with obesity versus those without obesity, reported W. Scott Butsch, MD, MSc, of the Cleveland Clinic in Ohio, and colleagues in the journal Obesity.
Therefore, the Obesity Society recommended that all people with obesity -- a BMI of 30 or higher -- get vaccinated with any of the current options.
"At present, there is no definitive way to determine which COVID vaccine is 'best' for patients overall or for specific patient subgroups, including those with obesity," they stated. "Current FDA-approved COVID-19 vaccines from Pfizer-BioNTech, Moderna and Johnson & Johnson were all highly efficacious against COVID-19-associated hospitalization and death in trials, and were found to be equally efficacious in persons with obesity compared to normal weight individuals."
In addition, because obesity was identified as a "high-risk" condition prioritized for vaccination in phase 1c by the CDC, the society likewise recommended that COVID care plans acknowledge that people with obesity are at higher risk for more severe infection and death.
Using data from FDA briefing documents and peer-reviewed literature, Butsch's group looked at the efficacy for each available vaccine in the overall trial population and subgroups of people with obesity.
"Analysis of COVID-19 vaccine efficacy in certain disease subgroups has been difficult because the number of trial participants with the disease was too small," said co-author Alexandra Hajduk, PhD, MPH, of Yale School of Medicine in New Haven, Connecticut, in a statement.
"This was not the case for obesity. Because the prevalence of obesity among trial participants was high, and because obesity is highly associated with hospital admission and death in COVID-19, the trial results were able to show that, contrary to concerns of reduced vaccine efficacy in people with obesity, that the vaccines were just as efficacious among persons with obesity compared with persons without obesity," she added.
Looking at the Pfizer vaccine first, the overall efficacy in over 36,000 people without prior infection was 95.0% (95% CI 90.0-97.9) compared with placebo.
When this cohort was divided into those with and without obesity, the vaccine efficacy was 95.4% (95% CI 86.0-99.1) in 13,218 participants ages 16 and older (roughly 32% of the cohort) with a BMI of 30 or higher. Conversely, efficacy was 94.8% (95% CI 87.4-98.3) among the participants without obesity.
For the Moderna vaccine, the overall efficacy was 94.1% (95% CI 89.3-96.8) among participants without prior COVID infection. Among those with obesity, which was about 35% of the overall cohort, efficacy was 95.8% (95% CI 82.6-99.0). Taking that one step further, in a subgroup of participants with severe obesity -- a BMI of 40 or higher -- vaccine efficacy was 91.2% (95% CI 32.0-98.9). In the 901 participants with severe obesity, there was only one case of severe COVID-19 that occurred after vaccination versus 11 cases in 884 participants with severe obesity in the placebo group.
Finally, for the Janssen/Johnson & Johnson vaccine, vaccine efficacy was 66.1% (95% CI 55.0-74.8) for the prevention of moderate to severe or critical COVID-19 infection 28 days after vaccination.
This vaccine's trial included 12,492 participants with obesity, accounting for 29% of the overall cohort. For these participants specifically, efficacy was 66.8% (95% CI 54.1-76.3) 14 days after vaccination and 65.9% (95% CI 47.8-78.3) 28 days after vaccination.
Of note, AstraZeneca's vaccine candidate, which isn't yet cleared for use in the U.S., doesn't have available efficacy data in people with obesity in its primary safety or efficacy trials.
The Obesity Society said there are plans to continue to evaluate additional vaccine data as they become available. In order to best evaluate and compare outcomes, the society is also strongly encouraging that long-term efficacy outcomes be stratified by obesity status, including with new data against emerging variants, like the Delta variant.
"In addition to general misconceptions about the disease of obesity, speculation on the effectiveness of COVID-19 vaccines in obesity has certainly added to vaccine hesitancy in those individuals with obesity," Butsch said. "I hope this position statement not only will encourage those with and without obesity to get vaccinated, but to continue the conversations on the existing weight bias in our current health policies and poor coverage and reimbursement of effective treatments for obesity."
Disclosures
Butsch reported relationships with Rhythm Pharmaceuticals and Novo Nordisk.
Other co-authors also reported disclosures.
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