Abstract
Higher weight status, defined as body mass index (BMI) ≥ 30 kg/m2, is frequently described as a risk factor for severity and susceptibility to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease (known as COVID-19). Therefore, study groups in COVID-19 vaccine trials should be representative of the weight spectrum across the global population. Appropriate subgroup analysis should be conducted to ensure equitable vaccine outcomes for higher weight people. In this study, inclusion and exclusion criteria of registered clinical trial protocols were reviewed to determine the proportion of trials including higher weight people, and the proportion of trials conducting subgroup analyses of efficacy by BMI. Eligibility criteria of 249 trial protocols (phase I, II, III and IV) were analysed; 51 protocols (20.5%) specified inclusion of BMI > 30, 73 (29.3%) specified exclusion of BMI > 30, and 125 (50.2%) did not specify whether BMI was an inclusion or exclusion criterion, or if BMI was included in any ‘health’ screenings or physical examinations during recruitment. Of the 58 protocols for trials in phase III and IV, only 2 (3.4%) indicated an intention to report subgroup analysis of vaccine efficacy by weight status. Higher weight people appear to be significantly under-represented in the majority of vaccine trials. This may result in reduced efficacy and acceptance of COVID-19 vaccines for higher weight people and exacerbation of health inequities within this population group. Explicit inclusion of higher weight people in COVID-19 vaccine trials is required to reduce health inequities.
Highlights
IntroductionVaccines began early in the coronavirus disease (COVID-19) pandemic, with rapid movement from feasibility studies through to human clinical trials and administration of vaccines in several countries [1]
The development of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)vaccines began early in the coronavirus disease (COVID-19) pandemic, with rapid movement from feasibility studies through to human clinical trials and administration of vaccines in several countries [1]
We excluded any trial that investigated a therapy that did not generate active immunity, included people previously infected by COVID-19, evaluated the efficacy of a vaccine designed to protect against other pathogens e.g., Bacille Calmette-Guerin (BCG) in the prevention or treatment of COVID-19, and protocols written in a language other than English
Summary
Vaccines began early in the coronavirus disease (COVID-19) pandemic, with rapid movement from feasibility studies through to human clinical trials and administration of vaccines in several countries [1]. Global confidence in COVID-19 vaccination has been buoyed by large randomised controlled trials demonstrating high vaccine efficacy and excellent safety profiles [2,3]. For clinical trials to accurately assess the safety and efficacy of COVID-19 4.0/). We define higher weight status as a body mass index (BMI) ≥ 30 kg/m2. In 2016, the World Health Organization (WHO) reported that 13% of the global population were of higher weight status [4]. Higher weight status has been considered a comorbidity in the literature, and used as the rationale to exclude people with higher weight from clinical research participation [8]
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