The Exclusion of Older Persons From Vaccine and Treatment Trials for Coronavirus Disease 2019—Missing the Target

Abstract

Older adults are at greatest risk of severe disease and death due to coronavirus disease 2019 (COVID-19). Globally, persons older than 65 years comprise 9% of the population, 1 yet account for 30% to 40% of cases and more than 80% of deaths. 2 Unfortunately, there is a long history of exclusion of older adults from clinical trials. In response, the National Institutes of Health instituted the Inclusion Across the Lifespan policy, requiring the inclusion of older adults in clinical trials. 3 Thus, we reviewed all COVID-19 treatment and vaccine trials on http:// www.clinicaltrials.gov to evaluate their risk for exclusion of older adults (≥65 years).

Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine Among Residents of Two Skilled Nursing Facilities Experiencing COVID-19 Outbreaks — Connecticut, December 2020–February 2021

“…Residents of long-term care facilities (LTCFs), particularly those in skilled nursing facilities (SNFs), have experienced disproportionately high levels of COVID-19–associated morbidity and mortality and were prioritized for early COVID-19 vaccination ( 1 , 2 ). However, this group was not included in COVID-19 vaccine clinical trials, and limited postauthorization vaccine effectiveness (VE) data are available for this critical population ( 3 ). It is not known how well COVID-19 vaccines protect SNF residents, who typically are more medically frail, are older, and have more underlying medical conditions than the general population ( 1 ).…”

Corticosteroids are associated with increased survival in elderly presenting severe SARS-Cov2 infection

“…They send a good signal for elderly, including those living in long terms care facilities or other institutions where corticosteroids could be prescribed according to an oxygen criterion, without systematic transfer to the hospital. Strengthening the therapeutic arsenal for the care of elderly with COVID-19 is critical as these patients may not fully benefit from vaccination because of the immune-senescence associated with advanced age and their exclusion from vaccine trials 4 .…”

“…Indeed, among these patients, the RECOVERY trial found no difference in the survival of patients treated or not with dexamethasone 3 . However, the heterogeneity in the severity of infection within the latter subgroup limits the drawing of strong conclusions 4 . This situation has raised concerns and, in some countries, such as France, recommendations do not support the systematic use corticosteroids for patients ≥ 70 years old 5 .…”

Creating an anti-ageist healthcare system to improve care for our current and future selves

“…In 2019, the US National Institutes of Health instituted a new policy, Inclusion across the Lifespan 12 , requiring older adults to be enrolled into clinical trials. Despite these safeguards, in a recent study of 847 COVID-19 vaccine and treatment trials in clinicaltrials.gov 13 , 195 (23%) had an age cut-off and an additional 252 (30%) trials had other exclusions preferentially affecting older adults; thus, 447 (53%) of trials were considered high risk for excluding older adults. Of 18 vaccine trials, 11 (61%) had age-based exclusions, while 7 (39%) had other potential age-related exclusions; thus, 100% were considered high risk for excluding older adults.…”