COVID-19 Therapy and Vaccine Trials Likely Exclude Patients Older Than 65, New Study Shows

Individuals over the age of 65 are likely to be excluded from more than 50 percent of trials studying COVID-19 therapies and 100 percent of COVID-19 vaccine trials, despite the fact that these older patients account for more than 80 percent of deaths related to the disease, according to a new study in JAMA Internal Medicine.

The study examined 847 COVID-19 studies indexed in the ClinicalTrials.gov database between Oct. 1, 2019, to June 1, 2020. Of these trials, around 23 percent included an age cut-off. A total of 447 trials — or 53 percent — had direct and indirect age-related exclusions that impacted adults older than 65.

Up to 43 percent of trials had any exclusions, but 30 percent of these trials did not have an age-based exclusion. Common reasons for indirect age-related exclusion among the reviewed trials included compliance concerns (213 trials), followed by broad nonspecified exclusions (174 trials), specific comorbidities (68 trials), requiring technology (21 trials) and “other” reasons (17 trials).

Among 232 published phase 3 trials, approximately 50 percent of these trials (115 trials) had age cut-offs or exclusions that preferentially affected older adults. In 18 COVID-19 vaccine trials, 61 percent included age cut-offs and the remaining trials also had broad nonspecific age-related exclusions, suggesting that it’s highly likely that all COVID-19 vaccine trials leave out patients older than 65.

“Some have argued that only vaccination of younger populations is needed to achieve herd immunity (67 percent level of immunity), and therefore, vaccination of older adults is not essential; however, the high level of immunity required, coupled with the fact that many settings (e.g., nursing homes) are comprised nearly exclusively of older adults, highlights the imperative for their inclusion in COVID-19 vaccine trials,” the researchers wrote.