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Manufacture Vaccines, Clinical Trials, COVID-19

Don’t Exclude the Aged

Despite being at higher risk of severe COVID-19, older adults are in danger of being excluded from more than 50 percent of COVID-19 clinical trials and 100 percent of vaccine trials, according to a review of COVID-19 trials on clinicaltrials.gov (1). The authors evaluated trials based on their risk of excluding adults over 65 years old and found that most trials featured either age cutoffs or broad, unspecified exclusions.

Although they acknowledge that some exclusion will always be necessary, the authors argue that enrollment of greater numbers of older adults in clinical trials is possible with advance preparation, staff training, and aging expertise. Senior author Sharon Inouye, Director of the Aging Brain Center in the Hinda and Arthur Marcus Institute for Aging Research at Hebrew SeniorLife, believes that many of the exclusion criteria are “not well-justified, and appear to be more for expediency or convenience of the trialists.”

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  1. BKI Helfand et al., JAMA Intern Med, [Epub ahead of print] (2020). DOI: 10.1001/jamainternmed.2020.5084

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