Clinical Interventions in Aging (Apr 2021)
Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist
Abstract
Melissa K Andrew,1,2 Kenneth E Schmader,3 Kenneth Rockwood,1 Barry Clarke,4 Janet E McElhaney5 1Department of Medicine, Division of Geriatric Medicine, Dalhousie University, Halifax, Nova Scotia, Canada; 2Canadian Center for Vaccinology, Halifax, Nova Scotia, Canada; 3Division of Geriatrics, Duke University Medical Center and GRECC, Durham Veterans Affairs Medical Center, Durham, North Carolina, USA; 4Department of Family Medicine, Dalhousie University, Halifax, Canada; 5Health Sciences North Research Institute, Sudbury, Ontario, CanadaCorrespondence: Melissa K AndrewDepartment of Medicine, Division of Geriatric Medicine, Dalhousie University, Veterans Memorial Building, 5955, Veterans Memorial Lane, Halifax, NS, B3H 2E1, CanadaTel +1 902 473-4995Email [email protected]: The COVID-19 pandemic has disproportionately impacted frail older adults, especially residents of long-term care (LTC) facilities. This has appropriately led to prioritization of frail older adults and LTC residents, and those who care for them, in the vaccination effort against COVID-19. Older adults have distinct immunological, clinical, and practical complexity, which can be understood through a lens of frailty. Even so, frailty has not been considered in studies of COVID-19 vaccines to date, leading to concerns that the vaccines have not been optimally tailored for and evaluated in this population even as vaccination programs are being implemented. This is an example of how vaccines are often not tested in Phase 1/2/3 clinical trials in the people most in need of protection. We argue that geriatricians, as frailty specialists, have much to contribute to the development, testing and implementation of COVID-19 vaccines in older adults. We discuss roles for geriatricians in ten stages of the vaccine development process, covering vaccine design, trial design, trial recruitment, establishment and interpretation of illness definitions, safety monitoring, consideration of relevant health measures such as frailty and function, analysis methods to account for frailty and differential vulnerability, contributions in regulatory and advisory roles, post-marketing surveillance, and program implementation and public health messaging. In presenting key recommendations pertinent to each stage, we hope to contribute to a dialogue on how to push the field of vaccinology to embrace the complexity of frailty. Making vaccines that can benefit frail older adults will benefit everyone in the fight against COVID-19.Keywords: SARS-CoV-2, COVID-19, vaccine, frailty, frail elderly, geriatrics
