Considering Frailty in SARS-CoV-2 Vaccine Development: How Geriatricians Can Assist

Figures & data

Figure 1 Roles for geriatricians arise across all stages in vaccine development, testing and implementation.

Box 1 Summary of 10 Key Recommendations for Involving Geriatrics Expertise in COVID-19 Vaccine Development, Evaluation and Program Implementation

COVID-19 vaccine design should account for immunosenescence and the importance of cell-mediated immune responses in frail older adults. Particularly in later phases, vaccine trials should be designed to include (and not explicitly exclude) frail older people. Recruitment of frail older adults will be optimized when we consider how to best reach targeted participants and start with a relationship of trust. Atypical presentations of illness (more common in frail older adults) should be considered in COVID-19 vaccine trial case definitions, which are the foundation of vaccine efficacy calculations. When a study includes frail older adult participants, a geriatrician should be on the DSMB. Measures of health and outcomes (eg, frailty and function) that are relevant to frail older adults should be included in COVID-19 vaccine trials. Even when a measure of frailty has not been included up front in a clinical trial of COVID-19 vaccines, efforts should be made to account for frailty in statistical analyses (eg, use of a retrospectively generated frailty index or propensity score with stratified estimates of vaccine efficacy, immunogenicity, reactogenicity and safety). When regulatory and advisory decisions are being made concerning vaccines targeting frail older adults, geriatrics expertise should be included. Post-implementation surveillance and evaluation of COVID-19 vaccines should incorporate relevant health and outcome measures, such as frailty and function. Communication of age- and frailty-specific knowledge and evidence gaps is important to maintain trust in public health messaging about COVID-19 vaccination.