TY - JOUR AU - Hajduczok, Alexander G AU - DiJoseph, Kara M AU - Bent, Brinnae AU - Thorp, Audrey K AU - Mullholand, Jon B AU - MacKay, Stuart A AU - Barik, Sabrina AU - Coleman, Jamie J AU - Paules, Catharine I AU - Tinsley, Andrew PY - 2021 DA - 2021/8/4 TI - Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study JO - JMIR Form Res SP - e28568 VL - 5 IS - 8 KW - COVID-19 KW - wearable devices KW - remote physiologic monitoring KW - heart rate KW - heart rate variability KW - respiratory rate KW - sleep KW - REM sleep KW - deep sleep KW - wearable KW - vaccine KW - monitoring KW - respiratory KW - physiological KW - cohort AB - Background: The Pfizer-BioNTech COVID-19 vaccine uses a novel messenger RNA technology to elicit a protective immune response. Short-term physiologic responses to the vaccine have not been studied using wearable devices. Objective: We aim to characterize physiologic changes in response to COVID-19 vaccination in a small cohort of participants using a wearable device (WHOOP Strap 3.0). This is a proof of concept for using consumer-grade wearable devices to monitor response to COVID-19 vaccines. Methods: In this prospective observational study, physiologic data from 19 internal medicine residents at a single institution that received both doses of the Pfizer-BioNTech COVID-19 vaccine was collected using the WHOOP Strap 3.0. The primary outcomes were percent change from baseline in heart rate variability (HRV), resting heart rate (RHR), and respiratory rate (RR). Secondary outcomes were percent change from baseline in total, rapid eye movement, and deep sleep. Exploratory outcomes included local and systemic reactogenicity following each dose and prophylactic analgesic use. Results: In 19 individuals (mean age 28.8, SD 2.2 years; n=10, 53% female), HRV was decreased on day 1 following administration of the first vaccine dose (mean –13.44%, SD 13.62%) and second vaccine dose (mean –9.25%, SD 22.6%). RHR and RR showed no change from baseline after either vaccine dose. Sleep duration was increased up to 4 days post vaccination, after an initial decrease on day 1. Increased sleep duration prior to vaccination was associated with a greater change in HRV. Local and systemic reactogenicity was more severe after dose two. Conclusions: This is the first observational study of the physiologic response to any of the novel COVID-19 vaccines as measured using wearable devices. Using this relatively small healthy cohort, we provide evidence that HRV decreases in response to both vaccine doses, with no significant changes in RHR or RR. Sleep duration initially decreased following each dose with a subsequent increase thereafter. Future studies with a larger sample size and comparison to other inflammatory and immune biomarkers such as antibody response will be needed to determine the true utility of this type of continuous wearable monitoring in regards to vaccine responses. Our data raises the possibility that increased sleep prior to vaccination may impact physiologic responses and may be a modifiable way to increase vaccine response. These results may inform future studies using wearables for monitoring vaccine responses. Trial Registration: ClinicalTrials.gov NCT04304703; https://www.clinicaltrials.gov/ct2/show/NCT04304703 SN - 2561-326X UR - https://formative.jmir.org/2021/8/e28568 UR - https://doi.org/10.2196/28568 UR - http://www.ncbi.nlm.nih.gov/pubmed/34236995 DO - 10.2196/28568 ID - info:doi/10.2196/28568 ER -