Physiologic Response to the Pfizer-BioNTech COVID-19 Vaccine Measured Using Wearable Devices: Prospective Observational Study

Alexander G Hajduczok, Kara M DiJoseph, Brinnae Bent, Audrey K Thorp, Jon B Mullholand, Stuart A MacKay, Sabrina Barik, Jamie J Coleman, Catharine I Paules, Andrew Tinsley, Alexander G Hajduczok, Kara M DiJoseph, Brinnae Bent, Audrey K Thorp, Jon B Mullholand, Stuart A MacKay, Sabrina Barik, Jamie J Coleman, Catharine I Paules, Andrew Tinsley

Abstract

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.

Keywords: COVID-19; REM sleep; cohort; deep sleep; heart rate; heart rate variability; monitoring; physiological; remote physiologic monitoring; respiratory; respiratory rate; sleep; vaccine; wearable; wearable devices.

Conflict of interest statement

Conflicts of Interest: CIP is a consultant for Axle Informatics for work not related to this manuscript. CIP is also the site PI for the Adaptive COVID-19 Treatment Trial (ACTT) and the ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 which receive funding from the National Institutes of Health. This work is not related to the submitted manuscript.

©Alexander G Hajduczok, Kara M DiJoseph, Brinnae Bent, Audrey K Thorp, Jon B Mullholand, Stuart A MacKay, Sabrina Barik, Jamie J Coleman, Catharine I Paules, Andrew Tinsley. Originally published in JMIR Formative Research (https://formative.jmir.org), 04.08.2021.

Figures

Figure 1
Figure 1
A total of 19 participants, 53% female, who were vaccinated with two doses of the Pfizer-BioNtech COVID-19 vaccine (mean time between doses 19.6, SD 2.8 days), transmitted continuous physiologic data via the WHOOP device. Changes from baseline were observed in HRV and were most pronounced on day 1 and 2 for dose 1 and only day 1 for dose 2. RR and RHR were unaffected following vaccination. Sleep duration initially decreased on day 1 post vaccine dose 1 and dose 2, with a compensatory increase from days 2 to 4, prior to return to baseline. Sleep deprivation was associated with a blunted HRV response, and premedication was associated with less change in RR and increases in REM and deep sleep percentages. HRV: heart rate variability; REM: rapid eye movement; RHR: resting heart rate; RR: respiratory rate.
Figure 2
Figure 2
Percent change from baseline in (A) heart rate variability, (B) respiratory rate, and (C) resting heart rate, measured 6 days following COVID-19 vaccine dose 1 (blue) and 2 (magenta). Data is reported as mean (SD).
Figure 3
Figure 3
Percent change from baseline in (A) total sleep duration, (B) REM sleep duration, and (C) deep sleep duration, measured 6 days following COVID-19 vaccine dose 1 (blue) and 2 (magenta). Data is reported as mean (SD). REM: rapid eye movement.
Figure 4
Figure 4
(A) Self-reported symptom duration following dose 1 and dose 2 of the COVID-19 vaccine. (B) Local and systemic reactogenicity experienced by participants by vaccine dose.
Figure 5
Figure 5
Hypothetical connection between physiologic response measured by wearables (HRV, RHR, RR), inflammatory response (serum CRP and proinflammatory cytokine levels), and host immunity dictated by antibody response to vaccination. Wearable monitoring of physiologic metrics could potentially be a simple and effective way to track the efficacy of vaccine-mediated protection against infection (dashed arrow). HRV highlighted as this parameter showed the greatest changes in this study. CRP: C-reactive protein; HRV: heart rate variability; RHR: resting heart rate; RR: respiratory rate.

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