Inter-individual variation in objective measure of reactogenicity following COVID-19 vaccination via smartwatches and fitness bands

  1. Giorgio Quer
  2. Matteo Gadaleta
  3. Jennifer M. Radin
  4. Kristian G. Andersen
  5. Katie Baca-Motes
  6. Edward Ramos
  7. Eric J. Topol
  8. Steven R. Steinhubl

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Abstract

The ability to identify who does or does not experience the intended immune response following vaccination could be of great value in not only managing the global trajectory of COVID-19 but also helping guide future vaccine development. Vaccine reactogenicity can potentially lead to detectable physiologic changes, thus we postulated that we could detect an individual’s initial physiologic response to a vaccine by tracking changes relative to their pre-vaccine baseline using consumer wearable devices. We explored this possibility using a smartphone app-based research platform that enabled volunteers (39,701 individuals) to share their smartwatch data, as well as self-report, when appropriate, any symptoms, COVID-19 test results, and vaccination information. Of 7728 individuals who reported at least one vaccination dose, 7298 received an mRNA vaccine, and 5674 provided adequate data from the peri-vaccine period for analysis. We found that in most individuals, resting heart rate (RHR) increased with respect to their individual baseline after vaccination, peaked on day 2, and returned to normal by day 6. This increase in RHR was greater than one standard deviation above individuals’ normal daily pattern in 47% of participants after their second vaccine dose. Consistent with other reports of subjective reactogenicity following vaccination, we measured a significantly stronger effect after the second dose relative to the first, except those who previously tested positive to COVID-19, and a more pronounced increase for individuals who received the Moderna vaccine. Females, after the first dose only, and those aged <40 years, also experienced a greater objective response after adjusting for possible confounding factors. These early findings show that it is possible to detect subtle, but important changes from an individual’s normal as objective evidence of reactogenicity, which, with further work, could prove useful as a surrogate for vaccine-induced immune response.

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  1. Version published to 10.1038/s41746-022-00591-z
  2. ScreenIT

    SciScore for 10.1101/2021.05.03.21256482: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    EthicsConsent: All participants in the study provided informed consent electronically.
    Sex as a biological variableAmong DETECT participants, 4,110 have reported receiving at least one dose of the vaccine (3,954 first dose only, 2,366 both first and second dose, 156 single dose), 57% were female and their median age was 56 (inter quartile range, IQR 44 - 66).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Limitations: The data collected as part of the DETECT study depends entirely on the participants’ willingness to use their wearable device and accurately reporting vaccination date and type. While we do not have direct control on self-reported information, the DETECT app provides an intuitive tool to self-report vaccination information, and an optional reminder to report information on the second dose after first one has been reported. While the information collected may not be as accurate as in a controlled laboratory setting, we rely on previous work confirming that self-reported symptoms and sensor data provide valuable information.33-35 Only daily sensor data is considered in this analysis, excluding intra-day data provided by some wearable sensor. These once-a-day values are indeed more stable and less affected by independent confounders like the specific activity performed by the individual during the day. Furthermore, the population in the DETECT study that has received a COVID-19 vaccine may not be representative of the population of the United States, as the study is open to individuals who have access to a wearable device technology.36 While research has found no racial or ethnic variation in smartwatch or activity tracker usage in the U.S., they are less commonly utilized by older individuals, those in the lowest socioeconomic tertile, and lower educational attainment.37 Another reason our results may not be representative of the broader population is that the firs...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2021.05.03.21256482v1 on medRxiv