Utilizing wearable sensors for continuous and highly-sensitive monitoring of reactions to the BNT162b2 mRNA COVID-19 vaccine

  1. Yftach Gepner
  2. Merav Mofaz
  3. Shay Oved
  4. Matan Yechezkel
  5. Keren Constantini
  6. Nir Goldstein
  7. Arik Eisenkraft
  8. Erez Shmueli
  9. Dan Yamin

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Abstract

Background

Clinical trial guidelines for assessing the safety of vaccines, are primarily based on self-reported questionnaires. Despite the tremendous technological advances in recent years, objective, continuous assessment of physiological measures post-vaccination is rarely performed.

Methods

We conducted a prospective observational study during the mass vaccination campaign in Israel. 160 participants >18 years who were not previously found to be COVID-19 positive and who received the BNT162b2 COVID-19 (Pfizer BioNTech) vaccine were equipped with an FDA-approved chest-patch sensor and a dedicated mobile application. The chest-patch sensor continuously monitored 13 different cardiovascular, and hemodynamic vitals: heart rate, blood oxygen saturation, respiratory rate, systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate variability, stroke volume, cardiac output, cardiac index, systemic vascular resistance and skin temperature. The mobile application collected daily self-reported questionnaires on local and systemic reactions.

Results

We identify continuous and significant changes following vaccine administration in nearly all vitals. Markedly, these changes are observed even in presumably asymptomatic participants who did not report any local or systemic reaction. Changes in vitals are more apparent at night, in younger participants, and in participants following the second vaccine dose.

Conclusion

the considerably higher sensitivity of wearable sensors can revolutionize clinical trials by enabling earlier identification of abnormal reactions with fewer subjects.

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  1. Version published to 10.1038/s43856-022-00090-y
  2. ScreenIT

    SciScore for 10.1101/2021.05.06.21256587: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Participants were met in person, roughly 24 hours prior to vaccination, and received a detailed explanation about the study, after which they were requested to sign an informed consent form.
    IRB: Ethical Approval: Before participating in the study, all subjects were advised, both orally and in writing, as to the nature of the study and gave written informed consent to the study protocol (appendix pp 25-35), which was approved by the Tel-Aviv University Institutional Review Board (0002522-1).
    Sex as a biological variableOut of the 160 participants in this study, 90 (56.25%) were women, and 70 (43.75%) were men.
    Randomization6 Safety data from a randomized controlled trial suggests a favorable safety profile for the BNT162b2 vaccine.7 Specifically, the local and systemic self-reported reactions during the first seven days after vaccination were mainly mild to moderate, with a median onset of 0–2 days after vaccine administration and a median duration of 1–2 days.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    PerMed mobile application: Developed originally to support the PerMed study,17 the PerMed mobile application passively collects smartphone sensory data, as well as allows participants to fill the daily questionnaires.
    PerMed
    suggested: None

    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:
    Our study includes several limitations. First, our cohort includes only 160 participants and may not adequately represent the vaccinated population in Israel and elsewhere. Nevertheless, despite this considerably small sample size, trends observed by the chest-patch sensor were found to be significant. Moreover, the proportion of those who reported local and systemic reactions and the type of reactions noted were similar to those observed in clinical trials 8. Second, all participants received the BNT162b2 vaccine, which was the only vaccine used in Israel. Given the similarities regarding the safety observed between different COVID-19 vaccines,8,11,12 we believe our findings are likely to be qualitatively similar in other vaccine types. Third, the rich data gathered by the chest-patch sensor was recorded for a relatively short period, four days. However, our findings from both the chest-patch sensor and the daily questionnaire (which was collected for a more extended period, i.e., 14 days) reveal that the vast majority of local and systemic reactions faded within two days. Fourth, we did not explicitly control for the effects of the clinical trial setting (i.e., participating in a trial, wearing a chest-patch sensor, potential concerns from the vaccine, etc.). While one may argue that the observed changes may be an artifact of the trial setting, we would expect to find these changes during the first vaccine dose as well. However, since we found no differences in most vitals ...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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.
    • Thank you for including a protocol registration statement.

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

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  3. Version published to 10.1101/2021.05.06.21256587v1 on medRxiv