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Physiological Response to the COVID-19 Vaccine: Insights From a Prospective, Randomized, Single-Blinded, Crossover Trial

  • COVID-19 remote early detection (COVID-RED) consortium
  • , Andjela Markovic*
  • , Vladimir Kovacevic
  • , Timo B Brakenhoff
  • , Duco Veen
  • , Paul Klaver
  • , Marianna Mitratza
  • , George S Downward
  • , Diederick E Grobbee
  • , Maureen Cronin
  • , Brianna M Goodale
  • *Corresponding author for this work
  • extern
  • Ava Aktiengesellschaft (AG)
  • University Medical Center Utrecht
  • University Medical Center

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

Background: Rapid development and implementation of vaccines constituted a crucial step in containing the COVID-19 pandemic. A comprehensive understanding of physiological responses to these vaccines is important to build trust in medicine. Objective: This study aims to investigate temporal dynamics before and after COVID-19 vaccination in 4 physiological parameters as well as the duration of menstrual cycle phases. Methods: In a prospective trial, 17,825 adults in the Netherlands wore a medical device on their wrist for up to 9 months. The device recorded their physiological signals and synchronized with a complementary smartphone app. By means of multilevel quadratic regression, we examined changes in wearable-recorded breathing rate, wrist skin temperature, heart rate, heart rate variability, and objectively assessed the duration of menstrual cycle phases in menstruating participants to assess the effects of COVID-19 vaccination. Results: The recorded physiological signals demonstrated short-term increases in breathing rate and heart rate after COVID-19 vaccination followed by a prompt rebound to baseline levels likely reflecting biological mechanisms accompanying the immune response to vaccination. No sex differences were evident in the measured physiological responses. In menstruating participants, we found a 0.8% decrease in the duration of the menstrual phase following vaccination. Conclusions: The observed short-term changes suggest that COVID-19 vaccines are not associated with long-term biophysical issues. Taken together, our work provides valuable insights into continuous fluctuations of physiological responses to vaccination and highlights the importance of digital solutions in health care.

Original languageEnglish
Article numbere51120
Number of pages14
JournalJournal of Medical Internet Research
Volume26
DOIs
Publication statusPublished - 31 Jul 2024

Bibliographical note

Publisher Copyright:
© 2024 JMIR Publications Inc. All rights reserved.

Funding

We thank the more than 17,000 participants who enrolled in this extensive study. Additionally, we thank the entire team at Ava AG and Julius Clinical as well as the consortium partners Roche Diagnostics Nederland BV (Almere, the Netherlands), Labormedizinisches Zentrum Dr. Risch (Vaduz, Liechtenstein), Sanquin (Amsterdam, the Netherlands), Vive (Aarhus, Denmark), Takeda Pharmaceuticals USA Inc (Cambridge, MA, USA), and King\u2019s College London (London, UK) for their contributions to the COVID-RED project. The COVID-RED project has received funding from the Innovative Medicines Initiative [60] 2 Joint Undertaking (grant agreement 101005177). This Joint Undertaking receives support from the European Union\u2019s Horizon 2020 [61] research and innovation programme and EFPIA [62].

FundersFunder number
King's College London
Takeda Pharmaceutical Company
Horizon 2020 Framework Programme
Roche Diagnostics Nederland BV
Labormedizinisches Zentrum
Innovative Medicines Initiative101005177
Innovative Medicines Initiative

    UN SDGs

    This output contributes to the following UN Sustainable Development Goals (SDGs)

    1. SDG 3 - Good Health and Well-being
      SDG 3 Good Health and Well-being

    Keywords

    • Adult
    • COVID-19 Vaccines/administration & dosage
    • COVID-19/prevention & control
    • Cross-Over Studies
    • Female
    • Heart Rate
    • Humans
    • Male
    • Menstrual Cycle
    • Middle Aged
    • Netherlands
    • Prospective Studies
    • Respiratory Rate
    • SARS-CoV-2/immunology
    • Single-Blind Method
    • Skin Temperature
    • Vaccination
    • Young Adult

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