Abstract
BackgroundClinical 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.MethodsWe 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.ResultsWe 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.Conclusionthe considerably higher sensitivity of wearable sensors can revolutionize clinical trials by enabling earlier identification of abnormal reactions with fewer subjects.
Highlights
Clinical trial guidelines for assessing the safety of vaccines, are primarily based on self-reported questionnaires
The photoplethysmography (PPG)based chest monitors purchased and used in this study collects the following 13 indicators of vital signs: heart rate, blood oxygen saturation (%), respiratory rate, systolic and diastolic blood pressure, pulse pressure, mean arterial pressure, heart rate variability (HRV—the calculation is based on a time-domain method in which the root mean square of successive RR interval differences are measured for a segment of ten beats and are presented in %), stroke volume, cardiac output (L/min), cardiac index (L/min/m2), systemic vascular resistance (SVR), and skin temperature (c)
Within the first 48 h post-vaccination, we identified significant changes in most 13 chest-patch indicators compared to the levels observed in the day prior vaccination (Fig. 1, Supplementary Table S1, and Fig. S2). At their peak, the heart rate increased by 9.85%, the systolic blood pressure increased by 3.91%, and the diastolic blood pressure increased by 3.78%
Summary
The photoplethysmography (PPG)based chest monitors purchased and used in this study collects the following 13 indicators of vital signs: heart rate (bpm), blood oxygen saturation (%), respiratory rate (br/min), systolic and diastolic blood pressure (mmHg), pulse pressure (mmHg), mean arterial pressure (mmHg), heart rate variability (HRV—the calculation is based on a time-domain method in which the root mean square of successive RR interval differences are measured for a segment of ten beats and are presented in %), stroke volume (mL/beat), cardiac output (L/min), cardiac index (L/min/m2), systemic vascular resistance (SVR) (dynes·sec·cm−5), and skin temperature (c). In order to improve the quality and reliability of the data and to ensure its continuous collection, we applied the following two measures: (1) Participants who did not complete the daily questionnaire by 7 p.m. received a notification in their mobile app to fill the questionnaire; (2) We developed a dedicated dashboard that helped us identify when participants did not fill in the daily questionnaires Those participants were contacted by the survey company and were encouraged to cooperate better. Further information on research design is available in the Nature Research Reporting Summary linked to this article
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
