In a first-of-its-kind study, researchers at Tel Aviv University equipped near 5,000 Israelis with smartwatches and monitored their physiological parameters over two years. Of those monitored, 2,038 received the booster dose of the coronavirus vaccine, allowing the researchers to objectively compare measures before and after the participants took the vaccine, and ensure the security of the vaccine. As well as, in collaboration with the Kahn Sagol Maccabi Research & Innovation Center (KSM – the research and innovation institute of Maccabi Health Services), the researchers examined the security of the booster by analyzing the medical files of 250,000 members of Maccabi Health Services anonymously (without identifying details) and with the approval of the Helsinki Committee. From the evaluation of this massive amount of information, the researchers were capable of evaluate the security of the vaccines from three perspectives: subjectively – what the participant reports, objectively – what the watch detects, and clinically – what the doctor diagnoses.
The research was carried out by PhD student Matan Yechezkel under the supervision of Prof. Dan Yamin, Head of the Laboratory for Epidemic Research and led in collaboration with Prof. Erez Shmueli, Head of the Big Data Laboratory, all from the Fleischman Faculty of Engineering at Tel Aviv University. Other collaborators were Dr. Tal Patalon and Dr. Sivan Gazit, Director and Deputy Director, respectively, of KSM, in addition to Dr. Amichai Painsky and Ms. Merav Mofaz from Tel Aviv University. The outcomes of the research were published in the celebrated journal Lancet Respiratory Medicine.
As Prof. Yamin explains: “We desired to test the security of booster vaccines against the coronavirus. We conducted a large-scale, two-year clinical study during which we equipped 4,698 Israelis with smart watches. The smartwatches were used to watch numerous parameters corresponding to heart rate, variation in heart activity, quality of sleep, variety of day by day steps taken, and more. As well as, the participants were asked to fill out day by day questionnaires about their health status in a customized application that we developed. Finally, we analyzed data on potential unusual events from the medical files of 1 / 4 of 1,000,000 randomly chosen, anonymous, insured members of the Maccabi Health Services.”
For the reason that medical file accommodates the date the booster vaccine was administered, researchers were capable of compare the condition of the vaccinated patient along with his/her baseline condition from 42 days before receiving the vaccine to the condition of 42 days after receiving the vaccine. The info was obtained from the questionnaires, smartwatches, and records of the Maccabi Health Fund.
“We saw clear and significant changes after administration of the vaccine, corresponding to a rise in heart rate in comparison with the heart beat rate measured before vaccination,” says Prof. Yamin, “after which we saw a return to the participant’s baseline, i.e., the heart beat levels after vaccination returned to their previous levels after six days. Hence, our study confirms the security of the vaccine. The research also allowed us to match subjective and objective indicators and medical diagnosis of the identical participant who received the primary booster and a number of months later the second booster. We found no difference within the physiological response recorded by the smartwatches or that reported by the participant within the app.” Actually, the smartwatches were much more precise.
The researchers noted that “essentially the most surprising finding was that the watches were more sensitive than the people they were monitoring. Many participants reported fatigue, headache, etc. after receiving the vaccine, and after two or three days reported that they felt normal and well. In contrast, from examining their watches, we saw distinct changes in heart rate that continued for several more days. There have been also vaccinated participants who didn’t report any unwanted side effects in any respect and yet definitely experienced physiological changes, based on data from their smartwatches. In other words, we learned that the smartwatches were more sensitive to changes typically feeling than the participants themselves.”
Within the medical literature, twenty-five unusual unwanted side effects attributed to the Corona vaccine were reported, and the researchers paid special attention to search for rare cases of inflammation of the center muscle (myocarditis) and pericarditis. Prof. Yamin and his colleagues checked the frequency of those unusual unwanted side effects amongst 1 / 4 of 1,000,000 Maccabi members and located no increase in serious incidents of any kind related to vaccination.
If the watch reports any minor changes within the muscles, and the participant reports only significant changes he feels, the medical file tells us about unusual events diagnosed by the doctors in addition to hospitalizations which may be related to vaccinations, with an emphasis on cardiac events. We did a comprehensive evaluation of all those twenty-five unusual unwanted side effects, and we didn’t see a rise of their incidence amongst those receiving the booster. We found the vaccine to be secure to make use of. The smartwatch sensors ‘felt’ that the vaccine was secure, the vaccinee himself reported that the vaccine was secure, and eventually, the doctors determined that the vaccine was secure. The outcomes of the study have far-reaching implications regarding objective testing of vaccine safety in the long run.”
Prof. Dan Yamin, Head of the Laboratory for Epidemic Research
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Journal reference:
Yechezkel, M., et al. (2022) Safety of the fourth COVID-19 BNT162b2 mRNA (second booster) vaccine: a prospective and retrospective cohort study. The Lancet Respiratory Medicine. doi.org/10.1016/S2213-2600(22)00407-6.