In a groundbreaking study, researchers at Tel Aviv University fitted nearly 5,000 Israelis with smartwatches and monitored their physiological parameters for two years. Of those monitored, 2,038 received the booster dose of the coronavirus vaccine, allowing researchers to objectively compare measurements before and after participants took the vaccine and confirm the vaccine’s safety. In addition, researchers in collaboration with the Kahn Sagol Maccabi Research & Innovation Center (KSM – the research and innovation institute of Maccabi Health Services) investigated the safety of the recall by analyzing the medical records of 250,000 members of Maccabi Health Services anonymously (without identifying details) and with the approval of The Helsinki Committee. From the analysis of this large amount of data, the researchers were able to assess vaccine safety from three perspectives: subjective – what the participant reports, objective – what the watch detects, and clinical – what the doctor diagnoses. .
The research was conducted by PhD student Matan Yechezkel under the supervision of Professor Dan Yamin, head of the Epidemic Research Laboratory and carried out in collaboration with Professor 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, respectively director and deputy director of KSM, and Dr. Amichai Painsky and Ms. Merav Mofaz from Tel Aviv University. The research results are published in the prestigious journal Lancet Respiratory Medicine.
As Professor Yamin explains: “We wanted to test the safety of booster vaccines against the coronavirus. We conducted a large-scale, two-year clinical study in which we fitted 4,698 Israelis with smartwatches. The smartwatches were used to monitor a number of parameters such as heart rate, variability in heart activity, sleep quality, number of daily steps taken… In addition, participants were asked to fill in daily questionnaires about their health status in a personal application that we developed. , we analyzed data on potential unusual events from the medical records of a quarter of a million anonymous, randomly selected insured members of Maccabi Health Services. »
Since the record contains the date of administration of the booster vaccine, the researchers were able to compare the condition of the vaccinated patient with his initial condition 42 days before receiving the vaccine with the condition 42 days after receiving the vaccine. The data is obtained from questionnaires, smartwatches and Maccabi Health Fund registers.
“We saw clear and significant changes after the vaccine was given, such as an increase in heart rate compared to the heart rate measured before vaccination,” says Professor Yamin, “and then we saw a return to baseline for the participant, i.e. post. – Vaccination heart rate levels returned to their previous levels after six days. Therefore, our study confirms the safety of the vaccine. The research also allowed us to compare subjective and objective indicators and the medical diagnosis of the same participant who received the first booster and a few months later the second booster. We found no difference in the physiological response recorded by the smartwatches or that reported by the participant in the app, in fact the smartwatches were even more accurate.
The researchers noted that “the most surprising finding was that the watches were more sensitive than the people they monitored. Many participants reported fatigue, headaches, etc. after receiving the vaccine, and after two or three days said they felt normal and healthy. In contrast, when we examined their clocks, we saw clear changes in heart rate that persisted for several days. There were also vaccinated participants who reported no side effects and yet definitely experienced physiological changes, based on the data from their smartwatches. . In other words, we learned that the smartwatches were more sensitive to changes in general mood than the participants themselves. »
In the medical literature, 25 unusual side effects attributed to the Corona vaccine have been reported, and researchers have been particularly careful to look for rare cases of inflammation of the heart muscle (myocarditis) and pericarditis. Professor Yamin and his colleagues studied the frequency of these unusual side effects in a quarter of a million Maccabi members and found no increase in serious events of any kind associated with vaccination.
If the watch reports minor muscle changes and the participant only reports significant changes they feel, the record tells us about unusual events diagnosed by doctors as well as hospitalizations that may be related to vaccinations, with an emphasis on cardiac events. . We did a comprehensive analysis of these twenty-five unusual side effects, and we found no increase in their incidence in people who received the booster. We found the vaccine to be safe to use. The smartwatch’s sensors “smelled” that the vaccine was safe, the vaccinee self-reported that the vaccine was safe, and finally the doctors determined that the vaccine was safe. The results of the study have far-reaching implications for objective testing of vaccine safety in the future. »
Prof. Dan Yamin, head of the Epidemic Research Laboratory