In a first-of-its-kind study in the world, researchers at Tel Aviv University equipped approximately 5,000 Israeli citizens with smart watches and monitored their physiological indices over two years. Of those monitored, 2,038 received the booster dose of the coronavirus vaccine, allowing researchers to compare their objective measures before and after the vaccine and confirm the safety of the vaccine. The conclusion is unequivocal: the vaccine is safe and does not cause side effects.
Back to normal within 6 days
The research was carried out as part of the doctoral thesis of Mr. Matan Yehezkel, under the guidance of Prof. Dan Yamin, head of the Laboratory for Dealing with Epidemics, and under joint management with Prof. Erez Shmoeli, head of the Big Data Laboratory at the Ivy and Alder Fleishman Faculty of Engineering. Also, the research was carried out in collaboration with Dr. Dr. Tal Patlon, director of the Maccabi Research and Innovation Institute (KSM), and Dr. Sivan Gazit, deputy director of the institute, as well as Dr. Amichai Painsky and Ms. Mirav Mofaz from Tel Aviv University. The results of the study were published in the prestigious journal Lancet Respiratory Medicine.
“We wanted to test the safety of booster vaccines against the corona virus. These days we are conducting a large-scale clinical study for two years, during which we equipped 4,698 Israelis with smart watches. The smart watch monitors a series of indicators, including heart rate, variations in heart activity, sleep quality , the number of daily steps and more. In addition, the participants are asked to fill out daily questionnaires about their state of health in a dedicated application that we developed. Finally, we analyzed anonymous data on possible unusual events from the medical files of a quarter of a million random insured persons of Maccabi Health Services,” explains Prof. Yamin.
Since the medical file indicates the date of receiving the booster vaccine, this allowed the researchers to compare the condition of the vaccinated with their baseline condition, starting 42 days before receiving the vaccine and ending 42 days after receiving the vaccine, both in questionnaires, in clocks, and in the records of the Maccabi Health Fund.
“We saw clear and significant changes, such as a clear increase in heart rate compared to the pulse measured before,” says Prof. Yamin, “then we saw a return to the basic condition of the vaccinated: the pulse levels before the vaccine returned to themselves after 6 days. Hence, our research confirms the The safety of the vaccines. The study also allowed us to compare the 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, and we discovered that there is no difference in the physiological response recorded by the smart watches or that reported by the participant in the app.”
When the smart technology is more sensitive than the person
The finding that surprised the researchers the most was that the clocks were more sensitive than the people. “Many subjects reported fatigue, headache, etc., and a few days later reported that they felt well again. That is, they returned to normal. However, in their watches, we still saw distinct changes in heart rate that continued for several more days. In addition, there were also vaccinees who did not report side effects at all, while they definitely experienced physiological changes. In other words, we are learning that the smart watches are more sensitive to changes in the general feeling than the subjects themselves,” says Prof. Yamin.
In the medical literature, 25 unusual side effects were recorded that were attributed to the corona vaccine, and special attention was paid to rare cases of inflammation of the heart muscle (myocarditis), and pericarditis. Prof. Yamin and his colleagues checked the frequency of these unusual cases among a quarter of a million Maccabi members and did not find any increase in serious incidents of any kind.
“The medical file tells us about unusual events diagnosed by the doctors as well as hospitalizations that may be related to vaccinations, with an emphasis on cardiac events,” says Prof. Yamin and concludes: “We did a comprehensive analysis of all those 25 unusual side effects, and we did not see an increase in their frequency among those who were vaccinated and those who were vaccinated The booster. We found that the vaccine is safe to use, the smart watch sensors also ‘felt’ it, the vaccinated themselves reportedly confirmed the watch sensors and finally the doctors also diagnosed that the vaccine is safe. The results of the study have far-reaching implications regarding the objective testing of vaccine safety in the future.”