Study provides safety assurance to the global population regarding COVID-19 booster vaccines

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 safety of the vaccine. Additionally, in collaboration with the Kahn Sagol Maccabi Research & Innovation Center (KSM – the research and innovation institute of Maccabi Health Services), researchers examined 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 the safety of the vaccines from three angles: subjectively – what the participant reports, objectively – what the watch detects, and clinically – 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 conducted 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, director and deputy director of KSM, respectively, and Dr. Amichai Painsky and Ms. Merav Mofaz from Tel Aviv University. The research results have been 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 two-year large-scale clinical study in which we fitted 4,698 Israelis with smartwatches. The watches smart devices were used to monitor a number of parameters such as heart rate, variation in cardiac activity, quality of sleep, number of daily steps taken… In addition, participants were asked to complete daily questionnaires about their health status in a custom 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 health services Maccabi.”

Since the medical record contains the date of administration of the booster vaccine, the researchers were able to compare the state of the vaccinated patient with his initial state 42 days before receiving the vaccine to the state 42 days after receiving the vaccine. The data was obtained from questionnaires, smartwatches and Maccabi Health Fund records.

“We saw clear and significant changes after the vaccine was given, such as an increase in heart rate compared to the pulse measured before vaccination,” says Professor Yamin, “and then we saw a return to baseline of the participant, i.e. the post-vaccination pulse 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 indicators subjective and objective and 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 application.” In fact, smartwatches were even more accurate.

The researchers noted that “the most surprising finding was that the watches were more sensitive than the people they were monitoring. Many participants reported fatigue, headaches, etc. after receiving the vaccine, and after two or three days said they felt normal and fine.” In contrast, when examining their watches, we saw distinct changes in heart rate that continued for several more days. There were also vaccinated participants who reported no side effects and yet definitely experienced physiological changes, based on data from their smartwatches. . In other words, we learned that smartwatches were more sensitive to changes in general sentiment than the participants themselves.”

In the medical literature, twenty-five unusual side effects attributed to the Corona vaccine have been reported, and researchers have paid particular attention to looking for rare cases of inflammation of the heart muscle (myocarditis) and pericarditis. Professor Yamin and his colleagues checked the frequency of these unusual side effects in a quarter of a million Maccabi members and found no increase in serious incidents of any kind associated with vaccination.

If the watch reports minor muscle changes, and the participant only reports significant changes they feel, the medical record tells us about unusual events diagnosed by doctors as well as hospitalizations that may be related to vaccinations, with 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 receiving the booster. We found the vaccine to be safe to use. The smartwatch’s sensors “smelled” the vaccine was safe, the vaccinee himself 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