By NoCamels Team
If there is one medical innovation that has penetrated the global consciousness in the past five years, it must surely be the vaccine, brought into the spotlight due to the COVID-19 pandemic.
The first inoculations against the coronavirus became available at the tail end of 2020, offering hope across the planet after more than a year of high infection rates and terrible death tolls from the disease, as well as months of lockdowns and restricted social interactions that exacted a high price from people, businesses and entire economies.
Some critics, however, expressed concern at the speed with which the vaccines were developed, arguing that there was insufficient exploration of the potential side effects – both immediately and later down the road.
Now, researchers at Tel Aviv University (TAU) have come up with an answer to at least some of the criticism, having developed the world’s first way of determining the safety of vaccines through smart sensors that use impartial physiological parameters to measure a person’s reaction to the dose.
The researchers say that while clinical trials for vaccines – including those against COVID-19 – do include safety tests, they rely on subjective reporting from participants, and not objective data gathered by professionals that offers clear and unambiguous insights.
“In most methods used today, clinical trials designed to evaluate the safety of a new drug or vaccine employ self-report questionnaires, asking participants how they feel before and after receiving the treatment,” explained Dr. Yftach Gepner of the Department of Epidemiology and Preventive Medicine at TAU’s Sackler Faculty of Medicine.
Gepner led the study along with Dr. Dan Yamin and Dr. Erez Shmueli from TAU’s Fleischman Faculty of Engineering.
Asking patients to describe how they feel after receiving the vaccine is “clearly a totally subjective report,” Gepner said, stressing again that even when Pfizer and Moderna developed their COVID vaccines, they used self-reports to prove their safety.
In their study, the researchers showed that smart sensors could be used to test the safety of new vaccines, working with Israeli participants who were receiving their second dose of an inoculation against COVID.
The volunteers were equipped with innovative chest sensors developed by the Petah Tikva-based company Biobeat, which measured their physiological reactions over a period beginning one day before they received the vaccine and lasting until three days after it was administered.
Biobeat has approval from the Food and Drug Administration in the US and received CE (Conformité Européenne) certification in Europe for its devices worn on the chest – which were used in the study – and the wrist. The two wearable devices were also recently adopted as a remote patient monitoring service and integrated into the Current Health home care platform offered by Best Buy Health in the US.
The sensors placed on a subject’s chest monitored 13 different physiological parameters, including heart and breathing rates, blood oxygen levels, temperature and blood pressure.
The participants were also asked to provide their own subjective report of how they felt during this period.
The study, which was recently featured in the journal Communications Medicine, found a “significant” discrepancy between the side effects the volunteers said they experienced and the side effects that were actually objectively measured.
According to the researchers, almost all the objective measures identified notable changes in the physiological parameters after vaccination, even among the subjects who had reported experiencing no reaction at all.
The study also found that while the side effects did escalate during the first 48 hours after vaccination, the physiological parameters being tested then returned to the levels measured before vaccination was received.
Responding to findings of the study, Gepner said there was now no reason to rely on self-reporting or simply wait for the appearance of rare side effects such as myocarditis. (According to Yale Medical School, this inflammation of the heart muscle was experienced by 35.9 per 100,000 people who had received a second dose of a mRNA vaccine against COVID-19.)
Continual monitoring at home, he explained, resolved this issue – simply, conveniently, cheaply and accurately.
“The message from our study is clear,” Gepner said. “The time has come to conduct continual, sensitive, objective testing of the safety of new vaccines and therapies.”
