Innovative technology will use smart sensors to ensure vaccine safety
Vaccine safety -- from subjective self-reports to physiological data


Date:
April 11, 2022
Source:
Tel-Aviv University
Summary:
A new study enables developers to determine vaccine safety via
smart sensors that measure objective physiological parameters.



FULL STORY ==========================================================================
A new study from Tel Aviv University enables developers, for the first
time in the world, to determine vaccine safety via smart sensors that
measure objective physiological parameters. According to the researchers,
most clinical trials testing the safety of new vaccines. including
COVID-19 vaccines, rely on participants' subjective reports, which
can lead to biased results. In contrast, objective physiological data,
obtained through sensors attached to the body, is clear and unambiguous.


==========================================================================
The study was led by Dr. Yftach Gepner of the Department of Epidemiology
and Preventive Medicine at TAU's Sackler Faculty of Medicine, together
with Dr. Dan Yamin and Dr. Erez Shmueli from TAU's Fleischman Faculty
of Engineering. The paper was published in Communications Medicine,
a journal from the Nature portfolio.

Dr. Gepner: "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. This is clearly a totally subjective report. Even
when Pfizer and Moderna developed their vaccines for the new COVID-19
virus, they used self-reports to prove their safety." In the current
study, researchers from Tel Aviv University demonstrated that smart
sensors can be used to test new vaccines. The study was conducted when
many Israelis received their second dose of the COVID-19 vaccine. The researchers equipped volunteers with innovative, FDA-approved sensors
developed by the Israeli company Biobeat. Attached to their chests, these sensors measured physiological reactions from one day before to three
days after receiving the vaccine. The innovative sensors monitored 13 physiological parameters, such as: heart rate, breathing rate, saturation (blood oxygen levels), heartbeat volume, temperature, cardiac output,
and blood pressure.

The surprising results: a significant discrepancy was found between
subjective self-reports about side effects and actual measurements. That
is, in nearly all objective measures, significant changes were identified
after vaccination, even for subjects who reported having no reaction
at all.

In addition, the study found that side effects escalate over the
first 48 hours, and then parameters return to the level measured before vaccination. In other words: a direct assessment of the vaccine's safety identified physiological reactions during the first 48 hours, with levels restabilizing afterwards.

"The message from our study is clear," says Dr. Gepner. "In 2022 the
time has come to conduct continual, sensitive, objective testing of
the safety of new vaccines and therapies. There is no reason to rely
on self-reports or wait for the occurrence of rare side effects like myocarditis, an inflammation of the heart muscle, which occurs in one of
10,000 patients. Preliminary signs that predict such conditions can be
detected with advanced sensors, identifying normal vs. extreme alterations
in physiological parameters and any risk of inflammation. Today trial participants are invited to the clinic for blood pressure testing,
but often their blood pressure rises just because the situation is
stressful. Continual monitoring at home solves these problems with simple, convenient, inexpensive, and accurate means. This is the kind of medicine
we should strive for in 2022."

========================================================================== Story Source: Materials provided by Tel-Aviv_University. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Yftach Gepner, Merav Mofaz, Shay Oved, Matan Yechezkel, Keren
Constantini, Nir Goldstein, Arik Eisenkraft, Erez Shmueli,
Dan Yamin.

Utilizing wearable sensors for continuous and highly-sensitive
monitoring of reactions to the BNT162b2 mRNA COVID-19
vaccine. Communications Medicine, 2022; 2 (1) DOI:
10.1038/s43856-022-00090-y ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2022/04/220411101349.htm

--- up 6 weeks, 10 hours, 50 minutes
* Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1:317/3)