by Arutz Sheva Staff
Israel Institute for Biological Research cleared to begin clinical testing of coronavirus vaccine starting next week.
Upon completion of rigorous preparations and R&D, the Israel
Institute for Biological Research (IIBR), has received all of the
necessary approvals from the Ministry of Health and the Helsinki
Committee to begin the most crucial stage in the development of a
vaccine. Clinical trials for the vaccine will begin on Sunday, November
1st
Defense Minister, Benny Gantz welcomed the approval for
clinical trials: "This is a day of hope for the citizens of Israel,
thanks to the researchers of the IIBR. Just two months ago I received
the first bottle of the vaccine. Today we already have 25,000 vaccine
doses and are starting the next phase of the test. I would like to thank
the dozens of researchers who work day and night on this national
mission in full cooperation with the Ministry of Health. In this complex
period, you are the 'commando unit' paving the way for the citizens of
Israel. You took on a mission of international and historical
importance. The defense establishment, Israeli government, and I will
continue to provide you with the support and resources required to
produce a safe and effective 'blue-and-white' vaccine. "
Clinical trials on human participants will be conducted over a period of several months, and will include three distinct phases.
Phase
1: The first phase includes a series of safety tests with the
participation of 80 healthy volunteers (aged 18-55), designated by Sheba
and Hadassah medical centers. The trial will begin on Sunday, November
1st. with two initial participants. Depending on their responses, the
vaccine will then be gradually administered to a total of 80 volunteers
(40 in each medical center).
Each volunteer will receive an
injection (vaccine or placebo). After a few hours of supervision he/she
will be discharged from the hospital, and will be monitored over a
period of three weeks. Scientists will check for any possible side
effects, and will monitor whether the volunteers develop antibodies to
the virus. The development of antibodies indicates a response to the
virus in the patients who received the vaccine.
Phase 2: The
second phase includes extensive safety tests with the participation of
960 healthy volunteers (over the age of 18). The trial is expected to
begin in December and will be held simultaneously in several medical
centers across the country. In this phase, scientists aim to complete
vaccine safety precautions, determine effective dosage, and further
determine the vaccine’s effectiveness.
Phase 3: The third phase
is a large-scale trial to test the effectiveness of the vaccine, with
the participation of up to 30,000 volunteers. The experiment is
scheduled to begin in April/May (subject to the success of the first two
phases). This is the last stage and after its successful completion,
the vaccine may be approved for mass use.
Director of the Israel
Institute for Biological Research, Prof. Shmuel Shapira: "We are now
beginning a crucial phase [in the development of the vaccine]: the
clinical trials phase. I believe in the abilities of our scientists and I
am confident that we can produce a safe and effective vaccine. The
commercial name of the vaccine is "BriLife". The first part of the name,
"Bri", alludes to the Hebrew word for health, "briut," the second part,
"il" alludes to Israel, and "life" speaks to the importance of the
vaccine. The name of the institute, IIBR is also hidden in the name. We
will continue to work to benefit the health of Israel's citizens, as
well as the economy and society of the State of Israel. Our final goal
is 15 million rations for the residents of the State of Israel and for
our close neighbors."
The IIBR has been preparing its response
capabilities for several years for a scenario with an unknown threat
(Unknown X). As part of its scientific assessments, the institute
purchased and developed advanced platforms, including infrastructure for
the rapid identification of epidemic pathogens and tools for the rapid
design of effective vaccines in response to outbreaks. Animal models
have been put in place to test the safety and efficacy of vaccines and
treatments and new infrastructure has been developed and established for
the rapid and efficient production of millions of vaccines – all this
under stringent regulatory conditions.
The vaccine developed by
the IIBR is based on an existing virus (VSV). Corona virus spikes have
been 'engineered' onto VSV, allowing the vaccine to attach to cells in
the body. This is a modern vaccine at the forefront of global
technology, which provides the required level of protection in a single
dose. The vaccine has been successfully tested on a number of "animal
models." The vaccine elicited an effective immune response in both small
animals (mice, hamsters and rabbits), and large animals (pigs). The
safety of the vaccine has been demonstrated in several tests, thus
opening the door for clinical trials with human participants.
The
institute has adapted a device for large-scale production of vaccines
(approximately 15 million). To date, the institute has produced more
than 25,000 vaccine doses for the first and second phases of the
clinical trials.
The IIBR is a center for research and
development in the fields of biology, chemistry and the environment. Its
mission is to strengthen the capabilities and resilience of the State
of Israel. The scientists at IIBR have accumulated extensive knowledge
and expertise over the decades in areas including: the development and
implementation of advanced methods for detection and identification,
research of disease processes, planning and development of vaccines and
diverse therapeutic methods and more. The institute employs hundreds of
scientists, some of them leaders in their fields in Israel and around
the world. They work in laboratories and biotechnological facilities
that enable the development and production of advanced products and
vaccines, under strict regulatory conditions.
Arutz Sheva Staff
Source: http://www.israelnationalnews.com/News/News.aspx/289817
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