The Israel Institute for Biological Research (IIBR) announced this weekend that after having completed all rigorous preparations and its research and development, the Institute has received all 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 next Sunday, November 1.
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,” Gantz said.
“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,” Gantz said.
The clinical trials on human participants are to 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.
“I believe in the abilities of our scientists and I am confident that we can produce a safe and effective vaccine,” said the director of the IIBR, Professor Shmuel Shapira.
“The commercial name of the vaccine is “BriLife” — the first part of the name, “Bri”, alludes to the Hebrew word for health,”briut,” and the second part, “il” alludes to Israel, and “life” speaks to the importance of the vaccine,” he said.
“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 doses for the residents of the State of Israel and for our close neighbors.”
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.