Image Credits: MOD Israel.
The Israel Institute for Biological Research Announces the Receipt of Approvals to Launch Clinical Trials on Human Participants for a COVID-19 Vaccine Developed by the Institute.
The Israeli Corona Vaccine.
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.