The government-run Israel Institute for Biological Research (IIBR) has received final approval to launch clinical trials with human participants for its COVID-19 vaccine candidate on November 1, the Israeli Ministry of Defense announced on Sunday.
The Health Ministry and the Helsinki Committee, a medical panel comprised of physicians and advocates that weighs research approval for human experiments, gave the okay for trials to start after “rigorous preparations and R&D,” said the Ministry of Defense.
The newly announced commercial name for the Israeli-developed, single-dose vaccine is Brilife, a combination of “Bri” which alludes to the Hebrew word for health, “briut,” “il,” for Israel, and “life.”
“We are now beginning a crucial phase [in the development of the vaccine]: the clinical trials phase,” said Professor Shmuel Shapira, the director of IIBR. “I believe in the abilities of our scientists and I am confident that we can produce a safe and effective vaccine.”
The institute said that, to date, it has produced more than 25,000 vaccine doses for the different phases of the clinical trials and has adapted a device for large-scale production of vaccines – approximately 15 million.
The Ness Ziona-based research institute has been at work since February, when tapped by Prime Minister Benjamin Netanyahu, to develop a vaccine for SARS CoV-2, the virus that causes COVID-19, with several breakthroughs along the way.
In summer, the institute’s scientists said that their vaccine candidate used vesicular stomatitis virus (VSV), an animal virus that does not cause disease in humans, and in which the spike protein was replaced with that of SARS-CoV-2. VSV is also the basis for a separate, effective vaccine against the Ebola virus.
“In this way, the body thinks it has been infected with the real [corona] virus, but actually it’s just a ‘costume,” said Dr. Hadas, a vaccine developer at the IIBR whose full name cannot be revealed, in a video put out by the institute. “So the body develops antibodies against the genetically engineered virus, but in the moment of truth, the body can identify, bind, and neutralize the virus.”
The IIBR’s vaccine is based on an existing virus (VSV) in which the spike protein was replaced with that of SARS-CoV-2. October 2020. Photo: Ministry of Defense Spokesperson’s Office
The vaccine, which the scientists called recombinant VSV-ΔG-spike or rVSV-ΔG-spike, had been tested on a number of animal models, including golden Syrian hamsters, mice, rabbits, and pigs, and was shown to be safe and well-tolerated, and able to bind and neutralize SARS-CoV-2 efficiently.