Israel announces entry into critical phase of COVID-19 vaccine development
The Ministry of Defence, the Israel Institute for Biological Research (IIBR) and the Ministry of Health announced on Sunday the approval for the start of the clinical trials in humans with the Coronavirus (COVID-19) vaccine, a critical phase towards the completion of the development of the serum.
In Gaza City, a mural depicting the COVID-19 coronavirus. Gaza, Oct 5, 2020. Photo by Majdi Fathi/TPS
Defence Minister Benny Gantz welcomed the development and said that “this is a day of hope for the citizens of Israel.”
With the completion of the preparations, research, development, and receipt of all approvals from the Ministry of Health and the Helsinki Committee for Medical Experiments in Humans, the IIBR will commence a trial on some 25,000 volunteers in the coming months.
The phase of clinical trials in humans will last several months and will include three phases, the first safety tests on 80 healthy volunteers aged 18-55.
The first phase of the trial will begin on Sunday with two volunteers, and depending on their responses to the vaccine, will be gradually expanded to 80 people. Each volunteer will receive an injection, whether the vaccine or placebo.
During the trial, the experimenters will examine whether any side effects have occurred and whether antibodies to the virus have appeared, indicating a response to the virus in the volunteers who received the vaccine.
Phase two includes safety tests on 960 healthy volunteers aged 18 and over. The trial is expected to begin in December. This stage is designed to complete vaccine safety tests, pinpoint the right doses, and continue to test measures of its effectiveness.
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 or May, depending on the success of the first two phases.
This is the last stage, after which if it will be successfully completed, the vaccine can be approved and the entire population can be vaccinated.
Director of the IIBR Prof. Shmuel Shapira said he was “convinced that we are bringing a very good, effective and safe vaccine.”
Earlier this month, Shapira announced that the vaccine was named “Brilife.” Br is the beginning of the word Briut in Hebrew, which means health, il stands for the State of Israel, and the third part is the word life.
“Our final goal is 15 million doses for the benefit of the residents of the State of Israel and our immediate neighbours,” he added.
The IIBR has been preparing for several years for a scenario of an unknown threat factor, the Unknown X. As part of the scientific preparation, the institute purchased and set up unique platforms, which constitute a national infrastructure for rapid identification of epidemic pathogens, and tools for rapid vaccine design were developed.
Animal models have been put in place to test the safety and efficacy of vaccines and treatments, new infrastructures have been developed and established for rapid and efficient production, amounting to millions of vaccines, under stringent regulatory conditions.
Towards the beginning of the clinical trials in humans, a facility for the large scale production of about 15 million vaccines was adapted at the IIBR.
To date, the institute has produced more than 25,000 vaccine doses for the first and second phases of clinical trials. A sufficient amount of vaccines is being produced at the institute to fill an additional one million doses
