Israel Defence Ministry has said that the human clinical trials of the COVID-19 vaccine will begin after the Ministry of Health and the Helsinki Committee grant necessary approvals. According to the Israel Institute for Biological Research (IIBR), it will start human clinical trials of vaccines from November 1. IIBR Director, Prof Shmuel Shapira, has confirmed the development.
“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,” Shapira said.
“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 added. IIBR was established in 1952 as part of the Israel Defence Forces’ Science Corps, and later became a civilian organisation.
The Helsinki committee deals with research approval and human experiments. It is mandated to ensure the well being of trial volunteers and also ensure that the experiment is conducted as per the approved medical guidelines, and laws.
In an official statement released today, Israel’s Alternate Prime Minister, Benny Gantz, thanked researchers who work day and night on “this national mission in full cooperation with the Ministry of Health”.
“This is a day of hope for the citizens of Israel, thanks to the IIBR researchers. 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,” the statement quoted him as saying. “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 defence establishment, the 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,” he stressed.
‘Blue and White’ refers to the colours in the Israeli flag, which also happens to be the name of the defence minister’s party.
The three stages of the human clinical trial involving over 30,000 volunteers are likely to last till mid-2021 and if all goes well, the vaccine could be ready for mass use only after that.
The first phase of the human trial will include a series of safety tests with the participation of 80 healthy volunteers (aged 18-55), designated by Sheba and Hadassah medical centres. Depending on their responses, the vaccine will then be gradually administered to a total of 80 volunteers — 40 in each medical centre. Each volunteer will receive an injection and discharged after a few hours of observation. They will then be monitored over three weeks. Scientists will check for any possible side effects and will examine if the volunteers develop antibodies to the virus.
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 centres across Israel. In the second phase, scientists aim to complete vaccine safety precautions, determine the effective dosage, and further determine the vaccine’s effectiveness.
The third phase will be a large-scale trial to test the effectiveness of the vaccine with the participation of up to 30,000 volunteers. If all goes well, the third and last phase of the trial is scheduled to begin in April or May 2021 and its successful completion would pave the way for approval for the mass use of the vaccine.
With PTI Inputs