Jerusalem, PTI: Israel Institute for Biological Research (IIBR) will start human clinical trials of its Covid-19 vaccine candidate Brilife from November 1. The institute has got all necessary approvals from the Ministry of Health and the Helsinki Committee, the Israeli Defence Ministry said.
The Helsinki Committee deals with research approval and human experiments.
The committee is mandated to ensure the well being and rights of trial volunteers and to ensure that the experiment is conducted as per the approved medical guidelines and ethics, besides various domestic laws, rules and regulations.
The guidelines are outlined in the Declaration of Helsinki and various relevant international conventions.
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.
"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," said Alternate Prime Minister-cum-Defence Minister Benny Gantz.
"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," Gantz was quoted as saying in an official statement.
"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 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.
The trial will begin on November 1 with two participants initially. 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.