The Defense Ministry on Sunday announced that the first human trials of its coronavirus vaccine will begin next Sunday, November 1, and continue through next spring before it can receive approval for full use.
The Israel Institute for Biological Research will begin the first phase of the testing process with two initial participants, increasing to 80 over the month of November. If they respond well to the vaccine and develop antibodies against the virus, the testing will expand to 960 people beginning in December.
If that larger group responds well to the vaccine, injections will then be given to some 30,000 people in April or May 2021. If the vaccine works well and there are no significant side effects, it will then be approved for full use in the general population.
The Defense Ministry said the trials will be conducted by two hospitals: Sheba Medical Center outside Tel Aviv and Hadassah Hospital in Jerusalem.
In each case, participants will receive an injection, either the vaccine or a placebo. After a few hours of observation, they will be allowed to go home, and will be monitored over a period of three weeks to check for side effects and to ensure that those given the vaccine develop antibodies against the virus.
“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 vial of the vaccine. Today, we already have 25,000 vaccine doses and are starting the next phase of the test,” said Defense 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 Health Ministry. 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,” he said.
The first stage of testing will use healthy participants, aged 18 to 55; the second stage will use healthy participants older than 18; and the third stage will have no limitation on the age or medical condition of the participants.
In the second stage of testing, the Defense Ministry said, scientists aim to “complete vaccine safety precautions, determine effective dosage, and further determine the vaccine’s effectiveness.”
The third and final stage will ensure its efficacy throughout the population.
The Institute for Biological Research, a generally shadowy organization that operates under the auspices of the Defense Ministry on issues related to chemical and biological warfare, said it used state-of-the-art techniques to create its vaccine.
The state-run laboratory based its vaccine on an existing virus, Indiana vesiculovirus, also known as VSV. The institute attached the spikes present on the novel coronavirus onto VSV, giving these portions of the virus a way to attach to the human body, which in turn allows the body to safely produce antibodies against it without being infected with the disease itself.
“This is a modern vaccine at the forefront of global technology, which provides the required level of protection in a single dose,” the Defense Ministry said.
This vaccine was first tested on small animals — mice, hamsters and rabbits — before being tested on pigs.
“The safety of the vaccine has been demonstrated in several tests, thus opening the door for clinical trials with human participants,” the laboratory said.
The Defense Ministry said it would be able to produce roughly 15 million doses of the vaccine.
It has so far produced 25,000 doses for the first and second phases of the human trials.
“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,” said the director of the Institute for Biological Research, Shmuel Shapira.
“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,” he said.
The vaccine is named Brilife, a portmanteau of the Hebrew word for health — bri’ut — and life. The name also contains the abbreviation for Israel, IL, as well as the letters that make up the acronym of the laboratory, IIRB.
As of Saturday night, the number of active cases in Israel stood at 15,876. Among those infected, there were 552 in serious condition, with 218 on ventilators. Another 158 were in moderate condition, with the rest displaying mild or no symptoms. The death roll was 2,372.