Israel begins mass-producing coronavirus vaccines ahead of human trials
Aiming for regulatory approval by July, Institute for Biological Research to develop 15 million doses for Israelis, Palestinians and other possible buyers
Israel has begun mass-producing a potential coronavirus vaccine ahead of its human trials and plans to distribute it to both Israelis and Palestinians if it is approved for use, officials said Monday.
The Defense Ministry on Sunday announced that the first human trials of its coronavirus vaccine will begin on November 1 and continue through the spring before it can receive approval for full use.
“In six months, the vaccine will be ready. In the meantime, the institute is working on mass production, without knowing whether the vaccine is good or not, so that we don’t reach a situation that in July, when we receive approval from the Health Ministry, we’ll be held up by production,” Prof. Amos Panet, who is on the advisory board for the Israel Institute for Biological Research, told Army Radio.
The director of the state-run institute, Shmuel Shapira, said they will produce 15 million doses in the first stage and estimated the shot could be ready by July.
“We will prepare doses for very close neighbors,” he told the Ynet news site, later clarifying that he meant the Palestinians.
He said other unnamed regional countries have also expressed interest.
“I received hints from other places, and I said it’s not my place, these are diplomatic questions for the State of Israel,” added Shapira.
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.
Israel is producing a domestic vaccine as a backup plan while it also conducts negotiations with pharmaceutical firms further ahead in the development process to receive doses when they become available. It has also been in contact with Russia and reportedly China to possibly use their vaccines if they prove effective.
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 for three weeks to check for side effects and to ensure that those given the vaccine develop antibodies against the virus.
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, which 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 — and then 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 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 Shapira, the director of the Institute for Biological Research.
“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 Monday morning, the number of active cases in Israel stood at 14,002. Among those infected, there were 510 in serious condition, with 206 on ventilators. According to the Health Ministry, 2,404 people have died of the virus in Israel.
