Israel biological institute: Corona vaccine Phase II trial done by December

Prof. Shmuel Shapira said they chose this vaccine because it is "innovative but not too revolutionary... Our goal was not to be first but to make a vaccine for the citizens of the State of Israel."

By MAAYAN JAFFE-HOFFMAN
Professor Shapira at a discussion in the Knesset Science and Technology Committee, August 18, 2020 (photo credit: KNESSET SCIENCE AND TECHNOLOGY COMMITEE SPOKESPERSON)
Professor Shapira at a discussion in the Knesset Science and Technology Committee, August 18, 2020
(photo credit: KNESSET SCIENCE AND TECHNOLOGY COMMITEE SPOKESPERSON)
Antibodies discovered by the Israel Institute for Biological Research are already in production in a foreign country, according to its director-general, Prof. Shmuel Shapira. He added that Phase I and Phase II clinical trials of the institute's coronavirus vaccine candidate should be completed by the end of December.
In May, IIBR filed patent requests for eight types of coronavirus antibodies that it had isolated, the Defense Ministry said. The antibodies are being used for the development of a drug to treat COVID-19 – the disease caused by the novel coronavirus.
Shapira said he expects that moderate and serious patients will be able to begin treatment with the antigens under the country’s compassionate use program “very soon.”
In contrast, he said that because Israel has never approved a new vaccine before, “the process is complex.” But he stressed that the delay in moving from animal to human trials was not IIBR’s responsibility.
“There are steps in the regulatory process that require time,” he stressed. “Every step should be reported to the Health Ministry, which then responds and asks questions. Of course, bureaucracy must not slow down development," he added.
“Our ultimate goal is to have a vaccine, and we are working in this direction,” Shapira said.
The IIBR vaccine candidate is based on a well-known method of vaccination, the institute said in a document it released earlier this summer. But what is new is the use of a VSV virus – a type of virus that does not cause diseases in humans.
Through genetic engineering, proteins are attached to the VSV virus to form coronavirus “crowns” that are identified by the body as COVID-19. As a result, the body produces antibodies against it.
According to the report, none of the hamsters that received IIBR’s vaccine and were then injected with coronavirus became sick.
Shapira said the vaccine is “innovative but not too revolutionary,” which is why they chose it.

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Phase I human trials will be conducted on hundreds of patients, and Phase II trials on thousands of people - including older adults and maybe even children. And the final phase, Phase III, the vaccine would be tested on as many as 30,000 people.
“We knew we would not be first,” Shapira said. “Our goal was not to be first but, first and foremost, to make a vaccine for the citizens of the State of Israel. That’s the goal.”
Passive immunization is when you are given antibodies formed by another patient who got the disease and developed them. An active vaccine, in contrast, is when you are injected with a dead or weakened version of an actual virus, which tricks your immune system into thinking you have the disease, and then creates antibodies to protect you.
Shapira said that in February, Prime Minister Benjamin Netanyahu asked IIBR to develop a vaccine and therapeutic antibodies for the benefit of the citizens of Israel.
“Since then, we have been working around the clock - on Saturdays and holidays,” he continued. “At this stage, we have come up with excellent solutions.”