“Experiments on humans should begin after the High Holy Days,” Defense Minister Benny Gantz said after a visit to the institute. “First of all, I would like to thank you, the people in the Defense Ministry and the people at the institute, who are doing a fantastic job.”
The human trials would be conducted in collaboration with the Health Ministry and “according to all the processes required in terms of medical safety,” he said.
Prof. Shmuel Shapira, director-general of the IIBR, said the institute “set off six months ago” to develop the vaccine, adding that now it has “an excellent vaccine in hand.”
“We will start safety and efficacy trials after the holidays, but we have a product in hand,” he said.
Prime Minister Benjamin Netanyahu had instructed the institute to begin working on a vaccine and antigens for the novel coronavirus at the start of the pandemic. Netanyahu, who spoke with Shapira by video conference on Thursday, said he hopes the vaccine will be available for use by the end of the first quarter of 2021.
Later, at a press conference from Shaare Zedek Medical Center, Netanyahu said human trials would run in three stages, with trials first on 100 people, then 1,000 and finally 30,000. The first two stages should be completed by the end of this year, he said.
“We have good news that can give us hope,” Netanyahu said. “The good news is that we are definitely making progress, as you know, in finding the vaccine at the Biological Institute. I welcome that.”
The prime minister added that he asked IIBR to start setting up the production plant already, in parallel with the experiments that will be done on the first people, so that Israel will be ready if the trials are successful.
The pace of the institute’s progress is in line with the schedules set at the outset by the IIBR, the National Security Council and the Defense and Health ministries, according to the Prime Minister’s Office.
The IIBR is waiting until after the High Holy Days to minimize the high risks involved in human testing. The company will be among fewer than two dozen that have started Phase 3 clinical trials for a coronavirus vaccine.
The trials are only starting by October because “there are regulatory processes that the vaccine needs to go through,” the Defense Ministry said.
There are currently more than 135 vaccine candidates undergoing preclinical trials, The New York Times’ Coronavirus Vaccine Tracker reports. In October, IIBR will join a short list of only 18 other candidates that are in Phase 1 clinical trials. There are six vaccines undergoing Phase 3 large-scale efficacy tests.
In June, IIBR researchers reported that they had successfully completed testing their vaccine candidate on hamsters.
The potential Israeli vaccine is based on a well-known method of vaccination, the institute said in a report released to the public. But what is new is the use of VSV – a type of virus that does not cause disease in humans.
Through genetic engineering, proteins are attached to the vesicular stomatitis 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, all the hamsters that received the institute’s vaccine and were then injected with coronavirus did not become sick.
The institute has also filed patent requests for eight types of coronavirus antibodies that it has isolated to be used for the development of a future drug to treat COVID-19.