The Institute for Biological Research, the Defense Ministry and the Health Ministry announced on Sunday that the institute is ready to start clinical trials on a potential coronavirus vaccine. The three-phase human trials are set to start on Sunday, November 1 and last for several months.
The researchers at the government institute said that so far, they have produced over 25,000 doses of the experimental vaccine, which has now been approved for human trials, for the first two stages of the clinical tests. The institute has just finished manufacturing enough of the material for the vaccine for another one million doses.
The first stage will be to conduct preliminary safety trials on 80 healthy volunteers between 18 and 55, in Sheba Medical Center in Tel Hashomer and Hadassah University Hospital in Jerusalem, 40 people in each hospital. The trial will start at first with just two volunteers – and will be increased to 80 people gradually according to their reactions.
Every volunteer will receive a shot, either of the vaccine or a placebo. After a few hours of monitoring, they will be released to their homes and three weeks of follow-up. During this period, they will be examined for any side effects and to see whether they have developed antibodies to the virus.
During the second stage, more extensive safety tests will be conducted on 960 healthy volunteers over age 18. This stage is scheduled to begin in December and will be carried out at the same time in a number of medical centers all over Israel. This part of the trial is intended to complete the safety testing of the vaccine, adjust the dosages of the vaccine and examine the measures of its effectiveness.
The third stage will be a broad trial to examine the vaccine’s effectiveness with up to 30,000 volunteers. It is scheduled to begin in April or May – depending on the success of the first two stages. This is the final stage, which if it is completed successfully will enable the approval of the vaccine and the vaccination of the entire population.
A scientist from the institute said they have already injected various animals with the vaccine to test its safety. “Not only did they not get sick and not develop symptoms of the disease, they also created antibodies that succeeded in neutralizing the real virus, the vicious virus,” she said.
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The institute’s director, Prof. Shmuel Shapira, said: “Our final target is 15 million doses to help the residents of Israel and our close neighbors.”
“We are at the beginning of the important and decisive stage for this entire development,” said Shapira. “I am sure of our vaccine and the ability of the institute’s scientists who developed it, so I am convinced that we are bringing an excellent, effective and safe vaccine to all Israelis.”
Defense Minister Benny Gantz hailed the breakthrough as “a day of hope for the citizens of Israel.”