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Israel to start COVID-19 vaccine trials on November 1

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The clinical trials on humans will take place over several months and will include three phases.

By ILANIT CHERNICK

In a major milestone, Israel’s Institute for Biological Research (IIBR) is set to start clinical trials for a coronavirus vaccine on November 1. 

The IIBR received the necessary approval from the Ministry of Health and the Helsinki Committee to commence the trials after it completed rigorous preparations and Research Development. 

Commenting on this achievement, Israel’s Defense Minister Benny Gantz said that “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 bottle of the vaccine,” he continued. “Today we already have 25,000 vaccine doses and are starting the next phase of the test.”

In a statement, the Defense Ministry explained that the vaccine developed by the IIBR is based on an existing virus (VSV). 

“Coronavirus spikes have been ‘engineered’ onto VSV, allowing the IIBR vaccine to attach to cells in the body,” they said. “This is a modern vaccine at the forefront of global technology, which provides the required level of protection in a single dose.” 

The vaccine, the Defense Ministry pointed out, has been successfully tested on a number of “animal models” and it “elicited an effective immune response in both small animals” including mice, hamsters and rabbits, as well as large animals like pigs. The safety of the vaccine has been demonstrated in several tests, “thus opening the door for clinical trials with human participants.”

The institute has adapted a device for large-scale production of vaccines. “To date, the institute has produced more than 25,000 vaccine doses for the first and second phases of the clinical trials.”

The clinical trials on humans will take place over several months and will include three phases.

The first phase will include a series of safety tests with the participation of 80 healthy volunteers (aged 18-55), designated by Sheba and Hadassah medical centers. On Sunday, it will begin initially with two participants. 

“Depending on their responses, the vaccine will then be gradually administered to a total of 80 volunteers,” the Defense Ministry said in a statement, adding that there will be 40 in each medical center.

 Following this, each of the volunteers will receive an injection, either the vaccine or a placebo and after a few hours of supervision, they will be discharged from the hospital.

They will then be monitored over a period of three weeks. 

“Scientists will check for any possible side effects and will monitor whether the volunteers develop antibodies to the virus,” the Defense Ministry said. “The development of antibodies indicates a response to the virus in the patients who received the vaccine.”

Explaining the second phase, the Ministry said that this will include extensive safety tests with the participation of 960 healthy volunteers, who are over the age of 18. 

“The trial is expected to begin in December and will be held simultaneously in several medical centers across the country,” it stressed, highlighting that “scientists aim to complete vaccine safety precautions, determine the effective dosage, and further determine the vaccine’s effectiveness.”

With the third phase, a large-scale trial will be conducted to test the effectiveness of the vaccine. This will include the participation of up to 30,000 volunteers and scheduled to begin in April/May.

If this last stage is completed successfully, the vaccine may be approved for mass production and use.

Thanking the dozens of researchers who continue to work day and night on this national mission, Gantz said that “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. The defense establishment, the Israeli government, and I will continue to provide you with the support and resources required to produce a safe and effective ‘blue-and-white’ vaccine.” 

Director of Israel’s Institute for Biological Research, Prof. Shmuel Shapira said that this is the beginning of “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,” he emphasized. 

Shapira said that the “commercial name of the vaccine is ‘BriLife,”’ explaining that “the first part of the name, ‘Bri,’ alludes to the Hebrew word for health, ‘briut,’ the second part, ‘il’ alludes to Israel, and ‘life’ speaks to the importance of the vaccine.” 

He added that the name of the institute, IIBR is also “hidden” in the name. 

Shapira made it clear that the team would 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 concluded.

 The IIBR is a center for research and development in the fields of biology, chemistry and the environment.

*Featured Image: An illustrative photograph of a COVID-19 vaccine. (By Joel Bubble Ben)

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