/Israeli COVID-19 vaccine to begin human trials next week – The Jerusalem Post

Israeli COVID-19 vaccine to begin human trials next week – The Jerusalem Post

The Israel Institute for Biological Research on Sunday announced it will begin human trials of its coronavirus vaccine,
Brilife, next week. The vaccine has received all necessary approvals from the Health Ministry and the Helsinki Committee for medical experiments on humans.

“This is a day of hope for the citizens of Israel,” Defense Minister Benny Gantz said. “Just two months ago, I received the first bottle of the vaccine. Today, we already have 25,000 vaccine doses.”

“I would like to thank the dozens of researchers who worked day and night on this national mission,” he said. “In this complex period, you are the unit that paves the way for the citizens of Israel.”

IIBR director Prof. Shmuel Shapira said this is an “important and crucial stage” in the development of the vaccine.

“I am confident in our vaccine,” he said. “I believe in it and in the ability of the institute scientists who developed it.”

The Phase I human trial will last several months and be conducted on 80 health volunteers between the ages of 18 and 55 at Sheba Medical Center in Tel Hashomer and Jerusalem’s Hadassah-University Medical Center.

The trial will kick off on November 1 with two volunteers. Depending on their responses, the others will gradually receive the vaccine candidate – 40 people at each medical center. Each volunteer will receive an injection, but some will receive a placebo.

Each volunteer will be monitored over the course of three weeks to determine if there are any side effects caused by the vaccine. Researchers will also examine whether volunteers develop antibodies to coronavirus, which leads to immunity.

When Phase I is completed, if successful, Phase II will commence, testing the vaccine on 960 healthy volunteers over the age of 18. Phase II is expected to begin in December at medical centers across the country. That phase is meant to complete safety tests and pinpoint the right doses, as well as to continue to gauge effectiveness.

If the first two phases are successful, a Phase III trial of 30,000 volunteers will begin next April or May for the final stage. Once completed, the vaccine can be approved, and the population can be vaccinated against the virus.

IIBR’s vaccine candidate is based on a well-known method of vaccination, the institute has said. What is new is the use of a vesicular stomatitis virus (VSV) – 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.

The N12 news site reported Sunday night that the vaccine was tested on pigs and found effective.

IIBR has been preparing for several years for an unknown threat such as this one. As part of the scientific preparation, the institute purchased and set up a national infrastructure for rapid identification of epidemic pathogens and developed tools for rapid vaccine planning in response to outbreaks.

Animal models have been put in place to test the safety and efficacy of vaccines and treatments. New infrastructure has been developed and established for rapid and efficient production, amounting to millions of vaccines, under stringent regulatory conditions.

The institute has the ability to produce 15 million doses.

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