Israel will begin human trials of COVID-19 vaccine candidates on November...

The Israeli Institute for Biological Research announced on Sunday that it would begin human trials of its coronavirus vaccine Brilife next week. The vaccine has received all necessary approvals from the Ministry of Health and the Helsinki Committee for Medical Experimentation on Humans. “This is a day of hope for the citizens of Israel,” said Defense Secretary Benny Gantz. “I received the first bottle of the vaccine only two months ago. Today we already have 25,000 doses of vaccine. “I want to thank the dozen of researchers who worked day and night on this national mission,” he continued. “At this complex time, you are the entity that is paving the way for the citizens of Israel.” IIBR Director Prof. Shmuel Shapira added that this is an “important and crucial phase” in the development of the vaccine. “I’m confident in our vaccine, I believe in it and in the skills of the institute’s scientists who developed it,” he said. The Phase 1 human study will last several months and will be conducted on 80 volunteers between the ages of 18 and 55 at Sheba Medical Center and Hadassah Hospitals. The process starts on November 1st with two volunteers. Depending on their answers, the other 80 will gradually receive the vaccine candidates – 40 people in each medical center. Each volunteer is given an injection, but some are given a placebo. Each volunteer will be monitored over a period of three weeks to see if the vaccine has any side effects. The researchers will also look to see if volunteers develop antibodies to the coronavirus, which leads to immunity. When phase 1 is completed, if successful, phase 2 begins, in which the vaccine is tested on 960 healthy volunteers over the age of 18. Phase 2 is expected to begin in December at medical centers across the country. This phase is designed to complete safety tests and determine the correct doses and further measure effectiveness. If the first two phases are successful, a phase 3 study with 30,000 volunteers will begin in April or May 2021. This is the final stage. Once completed, the vaccine can be approved and the population vaccinated against the virus. The IIBR vaccine candidate is based on a well-known vaccination method, according to the institute. What is new is the use of a vesicular stomatitis virus (VSV) – a type of virus that does not cause disease in humans. Genetic engineering binds proteins to the VSV virus to form coronavirus “crowns” that the body identifies as COVID-19. As a result, the body produces antibodies against it. IIBR has been preparing for an unknown threat like this for several years. As part of the scientific preparation, the institute acquired and established a national infrastructure for the 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 effectiveness of vaccines and treatments, and new infrastructure has been developed and established for fast and efficient production, which has totaled millions of vaccines under strict regulatory conditions for around 25,000 vaccine doses for the first and second phase of clinical trials established.

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