Israel’s Ministry of Health has approved the start of the second phase of clinical trials for the Israel Institute for Biological Research’s (IIBR) COVID-19 vaccine, following the successful completion of the first phase, according to a Defense Ministry statement.
The second-phase trial, which will involve testing some 1,000 healthy volunteers aged 18 and over, is expected to begin in the coming days. In this phase, scientists aim to determine safety, efficacy and dosages. Its success will enable a large-scale trial with the participation of up to 30,000 volunteers (Phase 3) in Israel and/or abroad.
The trial will take place at Sheba and Hadassah medical centers, and will gradually expand to additional medical centers throughout the country, according to the statement.
In the Phase 1 trial, 80 volunteers ages 18 to 55—40 at Hadassah University Medical Center in Jerusalem and 40 at Sheba Medical Center in Ramat Gan—were monitored for antibodies and side effects for three weeks after receiving an injection (vaccine or placebo). The first dose was administered on Nov. 1 at the Sheba Medical Center at Tel HaShomer.
According to the Defense Ministry statement, no significant side effects were identified, and two expert committees, internal and external, recommended the approval of the second phase. It is thus that the IIBR completed all the necessary preparations and is ready for the immediate launch of the second phase.
In response to the announcement, Israeli Defense Minister Benny Gantz said, “The scientists of the IIBR are Israel’s ‘elite unit,’ and have taken on an extremely important task—saving human lives. I see great importance in the development of an Israeli vaccine that will continue to serve Israeli society for years to come.”
