The Israel Institute of Biological Research has announced that it has received approval from the Ministry of Health to begin Phase II human clinical trials on its Covid-19 vaccine. 1,000 volunteers will participate in the Phase II trial compared with 80 in the Phase I trial.
The approval was granted after no severe side-effects were found in the volunteers who took part in the Phase I trial. Regarding the efficacy of the Phase I trial, the aim was to examine if antibodies against Covid-19 develop in the blood of the volunteers, and specifically the neutralizing antibodies. The Institute of Biological Research did not report whether these antibodies did develop.
Sources have informed "Globes" that these neutralizing antibodies did develop but the methods of the examination are not officially valid, therefore samples have been sent abroad for testing that is officially recognized. The approval was given for the Phase II trial to start on the assumption that partial results from the samples sent abroad will be available by the time the trial is set to begin.
The Phase II trial will begin at the Sheba Medical Center in Tel Hashomer and Hadassah Hospital in Ein Kerem, Jerusalem, and will gradually expand to other hospitals. Completion of the entire trial process including the Phase III trial is expected to be in the summer of 2021.
Minister of Defense Benny Gantz said, "The Institute of Biological Research researchers are Israeli commandos who have taken it upon themselves to undertake this mission which is of unparalleled importance and will save lives. I see major importance in the continued development of an Israeli vaccine to serve Israeli society in the years ahead."
Israel has already ordered enough vaccine shots for all the country's citizens from foreign companies. The vaccine doses are due to arrive throughout 2021 but it is unclear exactly when, so having an Israeli vaccine available by the summer could be an advantage.
Moreover, the Israeli vaccine is produced from a more traditional genetic engineering procedure than the Pfizer and Moderna vaccines and does not require storage at low temperatures.
Published by Globes, Israel business news - en.globes.co.il - on December 15, 2020
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