Israel Launches Coronavirus Vaccine Human Trials

Netanyahu “true exit from coronavirus crisis is development of a vaccine

Two Israelis were inoculated on Sunday morning with the first doses of Israel’s coronavirus vaccine candidate at Sheba Medical Centre in Tel Hashomer and Hadassah Medical Centre in Jerusalem’s Ein Kerem.

The first volunteers were Anar Ottolenghi, 34, a resident of Moshav Telalim in the South, who was vaccinated at Hadassah, and Segev Harel, 26, from Kfar Yona, east of Netanya, who was vaccinated at Sheba.

“I feel good, excited,” Ottonlenghi, a doctoral student in immunology at Ben-Gurion University of the Negev, said shortly after he was inoculated. “I want to encourage as many people as possible to join the experiment and help the entire public.”

Anar Ottolenghi, 34, becomes one of the first Israelis to trial the coronavirus vaccine, Hadassah Ein Kerem, November 1, 2020

The Israeli vaccine, known as “Brilife,” was developed by the Israel Institute for Biological Research. Sunday marked the start of the Phase I human trial.

The Health Ministry also is working with major pharmaceutical companies to bring vaccines to Israel, Prime Minister Benjamin Netanyahu said. The country has already signed contracts with American vaccine makers Arcturus and Moderna. Last week, it was revealed that the Mossad brought China’s coronavirus vaccine to Israel in recent weeks to study and learn from it.

Netanyahu stressed he has ordered that an enterprise for the permanent production of vaccines be established in the country.

Defense Minister Benny Gantz expressed “cautious optimism” because while he has trust in the in the country’s top doctors and scientists, “this process is still a long process. It will take time to follow, process the data, analyse the meanings, so patience is necessary.”

The Phase I trial will be conducted on 80 healthy volunteers between the ages of 18 and 55. 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 the coronavirus that lead to immunity.

Depending on the responses of these first two volunteers, others will gradually receive the vaccine candidate beginning on Tuesday in two phases – 40 people at each medical centre, IIBR head Prof. Shmuel Shapira said. Each volunteer will receive an injection, but some will receive a placebo.

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 centres throughout the country. That phase is meant to complete safety tests, pinpoint the right doses and continue to gauge effectiveness.

Shapira, like Gantz, expressed cautious optimism. “If I did not think we had a chance, we would not be here,” he said.

He compared Israel’s vaccine to others being developed, adding: “There are a lot of vaccines that are like birds on a tree,” meaning that they could be fleeting, as they are based on technologies that have not been used before in successful vaccines.

This is the case with the Moderna’s mRNA-1273 vaccine, which uses the mRNA (messenger RNA) delivery platform. Moderna has never completed production of a similar vaccine.

In Phase I, doctors are looking for any extreme side effects to the vaccine, which could cause the institute to pause and reevaluate, he said.

IIBR is not currently vying for Food and Drug Administration approval, but at a certain point, it could consider it, Shapira said.

Editors Notes:

This piece was originally taken from a Maayan Jaffe-Hoffman article in The Jerusalem Post.

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