As Israel Begins Human Trials, Experts Warn COVID Vaccine Still Long Way Off

THE MEDIA LINE — With two shots, Israel on Sunday began the first phase of human clinical trials for its coronavirus vaccine candidate, developed by the state-run Israel Institute for Biological Research (IIBR) in Ness Ziona.

Segev Harel, 26, a resident of Kfar Yona, near Netanya, received the first dose at Sheba Medical Center in Ramat Gan, while Anar Ottolenghi, 34, from Tlalim, a kibbutz in the Negev desert, was inoculated at Hadassah-University Medical Center in Jerusalem’s Ein Kerem.

“The true exit from the coronavirus crisis is in the development of vaccines. Therefore, this is a very important day, a day that gives a shot of encouragement,” Prime Minister Binyamin Netanyahu said after visiting Sheba with other top officials, including Defense Minister Benny Gantz and Health Minister Yuli Edelstein, where they met Harel.

The government on February 2 directed scientists at IIBR, which operates under the auspices of the Defense Ministry, to produce a vaccine. Researchers have so far produced 25,000 doses for the first and second phases of human clinical trials, with Prof. Shmuel Shapira, director of the institute, stating that the final goal for the BriLife vaccine is 15 million doses for Israel and its close neighbors, and that the vaccine could be ready by July 2021.

Yet two leading public health experts told The Media Line that the country still has a long way to go until a viable vaccine is available to the public.

“I’m very happy that we are moving on to human vaccination trials,” Prof. Gabriel Izbicki, director of the Pulmonary Institute at Jerusalem’s Shaare Tzedek Medical Center, told The Media Line. “But I want to be realistic [and] we are still a very long way off, in my opinion.”

“I’m very happy that we are moving on to human vaccination trials. But I want to be realistic [and] we are still a very long way off, in my opinion.”

Shapira’s timeline of next summer is the best-case scenario, according to Izbicki, with the realistic case taking longer, and the worst-case much longer, at one-and-a-half to two years.

“[An available vaccine] is definitely going to take longer because we need data, we need statistics [and] we need patients. It’s not a small trial,” added Izbicki.

Eighty healthy volunteers aged 18 to 55 are participating in the first phase of trials – 40 each at Sheba and Hadassah, according to the Defense Ministry. Starting Wednesday – and depending on the responses of the first two participants – the other 78 will gradually be administered shots.

The second phase of 960 volunteers over the age of 18, including some with preexisting conditions, is expected to begin in December at eight medical centers across the country.

The third and final phase is to start in April or May, pending the successful completion of the first two phases. This phase is to involve up to 30,000 volunteers, and if successfully completed, the vaccine can be approved for general use.

According to the Defense Ministry, the Phase I volunteers were chosen by Sheba and Hadassah. In addition to the age and health requirements, they were checked for antibodies to see if they had already been exposed to the novel coronavirus, in which case they could not participate in the trial.

After being administered the shot, the participants are monitored at home by the hospital.

“Each volunteer will receive an injection – a vaccine or placebo. After a few hours of supervision, he/she will be discharged from the hospital and be monitored over a period of three weeks,” the Defense Ministry said in a statement.

“Scientists will check for any possible side effects and will monitor whether the volunteers develop antibodies to the virus,” the statement continued. “The development of antibodies indicates a response to the virus in the patients who received the vaccine.”

Around two-thirds of the volunteers will receive the vaccine, with the rest getting the placebo.

Israel is also working on bringing vaccines into the country that are being developed abroad, recently signing agreements with Italy and Germany to receive doses when they become available in the European Union.

Udi Qimron, a professor in the Department of Clinical Microbiology and Immunology of Tel Aviv University’s Sackler Faculty of Medicine – and a frequent critic of the government’s handling of the coronavirus pandemic – told The Media Line that Israel’s vaccine efforts were “hopeless” compared to those of others.

“Even the competitors are not in a position to provide a vaccine soon, and therefore it would be a huge gamble to impose restrictions and lockdowns until a vaccine is available,” Qimron cautioned.

“Even the competitors are not in a position to provide a vaccine soon, and therefore it would be a huge gamble to impose restrictions and lockdowns until a vaccine is available.”