Israeli vaccine clears first stage as no major side effects reported

Defense Ministry institute to begin second phase of trials, testing coronavirus vaccine on 1,000 people; third phase expected in spring

Judah Ari Gross is The Times of Israel's religions and Diaspora affairs correspondent.

Sheba Medical Center nurse Hala Litwin injects a dose into Israel's first human test subject, Segev Harel, as part of trials for Israel's experimental coronavirus vaccine, BriLife, on November 1, 2020. (Defense Ministry)
Sheba Medical Center nurse Hala Litwin injects a dose into Israel's first human test subject, Segev Harel, as part of trials for Israel's experimental coronavirus vaccine, BriLife, on November 1, 2020. (Defense Ministry)

Israel’s Institute for Biological Research successfully completed the first stage of testing its coronavirus vaccine on Monday and plans to expand its trials to some 1,000 volunteers for the next phase, the Defense Ministry said.

“During the first phase, no significant side effects were identified, and two expert committees, both internal and external, recommended the approval of the second phase. As such, the institute completed all the necessary preparations and is ready for the immediate launch of the second phase,” the ministry said in a statement.

The first stage tested the state laboratory’s vaccine on 80 people out of Jerusalem’s Hadassah hospitals and Ramat Gan’s Sheba Medical Center.

The second phase of the clinical trials is scheduled to begin in the coming days and to take place over the course of several months, with approximately 1,000 volunteers taking part. It too will begin at the Sheba and Hadassah hospitals, but will gradually expand to other medical centers throughout the country, the Defense Ministry 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,” Defense Minister Benny Gantz said.

Vials of a potential coronavirus vaccine are seen on an assembly line in a photograph released by Israel’s Institute for Biological Research on October 25, 2020. (Defense Ministry)

The head of the secretive Ness Ziona-based laboratory, Shmuel Shapira, told the Knesset last month that the vaccine — dubbed Brilife, a portmanteau of the Hebrew word for health — bri’ut — and life — would likely only be ready for distribution to the public in the summer of 2021. He blamed over-regulation and lack of sufficient government support for causing significant delays in its trial process.

Some 15 million doses are being produced of the vaccine, which unlike those manufactured by international competitors Pfizer, Moderna and AstraZeneca is given in a single dose, Shapira told the Knesset’s Science and Technology Committee.

Israel has already started importing the Pfizer vaccine, with plans to begin administering it to at-risk segments of the population before the end of the year.

The Institute for Biological Research will require two more stages of testing before it is ready for wide-scale distribution.

In the second phase of the clinical trials, researchers will work to “complete vaccine safety precautions, determine effective dosage and further determine the vaccine’s effectiveness,” the Defense Ministry said.

That part of the trial will be open to anyone between the ages of 18 and 85, including people with preexisting medical conditions.

If that larger group responds well to the vaccine, injections will then be given to some 30,000 people in April or May 2021 — likely outside of Israel. If the vaccine works well and there are no significant side effects, it will then be approved for full use in the general population.

Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein watch the arrival of a plane transporting the first batch of Pfizer vaccines at Ben Gurion Airport on December 9, 2020. (Marc Israel Sellem/Flash90)

The US Food and Drug Administration’s approval of the Pfizer vaccine and expected imminent approval for others have raised questions about the need for a domestically produced option, which will be ready for distribution long after its international competitors.

The Defense Ministry refused to respond to a Times of Israel query about these criticisms, but it told Channel 13 news that the Institute for Biological Research vaccine was necessary to ensure Israel would have independent access to a vaccine.

It has been described by other officials as a backup plan to supplement vaccines purchased from pharmaceutical firms based abroad.

Defense Minister Benny Gantz, left, speaks with the director of the Institute of Biological Research, Prof. Shmuel Shapira, at the laboratory in Ness Ziona on August 6, 2020. (Ariel Hermoni/ Defense Ministry)

In his meeting with the Knesset, Shapira expressed rare criticism of the government for signing deals for millions of vaccines with non-Israeli firms.

“There is a tendency to give respect to companies whose mother tongue is English or sometimes Russian,” he said, alluding to a Russian vaccine that Israel has signed a deal to purchase, but which has faced concerns about its opaque trial and approval process.

“I think there is very good and responsible work being done, free of financial considerations, even though we are Hebrew-speakers,” Shapira told the committee. “We would be happy to get the same support as giant firms that make 30 times more than us.

“Had we not faced over-regulation, we would have made more progress,” he lamented. “We were already supposed to be in phase 3 clinical trials, and now we will only reach them in April.”

He added that phase 3 trials will be conducted outside Israel due to regulatory constraints.

“We have an effective and safe vaccine, and our intention is to make 15 million vaccines,” he said, adding that trying the vaccine on 80 people had revealed “very minor” side effects. He did not say what the side effects were.

Israel has earmarked or spent around NIS 1 billion for the purchase of vaccines from abroad, according to reports.

As part of the country’s agreement with Pfizer, Israel is to receive 8 million doses of the vaccine, enough to inoculate 4 million Israelis. The deal with Moderna would see 2 million doses purchase, enough for another million. The country’s population is over 9 million, not including the over 3 million Palestinians in the West Bank and over 2 million Palestinians in the Gaza Strip.

On Monday, Moderna said it would ask US and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirmed that the shots offer strong protection.

Israel is also in the final stages of talks with British pharmaceutical giant AstraZeneca to purchase “millions” of doses of its vaccine, which is currently under trial, Prime Minister Benjamin Netanyahu announced Friday. However, that vaccine is facing delays after it admitted additional research was needed after mistakes were made in the trials.

A vaccine is seen as the best hope to break the cycle of deadly virus surges and severe restrictions across much of the world since COVID-19 first emerged in China late last year and unleashed devastation on the global economy.

Infection levels in Israel are creeping back up as the nation gradually emerges from its second nationwide lockdown.

Times of Israel staff and agencies contributed to this report.

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