Israel’s vaccine candidate set to launch Phase II clinical trial

The death toll from the coronavirus in Israel passed more than 3,000.

Hadassah-University Medical Center's Prof. Yossi Karko (left) and Hannah Drori, chief of the hospital’s clinical research center, administer Brilife vaccine to a volunteer (photo credit: HADASSAH)
Hadassah-University Medical Center's Prof. Yossi Karko (left) and Hannah Drori, chief of the hospital’s clinical research center, administer Brilife vaccine to a volunteer
(photo credit: HADASSAH)
As the death toll from the coronavirus in Israel passed more than 3,000, Prime Minister Benjamin Netanyahu said he would be vaccinated on Saturday night and the Health Ministry announced it has approved the launch of Phase II clinical trial for the Israel Institute of Biological Research’s coronavirus vaccine candidate, known as Brilife.
Also, the health funds have said that they will begin vaccinations on December 23.
The IIBR trial is set to begin within the coming days at Sheba Medical Center, Tel Hashomer, and then will be expanded to other medical centers across the country.
“The scientists of the IIBR are Israel’s ‘elite unit,’ and have taken on an extremely important task – saving human lives,” said Defense Minister Benny Gantz Monday evening in a statement. “I see great importance in the development of an Israeli vaccine that will continue to serve Israeli society for years to come.”
A spokesperson for Sheba told The Jerusalem Post that it will imminently start intensive screening for the Phase II trial. “We are working in tandem with IIBR on researching the potential of this game-changing vaccine,” he said.
The Phase II trial will be done with 1,000 healthy volunteers aged 18 and over, including senior citizens. The aim of this phase is to complete vaccine safety precautions, determine effective dosages and further determine the vaccine’s effectiveness, a release explained.
The trial is being launched after a successful Phase I trial, from which data was examined by both internal and external committees. No significant side effects were identified. If the Phase II trial is also successful, it will enable the launch of a large-scale trial to test the effectiveness of the vaccine with the participation of up to 30,000 volunteers in Israel and abroad. Phase III is the final phase required to achieve approval for vaccination.
Earlier, the institute said it hopes to have vaccines available by summer. According to IIBR head Dr. Shmuel Shapira, “over-regulation” has slowed the progress of the Brilife vaccine.
“We should have been in Phase III, and now we will only reach it by April,” he said last month in the Knesset. “I think we have come a long and difficult way. When a [representative of a] prestigious regulatory institute saw what we went through, he said that what we
experienced was ‘too complex a path.’”
The institute has the ability to produce 15 million doses of the vaccine candidate, if approved. Israel has already ordered eight million doses of the Pfizer vaccine – more than 300,000 of which have arrived in Israel – as well as six million doses of Moderna’s vaccine candidate and 10 million doses of the AstraZeneca vaccine candidate.
The Moderna vaccine candidate is expected to be reviewed by an advisory committee of the US Food and Drug Administration for Emergency Use Authorization on December 17. Unlike Moderna’s and Pfizer’s vaccines, which are based on messenger RNA, Brilife is vector-based.
The vaccine takes the vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope. Once injected, it does not cause a disease by itself; VSV does not infect humans. Instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response.
WITH THE various vaccines on the horizon, Israelis are still trying to figure out which regulations can be lifted and which should stay in place. The Constitution, Law and Justice Committee approved the outline on Monday for opening malls, markets and museums.
The chairman of the committee, MK Yakov Asher of the United Torah Judaism Party, demanded that the Health Ministry speed up the process of regulating “green passports” and also bring an agreed wording to the barcode at the entrance to commercial places that will allow a wide and careful opening of the economy.
Dr. Sharon Alroy-Preis, head of Public Health Services, warned against the move, saying that, “at the moment, the morbidity indices are doubling every two weeks. This is not a stable situation that allows us to open up.”
She also cautioned that 55% of the country is now living in red or orange areas and that it would be a mistake to open up the country further. She warned that Israelis returning from Dubai, where there have been reports in recent days of huge parties with no virus precautions – as well as the fact that Ben-Gurion Airport has been crowded – could raise the infection rate. But others in the health establishment were more optimistic. With the help of vaccines, Israel would be able to return to a relatively normal routine around April, Israel’s coronavirus commissioner Prof. Nachman Ash said on Monday morning.
“I estimate that within a few months – in March, April – we will already have vaccinated a significant portion of Israeli residents, so that we can open up the economy, return to being active and more or less return to a normal life,” Ash said in radio interviews with Army Radio and Kan Bet. “I hope we can celebrate this Passover without the restrictions on gatherings, surrounded by our families.”
The Health Ministry on Monday morning reported that 1,707 cases of COVID-19 were diagnosed in the country on Sunday, with a positive result rate of 3.4%. On Monday as of 3 p.m., there were 656 positive cases diagnosed and 383 serious cases, of which 99 were on ventilators. The death toll stood at 3,003.
Idan Zonshine, Lahav Harkov and Jerusalem Post Staff contributed to this report.