Israel completes Phase I trial of its coronavirus vaccine candidate, Brilife

Putin confirms Russia could manufacture Sputnik V vaccine in Israel.

Hannah Drori, Chief of Staff of the Clinic Research Center at Hadassah (photo credit: HADASSAH SPOKESPERSON)
Hannah Drori, Chief of Staff of the Clinic Research Center at Hadassah
Hadassah-University Medical Center and Sheba Medical Center reported Thursday that they had administered the country’s coronavirus vaccine candidate to 80 volunteers, thus completing the Phase I clinical trial.
The Israel Institute of Biological Research’s vaccine candidate is known as Brilife. The Phase I trial kicked off on November 1. Some 40 healthy volunteers between the ages of 18 and 55 were inoculated at each of the two hospitals.
“We are pleased to announce that the first phase of the clinical research trial of the coronavirus vaccine was a success,” said director of the clinical research unit at Hadassah, Prof. Yossi Karko.
The trial participants have been and will continue to be regularly monitored for any adverse side effects. So far, Karko told The Jerusalem Post in a previous interview, all of the volunteers were feeling well. Sheba said the same.
The Phase II trial of Brilife, which will vaccinate older adults as well as some individuals with preexisting medical conditions, should start in hospitals across the country within the next three weeks.
Russian President Vladimir Putin has confirmed that his country is considering manufacturing and distributing its COVID-19 vaccine, Sputnik V, through the State of Israel.
At a ceremony marking the inauguration of new ambassadors in Moscow on Tuesday, Putin spoke about his country’s vaccine candidate, which earlier this week reported an efficacy of 91.4% based on a second interim analysis of data gathered during its Phase III trial. He then referenced Israel, saying “it is important that there is cooperation between Israel and Russia in the fight against coronavirus, including the possibility of supplying and producing a Russian vaccine on Israeli soil.”
The Israel Hayom daily first broke the story.
Prof. Zeev Rotstein, the head of Hadassah-University Medical Center, whose Moscow branch has been participating in the Phase III trial of Sputnik V, confirmed the report and said it is in fact included in the memorandum of understanding he signed with the company that manufacturing could take place in Israel.
“Once we sign the detailed contract, we will be able to begin moving forward with manufacturing the vaccine,” Rotstein told the Post.
He said the manufacturing would take place via a joint venture between Hadassah and one of the country’s major pharma companies.
At the same time, Rotstein is working to be able to take part in the Phase III study in Israel – not just in Moscow – and to get Sputnik V registered for use through the Health Ministry.
At the Moscow event, which according to Israel Hayom was attended by Israeli Ambassador to Moscow Alexander Ben Zvi, Putin also commented that relations with Israel are “good and beneficial” and that he maintains “regular contact” with Prime Minister Benjamin Netanyahu.
The prime minister first mentioned that he is in discussions with Putin over bringing Sputnik V to Israel during a press briefing earlier this month, when he said, “I recently spoke with Putin about the possibility of purchasing an option for the Sputnik V vaccine.”
Rotstein said his MOU includes purchasing 1.5 million doses of the vaccine, with an option to double the number of doses to 3 million.
The Russian vaccine is being developed by the Russian Direct Investment Fund and the Gamaleya Research Institute of Epidemiology. It has come under scrutiny by several Western experts, including some scientists in Israel, who have warned against the use of the vaccine until all internationally approved testing and regulatory steps have been taken.
Amit Asa, deputy director of the Samson Assuta Ashdod Hospital, told the Post that Russian regulatory authorities are not known to exercise enough scrutiny in their approval process of drugs and vaccines.
“It is better to be safe than sorry,” he said, noting that Israel should not readily distribute Sputnik V. “It is common practice in Israel with drugs, vaccinations and food to rely on acceptable authorities such as the American Food and Drug Administration and the European Medicines Agency, and I don’t see any reason to change that practice now when referring to the coronavirus vaccination... We don’t want to find ourselves in a couple of months with preventable adverse events.”