Israel completes Phase I study with its coronavirus vaccine candidate

Hadassah University Medical Center and Sheba Medical Center reported on Thursday that they had administered the country’s coronavirus candidate vaccination to 80 volunteers, completing the Phase I clinical trial.
The vaccine candidate from the Israel Institute of Biological Research is known as Brilife. The phase I trial started on November 1. About 40 healthy volunteers aged between 18 and 55 years were vaccinated in each of the two hospitals.
“We are pleased to announce that the first phase of the clinical research study of the coronavirus vaccine has been a success,” said Prof. Yossi Karko, director of the clinical research unit at Hadassah.
The study participants have been and will be monitored regularly for any adverse side effects. Until now, Karko said The Jerusalem Post in a previous interview all volunteers felt good. Sheba said the same.
Brilife’s Phase II trial, which will vaccinate older adults as well as some individuals with pre-existing 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 to mark the inauguration of new ambassadors in Moscow on Tuesday, Putin spoke about his country’s candidate vaccination, which earlier this week reported an efficacy of 91.4% based on a second interim analysis of data collected during the phase III study. He then referred to Israel, saying, “It is important that there is cooperation between Israel and Russia in the fight against the coronavirus, including the ability to supply and produce a Russian vaccine on Israeli soil.”

The Israel Hayom Daily broke the story for the first time.
Prof. Zeev Rotstein, the head of the Hadassah University Medical Center, whose Moscow branch has participated in the Phase III study of Sputnik V, confirmed the report, saying it is in fact included in the memorandum of understanding he communicated with the company. has signed that manufacture could take place in Israel.
“Once we have signed the detailed contract, we can start producing the vaccine,” Rotstein told the US PostHe said production would be through a joint venture between Hadassah and one of the country’s largest pharmaceutical companies.
At the same time, Rotstein is working on being able to participate in the Phase III trial in Israel – not just Moscow – and to register Sputnik V for use through the Ministry of Health.
At the Moscow event, which Israel Hayom said was attended by Israeli Ambassador to Moscow Alexander Ben Zvi, Putin also noted that relations with Israel are “good and useful” and that he maintains “regular contact” with Prime Minister Benjamin Netanyahu.
The Prime Minister first said he is in talks with Putin to bring Sputnik V to Israel at a press conference earlier this month when he said: “I recently spoke with Putin about the possibility of an option for Sputnik V. vaccine. “

Rotstein said his MOU includes the purchase of 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 been scrutinized by several Western experts, including some scientists in Israel, who have warned against using the vaccine until all internationally approved testing and regulatory steps have been taken.
Amit Asa, deputy director of Samson Assuta Ashdod Hospital, said Post that Russian regulatory authorities are not paying enough attention to their drug and vaccine approval process.

“Better to be safe than sorry,” he said, pointing out that Israel should not spread Sputnik V easily. “It is common practice in Israel to rely on acceptable authorities such as the US Food and Drug Administration and the European Medicines Agency with medicines, vaccinations and food, and I see no reason to change that practice now when I refer to vaccination against the drug. coronavirus … We don’t want to have avoidable side effects within a few months. “

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