The coronavirus vaccine being developed by the Israel Institute for Biological Research in Nes Tziona will require only one dose, not two like those being developed by Moderna and Pfizer, the center’s director general told lawmakers Monday.
Addressing the Knesset Science and Technology Committee, Prof. Shmuel Shapira said the third and final phase of testing in humans is expected to begin in April, and distribution of the vaccine could start as early as next summer.
He added that three million doses of the vaccine have already been produced and that Israel could produce a total of 15 million.
Phase 1 of the clinical trial was conducted at Sheba Medical Center, Tel Hashomer, nearTel Aviv, and at Hadassah University Hospital in Ein Karem, Jerusalem, with 80 participants.
The focus is on the safety of the vaccine. Shapira said the volunteers in the trial suffered “very minor” side effects. Phase 2 of the trial could begin in a week to 10 days, he said, “if we don’t encounter unnecessary delays.” That stage will have 960 participants and the third, some 30,000 participants.
Shapira added that the Israeli vaccine “has a scientific foot firmly on the ground, it’s not a new RNA vaccine.” He was referring to the fact that both Pfizer and Moderna’s vaccines trigger an immune response using messenger RNA, a method which has never been previously approved for use in vaccines.
“We don’t own stock and we have no economic consideration in our vaccines, just the good of Israeli citizens,” he said. “Scientific truth will triumph. People will understand that there is proper scientific interest here and people will believe in our vaccine.”
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He said that many countries have been in touch with the institute hoping to participate in the trials, and that senior health officials have asked to be part of the phase 2 study. “Our ethical and professional commitment is very high,” he said.
When asked by committee chairwoman Einav Kabla what she meant by “unnecessary delays,” Shapira replied, “overregulation.”
“Other companies in the world [that are developing vaccines] haven’t traveled the path we’ve traveled. No one else has submitted a safety file like ours with four animal models,” Shapira said.
The committee session was attended by the Health Ministry official responsible for corona vaccines, Dr. Uri Feinstein, who said that the first vaccine recipients, both in Israel and other countries, will be at-risk populations and health-care workers. “Apparently during the first stage we won’t give emergency approval for any of the vaccines for children and teenagers,” he said. “No company included children or teenagers [in their trials]. This will apparently come later.”
Feinstein said that nearly 90,000 people had been vaccinated during the clinical trials conducted around the world. The Health Ministry hopes that soon there will be enough inoculated people to allow broader follow up as o the efficacy and safety of the vaccines.
“In this pandemic information is accumulating very quickly, with a speed unfamiliar to me,” Feinstein said. “The pace of development and efforts at developing vaccines and drugs is advancing at a record pace.”