'Israeli over-regulation slowed country's COVID-19 vaccine release' - IIBR

Speaking at the Knesset on Monday, Israel Institute for Biological Research head Dr. Shmuel Shapira said that “we should have been in Phase III, and now we will only reach it by April."

By MAAYAN JAFFE-HOFFMAN
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe, October 30, 2020. (photo credit: REUTERS/DADO RUVIC/FILE PHOTO)
A woman holds a small bottle labeled with a "Coronavirus COVID-19 Vaccine" sticker and a medical syringe, October 30, 2020.
(photo credit: REUTERS/DADO RUVIC/FILE PHOTO)
BriLife, Israel’s coronavirus vaccine candidate could have been further along if not for the “over-regulation” that the Israel Institute for Biological Research encountered, according to its head Dr. Shmuel Shapira.
Speaking at the Knesset on Monday, he said: “We should have been in Phase III, and now we will only reach it by April. 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.’
“I will not expand beyond that,” Shapira continued. “Those who understand it will understand.”
Shapira confirmed that IIBR completed its Phase I trial five days ago. Phase II, which will include around 1,000 volunteers and take place at medical centers across the country, is expected to begin within 10 days, he said.
“We have the ability to produce 15 million [doses of] vaccines for the benefit of all Israeli citizens,” Shapira said.
He added that IIBR’s “ethical and professional commitment is very high” and that he believes the vaccine is safe and scientifically sound.
“People will believe in our vaccine,” Shapira said. “We are courting countries all over the world who want to participate in our [Phase III] trial.”
The Phase III trial is meant to include 30,000 volunteers.
The Phase I trial was tested on four animal models and 80 humans and was found to have few side effects and no severe ones.  
Shapira criticized decision-makers who have pre-purchased millions of vaccine candidates from overseas.

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“There is a tendency to respect companies whose mother tongue is English and sometimes Russian,” he said. “I think there is a very good and very responsible operation here that is free from economic considerations – even though we speak Hebrew.”
Shapira added that “we would be happy to receive the same support and sympathy that huge companies do that get thirty times what we do.”
Israel has signed contracts to receive vaccines, if shown to be successful, from three American companies: Pfizer and Moderna, both of which are far along in their Phase III trials, and Arcturus, which is about to complete its Phase I trial. In addition, Israel has an agreement with the British pharmaceutical company AstraZeneca.
Shapira previously explained that the “Bri” in BriLife is the first part of briyut, the Hebrew word for health, and the “il” stands for Israel, connecting to “Life.”