Israel Institute of Biological Research director general Prof. Shmuel Shapira has voiced criticism of the overly strict regulation applied to the development of the Covid-19 human vaccine that his institute is developing, and the speed with which the government has closed huge deals with overseas pharmaceutical companies for their vaccines.
He told the Knesset Science and Technology Committee, "We don't have strong enough backing. There is in Israel a very big tendency to give respect to companies whose mother tongue is English. We are not a company that is offering shares, there are no shares in the Institute. We are very very reliable. Our professional and ethical commitment is very high, and we keep our feet firmly on the ground."
Shapira added, "We have come a long way, which was very difficult. The very strict regulator in Germany,where people are very formal, saw what we had been though and thought that it was too long and too complicated, and I won't expand on that. Even senior people in Israel want to volunteer for our next trial."
Israel has already ordered eight million doses of vaccine from Pfizer, 10 million doses from AstraZeneca, and unknown millions from Moderna. Vaccinations should begin in January, while the Israel Institute of Biological Research's vaccination won't be ready until the summer at the earliest. The Institute began vaccinating volunteers early last month, as part of a Phase I trial to see if the vaccine produces enough antibodies. If that trial is successful, the Institute will begin a Phase II/III trial in the middle of the first half of 2021.
Shapira said, "We are not a commercial company, so we have no business considerations to take into account. There is only one consideration, the benefit of the citizens of the State of Israel. We are the only place in Israel that has the ability to produce vaccines. If we had not encountered obstacles on the way, over-regulation and excessive strictness, which other companies abroad have not had to deal with, then we could already have been in more advanced trials."
"Every day we have to fight and I hope that we won't have to overcome more hitches. We already have an effective and safe vaccine. We tried it out on four types of animals before we moved onto human trials. With small animals and mice it was both effective and safe, and now we have 80 volunteers with barely any side effects. In contrast to declarations from other companies, we are very responsible."
He said that the Israeli vaccine would probably require only one injection, compared with two for all the companies that have announced successful Phase III results. "It would be very difficult to vaccinate all of Israel once, but to have to do it twice?"
He continued, "Even though we speak Hebrew, I would still like to receive support. I think that scientific truth will triumph. I very much hope that everyone will understand that genuine scientists are behind this. Our interest is properly scientific. So far we have invested NIS 250 million, so the cost is very attractive. We have received enquiries from all round the world."
The Israeli vaccine uses similar technology to that being developed by AstraZeneca and Johnson & Johnson, based on genetic engineering of the virus in such a way that it does not harm humans.
Published by Globes, Israel business news - en.globes.co.il - on December 1, 2020
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