The Israeli vaccine destroys the first phase as no major side effects have been reported

The Israeli Biological Research Institute successfully completed the first phase of testing its corona virus vaccine on Monday, and plans to expand its testing to 1,000 volunteers for the next phase, the Ministry of Defense said.

“During the first phase, no significant side effects were identified and both the internal and external expert groups recommended the approval of the second phase. Therefore, the company has completed all the necessary preparations and is ready to start the second phase immediately,” the ministry said in a statement.

The first phase was the vaccination of 80 people at the Hadasa Hospitals in Jerusalem and the Sheba Medical Center in Ramadan.

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The second phase of clinical trials is scheduled to take place over several months starting in the coming days, with about 1,000 volunteers participating. It will also start at Sheba and Hadasa hospitals, but will gradually expand to other medical centers across the country, the defense ministry said.

“IIPR scientists are Israel ” elite unit ‘, and have a very important role to play in saving human lives. I see the greater importance in the development of the Israeli vaccine, which will continue to serve the Israeli community for many years to come,” said Defense Minister Benny Kantz.

Vials of a corona virus vaccine can be seen in an assembly line in a photo released by the Israeli Biological Research Institute on October 25, 2020. (Ministry of Defense)

Shmuel Shapiro, head of the secret Ness Siona-based laboratory, told Concise last month that the vaccine – known as Prelife, the Hebrew word for health – bri’ut – and Life – will only be ready for distribution to the public in the summer of 2021. He blamed the lack of adequate government support for causing too much testing and significant delays in its testing process.

About 15 million doses of the vaccine are produced in a single dose, unlike those produced by international competitors such as Pfizer, Moderna and Astrogeneneca, Shapiro told Knesset’s science and technology team.

Israel has already begun importing the Pfizer vaccine, and plans to deliver it to dangerous areas of the population by the end of this year.

Two more phases of testing will be required before the biological research institute is ready for widespread distribution.

In the second phase of clinical trials, researchers will work to “complete vaccine safety precautions, determine effective dosage and further determine the effectiveness of the vaccine,” the defense ministry said.

That part of the test is open to anyone between the ages of 18 and 85, including those with pre-existing medical conditions.

If that large group responds well to the vaccine, about 30,000 people will be vaccinated in April or May 2021 – which may be outside of Israel. If the vaccine works well and there are no significant side effects, it will be approved for full use in the general population.

Prime Minister Benjamin Netanyahu and Health Minister Yuli Edelstein watch the arrival of the first batch of Pfizer vaccines on December 9, 2020 at Ben Gurion Airport. (Mark Israel Pet / Flash 90)

The approval of the U.S. Food and Drug Administration and the immediate approval of others for the Pfizer vaccine has raised questions about the need for a locally produced option that would be ready for distribution long after its international competitors.

The Ministry of Defense declined to comment to the Times of Israel on the criticism, but said it needed a biological research vaccine to ensure that Israel had independent access to a vaccine for Channel 13 news.

It has been described by other officials as a backup plan to provide additional vaccines purchased from pharmaceutical companies abroad.

Defense Minister Benny Kants speaks with Professor Shmuel Shapiro, director of the Left, Biological Research Institute, on August 6, 2020, in a laboratory in Ness Siona. (Ministry of Aerial Harmony / Defense)

During his meeting with the Knesset, Shabira rarely criticized the government for signing millions of vaccine agreements with non-Israeli companies.

“There is a tendency to pay homage to companies whose mother tongue is English or sometimes Russian,” he said, adding that Israel had signed an agreement to buy a vaccine from Israel, but faced concerns about its opacity testing and approval process.

“Even though we are Hebrew speakers, I think the best and responsible work is being done, regardless of finances,” Shabira told the group. “We would be happy to get the same support from the giant companies that do 30 times more than us.

“If we hadn’t faced more control, we would have made more progress,” he lamented. “We should already be in phase 3 clinical trials and now we will only reach them in April.”

He said Phase 3 trials would be conducted outside Israel due to regulatory sanctions.

“We have an effective and safe vaccine, and our goal is to produce 15 million vaccines,” he said, adding that vaccinating 80 people had “very minor” side effects. He did not say what the side effects were.

Reports suggest that Israel has set aside or spent about $ 1 billion to buy vaccines from abroad.

As part of the country’s agreement with Pfizer, Israel is to receive an 8 million dose of the vaccine, which is enough to vaccinate 4 million Israelis. The deal with Moderna will see the purchase of 2 million doses, which is enough for another million. The country has a population of over 9 million, including more than 3 million Palestinians in the West Bank and more than 2 million Palestinians in the Gaza Strip.

On Monday, Moderna said it would ask U.S. and European regulators to allow the emergency use of its COVID-19 vaccine, confirming that the new study results provide strong protection of the footage.

Israel is in the final stages of talks with British pharmaceutical company AstraZeneca to buy “millions” of drugs, which are currently under investigation, Prime Minister Benjamin Netanyahu announced on Friday. However, those vaccines face delays after admitting that further research is needed after mistakes have been made in the tests.

Since COVID-19 first appeared in China late last year and unleashed a catastrophe on the world economy, a vaccine is seen as the best hope to break the cycle of deadly viral outbreaks and harsh controls around the world.

The level of infection in Israel is creeping up again as it gradually emerges from its second nationwide location across the country.

Israeli staff and agents contributed to the report.

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