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Israel’s COVID-19 vaccine being delayed by red tape, bio institute head laments

Israel’s domestically produced coronavirus vaccine will only be ready for distribution to the public in the summer of 2021, the head of the institute manufacturing it said Monday, complaining that over-regulation and lack of sufficient government support have caused significant delays in its trial process.

Some 15 million doses are being produced of the vaccine, called Brilife, which unlike those manufactured by international competitors Pfizer, Moderna and AstraZeneca is given in a single dose, according to Prof. Shmuel Shapira, the director-general of the Defense Ministry’s Israel Institute for Biological Research.

Speaking at a meeting of the Knesset Science and Technology Committee, Shapira expressed rare criticism of the government for signing deals for millions of vaccines with non-Israeli firms, which are far ahead of the Israeli vaccine’s schedule.

“There is a tendency to give respect to companies whose mother tongue is English or sometimes Russian,” he said, also referring to a Russian vaccine that Israel has signed a deal to purchase, but which has faced concerns about its opaque trial and approval process.

“I think there is very good and responsible work being done, free of financial considerations, even though we are Hebrew-speakers,” Shapira told the committee. “We would be happy to get the same support as giant firms that make 30 times more than us.

“Had we not faced over-regulation, we would have made more progress,” he lamented.

“We were already supposed to be in the Phase III clinical trials, and now we will only reach them in April.”

He added that Phase III trials will be conducted outside Israel due to regulatory constraints.

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

“We ended Phase I trials five days ago and are planning to start Phase II within 10 days,” he added. “Our vaccine is a bird in the hand, not birds in the bush. I am confident that this will be the vaccine of Israel’s citizens.”

Brilife, a portmanteau of the Hebrew word for health — bri’ut — and life, has been described by officials as a backup plan to supplement vaccines purchased from pharmaceutical firms based abroad, which are planning to begin to distribute inoculations in the coming months or earlier.

The three-phase trial system used by the US Food and Drug Administration and adopted around the world is designed to test for the safety and efficacy of any potential vaccine. The process of developing and testing a therapy normally takes years, if not decades, and even an approval for summer 2021 rollout, some 18 months after the pandemic began, would be among the fastest in history.

The first phase of Brilife’s clinical trial involved some 80 volunteers ages 18 to 55. The second phase will test roughly 1,000 volunteers aged 18 to 85 at eight hospitals around the country. In this phase, volunteers with preexisting conditions will be allowed to participate.

If that larger group responds well to the vaccine, injections will then be given to some 30,000 people in April or May 2021. If the vaccine works well and there are no significant side effects, it will then be approved for full use in the general population.

Last month, the Defense Ministry announced that Israel had begun the process of mass-producing the potential coronavirus vaccine and plans to distribute it to both Israelis and Palestinians if it is approved for use.

The Institute for Biological Research, which operates under the auspices of the Defense Ministry on issues related to chemical and biological warfare, said it used state-of-the-art techniques to create its vaccine.

Israel has earmarked or spent around NIS 1 billion for the purchase of vaccines from abroad, according to reports.

As part of the country’s agreement with Pfizer, Israel is to receive 8 million doses of the vaccine, enough to inoculate 4 million Israelis. The deal with Moderna would see 2 million doses purchase, enough for another million. The country’s population is over 9 million.

On Monday, Moderna said it would ask US and European regulators to allow emergency use of its COVID-19 vaccine as new study results confirmed that the shots offer strong protection.

Israel is in the final stages of talks with British pharmaceutical giant AstraZeneca to purchase “millions” of doses of its vaccine, which is currently under trial, Prime Minister Benjamin Netanyahu announced Friday. However, that vaccine is facing delays after it admitted additional research was needed after mistakes were made in the trials.

A vaccine is seen as “the best hope to break the cycle of deadly virus surges and severe restrictions across much of the world since COVID-19 first emerged in China late last year and unleashed devastation on the global economy.”

“Infection levels in Israel are creeping back up as the nation gradually emerges from its second nationwide lockdown.”

Header: Vials of a potential coronavirus vaccine are seen on an assembly line in a photograph released by Israel’s Institute for Biological Research on October 25, 2020. (Defense Ministry)

Source: TOI