Much can be said about the failures of the Israel Institute for Biological Research and the scandalous conduct of its Director-General Professor Shmuel Sh​apira, particularly over the past two years.

Shapira's failures were known to the supervising body of the Defense Ministry and led to the establishment of a special committee to overlook the Biological Institute. The professional committee recommended that some of the institute's activities be canceled, certain units closed, and that the institute should re-evaluate its conduct altogether.

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Shapira took advantage of the national crisis that was caused by the coronavirus pandemic. He grabbed onto the opportunity to rescue the Institute from the distress he himself had caused and promised the government to provide the Israeli public with a vaccine within "a few months."

Having embraced this promise, Prime Minister Benjamin Netanyahu assured that Israel would be one of the first countries in the world to develop a vaccine.

But the Institute did not possess the knowledge or experience necessary to develop a vaccine within the promised time, nor did it have the ability to compete with other global companies in the race for the inoculation.
As a result, the Defense Ministry's professional committee recommended that the Institute discontinue its vaccination development.

After the committee's inspection, the vaccination department of the institute began preparations for the discontinuation of the vaccine development process.

Shapira denied all allegations against him, rejected the recommendations and refused to provide details on the vaccine development progress and capabilities of the institute, claiming that the information is classified.

Now that Israel has begun the vaccination process using Pfizer and Moderna vaccines, there is growing criticism of the institute and of Shapira's actions and the promises he made in vain, including from senior Health Ministry officials.

The government has invested more than half a billion shekels ($157 million) in the institute's vaccine development until now. The organization's budget is NIS 300 million ($94 million), and the vast majority of its resources are being directed towards the development of the vaccine, as opposed to its usual focus on national security.

Additionally, the institute received a special budget of NIS 100 million ($31 million) and another NIS 150 million ($47 million) to execute the first and second stages of the trial.

The third phase of the clinical trial is estimated at another NIS 120 million ($37 million). To this must be added the cost of producing the vaccines.

Based on various estimates, like Pfizer's production cost, for example, each vial costs $15. Keep in mind that Pfizer is a global pharmaceutical giant that is expected to produce billions of vaccines.

If the institute produces the 15 million vaccinations, as it said it would, then even according to the most conservative estimates, the process will cost more than a billion shekels. If we add to that the amount of money it will take to build an industrial infrastructure for vaccine production, then the cost will be even higher.

Also, by then, many more vaccines will be available on the market.

Israel has agreements with three global vaccine companies that will provide enough doses to inoculate the entire population at the price of about 1 billion shekels. The vaccination campaign has begun, and it is estimated that most Israelis will be vaccinated this year.

This means that by the time the Biological Institute's vaccine is approved – assuming the clinical trials are successful – Israel will be much more ahead in its inoculation program and will be in the thick of substantial financial debt.

The Biological Institute's vaccine will cost Israel between 1.5 to 2 billion ($313-627 million) shekels for a product that will no longer be needed, in a market that will be full of much more efficient and cheaper alternatives, and all this while Israel will still be in the midst of an economic and health crisis.

The failure of the Biological Institute hardly surprises anyone familiar with its conduct. The institute was created to address specific security threats, not compete with global companies that specialize in vaccine development.
Shapira's promises were illusions that came at a price. It resulted in Israel allocating astronomical sums on the vaccine development when such expenditures could have been avoided.

Besides the complexity of execution and the high cost of the third phase of the trial, there is also the matter of timing. The Biological Institute will only start the third phase of the trial in a few months, right in the middle of the vaccination campaign.

This would raise several problems. The first one is an ethical problem, as half of the trial participants receive placebo treatments. These participants will roam around the country, thinking they are vaccinated, but in truth may infect others.

"The participants of the trial have agreed to take the risk of receiving placebo, but what have others done to deserve to get infected?" said a former senior institute worker.

Worse still, the existing vaccines have been so rapidly approved because they were the first ones to be developed, and nobody had been vaccinated. Now that there is a vaccine that has been used to inoculate large masses, the third stage of a trial is much more problematic and will take several years to yield reliable results. It will also be much more challenging to recruit volunteers when a proven and reliable vaccine already exists.

"It seems that they [the Biological Institute] will not be able to conduct the third phase of the trial in Israel," says Prof. Amos Pent, a virologist at the Faculty of Medicine at the Hebrew University and member of a committee that works together with the Biological Institute to develop a vaccine.

"It will need to be conducted in a different country where the [coronavirus] morbidity is still widespread, like Africa or India."

According to Pent, the continuation of the Israeli vaccine development is justified due to the need for "vaccine independence." If the third phase of the trial is transferred abroad, its cost will go up exponentially.

Others say that the Israeli vaccine will not be able to compete with other vaccines. "Even in case of additional vaccinations or mutations [of the virus], international companies will provide much cheaper products much faster than the Biological Institute's developments. It is better to stop this now and save enormous capital."

As for the "vaccine independence," a senior source familiar with state systems said that "we do not have technological, economic, agricultural, medical, military and other independence. These are slogans of the 1950s. In today's world, vaccines are purchased from giant companies abroad that specialize in this. Taking the small Biological Institute, that doesn't have any advantages in the field, and pouring billions [of shekels] for a grandiose project while there is an efficient and cheap solution available, is no less than a national failure."

Meanwhile, a survey that we conducted reveals that even the Biological Institute employees are not going to wait around and are in line to get a Pfizer vaccine just like everyone else.

The Biological Institute stated via a Defense Ministry spokeswoman: "The institute intends to ensure Israel's full independence in the development and production of vaccines regardless of foreign factors. The location of the third phase [of the trial] is still being deliberated, along with the progress of the second phase that has begun these days in hospitals. No decision has yet been made on the subject.

"The budget for the third phase is [in the process of being] formulated. The estimate will be submitted to the government for approval. The institute has so far produced a million vaccination doses and indents to continue and produce as needed. Vaccine production requires a specific budget, which will also be presented to the decision-makers."

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It was the second such breakthrough this week by IIBR scientists, who earlier this week said they had successfully isolated a key coronavirus antibody.

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Bennet, on Monday, called the step a "significant breakthrough" toward a possible treatment for SARS-CoV-2, the coronavirus that is the source of the COVID-19 pandemic. 

Rivlin met with the scientists spearheading the development of a series of antibodies that effectively neutralize the violent virus through various mechanisms originating in infected people.

The president also discussed the possibility of building a vaccine production plant in Yeroham in southern Israel and urged Bennett to expedite its construction.

IIBR scientists believe the technological breakthrough could shorten the process of finding a cure, which will span several months, and should provide protection even if the virus mutates. 

In the coming days, the IIBR will file a patent for the antibodies it developed and later publish their work in a scientific journal for peer-based review. 

"Last week we celebrated 72 years of independence, and biological independence is critical for the State of Israel," Rivlin said during his visit. "The entire world is hoping for the day an antibody is found, a vaccine, a cure or treatment that will allow us to save lives. From my conversations with world leaders, it's apparent that when it comes to breakthroughs and innovation, their eyes are on us. 

"The process is complex and lengthy, but any breakthrough you achieve is a significant step toward victory. I'm hopeful that the 'deliverer will come out of Zion' – a delivery that will help us guarantee the health of anyone whose life is in danger, allow us to free grandma and grandpa and the entire at-risk population from this difficult quarantine, and to liberate the entire economy," the president said. 

"This institution is our pride," he told the researchers. "Thank you, you are the glory of the State of Israel."

Bennett said: "This is a great day for Israel. This is another tremendous Israeli breakthrough in less than a week, which will help us cope not only with the current strain of the coronavirus but with possible mutations. I instructed the defense establishment and the IIBR to move ahead at the highest speed to develop a mass cure. We will not spare money or resources and do everything in our power to shorten the time it takes to have a commercial medicine."

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The "monoclonal neutralizing antibody" developed at the Israel Institute for Biological Research "can neutralize [the disease-causing coronavirus] inside carriers' bodies," Bennett said in a statement.

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Bennett visited the IIBR on Monday where he was briefed "on a significant breakthrough in finding an antidote for the coronavirus."

A statement from the defense minister quoted IIBR Director Shmuel Shapira as saying that the antibody formula was being patented, after which an international manufacturer would be sought to mass-produce it.

Shapira said the developmental stage for the antibody was complete. The antibody has yet to receive an official name.

The IIBR has been leading Israeli efforts to develop a treatment and vaccine for the coronavirus, including the testing of blood from those who recovered from COVID-19, the respiratory disease caused by the virus.

Antibodies in such samples – immune-system proteins that are residues of successfully overcoming the coronavirus – are widely seen as a key to developing a possible cure.

The antibody reported as having been isolated at the IIBR is monoclonal, meaning it was derived from a single recovered cell and is thus potentially of more potent value in yielding a treatment.

Elsewhere, there have been coronavirus treatments developed from antibodies that are polyclonal, or derived from two or more cells of different ancestry, the magazine Science Direct reported in its May issue.

It should be noted that experts estimate the testing period for the antibody could be at least one year. They also stressed that at this stage the antibody has only been researched in a lab and that many hurdles must be crossed before it is turned into a medicine.

About 100 research groups around the world are pursuing vaccines, with nearly a dozen in the early stages of human trials or poised to start. But so far there's no way to predict which -- if any -- vaccine will work safely, or even to name a front-runner.

"I am proud of the staff at the Israel Institute for Biological Research who have made a huge breakthrough.… the Defense Ministry in its entirety will continue operating on the front lines of the war against the coronavirus," Bennett added.

Earlier Monday, Prime Minister Benjamin Netanyahu pledged $60 million (about NIS 210 million) at an international donors conference to raise funds for the joint fight against the virus.

"I am confident that Israel's leading research institutions, its world-renowned scientists and our unique culture of innovation can enable us to play an important role in advancing solutions… We hope to work with other countries to leverage our unique capabilities to find solutions for the benefit of all," Netanyahu said.

Former Soviet dissident Natan Sharansky, the winner of the 2020 Genesis Prize, announced Monday that he will donate the $1 million award to organizations fighting the coronavirus pandemic and assisting people most affected by the outbreak.

Israel was one of the first countries to close its borders and impose increasingly stringent restrictions on movement to hamper the domestic coronavirus outbreak. It has reported 16,246 cases and 235 deaths from the illness.

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