State comptroller accuses Institute for Biological Research of providing inaccurate information regarding the progress and expenses of vaccine development and withholding true figures

State Comptroller Matanyahu Englman released his annual report on Tuesday in which he dedicated an entire chapter to what he called Israel’s “failed” efforts to develop homegrown COVID-19 vaccine and antibodies.

Englman stated that the Institute for Biological Research, where the vaccine was developed, provided inaccurate information regarding the progress and expenses of the vaccine’s development, concealing the true figures.

Production of Israeli COVID-19 vaccine
(Photo: Institute for Biological Research, Defense Ministry)

“Although it may have been acceptable during the initial period due to the state of emergency in Israel, the institute’s ongoing misconduct and disregard for regulations and due process cannot be ignored,” the comptroller wrote.

On February 2, 2020, Prime Minister Benjamin Netanyahu and Prof. Shmuel Shapira, the director of the Institute for Biological Research, met to discuss the outbreak of the novel coronavirus, which had started to spread in various countries around the world.

At the time, Shapira wrote that their facilities were capable of developing and producing a vaccine and antibodies to combat the spreading pandemic.

Shortly thereafter, Netanyahu commissioned the development of a vaccine, stating that Israelis needed to be “capable of taking care of ourselves.” Despite two and a half years of development and approximately NIS 230 million investment, the project was ultimately terminated, and an Israeli vaccine was never produced.

The comptroller strongly criticized Shapira, who oversaw the development of the treatment, for the letter he issued to Netanyahu which made him approve the production of the Israeli vaccine in the first place, among other things.

Shmuel Shapira
(Photo: Dolev Juli)

Englman stated that the letter did not address important components necessary for developing and producing vaccines. Consequently, the timeline presented in the letter does not reflect the reality of these crucial processes. Furthermore, the letter did not cover any budgetary aspects.

The report highlighted that the director’s proposal did not consider the institute’s limited production capabilities as described in the document. The production facilities of the institute are outdated, do not meet current regulatory standards completely, and experience frequent maintenance problems.

Although there was initially optimism surrounding the development of an Israeli vaccine, the institute faced some difficulties. The comptroller’s report indicated that a few days after Netanyahu’s decision, the project’s requirements were issued. These requirements estimated the total cost to be around NIS 62.6 million and stated that 50 employees would be needed.

The report noted that the institute submitted its requirements on February 6, 2020. However, it did not mention the time frame and budget needed to update its facility to current GMP (Good Manufacturing Practice) standards, nor did it provide details about the costs and time required to complete clinical trials.

Englman wrote that these factors were crucial and supposedly omitted to receive faster approval.

Institute for Biological Research
(Photo: Institute for Biological Research, Defense Ministry)

After the initial report on the project in February, the estimated costs increased by more than 50%, totaling NIS 90 million. Additionally, the program’s duration was extended from 11 months to two years.

Everything appeared to be on track at the time. In late March 2020, during Israel’s first lockdown, Prof. Shapira notified the Defense Ministry that the IBR had made significant progress in the development of a vaccine, reaching an advanced stage.

As per Prof. Shapira’s statement, there was a “significant breakthrough in the effort to combat coronavirus, and we could have a vaccine prepared for pre-clinical testing and mass production in the near future.”

But a vaccine did not materialize, and the budget for the project continued to balloon. In August 2020, Prof. Shapira requested that the ministry make budgetary adjustments to address the emergence of new strains of COVID-19.

The IBR director acknowledged that the project now had new requirements that were not previously included in the original plan.

Institute for Biological Research labs
(Photo: Institute for Biological Research, Defense Ministry)

One of the demands made by the institute was the need to incur costs of nearly $30 million (NIS 102 million at the time) for adjusting the production line and contracting a company that provides clinical research services. The institute presented a Gantt chart of the project to the state comptroller, which indicated that the anticipated completion date for the project was June 2022.

In late December 2020, a discussion was held regarding the project that was entering its third phase. Deputy Defense Minister Alon Schuster led the discussion and concluded that the expected cost of the clinical trial would range between $350 and $370 million.

According to the report, by the end of 2020, the total cost of the project had skyrocketed by more than twenty-fold from the initial budget of NIS 63 million to nearly NIS 1.4 billion. Meanwhile, Israel had already begun using Pfizer’s COVID vaccine at the time.

“The urgency at the start of the pandemic can’t justify presenting an incomplete view of the project’s data, requirements, and procedures for several months,” Englman wrote.

Additionally, during that time, concerns were raised about insufficient data in the project’s reports, which were critical in determining the necessary budget to finish it, as well as the institute’s lack of experience in the process.”

The vaccination and antibodies project, which had a cost of nearly NIS 230 million, was terminated in July 2022 before the development and production of vaccines and antibodies were completed.

Institute for Biological Research labs
(Photo: Institute for Biological Research, Defense Ministry)

“Crisis management requires making swift decisions and implementing effective actions under pressure,” the comptroller stated. “However, urgency cannot be used as an excuse for the significant failures that occurred after February 2020, when vaccine development was initiated by the institute.”

Englman found faults with the management of the project at the institute. The report indicates that the project was approved without submitting the necessary forms required to finalize it, and did not provide a clear explanation for the necessity of the vaccine. Additionally, the project neglected to consider the budgetary requirements of similar projects implemented around the world.

The Israeli vaccine project was carried out without the supervision of an oversight committee appointed by the Defense Ministry. The committee met only once in June 2020, but failed to receive cooperation from the institute and did not convene again.

The comptroller pointed out that the project was conducted without identifying potential risks and without setting up the necessary milestones to obtain regulatory approval for the project.

Another issue highlighted by Englman is related to the mechanism of the vaccine and its ability to generate an immune response. The report states that even though there were initial concerns regarding the vaccine’s mechanism of action, this matter was not addressed.

The Health Ministry authorized the institute to commence human clinical trials even in the absence of solid evidence demonstrating the vaccine’s effectiveness. This increased the likelihood that the clinical trials would reveal the vaccine to be ineffective, thereby increasing the associated risks.

Institute for Biological Research vaccines
(Photo: Institute for Biological Research, Defense Ministry)

Englman pointed out that “one of the world’s largest pharmaceutical companies conducted a clinical trial on a vaccine using the same platform and a similar dosage as the one developed by the institute. In January 2021, the company announced that the vaccine did not generate a sufficient immune response, resulting in the termination of its development.

Despite the unfavorable results, neither the institute nor the Defense Ministry made any effort to understand the company’s shortcomings, nor did they analyze the trial’s results. Consequently, the institute proceeded to develop the vaccine with the same ineffective guiding principles.

The comptroller drew attention to the old and outdated equipment at the institute. In his report, Engelman stated that before the COVID pandemic, the production lines at the institute were outdated and not operating in an organized manner. They have since been upgraded to meet modern standards, at a cost of NIS 500-700 million.

In 2018, the institute acknowledged that its facilities were outdated and did not comply with current GMP standards. However, in January 2021, the Health Ministry granted the institute a GMP certification valid for three years.

Subsequent inspections by the ministry identified several issues with the institute’s facilities and inadequately trained staff. Eventually, the ministry concluded that an inspection was necessary to approve the production of the Israeli vaccine for phase 3, but this inspection never took place or was approved.

The Institute for Biological Research in Israel is under the authority of the Defense Ministry, which has stated that “The COVID outbreak created an emergency situation, which led to uncertainty regarding the characteristics of the virus, the extent of its spread, and mortality rates. Under these circumstances, the institute conducted research and proposed a project to develop a vaccine in order to ensure the safety of Israel.”

“The institute relied on its unique scientific capabilities and development teams to develop the vaccine in approximately nine months, using significantly fewer resources and budget than other countries. The vaccine successfully passed two rounds of clinical trials and underwent rigorous monitoring at various stages, including by the Health Ministry,” the statement continued.

After the majority of Israelis were vaccinated, the production and testing processes were halted. Although a vaccine was not released, the investment in development upgraded the institute’s capabilities to deal with biological and chemical threats in the future.”

As reported by Ynetnews