Israel’s COVID vaccine unlikely to hit market until Q1 2023

Made-in-Israel vaccines not expected before 2026.

MAY 6, 2021 22:19

A medical worker holds a syringe with Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) before administering an injection at a vaccination centre in a shopping mall in Saint Petersburg, Russia February 24, 2021. (photo credit: REUTERS) — A medical worker holds a syringe with Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) before administering an injection at a vaccination centre in a shopping mall in Saint Petersburg, Russia February 24, 2021.

(photo credit: REUTERS)

It is unlikely that any quantity of the Israel Institute for Biological Research’s BriLife vaccines will be available for market distribution until the first quarter of 2023 due to delays both with the clinical trials and signing a contract to enable the technology transfer.

IIBR is in negotiations with Jerusalem’s BiondVax Pharmaceuticals Ltd. to manufacture its coronavirus vaccine, The Jerusalem Post has learned.

The Defense Ministry said that it could not provide details on commercial contracts and would not confirm the timeline.

BiondVax describes itself on its website as a “biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses.” It is traded on Nasdaq.

Although BiondVax CEO Amir Reichman declined to comment on any negotiations between his company and any other research institutions, he told the Post that if a tech transfer would occur between IIBR and a potential licensee, “it would take several months and up to a year to manage before commercial batches would be available to the market.”

A source who is connected to the project told the Post that negotiations for commercialization of BriLife have been ongoing for several months, but that the Israeli government was holding out in hopes it would secure a larger bidder or better terms.

So far, Israel has invested around NIS 175 million in the development of BriLife, according to the Defense Ministry. However, it is unclear how much of this investment was used directly for the development of BriLife and how much was used refurbishing IIBR’s facility in Ness Ziona. IIBR has said it has the ability to produce 15 million doses.

Vaccine developers, such as BioNTech, whose technology is being used by Pfizer for its coronavirus vaccine, usually make their money through royalties.

In “normal times” a developer can wait until the end of its Phase II clinical trial to start contracting and run Phase III in parallel with a tech transfer to a licensee. However, since a transfer can take more than a year to complete, IIBR’s delaying a manufacturing contract could mean its vaccine hits the market too late to be useful.

Israel has already inoculated the majority of its eligible citizens and purchased enough vaccines to last until the end of 2022. As such, Prof. Yossi Caraco, head of the Clinical Pharmacology Unit at Hadassah, told the Post that BriLife “can be used to vaccinate other countries that need a vaccine.”

Why not produce the vaccine locally?

Recall that in February 2020, Prime Minister Benjamin Netanyahu instructed IIBR to not only create a coronavirus vaccine but to establish a vaccine factory. In August, when IIBR announced it was ready to launch a Phase I clinical trial, the prime minister said that he had asked the institute to start setting up the production plant, parallel with the first human trials, so that Israel will be ready if the trials are successful.

It seems there has been little or no progress on this manufacturing site, and made-in-Israel vaccines are at least another seven years off. This is despite the fact that BiondVax, Perrigo Pharmaceuticals and the Defense Ministry each have been to the southern city of Yeruham multiple times and there is a “detailed plan” for launching a manufacturing facility in the Jewish state, according to Yeruham Mayor Tal Ohana.

She said she hopes that this facility would manufacture BriLife.

Sources involved in the discussions told the Post that one option is to purchase and refurbish an old Caroline Cosmetics factory in the area, but that it would take at least another five to seven years to finish construction, start manufacturing, and win validation by the Europeans and Americans.

In other words, even if a contract were signed and work started tomorrow, there would be no vaccine manufacturing in Israel before 2026.

“We really believe in the Israeli vaccine,” Ohana said. “It is the only way to be vaccine independent. I really hope that IIBR gets final confirmations from the Food and Drug Administration and can then begin manufacturing in Yeruham.”

She added that the city has also been in touch with Moderna about manufacturing its coronavirus vaccines in Yeruham as well, but they are hoping for BriLife.

“I think it will be IIBR, but we have not closed the door on Moderna,” Ohana told the Post.

Reichman, who said he has been consulting with the government about building a vaccine manufacturing site in Israel, clarified that companies like Moderna and Pfizer are more likely interested in establishing research and development facilities and not vaccine manufacturing plants in the Jewish state.

Moreover, he said that if Israel’s goal is to achieve vaccine independence, then manufacturing Pfizer vaccines would not provide that. The intellectual property would still belong to Pfizer, and Israel would just be the producer. As such, Pfizer could require Israel to ship its vaccines wherever it wants rather than using them for Israeli citizens.

“Today, Israel is completely dependent on external intellectual property and external manufacturing capacity,” Reichman stressed. “With this pandemic, we were lucky because early in the pandemic we contracted and secured vaccine deliveries.”

But he said that in a future pandemic, Israel might not be so lucky.

“It is important for Israel to have both the IP (intellectual property) and the capacity to manufacture” vaccines, he said..