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Friday, 06/19/2020 9:41:33 AM

Friday, June 19, 2020 9:41:33 AM

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The Vaccine and the Israel Institute for Biological Research: Public Exposure, Success Stories & Tough Questions
As far as the Coronavirus pandemic is concerned, as time passes, it becomes obvious that life will not return to normal (or at least to a new kind of normal) before an effective vaccine has become available to millions. Only when a proven vaccine has become available will people be able to fly freely from one place to another and the rules of social distancing will no longer be necessary. Until then, countries will continue to balance between the war against the pandemic and the need to enable economic life to the highest possible standard.

Two startling and apparently contradictory developments regarding the vaccine have taken place in Israel this past week. On the one hand, the Israel Institute for Biological Research (IIBR) registered a patent on a vaccine against the Covid-19 virus, as reported here for the first time. This move indicates a high degree of confidence in the estimate that Israel is about to develop an effective vaccine. On the other hand, Israel acquired the option of purchasing an innovative vaccine manufactured by the Moderna Company in the USA. The price of this option, according to media sources, is US$ 66 million.

First, the Israeli vaccine: the principles of the vaccine were submitted to the Israel Patent Office, to be announced publicly, which indicates a high degree of confidence in the belief that IIBR holds the formula that would enable an Israeli vaccine at a probability of near 100%. Apparently, the vaccine will be ready in about ten months, plus or minus.

The organization that developed the vaccine and had it registered as a patent, the Israel Institute for Biological Research (IIBR), is subordinated to the Prime Minister's Office as well as to the Ministry of Defense (IMOD). It is charged with the task of providing solutions to chemical and biological threats facing Israel, from enemy countries and from natural sources (like the Coronavirus pandemic).

Fortunately, against the background of a surge of reports worldwide, to the effect that a pandemic should be expected at some unspecified time, IIBR started preparing to develop a vaccine for the virus, which would apply to the "Corona" virus family generally. These vaccines are not based on a weakened specific virus injected into the human body in order to "teach" the body to produce antibodies against it – as was the case in the past. Instead, this vaccine utilizes a technology that has been available for three years, which is based on a non-pathogenic virus that causes the body to "identify" it as the Covid-19 virus using genetic engineering methods. In response, the body will produce antibodies that prevent the "spikes" of the real virus from connecting to cells in the human body. As the prototype of the vaccine had been available in advance, all IIBR had to do was complete the development of the vaccine according to the specific characteristics of the new Covid-19 virus, based on its genome.

After the Prime Minister instructed IIBR to set the development of the vaccine as their top priority, and allocated special budgets for this purpose, IIBR started working around the clock. Their work included testing of the new vaccine on animals (rodents). These tests were successful. At the same time, IIBR started developing a cure for patients already suffering from Coronavirus, based on antibodies produced from the blood of patients who had recovered from Coronavirus and existing drugs, and adapting it to the new disease.

But finding a vaccine is the jewel in the crown, the overriding effort of IIBR, along with a handful of organizations, worldwide, leading the global race to find an effective vaccine.

Now we report that the patent submitted this week to the Israel Patent Office includes the details of the elements of the protein envelope of the vaccine, and the data of the non-pathogenic virus to be injected as part of the vaccine, wrapped in that protein. Israel has already purchased millions of vials for the production of the new vaccine.

The registration of the patent has placed the formula of IIBR in the public domain. Initially, the patent is valid for one year, and should subsequently be registered globally, having endured any objections that might have been filed. At the same time as registering the patent, a drug license should be obtained for the vaccine. IIBR still has to complete the vaccine licensing process after having tested it on humans, plus a safety procedure, and this process may not be conducted opposite the Israel Ministry of Health, but rather directly opposite the US Food and Drug Administration (FDA), so that the vaccine may be acknowledged worldwide immediately, and owing to the more lenient procedures introduced by US authorities since the outbreak of the Coronavirus pandemic.

It should be noted that IIBR, located in Ness-Ziona, has already registered a patent endorsed by FDA, for the drug Evoxac – developed originally in an attempt to provide a solution for nerve gases. Pharmaceutical manufacturers around the world are currently reviewing the option of using this drug to treat symptoms associated with Alzheimer's disease. In the development of the Israeli vaccine, IIBR may cooperate with pharmaceutical manufacturers in Israel and around the world, and contacts are expected soon.

How can this dramatic development be reconciled with the decision to acquire options for the purchasing of vaccines from the Moderna Company? It cannot be reconciled, mainly in view of the question of whether the RNA method, based on which this vaccine is being developed (a molecule made up of genetic matter similar to DNA, which causes the cells to produce proteins instead of having the virus envelope protein injected into the body after it had been grown in some culture outside the body) will actually prove itself for the first time. Apparently, Israel is trying to insure itself by having at least one vaccine available for the population – either from Israel or from the USA (although in the case of the Moderna Company, the amount of vaccines assured in the context of the option will be enough, at best, for only 10% of the population).

Meanwhile, the global race for the vaccine and the latest developments have further emphasized the question presented in this column a few weeks ago: why Israel does not have even a single plant capable of manufacturing the vaccine compounds commercially (one such plant, having a limited production capacity, exists only at IIBR).

About four years ago, IIBR sent a letter to the Minister of Health, warning of the fact that Israel (still) did not have a vaccine manufacturing plant. The reason for maintaining such a plant, even through state support if it were not economically viable, may be similar to the manner in which the defense establishment maintains unsuccessful plants for the manufacture of light and heavy ammunition. Obviously, during peacetime similar ammunition may be purchased for less in many countries around the world. Such manufacturing facilities are never economically viable, but Israel does not want to be dependent on any foreign country for the supply of basic ammunition in the event of a war. For this reason, IMOD supports the manufacturers in question on a regular basis.

In the case of epidemics, too, no friends can be relied upon. The Coronavirus pandemic has proven it.

The need for an Israeli vaccine manufacturer could have become more acute early last winter, when it turned out that the vaccines for the aggressive flu expected this year were in short supply, even before anyone knew anything about the Coronavirus pandemic. Unfortunately, even though it is very logical for Israel to have at least one vaccine manufacturer, this issue suffers from a well-known Israeli syndrome: responsibility, or more precisely – the absence of a definite assignment of responsibilities. Unlike "standard" security or health threats, the pandemic threat falls between two categories: a pandemic brought about by biological warfare or by a biological terrorist attack (which is the responsibility of IMOD's Special Assignments Division), or a pandemic brought about by natural causes, like the Coronavirus pandemic, which is the responsibility of the Ministry of Health. As the issue is the responsibility of two different government ministries, none of them is fully responsible for it.

Back to the warning letter from IIBR to the Minister of Health: pursuant to the letter, the Ministry established a junior-level committee to review the issue of establishing a vaccine manufacturing plant. As with most committees – the idle discussions of this committee produced no tangible results.

Over the last few weeks, discussions regarding the establishment of Israel's first vaccine manufacturing plant, in Yeruham, have gained momentum. Tal Ohana, Head of the Yeruham Municipality, has been lobbying and promoting the initiative opposite government organs, but a model and an investor for the plant are yet to be found, to provide a guaranteed solution for the demand for vaccines in Israel for the coming winter: vaccines for the regular flu and vaccines for the Coronavirus.

https://www.israeldefense.co.il/en/node/43637

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