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The Israeli MOH had no adverse events reporting system for the entire year of 2021. They commissioned a research team to analyze the reports from a new system implemented on December 2021. A leaked video reveals that in June, the researchers presented serious findings to the MOH, that indicated long-term effects, including some not listed by Pfizer, and a causal relationship – so the Ministry published a manipulative report, and told the public that no new signal was found

“Here we will have to really think medical-legal. Why medical-legal? Because for quite a few adverse events we said: ‘OK, it exists, and there is a report, but still get vaccinated’. I mean, we have to think about how to write it and how to present it correctly. So this will not yield lawsuits later: ‘Wait, wait, wait, you said everything will pass and you can get vaccinated. And now look what happened to me. The phenomenon continues'”.

The speaker is Prof. Mati Berkowitz, a pediatric specialist, head of Clinical Pharmacology and Toxicology unit at Shamir Medical Center, and head of the research team appointed by the Israeli Ministry of Health (IMOH) to examine the safety of the COVID-19 vaccine. This crucial study was based on a new adverse event reporting system the MOH launched in December 2021 – 12 months AFTER rolling out the vaccines to the public, as the system implemented in December 2020, as they now officially admit, was dysfunctional and did not allow an analysis of the data. In an internal Zoom meeting in early June, the recording of which was leaked to the press, Prof. Berkowitz warned MOH senior officials that they should think carefully how to present his study’s findings to the public, otherwise they may be sued, since they completely contradict the MOH’s claims that serious side effects are rare, short term and transient. After analyzing the reports received over a period of 6 months, the research team found that many serious side effects were in fact long-term, including ones not listed by Pfizer, and established causal relations with the vaccine. Yet, instead of publishing the findings in a transparent manner to the public, the MOH withheld the findings for nearly two months, and when it finally released an official document, it misrepresented and manipulated the findings, minimizing the extent of reports, and stating that no new adverse events (“signals”) were found, and that the events that were detected were not necessarily caused by the vaccine, even though the researchers themselves said the exact opposite.

Background: “The world’s laboratory” had no reliable monitoring system

As is well known, Israel was crowned, by none other than Pfizer’s CEO Albert Burla, “the world’s laboratory”. And for a good reason. Indeed, Israel has a very high vaccination rate and was the first in the world to give boosters to everyone. In fact, Pfizers’ request for the approval of the boosters was at least partially based on the so-called study conducted in Israel. Israel was also one of the first countries in the world to vaccinate pregnant women.

Yet, as the MOH now admits, during this entire critical year in which the vast majority of Israelis were vaccinated, most of them with 2-3 doses, the vaccine adverse events reporting system was dysfunctional and did not enable a reliable analysis of the data.

In fact, since the beginning of the vaccination campaign, many Israeli experts have expressed serious concerns regarding the ability of the IMOH to monitor the safety of the vaccine and provide reliable data to the world. Nevertheless, the IMOH told the Israeli public, the FDA, and the entire world, that they have a surveillance system, and that they are closely monitoring the data. For example, Prof. Retsef Levy from MIT, an expert in health systems and risk management, voiced serious criticism during a Vaccines and Related Biological Products Advisory Committee meeting on September 17 which focused on the approval of the booster dose, stating that the system is dysfunctional and that the safety of COVID-19 vaccines is not monitored properly. In response, Dr. Sharon Alroi-Preis, the Health Ministry’s head of public services and a top COVID adviser to the Israeli government, claimed that she is “pretty surprised with Retsef Levi’s comment that Israel doesn’t follow adverse events”. Dr. Alroi-Preis stated: “It’s our data. I’m in charge of it. So I know exactly what is being reported to us”.

Only at the end of December 2021, a year after starting the vaccine rollout did the MOH finally institute a proper system, to coincide with the rollout of COVID-19 vaccines in children aged 5-11. The new system is based on a non-anonymous digital reporting form, which the Ministry asked all public HMOs (Health Management Organizations) to distribute among all patients after they had been vaccinated, so that those who suffered side effects could report them. At the same time, the ministry appointed Prof. Mati Berkowitz and his staff members to analyze the reports. The analysis was done on reports received from the HMOs in Israel over a period of 6 months – from the beginning of December 2021 to the end of May 2022.

The team examined both the close categories of side effects that were set by the MOH (there were 7 such categories), and the free text (they identified 22 categories of side effects). Due to limited time and resources, they decided to first analyze only the 5 most common side effects they identified: 1. neurological injuries; 2. general side effects; 3. menstrual irregularities; 4. musculoskeletal system disorders; and 5. digestive System/kidney and urinary system.

New signals, long-term adverse events, and re-challenge

In early June, the researchers presented their findings to MOH senior officials, including Dr. Emilia Anis, head of the MOH’s epidemiological department. Here are their main findings and points:

1. New signals – The research team identified and characterized side effects not listed by Pfizer, including neurological side effects such as hypoesthesia, paresthesia, tinnitus, and dizziness; back pain; and Digestive System symptoms in children (abdominal pain).
2. Long-term events – The research team repeatedly stressed during the discussion that their findings indicate that, contrary to what we were told so far, in many cases, serious adverse events are long-term, last weeks, months, a year, or even more, and in some cases – are ongoing, so that the side effect still lasted when the study was over. These include menstrual irregularities and various neurological side effects, muscle-skeletal injuries, GI problems, and kidney and urinary system adverse events.
3. Re-challenge – The researchers found many cases of re-challenge – recurrence or worsening of a side effect following repeated doses of the vaccine. In fact, they identified cases of re-challenge in all the 5 most common side effects they analyzed – e.g., neurological injuries; general side effects; menstrual irregularities;  musculoskeletal system disorders; and digestive system/kidney and urinary system.

An important example that demonstrates the severity of these findings is menstrual disorders.

* Long-lasting – In one of the slides, the researchers wrote: “Studies carried out on the above-mentioned subjec noted short-term abnormalities (up to a few days) in the menstrual cycle. However, over 90% of the reports detailing the characteristics of the duration of this adverse event indicate long-term changes (emphasis in the original. Y.S). Over 60% indicate duration of over 3 months”.

* Rechallenge – Then in ~10% of the cases, the problem recurred following additional doses.

1. Professor Retsef Levi, who is also a member of the Israel Public Emergency Council for the COVID 19 Crisis, said in an interview with GB News that the example of long-term menstrual disorders detected in the study also demonstrates the authorities’ response to the public’s reports. At first, they utterly deny any causal relationship between these disorders and the COVID-19 vaccines – in this case they denied it despite countless reports that flooded the internet from the very beginning of the vaccination rollout. Then, when the reports still continued and became impossible to deny, the authorities, and experts on their behalf, changed the narrative admitting there might be a relationship, but even if there is one, the symptoms are mild and transient. They only last a few days and they have no future implications on fertility.
   

   The researchers’ conclusions: The findings establish causality, and may lead to lawsuits

   1. Causality – The researchers emphasize that, according to the literature, these findings establish causal relations between the vaccine and the side effect.

   As can be heard in the following clip, Prof. Berkowitz stresses that it increases the chances of causality “from possible to definite”:

   “One of the things that are strong here is the re-challenge. We know about medications. There is the Naranjo scale [the Adverse Drug Reactions (ADR) Probability Scale]. Naranjo, when there is an adverse event which recurs with the re-challenge, it turns from ‘possible’ to definite, to significant”.

   2. Think Medical-Legal – as if all this wasn’t damning enough, Prof. Berkowitz warns the MOH officials, in reference to the long-lasting side effects, they should think carefully how to present his study’s findings to the public, since they completely contradict their claims that serious side effects are rare, short term and transient.

The HMO’s are keeping the data close to their chests

The research team explained during the meeting that their study one important limitation – they only got cooperation from one small HMO to share the data it received from the new reporting system. (Israel’s health system is divided into 4 different HMO-type organizations; each Israeli is signed up with one of them), while none of the other 3 HMO’s shared their data, including Israel’s 2 largest ones – Clalit and Maccabi. Prof. Berkowitz said that they are keeping the data ‘close to their chests.

The only HMO that did fully cooperate (Meuhedet) is very small, representing only about 15% of the Israeli population, with a heavy religious population, who has lower vaccination rates than the general population, and seldom use smartphones, so most of them were not even able to receive the text message.

Two other limitations mentioned by the research team:

• The most severe cases were not even included in the analysis. There were 173 cases of hospitalization and ER visits that were separately examined by a dedicated expert committee.
• The researchers stressed they still have a lot of work, since they only analyzed the 5 top common side effects,  but there were 17 others (including cardiovascular, which was 6^th most common) that they did not yet analyze.

‘The denominator report’ – concealment, manipulation and cover-up

Although the IMOH was aware of these findings, they withheld them for 2 months, not only from the public, but even from their own expert committee that decided on June 30 to approve the vaccine for infants as young as 6 months. That decision was made 3 weeks after the IMOH had been warned about these results and their implications.

The formal report was finally released, on August 20, in a closed press briefing, and surprisingly, the MOH admitted in this report, black on white, that Israel did not have a functional adverse events reporting system until December 2021. The unbelievable explanation was: “As the vaccination operation progressed, data was received from the anonymous online form, but without the ability to process and professionally validate the data”.

Yet, even after receiving such serious findings and warnings, they manipulated the data and tried to hide crucial information to make the vaccine look safe.

• ‘No new signal’ – The MOH went so far as to claim there were no new adverse events found in the study that were not already known – no new signals. What about the neurological injuries, which the researchers said are not even mentioned in Pfizer’s label? What about the long duration, or the re-challenge? None of these findings are anywhere to be found in the official report.

• Manipulating the numbers – In order to promote the narrative of “rare adverse events”, the MOH divided the number of reports received with a denominator of the total number of doses given in Israel for the entire year and a half since the beginning of the vaccine rollout – ~18 million, hiding the fact that they only instituted the system in December 2021, and that the analysis was done on reports received during the 6 months until May 2022, from one small HMO.
  This ignores the known fact that such passive reporting systems cover only a fraction of the actual events. That would still be true even if the system was operational throughout the entire vaccination period and used by all HMOs (which of course is not the current case). This manipulation – using the denominator of the total doses, was repeated in each of the categories of the side effects in the report.

Furthermore, it turns out that in order to downplay the rate of reports on menstrual irregularities, the MOH used a denominator of the total number of all adult doses – ~16 million – and thus, absurdly, included men in the equation of how common menstrual irregularities are.

Global implications

The discussion exposed in the leaked video has far-reaching and worrying implications, at a global level. While Israel is a relatively small country, it was dubbed “the world’s laboratory”. The eyes of much of the world were on it, and the FDA and other regulators have repeatedly cited its experience with the vaccine as a basis for policymaking, including for boosters and mandates and much else. So if Israel did not in fact have a functioning adverse event monitoring system in place and its data was a fiction, and even when it did launch a proper monitoring system a year too late, with analysis of the system’s findings, completely ignored and withheld – what was the FDA really relying on? What were all those regulators relying on?

The Ministry of Health did not respond to Real-Time Magazine’s requests for comment. Prof. Mati Berkowitz refused to comment and referred us to the IMOH.

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