Playing Hardball in Government and Politics

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Warns ministry could be open to lawsuits for encouraging public to vaccinate while claiming side effects mild, transient

As is well known, Israel has a very high vaccination rate and was crowned, by no other than Pfizer’s CEO Albert Burla, “the world’s laboratory”. Yet, as it turns out, during this entire critical year in which the vast majority of the Israeli population was vaccinated, most of them with 2-3 doses, the Israeli vaccine monitoring system was completely dysfunctional and did not enable a reliable analysis of the data. In fact, there was no reliable system that you could say was even remotely similar to the American VAERS or the UK Yellow Card system.

As mentioned, only at the end of December 2021, a full year after starting the vaccine rollout, did the Ministry of Health finally launch a proper system, based on a non-anonymous digital reporting form that 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 six months – from the beginning of December 2021 to the end of May 2022.

As the recording shows, the findings of the study are very serious and alarming, including side effects that are not listed on Pfizer’s package inserts. They indicate serious systemic side effects from the vaccine, including menstrual irregularities, neurological injuries, GI, kidney and urinary adverse events are in fact not rare and transient as claimed by Pfizer and health authorities, but many times are serious and long-lasting. And that in many cases, even if they do pass, these side effects recur or even worsen after repeated doses. The research team was very concerned and made it clear to the IMOH officials in attendance that these findings establish, according to the medical literature, a causal relationship with the vaccine.

The research team asked the officials to publish the findings transparently to the public and as a scientific paper. Nevertheless, despite their seriousness, the IMOH withheld them for 2 months and only very recently published a formal report on this work. However, the gap between the official report and what the researchers presented in this behind-close-doors discussion could not be greater. In fact, the report completely contradicts what was said in the discussion and offers no trace of the deep concern expressed by the researchers.
 

Serious side effects: not rare, not transient

The research team repeatedly stressed during the discussion that their findings indicate that, contrary to what has been thought and claimed so far, in many cases, serious adverse events are long-lasting. An important example is menstrual irregularities – an adverse event on which mountains of reports have accumulated since the launch of the vaccination rollout in December 2020. In one of the slides presented by the researchers in the recorded zoom discussion, the researchers wrote: “Studies carried out on the above mentioned subject 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”.

Professor Retsef Levi from MIT, an expert in health systems and risk management and a member of the Israel Public Emergency Council for the COVID 19 Crisis, said in an interview with GB News that the authorities’ response to the women’s reports reflects the worrying process through which the authorities, instead of treating reports from the public as signals that need to be investigated and examined, simply dismiss or deny them, even when it is quite clear that they are accumulating. At first, the authorities denied any causal relationship between the COVID-19 vaccines and menstrual irregularities, despite countless reports that flooded the internet from the very beginning of the vaccine rollout. Then, when the reports still continued to come, the authorities and experts on their behalf started to acknowledge the existence of a relationship, but still continue to claim, even today, that these are mild and transient changes that have no future consequences for fertility.

As can be seen from the above slide, the findings reveal that various neurological side effects are likewise not transient but long-lasting. In fact, according to the researchers, most of the reports that referred to their duration state that they lasted for over three months, and a third stated that they lasted for over a year. Similarly, other systemic side effects, such as musculoskeletal injuries, GI problems and kidney and urinary adverse events, are not short and transient.
 

The findings establish a causal relationship

Another important and worrying finding is a phenomenon called re-challenge – recurrence or worsening of a certain side effect after repeated doses of the vaccine. For example, the researchers explain during the discussion that not only do menstrual irregularities continue in many cases for several months, but that in about 10% of the cases, the problem returned after the women received additional doses. These two findings – the long duration and the re-challenge phenomenon – are very troubling to the researchers, and they repeatedly bring them up throughout the discussion, emphasizing that this is new and important information, which was not recognized in the research literature until now. Moreover, the researchers emphasize to Dr. Emilia Anis, head of the IMOH’s epidemiology division, that these findings actually establish causal relations with the vaccine. Prof. Berkowitz also emphasizes that the re-challenge phenomenon is defined in the medical literature by professionals as establishing causal relations between the vaccine and the side effect:

“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”. 

One of the IMOH officials present at the meeting also pointed out that Pfizer itself claimed, in the discussion about long-term effects, that the company had no knowledge of this:

“I also really think that the company should be updated, because the last time we were present at the discussion, at least, and there was a discussion about long-term effects, they said they had no knowledge about it. So there is knowledge about it, and there is information.” 

 

As mentioned, the researchers are very concerned about the findings that emerged in their study, and in particular about the ongoing side effects and the re-challenge phenomenon. So much so, that they warn the Ministry of Health officials that they might be exposed to lawsuits and must be very careful when writing about them and presenting them, so as not to expose themselves to lawsuits.
 

New adverse events not mentioned in Pfizer’s label

The researchers repeatedly and explicitly say during the recording that the analysis of the reports they conducted identified and characterized neurological side effects that were unknown and not mentioned in the physician’s leaflet of Comirnaty, including hypoesthesia, paresthesia, tinnitus, dizziness and more. Also, according to the researchers,
another new phenomenon they identified, which is not mentioned in Pfizer’s leaflet, is back pain.
 

The HMOs keep the information close to their chest

During the discussion, the researchers explain an important point, which is critical to understanding the scope of the reports on the side effects identified in the study: it turns out that although all the HMOs in Israel were asked by the MOH to forward their reports on the side effects to the ministry, in practice, the bulk of the data came from only one small HMO – Meuchedet, while the rest of the HMOs, and especially Maccabi and Clalit – the two largest HMOs in Israel, did not cooperate. “This means that there are HMOs that keep the information close to their chests,” said Prof. Berkowitz during the meeting. The significance of this information is crucial, since only 17% of children and 13% of adults in Israel are insured by Meuchedet. In other words, the scope of the reports identified by the research team represents at best about 15% of the country’s population.

The fact that voluntary monitoring systems suffer from inherent underreporting is well known. For example, regarding the American VAERS system, the estimates are that the reports represent 1%-10% of the adverse events in reality. In the current case, in addition to the inherent problems, the underreporting is particularly large, among other things, because the researchers considered only side effects that appeared up to 30 days after the vaccination to be included in the study and did not examine any events leading to hospitalization or death, which were examined by separate expert committees. That is, many reports were filtered out in advance.
 

Concealment and deception in the report

As mentioned, 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.

And even when they did finally publish a formal report on this work, not only did they censor the serious findings – they had the audacity to claim there were no new AEs 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 that the researchers were so concerned about and stressed that they are clear indications of a causal relationship with the vaccine? None of these findings is anywhere to be found in the ministry’s official report to the public.

And as if that is not enough, the MOH downplayed the reporting rate by taking the number of patient reports received and dividing them by the total number of vaccine doses given in Israel for the entire year and a half since the beginning of the vaccine rollout.

This is misleading, pure and simple. They only started this new monitoring system on December 21, 2021 – by that time, the vast majority of the population had already been vaccinated with 2 or 3 doses.

Moreover – in its formal report, the MOH censors the fact that the study only includes reports from one small HMO which represents, as mentioned, about 15% of the population in Israel. This creates a misleading picture, according to which the rate of reporting of side effects in Israel is extremely minimal.
An amazing fact emerges from the official report: it turns out that for the entire first year of the vaccine rollout, during which the vast majority of vaccine doses were given to the Israeli public, the Ministry of Health completely ignored adverse events reported by the Israeli public.

The unbelievable excuse they made: “As the vaccination operation progressed, data was received from the anonymous online form, but without the ability to process and professionally validate the data”. Is it possible that the Ministry of Health, which prided itself on its information technologies, did not know that the reporting form it created was problematic and did not allow for valid analyses and processing? Why then did the Ministry of Health continue to use this invalid and dysfunctional system for an entire year, during which almost all of the country’s citizens were vaccinated, and only in December 2021, a year too late, remembered to “learn from the experience gained” and build a new system?

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 on 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 if even when it did launch a proper monitoring system a year too late, the analysis of the findings they 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. Matti Berkovitz refused to comment and referred us to the IMOH. 

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