Safe and effective?

How the agreement between Pfizer and Israel limited the safety testing of the product

Most citizens of the Western world were vaccinated in 2021 with one of the most innovative vaccines developed using mRNA technology. The vaccines have been marketed as effective and safe and any attempt to question their safety has been labelled as ”Fake News”. The State of Israel has served Pfizer as a ”laboratory of the world” (according to the testimony of the CEO of Pfizer himself) and based on reports, fateful decisions were made at an international level.

In this article, I will present to you how the State of Israel’s agreement with Pfizer caused an inconceivable distortion regarding what is known as ”scientific research” and how the State of Israel became Pfizer’s marketing agent instead of acting as a regulator in the service of its citizens. Which has led to harm not only to them but also to you, the readers.

Background

A few months before the outbreak of the corona plague, most members of the Israeli Helsinki Committee resigned. A committee whose purpose is to approve experiments on humans, this is due to a significant violation of their authority and their transformation into almost ”rubber stamp” in the pharmaceutical companies’ service.

At the end of 2020, Pfizer announced an amazing achievement – the development of an innovative, effective, and safe vaccine against what was perceived at the time as a ”deadly epidemic”. The State of Israel was the first to begin a massive, not to say ”aggressive” immunization operation, in which the state undertook to vaccinate most of the population in the shortest possible time. In doing so, the State of Israel became Pfizer’s international laboratory, while its citizens voluntarily, without informed consent, ”volunteered” to participate in the largest medical trial ever.

The State of Israel’s contract with Pfizer includes research collaboration, but large parts of it have been blacked out and remain confidential to the public. This included the page numbers being blacked out, so it is possible that the revealed agreement is not the final or official document, but a draft. It also mentions Dr Sharon Alroy-Preis, in her name, and not by virtue of her position as head of public health services in Israel. I will relate to it later.

Sharon Alroy Preis, on a huge supportive advertisement done by the Israeli Medical Doctors Organization, funded by Pfizer. Photo by Avi Barak
Sharon Alroy Preis, on a huge supportive advertisement done by the Israeli Medical Doctors Organization, funded by Pfizer. Photo by Avi Barak

Dr. Guy Shinar is a member of PECC, the Public Emergency Council For The Covid19 Crisis. A council that was established by doctors and professors from different fields, to present an alternative attitude towards dealing with the covid+19 crisis. He is a physicist with over 20 years of experience in medical device research and development, clinical trials, and regulatory affairs. He is an inventor, co-founder, and chief technology officer in several start-up companies. He holds a PhD degree from the Weizmann Institute of Science, where he specialized in systems biology and chemical reaction network theory.

He analysed the agreement, what is in it, what is not in it, and especially how this agreement might have affected the decision-making processes in Israel. The following are the main points of his claims and conclusions:

The research collaboration agreement between the Ministry of Health and Pfizer [1] is a fascinating document, showing line by line how a state voluntarily dissolves sovereign powers, and becomes an overnight marketing and distribution agency on behalf of a commercial company.

In exchange for the right to be the first country in the world to distribute the vaccine among its population, Israel entered into two agreements with Pfizer: (1) a production and supply agreement that was not published in public at all; (2) Research Collaboration Agreement [1] discussed in his article.

In the research collaboration agreement between the state of Israel and Pfizer, only elements related to efficiency were defined. None of the agreed-upon outcomes was safety outcomes such as overall mortality, hospitalizations for any reason or data collection on side effects.

The research collaboration agreement was signed on 6.1.2021. Its stated purpose was to measure and analyse epidemiological data arising from the administration of the vaccine to the population in Israel, and to determine whether herd immunity is obtained because of the vaccine.

The agreement defined the results of the joint study. All outcomes were explicitly defined as efficacy outcomes, such as the number of corona cases, the number of corona hospitalizations, and corona mortality, or measures of vaccination rate in Israel, such as the number of vaccinated by age and demographic characteristics.

A protest in Tel Aviv. Photo by Avi Barak
A protest in Tel Aviv. Photo by Avi Barak

None of the explicitly agreed-upon outcomes was safety outcomes, such as overall mortality, hospitalizations for any reason or the known side effects of vaccines wherever they are.

The agreement included a statement, according to which both parties recognize that the success of the cooperation depends on the pace and scope of vaccination for the population in Israel. The Ministry of Health has ensured that the distribution and vaccination to the population will be carried out promptly. This is without any conditions regarding the safety of the vaccine, except for a ”catastrophe” that will result in the vaccine being withdrawn from the shelves.

It is not clear from the agreement which of the parties determines what is defined as a ”catastrophe” and what steps are taken to identify that ”catastrophe” before or at the beginning of its occurrence.

The agreement defines that Pfizer will cooperate with the Ministry of Health by providing, at its discretion, experts with professional knowledge in infectious and respiratory diseases, vaccines, epidemiology, mathematical model development, data analysis and public health.

The Ministry of Health has relinquished its scientific independence not only in setting research objectives but also in conducting them. In fact, Pfizer was given the authority to conduct the research at its discretion without being mentioned in the research body. Thus, the study can be portrayed as independent of Pfizer, although not necessarily so.

The parties agreed to provide each other with documentation and computer programs for statistical analysis of the data. In other words, the agreement defines Pfizer’s role not only in providing the vaccines and setting research goals but also in providing experts in data analysis and software for their analysis. Thus, the Ministry of Health relinquished its scientific independence not only in setting research objectives but also in conducting them

One of the clauses in the agreement discusses publications because of the joint study. The parties agreed to publish together in the scientific and medical literature, noting the contribution of each of them. But – and this is an important but – each party has the right to prevent the other party if they decide to publish separately not mentioning it in the publication. In other words, Pfizer has the power under the agreement to omit any reference to its contribution to research, so its involvement in setting research goals, methods or even in writing it is not mentioned at all. Thus the study can be portrayed as independent of Pfizer, although not necessarily so.

In addition, if either party wishes to publish without the other party, then it is the duty of the party wishing to publish to submit the publication for review and receipt of comments from the other party. (The time allotted for the review is blacked out and we do not know what it is.) This is how the party who is not interested in the publication can suspend it – which may empty the publication of content in a dynamic event like the Corona. In other words, the agreement gives Pfizer considerable control over the content and timing of the publications.

It should be noted that entire clauses in the agreement – such as legal liability and indemnification – are blacked out. So are whole sentences or key numbers from other sections.

Finally, under the agreement the Ministry of Health gives Pfizer the right to use data collected as part of the collaboration, for purposes such as research and development, submission to regulatory authorities, scientific publication, and other business objectives.

A big demonstration in Raanana, by PM Naftali Bennet’s private residence. The Police is trying to disperse the demonstration by using water cannon.  Photo by Moran Hanan
A big demonstration in Raanana, by PM Naftali Bennet’s private residence. The Police is trying to disperse the demonstration by using water cannon.  Photo by Moran Hanan

Why is the agreement with Pfizer so significant?

Because it turns the state from a sovereign to an agent of a commercial pharmaceutical company seeking to operate in its territory.

The role of the state is to continually improve the health of its citizens and residents. As a result, it imposes safety, efficacy, and quality requirements on pharmaceutical companies, and operates a regulatory system with legal authority to determine whether the drugs meet these requirements. The role of the pharmaceutical company is to test the efficacy and safety and ensure the quality, to the full satisfaction of the state. The one who markets and distributes the drugs is of course the drug companies and not the state.

All the Israeli studies signed by senior officials of the Ministry of Health, which appear to have been produced under the cooperation agreement, were carried out in its spirit. None of them examined the two main outcomes required for a reliable assessment of the relationship between vaccine efficacy and safety: overall mortality and hospitalizations from all causes.

This is not the case under the agreement with Pfizer, in which the Israeli Ministry of Health assumes some of the supervisor’s duties, and in fact, puts itself in a conflict of interest with its role as a supervisor: it follows from the agreement that the Ministry of Health becomes:

(1) a distributor and marketer of vaccines for the population (2) a contractor researching and collecting data on outcomes aimed at evaluating the effectiveness of vaccines only, and not their safety; (3) The ’publisher’ of the results of the study, under the academic guise of its health authorities (such as the major health funds or the Ministry of Health itself) writes articles whose publication requires Pfizer’s approval.

It is worth noting here that all the Israeli studies signed by senior Ministry of Health officials, which appear to have been produced under the cooperation agreement, were carried out in its spirit. None of them examined the two main outcomes required for a reliable assessment of the relationship between vaccine efficacy and safety: a valid comparison of overall mortality and hospitalizations for any reason between vaccinated and unvaccinated. Only one article [2] (and a letter to the editor that followed it [3]) examined any safety outcome – myocarditis – and concluded that it appears infrequently and is usually mild. The rest [4-7] tested only efficacy results, exactly as explicitly defined in the agreement.

Thousands of citizens responded to the Health Ministry Facebook post with complaints and descriptions of serious injuries they experienced following the injections. The Ministry of Health's response was immediate: Thousands of responses were deleted. Vigilant citizens who saw what was happening hurried to take screenshots and thus kept the evidence of the Ministry of Health's criminal move.

This is the place to note that the State of Israel did not take care to establish a system of reporting side effects that occurred right after the injections. To date, there is no efficient and easy-to-operate reporting system. Injured civilians are rejected by the system and their harm is classified as non-vaccine-related, without collecting statistics. Repeated requests from civic organizations to receive the data are rejected by the Ministry of Health in violation of the Freedom of Information Act. Petitions on the subject have been filed in court and time and time again the Ministry of Health has delayed the presentation of the data contrary to the court order. This includes data on abortions and silent births since the start of the vaccination campaign.

Ahead of the first booster, the Ministry of Health posted a Facebook post calling on citizens to come and get vaccinated, while reassuring them that the vaccine is effective and safe. Thousands of citizens responded to the post with complaints and descriptions of serious injuries they experienced following the shots. The Ministry of Health’s response was immediate: Thousands of responses were deleted. Vigilant citizens who saw what was happening hurried to take screenshots and thus kept the evidence for the criminal move. At the end of the article, you will find a video edited by activist Avi Barak on the subject.

Fighting the Green note, in Raanana. Photo by Moran Hanan
Fighting the Green note, in Raanana. Photo by Moran Hanan

You will also find a link to activist Avital Livni’s testimony project, in which she interviews victims who have agreed to share their stories.

Not only were many injured, but the complainants are also classified as ”vaccine opponents” and their harm is denied by the system.

Many of the articles, which appear to have been written as a result of the cooperation agreement, were published in an expedited procedure in the best medical journals, in particular, The prestigious New England Journal of Medicine (NEJM). Publishing in NEJM is of very high prestige and may have a lot of weight in terms of promotion in academia. Some of the articles are signed by the head of the public health services, Dr Sharon Alroy-Preis (six publications in NEJM) and the director-general of the Ministry of Health, Prof. Nachman Ash (three publications in NEJM) [2-7]. Here it is worth noting that according to the PubMed database, Dr Alroy-Preis published only three articles before her appointment as head of public health services in 2020 and since her appointment about a year and a half ago she has published no less than 16 articles.

The research collaboration agreement between the Ministry of Health and Pfizer reflects a concept that the vaccine is safe to use and all that remains to be researched about it are various indicators that are supposed to demonstrate its effectiveness. This is even though at the time of entering into the agreement there was no (and in my opinion not yet!) Reliable information about its safety: Pfizer’s randomized trial [8] was small and short to allow sufficient characterization of safety, and to my knowledge, no subsequent trial examined differences in overall mortality or hospitalizations for any reason. Between randomly assigned or paired groups of vaccinated and unvaccinated.

When it comes to testing the effectiveness and safety of Pfizer's vaccine, Balicer has a conflict of interest: on the one hand, he encourages the sweeping use of the vaccine in his role as head of the Corona Cabinet, and on the other hand, he examines its safety and effectiveness as head of Clalit's research unit. In addition, Clalit receives grants from Pfizer. He is portrayed above his pages as a scientist and researcher only. He refuses to share the mortality data with the scientists who contacted him on the subject. A petition was filed in court on this issue as well.

In August 2021 a new study was published in NEJM, in which Prof. Balicer and his team compared the incidence of possible vaccine side effects between a group of about 900,000 vaccinated and 900,000 unvaccinated [4]. The groups are paired so that their medical and demographic characteristics are very similar statistically. The comparison was performed for 42 days from the first vaccine. Surprisingly, no comparison of overall mortality between the vaccinated and unvaccinated was made. This is despite the fact that the article explicitly states that the figure is known to have been used to determine the end of the follow-up period for each and every participant (p. 1083 left column paragraph 3).

These numbers should be transparent to everyone! And yet even though Dr Shinar and his partner, Prof. Retzef Levy, twice asked Balicer to obtain the overall mortality data in the vaccinated group and the non-vaccinated group in his study, Balicer did not respond to any of their inquiries.

When it comes to testing the effectiveness and safety of Pfizer’s vaccine, according to Dr Shinar and his colleagues at PECC, Blitzer has a conflict of interest: on the one hand, he encourages vaccination of all the population regardless of their age, health etc, in his role as head of the Corona Cabinet, and on the other As head of the research unit of Clalit Health Fund.

In addition, Clalit receives grants from Pfizer, and the claim of Balicer and the other authors of the article that these are not related to the subject of the study does not solve the reason for the defect that a sponsor publishes reports that are supposed to criticize the funder [5]. Balicer’s role as head of the Corona Cabinet is not mentioned anywhere in the article: he is portrayed above his pages as a scientist and researcher only.

A new article from Clalit Health Fund hides the overall mortality data related to the fourth vaccine, despite these critical data being in Clalit’s possession

Clalit’s new article claims to test the effectiveness of the fourth vaccine in preventing coronary mortality among people aged sixty to one hundred. This article, like all the others, published so far by Clalit researchers, also ignores the most important thing: the connection between the vaccine and the overall mortality rate, not due to Covid. This is even though it is clear from the article that the figure is known to Clalit.

Non-publication of the overall mortality distribution among the vaccinated or non-vaccinated is scandalous: The matter will be heard in the District Court in early June in a petition filed by members of the PECC Prof. Retzef Levy and Dr Guy Shinar regarding the two previous articles in which the distribution of Total mortality was not presented, even though the figure is in its hands.

An increase of 48% in mortality of people aged +70 compared Feb 2022 to Feb 2020 has occurred as the 4th shot was given  

Here is the place to note: The year 2022 began with a big spike in mortality. From mid-January, the State of Israel began giving the fourth shot (the second booster). In February mortality reached an unprecedented peak. A spike of 23% compared to 2021 (a month and a half after the beginning of the vaccination campaign) and a spike of 36% in overall mortality compared to February 2020. Among adults aged 70+, the spike in mortality reaches 43% and taking into account that that year was 29 days in February, the increase is 48%.

Green note = Black stain. A demonstration by the Parliament (The Knesset) entrance. Photo by Avi Barak
Green note = Black stain. A demonstration by the Parliament (The Knesset) entrance. Photo by Avi Barak

In conclusion

In this article, I focused on exposing the connection between Pfizer’s exceptional contract with the State of Israel, and the nature of the studies published by Israeli researchers in scientific journals. Emphasis on deliberate avoidance of disclosure of data that may indicate the safety of the preparation. I haven’t described here the data that the Israeli Ministry of Health hides from the public, regarding serious adverse events. Those of you who want to learn a bit about these cases are invited to watch the vax testimonies project.

In my opinion, it is important for the general public to be aware of this disturbing aspect before choosing to take additional doses of the preparation. I encourage the readers to visit the PECC website and learn more. I wish to thank Dr Guy Shinar who kindly allowed me to use his articles as a resource to write this one. Thanks also to Avi Barak and Moran Hanan, the photographer and activists who shared their photos.

About the Author

Noga Ronen is an Israeli activist. She was involved in the anti-Netanyahu’s corruption movement and lead the protests of the ”Black flags” movement in the North of Israel. She has been living in Finland since November 2020.


https://govextra.gov.il/…/11221-moh-pfizer…

https://www.nejm.org/doi/full/10.1056/NEJMoa2109730
https://www.nejm.org/doi/full/10.1056/NEJMc2116999
https://www.nejm.org/doi/full/10.1056/nejmoa2114228
https://www.nejm.org/doi/10.1056/NEJMoa2114255
https://www.nejm.org/doi/full/10.1056/NEJMc2104036
https://www.nejm.org/doi/pdf/10.1056/NEJMc2119358
https://www.nejm.org/doi/full/10.1056/nejmoa2034577

1. BMJ 2021;372:n728 (https://www.bmj.com/content/372/bmj.n728/rr-0…)

2. N Engl J Med 2021; 385:e83 (https://www.nejm.org/doi/full/10.1056/NEJMoa2114114…) – See Table 2

3. https://www.fda.gov/media/151733/download

4. N Engl J Med 2021; 385:1078-1090

(https://www.nBejm.org/doi/full/10.1056/nejmoa2110475)

5.https://www.nejm.org/…/nejmoa2110475_disclosures.pdf

6. N Engl J Med 2021; 385:2413-2420 (https://www.nejm.org/doi/full/10.1056/NEJMoa2115624)

The Israeli Central Bureau of Statistics
https://www.cbs.gov.il/he/Pages/search/TableMaps.aspx?CbsSubject=%D7%AA%D7%9E%D7%95%D7%AA%D7%94%20%D7%95%D7%AA%D7%95%D7%97%D7%9C%D7%AA%20%D7%97%D7%99%D7%99%D7%9D (the 4th document from the top: Deaths of Israeli Residents, by Year and Month, 2000-2022 – All Ages)

recommendation for further reading and listening:
https://www.vaxtestimonies.org/en/
https://pecc-il.org/
https://rumble.com/voyw2j-how-israeli-ministry-of-health-deleted-thousands-of-testimonies.html