A bit of background: at the end of 2020, Israel was facing an empty trough. None of the aggressive measures taken by Israel against COVID – lockdowns, social distancing, school closures and attempts to cut off the chain of infection by means of quarantine – had succeeded in preventing the spread of the virus.
In addition, the then Prime Minister Benjamin Netanyahu faced the threat of the disbanding of his government and the replacement of his leadership in the elections. All this was overshadowed by indictments pending against him. Netanyahu decided to bet on Pfizer’s vaccine as the strategy that could potentially allow him to solve the COVID problem, with the added benefit of substantial political gain.
In this way, in exchange for the privilege to be the first country in the world to roll out the vaccine among its population, Israel entered into two agreements with Pfizer: a production and supply agreement that was not made public at all; and “The Real World Epidemiological Evidence Collaboration Agreement,” which is discussed in this article.
“The Real World Epidemiological Evidence Collaboration Agreement” was signed on January 6th, 2021. Its declared purpose was to collect and analyze epidemiological data arising from the vaccination of the population in Israel, and to determine if herd immunity would be achieved as a result of the vaccine. In the framework of this agreement, research outcome measures were defined.
Outcome measures did not include safety. All outcome measures explicitly defined in the agreement were efficacy outcomes, such as the number of those infected with COVID, number of hospitalizations with COVID, and death from COVID, or indices on the speed of the vaccine rollout in Israel, such as the number of vaccinated by age and demographic characteristics.
None of the outcome measures that were explicitly agreed upon in advance were safety outcomes, such as overall mortality, hospitalizations from any cause or the known side effects of vaccines, whatever they may be.
What constitutes a “catastrophe?” – The agreement included a declaration, according to which the two parties recognize that the success of the cooperation depends on the rate and extent of the vaccine rollout to the population in Israel. Israel’s Ministry of Health promised that the distribution, deployment, and provision of the vaccine to the population would be carried out in a timely manner.
This was agreed without any condition regarding vaccine safety, with the exception of a “catastrophe” which would lead to the vaccine being taken off the shelves. It isn’t clear from the agreement what constitutes a catastrophe, which of the parties gets to declare a catastrophe and what steps should be taken in order to identify a catastrophe before or at the beginning of its occurrence.
Pfizer will provide experts and expertise – The agreement defines that Pfizer will collaborate with Israel’s Ministry of Health by providing, at Pfizer’s own discretion, experts in the fields of: infectious and respiratory diseases, vaccines, epidemiology, mathematical modeling, data analysis and public health. The parties agreed to provide each other with documentation and computer programs for data analysis.
In other words, the agreement defines that Pfizer’s role not only amounts to providing vaccines and setting research goals, but also provision of experts in data analysis, and data analytics computer programs. As such, Israel’s Ministry of Health gave up its scientific independence, not only in determining the research goals, but also in performing the research.
Control over publications – One clause in the agreement discusses publications as a result of the collaborative research. The parties agreed to publish together in the scientific and medical literature, while marking the contribution of each of them. However – and this is a big “however” – in case the other party decides to publish separately, each of the parties maintains the right to prevent the other party from mentioning the first party in the publication.
In other words, Pfizer has the power under the agreement to omit any reference to its contribution to the research, so its involvement in setting research goals, methods or even in writing the research results is not mentioned at all.
Thus, a study may be portrayed as independent of Pfizer, although it is 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 feedback from the other party (the time allotted for the review is redacted and we do not know how long it is). This is how the party who is not interested in the publication can potentially delay it – which may render the publication meaningless in a dynamic event such as COVID. In other words, the agreement gives Pfizer considerable control over the content and timing of the publications.
Pfizer’s right to use the data collected – 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.
Redacted sections – It should be noted that entire sections in the publicly available version of the agreement are redacted, as are whole sentences or key numbers from other sections. Section 6, which deals with indemnifications and limitations of damages and liability, is redacted in its entirety.
The same goes for Section 10.10 dealing with dispute resolution. In Section 3, which details the contributions of each party to the collaboration and is therefore the heart of the agreement, there is a redacted sentence at a particularly troubling place: right after the mutual acknowledgment by Pfizer and the Ministry of Health that “the viability and success of the Project is dependent on the rate and scope of vaccinations in Israel,” and right before the Ministry of Health’s disturbing contractual commitment to assure what appears to be an all-out “rapid distribution, deployment and use” of the vaccine.
The name and title of Pfizer’s signatory to the agreement, as well as the name of their representative for dispute resolution, are also redacted. Why this is necessary is puzzling.
Why is the agreement with Pfizer so significant? Because it turns the state from a sovereign entity into an agent of a commercial pharmaceutical company seeking to operate in its territory. A role of the state is to protect the well being 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 or not 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 company and not the state. This is not the case under the agreement with Pfizer, in which the Ministry of Health takes on some of the roles of the supervised, and in fact puts itself in a conflict of interest with its own role as the supervisor: it follows from the agreement that the Ministry of Health turns into: (1) the vaccine distributor and marketer for the population; (2) a research and data collection contractor on outcomes aimed at evaluating the efficacy of vaccines alone, and not their safety; (3) the “publisher” of scientific articles – effectively requiring Pfizer’s approval – under the academic guise of its own health authorities (such as the major health funds or the Ministry of Health itself).
The Ministry of Health research about the vaccine, co-authored by senior officials and published in the prestigious New England Journal of Medicine (NEJM), the Lancet and Circulation, is predominantly about the efficacy research outcomes defined in the collaboration agreement. No less than 10 articles tested only efficacy outcomes, exactly as explicitly defined in the agreement. Two articles (and a letter to the editor) examined a single safety outcome – myocarditis – and concluded that it appears infrequently and is usually mild.
None of the articles report on the two main outcomes required for a reliable assessment of the vaccine’s benefit to risk ratio: overall mortality for any reason and hospitalizations for any reason, as compared in a statistically valid manner between the vaccinated and the unvaccinated.
Why did Ministry of Health officials enter into this agreement? Why didn’t they maintain their role as regulators, and why did they volunteer to serve as Pfizer’s marketing, distribution, research and publication branch? It appears highly likely that pressure from Netanyahu and his bureau contributed to the matter. But the personal angle, and the potential conflict of interest it may entail, cannot be ignored: the academic prestige conferred by numerous articles published in NEJM and the Lancet can be life-changing in terms of academic prestige and promotion.
So what exactly do we have here? The research collaboration agreement between the Ministry of Health and Pfizer reflects a preconceived notion according to which the vaccine is safe to use and all that remains to be researched are various indicators that are supposed to demonstrate its efficacy.
This is despite the fact that at the time of entering into the agreement the safety assessment of the Pfizer vaccine was based on a randomized trial that was too small and short to allow sufficient characterization of key safety aspects, such as overall mortality from any cause.
Abandoning this preconceived notion became almost impossible once the agreement was signed, due to a confluence, not only between Netanyahu’s political agenda and Pfizer’s commercial interests, but also potentially between them and the academic prestige of senior Ministry of Health officials. Israel would have done well if it had refrained from entering into the agreement.
In this way, Israel could have rolled out its vaccination program in a measured way among the at-risk populations, without having to do so hastily as a result of a contractual obligation, and without forcing it in practice through the Green Pass on the entire population, and on children, in particular.