What unpublished Pfizer vaccine documents reveal about its risks
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“As the standard has become,” US judge Mark T. Pittman says resignedly in his January ruling, “the parties were unable to agree on a production schedule. mutually acceptable”. The parties are the United States Food and Drug Administration (FDA) and the non-profit Public Health Professionals and Physicians for Transparency (PHMPT). The latter forced the former, via the country’s Access to Information Act, to release documents regarding the procedures that led to the approval of Comirnaty, Pfizer-BioNTech’s mRNA vaccine. The process began in September
.
The FDA was ordered by the judge to make public 300 thousand pages of documents, starting with the immediate release of 12 thousand, followed by 55 thousand pages per month. Earlier, in November, the agency had proposed releasing the documents at the rate of 500 pages per month. That means full release would take 55 years or more. The justification for this intergenerational plan is that only ten employees take care of this task, and that they were already busy with 400 other requests for information via the access to information law . It is necessary, for example, to anonymize patients in the documents. But the judge was not convinced.
The judge ordered the NGO and the agency to publish a progress report on April 1st. The first batch of 55 thousand pages was released on March 1, losing attention in the news to the situation in Ukraine. The complaining NGO selected 150 files, equivalent to 300 pages ( less than 0.2% of the total) and made them available on its website. The Gazeta do Povo brings below a selection of the information contained in these documents, with explanations and points of caution.
A document contains previously confidential information from 400 locations where the vaccine studies were carried out, and the researcher responsible for each one. The vast majority are in the United States, but South Africa, Germany, Argentina, Turkey and even Brazil were also involved. Some researchers were responsible for more than one center. For example, researcher Laura Hammit of Johns Hopkins University was left with nine centers. In Brazil, two sites were involved: Cristiano Zerbini took care of the study at CEPIC (Centro Paulista de Investigación Clínica e Serviços Médicos Ltda.), in São Paulo; and Edson Moreira da Fiocruz conducted the study at Hospital Santo Antônio and Associação Obras Sociais Irmã Dulce, in Salvador.
Four locations where the study was conducted by subcontractor Ventavia Research are also listed. Group, from which came a complaint of bad research practices by former employee Brook Jackson published in November
in the scientific journal British Medical Journal (BMJ). Brook Jackson has 12 years experience in clinical trials and had immediate under CEO at Ventavia, overseeing the company’s compliance with laws, regulations, and scientific protocols.
The BMJ post was labeled on Facebook as “contextless” by the security-checking agency. Lead Stories facts. A public dispute ensued between the agency and the magazine. Jackson is currently suing Ventavia and Pfizer in a Texas court that last month released a process paperwork.
The former clinical auditor claims to have observed daily “ fabrication and falsification of information in blood samples, vital signs, signatures and other essential data” of the local study, accuses Ventavia of having included illegitimate participants, including family members, of having kept the immunizer at an inappropriate temperature, among other bad practices. It is important to remember that only 2% of the test sites were managed by Ventavia.
Swallowing coin, being struck by lightning: adverse events?
Particularly interesting is the document titled “Cumulative Analysis of Reports of Post-Authorization Adverse Events from [Comirnaty] received by 2019 of February 2021”. The first doses of the immunizer were authorized for storage on December 1, 2020, and for emergency use ten days later in the United States. Full approval came almost a year later, on 21 August 2021. Therefore, the data included in this report spans up to six months before Pfizer’s full vaccine approval.
The cumulative analysis was produced in response to an FDA request for a pharmacovigilance plan , as the document’s introduction shows. Before discussing the results, it is very important to clarify the difference between adverse event and side effect
. An adverse event is almost literally anything negative that can happen to a participant in a clinical trial such as vaccine development.
In a similar document regarding the safety of Pfizer’s vaccine for children, available on the FDA website, is listed as an adverse event, for example, the case of a child who swallowed a coin (p. 45). Another report on the competitor Moderna’s mRNA vaccine lists as a serious adverse event the case of an elderly person who was struck by lightning (p. 400 ). No one in their right mind would think that these would be effects of having the vaccines. The word effect implies a relationship of cause and consequence.
We know that myocarditis in young men at a rate of 10 The 20 for 100 a thousand is a probable effect of the Pfizer vaccine. But that’s because more investigations were done to link the adverse event to this factor. It is out of caution that the researchers include all types of adverse events not only from those patients who received the vaccine but also from those who did not receive it and are in the control group (which does not receive anything) or placebo (which receives something innocuous without knowing if it is the vaccine). or not). Initially, at least, the researchers also do not know who received the vaccine and who did not (the lack of anonymization of participants was one of the defects alleged by Brook Johnson in the case of the Ventavia’s local tests). Furthermore, by actively or passively collecting adverse events, researchers also do not know whether an adverse event such as, say, a stroke is comparable to swallowing a coin or being struck by lightning, or is more similar to young male myocarditis. .
Therefore, those who are using the release of these documents to claim or insinuate that all adverse events listed in the cumulative analysis were caused by the Pfizer vaccine are disinformation, in a way conscious or not.
Results of the cumulative analysis until February of 2021
Following the court’s request for information, the FDA removed from the cumulative analysis report the total number of doses delivered worldwide (p. 6), but reports that there are 42 thousand reports of adverse events, 2% of which are deaths. The removal of information is done with a gray stripe with a black color code that comes from US law and means that sensitive information has been hidden. It may be sensitive to the federal government, or commercially sensitive information to the vaccine manufacturer.
For example, the number of new employees Pfizer has hired full-time at time to deal with adverse event reports, which is inside information about the company, as well as the number of employees it planned to hire by June 2019. The FDA does not exist to commercially harm Pfizer, but to regulate its work and monitor the safety of its products. However, removing the information on the total number of doses has the effect of making it difficult to calculate the incidence of each type of adverse event per dose
.
The inadequacy of adverse event reports to make causal conclusions is evident when analyzing the 2020 thousand cases. For example, 71% of the reports are about women, against 22% of men (the rest have no gender information). This is not in line with one of the best-known worrisome adverse
-effects , which occurs more in young men. One hypothesis that best explains this is that women are more likely than men to seek medical help, and are more averse to taking risks. This exemplifies how the reports have noises of different influences that have nothing to do with the real incidence of real side effects. However, more people in the vaccinated group had adverse events compared to the placebo group. Severe fever was 10 times more common among vaccinees, for example.
The central theme of many of the documents released is precisely the adverse effects covered by the cumulative analysis of a year ago. It is already out of date. We have analyzes involving more people, with more rigor. One of them, organized by a consortium of health plans, was published in Journal of the American Medical Association (JAMA), with the first authorship of Nicola Klein, from the Center for Vaccine Studies of the Kaiser Permanente health plan. The study tracked adverse events weekly in 6.2 million patients at two doses each through June 2021, exceeding the time coverage of Pfizer’s cumulative analysis. Approximately half of these received the Pfizer vaccine, half received the Moderna vaccine, also mRNA.
Health plan scientists investigated by statistical test whether adverse events observed in vaccinees are above expected levels. Inflammation of the heart and its lining has been observed in 34 cases, 85% of them in young men. This event was higher than expected for the general population, which we know from other studies, as this inflammation, in addition to being an adverse event, is also a side effect. Consistent with other studies, it was mild and passed quickly in most cases. No other adverse event was more present among vaccinees than in the general population.
More information released by the court
Although it is a small fraction of what is to come in the 55 thousand pages of information to be released monthly by the FDA regarding the Pfizer/BioNTech vaccine, there is already a lot of information in the 150 released files. The main information is from the cumulative analysis report, around which many other files orbit, being raw data. There is more worth mentioning in this opening comment.
In Comirnaty’s defense, especially against exaggerated criticism, some may be tempted to claim that the vaccine’s intended use is what it is for. delivering now: reducing the risk of a more serious covid painting. The documents show that this is not true and the vaccine was presented to the FDA as “active immunization to prevent coronavirus disease 2019 (COVID-14)”. Preventing the disease is different from preventing a worse picture of it.
The documents show that Pfizer already knew, through animal models, that more doses intensified adverse effects: “The incidence and severity of reactions was greater after the second or third injection compared to the first injection. Most animals had very mild swelling after the first dose. After the second or third dose, the severity of the edema increased to a moderate or, rarely, severe degree.” It is also revealed that the manufacturer was aware of the rapid decay of vaccine protection.
It is confirmed by the files that the immunizer does not stay at the site of application and spreads through the body, as it had already been suggested by the European Medicines Agency and a leaked Japanese report. mRNA nanoparticles are found in small amounts in the ovaries, spleen and 12% remain in the liver after 48 hours of injection.
We are only at the beginning of the journey of finding out what went on behind the scenes at the FDA when Pfizer applied for a license for the Comirnaty vaccine. However, as in the case of the report of the cumulative analysis of adverse events, great caution must be used when interpreting the novelty of the information. Circulating a list of over 1,000 adverse events listed in the report as if they were all known as side effects
