By MATTHIAS OHLDORFF | The US Food and Drug Administration (FDA) was forced by a US judge in a long struggle to publish the documents of the pharmaceutical company necessary for approval. Originally, the FDA had blocked them from the public for 75 years at Pfizer’s request. The documents are indeed quite revealing: many participants suffered severe cardiovascular and nervous system injuries or other damage and therefore dropped out prematurely. Eight people died. An unusually large number of subjects ended their participation in the study prematurely.
The FDA approved the novel BioNTech Covid-19 mRNA vaccine after only 108 days under enormous political pressure. There was talk of the vaccine’s “safety, efficacy and product quality”. Strangely, however, the approval documents and the manufacturer’s study data were to be kept secret for 75 years! It is thanks to an association of doctors, scientists and medical journalists that these have now been made publicly available. They won their release in an texan district court via the so-called Freedom of Information Act, a law that regulates access to official records in the USA [link, link]. According to the ruling, the FDA must release 55,000 pages per month, with the last push coming on 1/6/2022.
Here is an original quote from the FDA’s approval letter:
“Our scientific and medical experts have conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information on hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and efficacy, and performed a detailed evaluation of the manufacturing processes, including inspections of the production facilities,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We have not lost sight of the fact that the COVID-19 public health crisis in the US continues and that the public is in need of safe and effective vaccines. The public and medical community can be confident that we have approved this vaccine expeditiously, but while maintaining our existing high standards for vaccines in the US.”
Actually, according to such statements by the regulatory authority, no or hardly any side effects should be expected. What kind of picture do Pfizer’s study documents actually paint?
Number of study participants
The subjects in their entirety were divided into one group for immunity testing (Immunogeneity) and one for drug safety (Safety Results); a total of 44,000 people (p.15) are said to have participated.
The comparatively low number of reported study participants for drug safety (Safety Results, p.146) in the phase I study is striking. According to Pfizer’s own information, there were only 206 “guinea pigs” [link]. These participants were further divided into two subgroups. For BNT162b1, there were 84 younger (18-55 years) and 36 older participants (56-85 years). For the second version of the product, BNT162b1, there were 110 younger and 36 older participants.
In the phase I trial (BNT-162-01), between 40 and 45% adverse events (AEs) were observed for both vaccine variants within the first 28 days, but all disappeared. Afterwards, the adverse events were observed over a period of 6 months [link].
Severe damage or death
Skin irritations such as swelling at the injection site, dermatitis (four people affected) or urticaria or wheals (two people) and skin rashes occurred from time to time. About 100 people fell ill with corona after the vaccination [link]. Mild nervous system disorders included headache, dysphagia, dizziness, fatigue, night sweats, nausea, fainting and sensory disturbances. Other test persons did not get off so lightly; there were individual cases who suffered from depression, one-sided deafness, cerebral infarction, facial paralysis, Parkinson’s disease or metastases in the brain. In three patients, the blood pressure increased (hypertension), in others the heart rate (tachycardia), there was atrial fibrillation (two subjects) or even dangerous circulatory disturbances of the brain (ischaemia) and life-threatening blockages of the coronary vessels by blood clots. One subject suffered a pulmonary embolism. This is a critical situation caused by the blockage of a pulmonary vessel by clotted blood (thrombus). There were also cases of limb pain, muscle weakness or paralysis of both legs (paraparesis). Eight subjects died after the first or second vaccination. In the original document [link] they appear on pages 18, 47, 80, 86, 87, 101, 106 and 107. The causes of death were not given in most cases. Is this the reason for the mass drop-out of subjects from the study?
Subjects noticed the massive damage to their health
In any case, this conclusion is obvious when one considers that more than 800 subjects either withdrew their consent (about 675), could no longer be reached (about 165), stated that they had moved or changed jobs, or dropped out of the trial on medical orders. This conclusion is also suggested by the reasons given for dropping out of the trial: for example, one patient stated that she had reread the terms of the contract and therefore no longer wanted to participate.
Screenshot: document 125742
Some patients reconsidered before the 2nd vaccination, sometimes even shortly before the vaccinator could give the injection (example not shown).
Screenshot: document 125742
On the part of the authorities, it is generally assumed that only a very small number of cases are entered into the databases by the doctors. How should the quality of Pfizer’s figures be assessed?
Under-reporting in the registration study?
According to the US health authorities CDC and FDA, only a fraction of cases are entered into the vaccine injury databases such as VAERS. The actual number of people who have fallen ill is therefore many times higher.
“Underreporting” refers to the fact that VAERS receives reports for only a small proportion of actual adverse events. The extent of underreporting varies widely.”
This will be even worse in this investigation of the pharmaceutical company, which is guided by economic interests, since Pfizer was the employer of the doctors investigating or was the client of subcontractors. Presumably, therefore, the doctors covered up many cases of illness out of self-interest. It is also inconceivable that such dangerous drugs could have been approved on a large scale without political corruption.
Note: The list of test persons registered by Pfizer for various reasons was sifted through for this article and evaluated in a rough estimate; an exact statistical registration would have taken days.
