The Paul-Ehrlich-Institut, Germany’s vaccine regulator, has responded to Andreas Schöfbeck’s letter (translated here), suggesting on the basis of BKK billing data that officially acknowledged rates of adverse vaccine reactions substantially understate the risk of vaccination. It is not a good response.
The information in the BKK letter is general and unspecific. For example, it is not stated how many of the cases refer to mild reactions and how many – in the sense of the Drug Act – to severe reactions. Local and transient general reactions, for example, which occur in many vaccinated persons and have also been found in clinical trials, belong to the known and expected vaccination reactions that are not subject to mandatory reporting according to IfSG § 6 para. 1 no. 3.
The argument throughout is that only a subset of vaccine reactions are subject to mandatory reporting requirements, and thus Schöfbeck’s higher numbers, derived from billing data, are unremarkable. This is a very strange and yet also typical bureaucratic response. We want to know whether the vaccines are safe or not, but the PEI functionaries only care about making it clear that any underreporting is in accordance with statute.
Beyond that, I very much doubt we are talking about all that many “local and transient general reactions” here. By definition, these are reactions for which BKK insured sought medical treatment from their doctors. Many of these diagnoses would have been obtained by people who were too unwell to work, and needed to receive physician-certified sick leave.
Thus, the ICD-10 numbers given in the chart “Coded vaccination side effects after Corona vaccination” code for vaccination reactions in general. For example, T88.0 codes “Infection after vaccination,” but a SARS-CoV-2 infection after vaccination is not a side effect subject to mandatory reporting under the Drug Act. Therefore, billing data cannot be equated with adverse reactions.
Indeed, this goes some way to explaining the difference between BKK and PEI numbers, but the larger point here must surely be that a SARS-CoV-2 infection after vaccination should be subject to mandatory reporting, as we have seen that it is one of the most important and obvious side-effects of Corona vaccination.
Furthermore, it cannot be inferred from the letter whether a causal connection with the vaccination has actually been established.
How ridiculous. Their doctors determined that there was a causal connection, which is why they used these billing codes. That is more than can be said of all the official Corona deaths, which are determined solely on the basis of a positive PCR test in proximity to death, and no other medical diagnoses at all.
According to the Paul Ehrlich Institute’s safety report, a total of 244,576 suspected cases of adverse reaction following Cormanty, Sikevax, Vaxzevria and COVID-19 Vaccine Janssen were reported to the Paul Ehrlich Institute in the period 27.12.2020 to 31.12.2021. Of these, there were 2,255 reported cases of a suspected adverse reaction with a fatal outcome. This does not mean that a causal relationship with the vaccination actually exists. These cases are being reviewed for a causal relationship with the vaccination. In 85 individual cases in which patients died from vaccination risks such as thrombosis-with-thrombocytopenia syndrome, bleeding due to immune thrombocytopenia or myocarditis at a plausible time interval from the respective vaccination, the Paul Ehrlich Institute assessed the causal relationship with the vaccination as possible or probable. Otherwise, there was no increase and thus no risk signal in comparison with the statistically expected number of deaths in the same period.
We know that myocarditis – one side-effect among many – is vastly more common than PEI numbers would give us to understand. They will dispute every last causal connection, until they have arrived at the absolute minimum risk figures they can plausibly defend. Otherwise, the last sentence is just not true: Germany had substantially elevated mortality throughout Fall 2021, well beyond the deaths ascribed to Corona, as even mainstream press outlets here have acknowledged.
The established voluntary reporting system of suspected adverse drug reactions (ADRs) is based on the recognition of symptoms or diseases that are assumed to be related to the administration of the drug and is subject to the clinical judgement of the physician. Physicians and pharmacists have professional obligations to report suspected ADRs to the respective Drug Commission – the Drug Commission of the German Medical Profession or the Drug Commission of the German Pharmacists (AMK) – which exchange information on ADRs with the Paul Ehrlich Institute or the Federal Institute for Drugs and Medical Devices. In addition, according to § 6 par. 1 no. 3 of the Infection Protection Act, physicians and non-medical practitioners are obliged to report suspected adverse health effects beyond the normal extent of a vaccine reaction to the local health authority. From there, the reports are pseudonymised and forwarded to the Paul Ehrlich Institute.
Yet, but either a) the doctors aren’t doing this at the rate that they should be (Schöfbeck’s theory), or b) reportable side effects are too narrowly defined to yield usable statistics.
The Paul Ehrlich Institute has also begun planning a non-interventional study to comprehensively investigate the long-term safety of the only COVID-19 vaccines available in the EU and thus also in Germany.
In the study, which is also supported and funded by the BMG, diagnostic data from the billing data available to the health insurance funds are to be evaluated and linked at the Paul Ehrlich Institute with the vaccination data of the Digital Vaccination Rate Monitoring (DIM data). The study is to be launched in the near future.
Oh, excellent, so the PEI has begun to plan a study that will look into the issues Schöfbeck has raised. They can force vaccines upon millions of people who don’t want them, and maybe at some point in the future they will begin to think about planning a study on what adverse effects these vaccines might inflict. Public health regulators with something to hide just love studies. You can design them however you want, include whatever data you want, omit whatever you want, so it ends up saying just what you want it to and no more. What they don’t like, is openly available raw data that anyone can study and interpret.