RECHTSANWALT DDR RENATE HOLZEISEN

Im vorliegenden Fall wurde diese Krisensituation, wie oben ausgeführt, niemals „ordnungsgemäß“ festgestellt.

Für die Zwecke von Absatz 1 Buchstabe c ist unter einer medizinischen Versorgungslücke zu verstehen, dass für eine Erkrankung kein zufrieden stellendes Mittel zur Diagnose, Vorbeugung oder Behandlung in der Gemeinschaft zugelassen ist oder, selbst wenn dies der Fall ist, das betreffende Arzneimittel keinen bedeutenden therapeutischen Nutzen für die von dieser Erkrankung betroffenen Patienten mit sich bringt.
1. Nichtigkeit wegen Nichtvorhandensein eines positiven Nutzen-RisikoVerhältnisses laut Artikel 1 Nummer 28a der Richtlinie 2001/83/EG
Für die Ermittlung des Nutzen-Risiko-Verhältnisses müssen beide Komponenten, sprich der Nutzen und das Risiko faktenbasiert beurteilt werden können und beurteilt werden.
1.1. Nichtvorhandensein eines nachweisbaren Nutzens
Entgegen der Erklärungen von Pfizer-BioNTech, dass “Comirnaty” einen Wirksamkeitsgrad von 95 Prozent hätte (siehe bspw.Apotheken Umschau vom 18.11.2020- Dok. A.18.1) hat der Wissenschaftler und Mitherausgeber des British Medical Journal (BMJ), Peter Doshi bereits im November 2020 große Zweifel daran geäußert (Dok. 18.2) und dann in einem am 4. Jänner 2021 veröffentlichten Artikel diese Zweifel im Detail nochmals wie folgt wissenschaftlich untermauert (Dok. A.18.3):

“Five weeks ago, when I raised questions about the results of Pfizer’s and Moderna’s covid-19 vaccine trials, all that was in the public domain were the study protocols and a few press releases. Today, two journal publications and around 400 pages of summary data are available in the form of multiple reports presented by and to the FDA prior to the agency’s emergency authorization of each company’s mRNA vaccine. While some of the additional details are reassuring, some are not. Here I outline new concerns about the trustworthiness and meaningfulness of the reported efficacy results.

“Suspected covid-19″

All attention has focused on the dramatic efficacy results: Pfizer reported 170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these numbers were dwarfed by a category of disease called “suspected covid-19”— those with symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.”

With 20 times more suspected than confirmed cases, this category of disease cannot be ignored simply because there was no positive PCR test result. Indeed this makes it all the more urgent to understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or without a positive PCR test result, would be a relative risk reduction of 19% (see footnote)—far below the 50% effectiveness threshold for authorization set b y regulators. Even after removing cases occurring within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).

If many or most of these suspected cases were in people who had a false negative PCR test result, this would dramatically decrease vaccine efficacy. But considering that influenza-like illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses, adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may be due to a different causative agent.

But why should etiology matter? If those experiencing “suspected covid-19” had essentially the same clinical course as confirmed covid-19, then “suspected plus confirmed covid-19” may be a more clinically meaningful endpoint than just confirmed covid-19.

However, if confirmed covid-19 is on average more severe than suspected covid- 19,we must still keep in mind that at the end of the day, it is not average clinical severity that matters, it’s the incidence of severe disease that affects hospital admissions. With 20 times more suspected covid-19 than confirmed covid-19, and trials not designed to assess whether the vaccines can interrupt viral transmission, an analysis of severe disease irrespective of etiologic agent—namely, rates of hospitalizations, ICU cases, and deaths amongst trial participants—seems warranted, and is the only way to assess the vaccines’ real ability to take the edge off the pandemic.

There is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t mention the 3410 “suspected covid-19” cases. Nor did its publication in the New England Journal of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to have reported it is FDA’s review of Pfizer’s vaccine.

The 371 individuals excluded from Pfizer vaccine efficacy analysis Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance between randomized groups in the number of these excluded individuals: 311 from the vaccine group vs 60 on placebo. What were these protocol deviations in Pfizer’s study, and why were there five times more participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are difficult to even spot in Pfizer’s report and journal publication. Fever and pain medications, unblinding, and primary event adjudication committees

Last month I expressed concern about the potential confounding role of pain and fever medications to treat symptoms. I posited that such drugs could mask symptoms, leading to underdetection of covid-19 cases, possibly in greater numbers in people who received the vaccine in an effort to prevent or treat adverse events. However, it seems their potential to confound results was fairly limited: although the results indicate that these medicines were taken around 3-4 times more often in vaccine versus placebo recipients (at least for Pfizer’s vaccine) their use was presumably concentrated in the first week after vaccine use, taken to relieve post-injection local and systemic adverse events. But the cumulative incidence curves suggest a fairly constant rate of confirmed covid-19 cases over time, with symptom onset dates extending well beyond a week after dosing.

That said, the higher rate of medication use in the vaccine arm provides further reason to worry about unofficial unblinding. Given the vaccines’ reactogenicity, it’s hard to imagine participants and investigators could not make educated guesses about which group they were in. The primary endpoint in the trials is relatively subjective making unblinding an important concern. Yet neither FDA nor the companies seem to have formally probed the reliability of the blinding procedure, and its effects on the reported outcomes.

Nor do we know enough about the processes of the primary event adjudication committees that counted covid-19 cases. Were they blinded to antibody data and information on patients’ symptoms in the first week after vaccination? What criteria did they employ, and why, with a primary event consisting of a patient-reported outcome (covid-19 symptoms) and PCR test result, was such a committee even necessary? It’s also important to understand who was on these committees. Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer staff members. Vaccine efficacy in people who already had covid?

Individuals with a known history of SARS-CoV-2 infection or previous diagnosis of Covid-19 were excluded from Moderna’s and Pfizer’s trials. But still 1125 (3.0%) of participants in Pfizer’s trials were deemed to be positive for SARS-CoV-2 at baseline. Vaccine safety and efficacy in these recipients has not received much attention, but as increasingly large portions of many countries’ populations may be “post-Covid,” these data seem important.

By my count, Pfizer apparently reported 8 cases of confirmed, symptomatic Covid-19 in people positive for SARS-CoV-2 at baseline (1 in the vaccine group, 7 in the placebo group,

But with only around four to 31 reinfections documented globally, how, in trials of tens of thousands, with median follow-up of two months, could there be nine confirmed covid-19 cases among those with SARS-CoV-2 infection at baseline? Is this representative of meaningful vaccine efficacy, as CDC seems to have endorsed? Or could it be something else, like prevention of covid-19 symptoms, possibly by the vaccine or by the use of medicines which suppress symptoms, and nothing to do with reinfection?”

Anhand der offiziell verfügbaren Daten kommen daher renommierte Wissenschaftler, wie Peter Doshi, zum Schluss, dass die Wirksamkeit von “Comirnaty” nicht bei den kolportierten 95 Prozent, sondern bei unter 30 Prozent liegt, und damit unter der für das Wirksamkeitserfordernis der Covid- 19-„Impfstoffe“ von der FDA gesetzten 50 Prozent Marke (Dok. A.18.4).
Darüber hinaus liegt kein Nachweis vor, dass die mit “Comirnaty” „geimpften“ Personen sich nicht infizieren und nicht Überträger des SARS-COV-2-Virus sein können. Die Studien sind außerdem so angelegt, dass dieser Nachweis gar nicht erbracht werden kann.
Das Robert Koch Institut erklärt auf seiner hompage ausdrücklich folgendes: „Wie lange der Impfschutz anhält, ist derzeit noch nicht bekannt. Der Schutz setzt auch nicht sofort nach der Impfung ein, und einige geimpfte Personen bleiben ungeschützt. Zudem ist noch nicht bekannt, ob die Impfung auch vor einer Besiedelung mit dem Erreger SARS-CoV-2 bzw. vor einer Übertragung des Erregers auf andere Personen schützt. Daher ist es trotz Impfung notwendig, sich und seine Umgebung zu schützen, indem die AHA + A + L-Regeln (Abstandsregeln, MNS) beachtet werden.“ (Dok. 18.5).
Der Nachweis des Nutzens, im Sinne einer positiven therapeutischen Wirkung des Wirkstoffs „“Comirnaty”“ ist daher nicht erbracht und allein schon deshalb die bedingte Zulassung EU-rechtswidrig.
1.2. Nicht erfasste wesentliche Risiken und damit unbestimmtes und derzeit unbestimmbares Risiko
Laut Artikel 1 Nr. 28 Richtlinie 2001/83/EG ist ein mit der Verwendung des Arzneimittels verbundenes Risiko wie folgt definiert: „ – jedes Risiko im

Zusammenhang mit der Qualität, Sicherheit oder Wirksamkeit des Arzneimittels für die Gesundheit der Patienten oder die öffentliche Gesundheit.“

Laut Anhang I (Zusammenfassung der Merkmale des Arzneimittels) zum hier angefochtenen Durchführungsbeschluss der Europäischen Kommission (Dok 2.2) Punkt 4.5 (Wechselwirkungen mit anderen Arzneimitteln und sonstigen Wechselwirkungen) „wurden keine Studien zur Erfassung von Wechselwirkungen durchgeführt.“
In Anbetracht des Umstandes, dass die sog. Covid-Jmpfstoffe“, wie “Comirnaty”, in erster Linie zum Schutz der älteren und gesundheitlich vorbelasteten Bevölkerung zum Einsatz kommen sollen, und diese Bevölkerungsgruppe im Regelfall ein oder mehrere Medikamente regelmäßig zu sich nimmt, muss der Umstand, dass die Wechselwirkungen von “Comirnaty” mit anderen Arzneimitteln nicht geprüft wurden, zur Feststellung führen, dass die von Cormirnaty ausgehenden Risiken allein schon aus diesem Grund derzeit in keinster Weise erfassbar, geschweige denn einschätzbar und beurteilbar sind.
Allein schon dieser Umstand hätte daher zu einer Ablehnung des Zulassungsantrages führen müssen!
1.3. Nichtberücksichtigung wesentlicher Risiken, die eine bedingte Zulassung eines für eine grundsätzlich gesunde Population gedachtes Arzneimittel niemals erlauben
Wesentliche mit der Verabreichung des Wirkstoffs “Comirnaty” verbundene Risiken wurden der EMA bereits mit einer am 1.12.2020 von Dr.med. Wolfgang Wodarg und Dr. Mike Yeadon eingereichten Petition betreffend die damals bevorstehende Zulassung von “Comirnaty” unterbreitet (A.19).

Leider wurde diese Petition, genauso wie die auch von Klägerinnen am 19.12.2020 in erster Linie an die EU-Kommission und die EMA elektronisch zugestellte Abmahnung (Dok. A.4) ignoriert.

Aus der von Prof.Dr.rer.nat. Stefan W. Hockertz, Toxikologe, Immunologe und Pharmakologe, European reg. Toxicologist verfassten wissenschaftlichen Beurteilung (Dok. 20) geht in Bezug auf die nicht berücksichtigten Risiken einer Verabreichung des Wirkstoffs “Comirnaty” folgendes hervor:
„II.It is my professional opinion that the design of the clinical trial and the clinical trial data originating from that trial is inadequate to accurately assess safety and efficacy of BNT162b2.
It is my professional opinion that the design of the BNT162b2-specific preclinical animal testing studies ad the data originating from those studies is inadequate to accurately assess quality, safety and efficacy of BNT162b2.
It is my professional opinion that the risks associated with BNT162b2 far outweigh any potential benefits because:
)BNT162b2 has not been properly tested in animals and humans;
) It has not been determined if BNT162b2 can stop transmission of the SARS- CoV-2 virus from BNT162b2 recipient to others and infection of BNT162b2 recipient;
)It cannot be ruled out that BNT162b2 may cause SARS-CoV-2 to evolve into deadlier forms;
)It cannot be ruled out that BNT162b2 causes disease enhancement (pathogenic priming, antibody dependent enhancement) and other adverse effects on the functioning of the immune system, threats to fertility/pregnancy and other serious injuries and threats to the health of BNT162b2 recipients; …
)BNT162b2 is not a vaccine as its ability to provide active acquired immunity to a particular infectious disease (COVID-19) has not been proven due to the flawed designs of the human trial and the preclinical animal models. If anything, BNT162 in essence performs like an experimental and unproven therapeutic drug with extremely questionable efficacy, except BNT162 would be taken strictly prophylactically, even by the perfectly healthy, and more than likely carries a significantly higher risk of serious and life-altering injury than a therapeutic drug. Consequently, therapeutic drugs are far superior to BNT162b2. For the avoidance of doubt, the use of the term “vaccine” in connection with a sentence or paragraph that also references BNT162b2 (e. g., or other vaccines”) does not change the fact that BNT162bs does not fall under the definition of a vaccine;
It is my professional opinion that the public will suffer irreparable harm if the

CMA of “Comirnaty” (BNT162b2) is being upheld, because both governments of EU member states and employers and other stakeholders in the EU have begun recommending BNT162b2 for widespread use. Because BNT162b2 has not been properly tested, important public policy decisions regarding its use are and will be based on misleading evidence. The medical and economic consequences to EU member states and their residents and citizens could hardly be higher.

It is my professional opinion that if BNT162b2 remains approved without it being appropriately tested and its efficacy having been accurately being reviewed, then any potential acceptance or mandate of BNT162b2 is likely to be based on inaccurate evidence regarding BNT162b2, namely that it is safe and will reduce COVID-19 disease and deaths….
Threats to fertility, pregnancy and lactation
The design of the clinical trial is not adequate to assess threats to fertility, pregnancy, lactation and breast feeding of infants.